Medication-Assisted Treatment For Opioid in Opioid Treatment Programs

A Treatment Improvement Protocol TIP 43

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES and Mental Health Services Administration

Center for Substance Abuse Treatment MEDICATION- www.samhsa.gov ASSISTED TREATMENT Medication-Assisted Treatment For Opioid Addiction in Opioid Treatment Programs

Steven L. Batki, M.D. Consensus Panel Chair Janice F. Kauffman, R.N., M.P.H., LADC, CAS Consensus Panel Co-Chair Ira Marion, M.A. Consensus Panel Co-Chair Mark W. Parrino, M.P.A. Consensus Panel Co-Chair George E. Woody, M.D. Consensus Panel Co-Chair A Treatment Improvement Protocol TIP 43

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Center for Substance Abuse Treatment

1 Choke Cherry Road Rockville, MD 20857 Acknowledgments The guidelines in this document should not be considered substitutes for individualized client Numerous people contributed to the care and treatment decisions. development of this Treatment Improvement Protocol (see pp. xi and xiii as well as Appendixes E and F). This publication was Public Domain Notice produced by Johnson, Bassin & Shaw, Inc. All materials appearing in this volume except (JBS), under the Knowledge Application those taken directly from copyrighted sources Program (KAP) contract numbers 270-99- are in the public domain and may be reproduced 7072 and 270-04-7049 with the Substance or copied without permission from SAMHSA/ Abuse and Mental Health Services CSAT or the authors. Do not reproduce or Administration (SAMHSA), U.S. Department distribute this publication for a fee without of Health and Human Services (DHHS). specific, written authorization from SAMHSAís Christina Currier served as the Center for Office of Communications. Substance Abuse Treatment (CSAT) Government Project Officer, and Andrea Kopstein, Ph.D., M.P.H., served as Deputy Electronic Access and Copies Government Project Officer. Robert Lubran, of Publication M.S., M.P.A., and Alan Trachtenberg, M.D., served as CSAT technical experts. Lynne Copies may be obtained free of charge from McArthur, M.A., A.M.L.S., served as SAMHSAís National Clearinghouse for Alcohol the JBS KAP Executive Project Co-Director. and Drug Information (NCADI), (800) 729-6686 Barbara Fink, R.N., M.P.H., served as or (301) 468-2600; TDD (for hearing impaired), the JBS KAP Managing Project Co-Director. (800) 487-4889; or electronically through the Other JBS KAP personnel included Dennis following Internet World Wide Web site: Burke, M.S., M.A., Deputy Director for www.ncadi.samhsa.gov. Product Development; Wendy Caron, Editorial Quality Assurance Manager; Recommended Citation Frances Nebesky, M.A., Quality Assurance Editor; Leah Bogdan, Junior Editor; Emily Center for Substance Abuse Treatment. Tinkler, Junior Writer; and Pamela Frazier, Medication-Assisted Treatment for Opioid Document Production Specialist. Catalina Addiction in Opioid Treatment Programs. Vallejos Bartlett, M.A., Margaret Brooks, Treatment Improvement Protocol (TIP) Series J.D., Jonathan Max Gilbert, M.A., Randi 43. DHHS Publication No. (SMA) 05-4048. Henderson, and Deborah J. Shuman Rockville, MD: Substance Abuse and Mental were writers. Health Services Administration, 2005.

Disclaimer Originating Office The opinions expressed herein are the views Practice Improvement Branch, Division of of the consensus panel members and do not Services Improvement, Center for Substance necessarily reflect the official position of CSAT, Abuse Treatment, Substance Abuse and Mental SAMHSA, or DHHS. No official support of or Health Services Administration, 1 Choke endorsement by CSAT, SAMHSA, or DHHS Cherry Road, Rockville, MD 20857. for these opinions or for particular instruments, DHHS Publication No. (SMA) 05-4048 software, or resources described in this document is intended or should be inferred. Printed 2005 Contents

What Is a TIP? ...... ix Consensus Panel ...... xi KAP Expert Panel and Federal Government Participants ...... xiii Foreword ...... xv Executive Summary ...... xvii Chapter 1óIntroduction ...... 1 Purpose of This TIP ...... 1 Key Definitions...... 2 Audience for This TIP...... 2 A Decade of Change...... 2 Remaining Challenges...... 6 The Future of MAT ...... 10 Chapter 2óHistory of Medication-Assisted Treatment for Opioid Addiction...... 11 Emergence of Opioid Addiction as a Significant Problem and the Roots of Controversy ...... 11 Origins of Opioid Maintenance Therapy ...... 17 Regulatory History...... 21 Chapter 3óPharmacology of Medications Used To Treat Opioid Addiction ...... 25 Pharmacology and Pharmacotherapy ...... 28 Dosage Forms ...... 31 Efficacy...... 32 Side Effects ...... 33 Interactions With Other Therapeutic Medications...... 36 Safety ...... 42 Chapter 4óInitial Screening, Admission Procedures, and Assessment Techniques ...... 43 Initial Screening ...... 43 Admission Procedures and Initial Evaluation ...... 46 Medical Assessment ...... 49 Induction Assessment ...... 53 Comprehensive Assessment ...... 53 Appendix 4-A. Example of Standard Consent to Opioid Maintenance Treatment ...... 61

iii Chapter 5óClinical Pharmacotherapy ...... 63 Contraindications to Opioid Pharmacotherapy ...... 64 Stages of Pharmacotherapy...... 65 Medically Supervised Withdrawal ...... 78 Take-Home Medications ...... 81 Office-Based Opioid Therapy...... 85 Chapter 6óPatientñTreatment Matching: Types of Services and Levels of Care ...... 87 Steps in PatientñTreatment Matching ...... 88 Patients With Special Needs ...... 91 Treatment Planning...... 95 Chapter 7óPhases of Treatment...... 101 Rationale for a Phased-Treatment Approach and Duration ...... 101 Phases of MAT ...... 102 Transition Between Treatment Phases in MAT...... 119 Readmission to the OTP ...... 120 Chapter 8óApproaches to Providing Comprehensive Care and Maximizing Patient Retention ...... 121 Core Services ...... 121 Retaining Patients in MAT...... 122 Counseling and Case Management, Behavioral Treatments, and Psychotherapy ...... 124 Benefits of Family Involvement...... 133 Integrative Approaches...... 135 Relapse Prevention...... 136 Referral to Social Services...... 138 Involuntary Discharge From MAT...... 138 Patient Advocacy ...... 142 Chapter 9óDrug Testing as a Tool...... 143 Purposes of Drug Testing in OTPs...... 143 Benefits and Limitations of Drug Tests ...... 144 Drug-Testing Components and Methods ...... 148 Development of Written Procedures...... 151 Other Considerations in Drug-Testing Procedures...... 154 Interpreting and Using Drug Test Results...... 155 Reliability, Validity, and Accuracy of Drug Test Results...... 158

iv Contents Chapter 10óAssociated Medical Problems in Patients Who Are Opioid Addicted ...... 161 Integrated Versus Referral Services ...... 162 Routine Testing and Followup for Medical Problems...... 163 Acute, Life-Threatening Infections ...... 163 Infectious Diseases...... 164 Patients With Disabilities ...... 173 Pain Management...... 174 Hospitalization of Patients in MAT ...... 178 General Medical Conditions and MAT ...... 178 Chapter 11óTreatment of Multiple Substance Use...... 179 Prevalence of Multiple Substance Use in MAT...... 180 Common Drug Combinations Used by Patients in MAT ...... 181 Effects of Other Substance Use...... 182 Management of Multiple Substance Use in MAT...... 186 Inpatient Detoxification and Short-Term Stabilization...... 188 Chapter 12óTreatment of Co-Occurring Disorders ...... 189 Prevalence of Co-Occurring Disorders...... 190 Motivation for Treatment and Co-Occurring Disorders...... 191 Etiology of Co-Occurring Disorders ...... 191 Screening for Co-Occurring Disorders...... 192 Making and Confirming a Psychiatric Diagnosis ...... 194 Prognosis for Patients With Co-Occurring Disorders ...... 197 Treatment Issues...... 199 Appendix 12-A. Internet Resources for Accessing Psychiatric Instruments ...... 209 Chapter 13óMedication-Assisted Treatment for Opioid Addiction During Pregnancy ...... 211 Acceptance of Maintenance as the Standard of Care ...... 211 Diagnosing Opioid Addiction in Pregnant Patients ...... 212 Medical and Obstetrical Concerns and Complications ...... 212 Methadone Dosage and Management ...... 215 Postpartum Treatment of Mothers in MAT ...... 218 Breast-Feeding ...... 218 Effects on Neonatal Outcome ...... 218 Use of During Pregnancy...... 220 Importance of Integrated, Comprehensive Services ...... 222 Nutrition Assessment, Counseling, and Assistance ...... 223

Contents v Chapter 14óAdministrative Considerations ...... 225 Staffing...... 225 Medication Diversion Control Plans...... 230 The Community Effort ...... 231 OTPs and National Community Education Initiatives ...... 236 Evaluating Program and Staff Performance...... 238 Appendix AóBibliography...... 241 Appendix BóAbbreviations and Acronyms ...... 279 Appendix CóGlossary...... 283 Appendix DóEthical Considerations in MAT...... 297 Fundamental Ethical Principles...... 297 Ethics in Practice...... 298 Ethics: Conclusion...... 303 Appendix EóResource Panel ...... 305 Appendix FóField Reviewers ...... 307 Index ...... 317 CSAT TIPs and Publications Based on TIPs ...... 331

vi Contents Exhibits 1-1 NIDA Comprehensive Care-Related Principles of Effective Drug Addiction Treatment...... 8 3-1 Pharmacotherapeutic Medications for Opioid Addiction Treatment ...... 26 3-2 Requirements for Physiciansí Waivers To Dispense or Prescribe Buprenorphine and Buprenorphine- to Patients Who Are Opioid Addicted ...... 27 3-3 Intrinsic Activity of Full Agonist (Methadone), Partial Agonist (Buprenorphine), and Antagonist (Naloxone) Therapy ...... 31 3-4 Possible Side Effects of Opioid Agonist and Partial Agonist Therapy...... 34 3-5 Reported Drug Interactions With Methadone ...... 37 3-6 Other Inducers and Inhibitors of CYP450 and CYP3A4...... 40 4-1 Suicide Risk Factors...... 45 4-2 Recommended Responses to Indicators of Suicidality ...... 45 4-3 Recommended Procedures for Identifying and Addressing Domestic Violence...... 57 5-1 Using Signs and Symptoms To Determine Optimal Methadone Levels ...... 68 5-2 Induction SimulationóModerate to High Tolerance ...... 69 5-3 Use in Preceding 30 Days (407 Methadone-Maintained Patients by Current Methadone Dose) ...... 73 5-4 Methadone Dose/Mean Plasma Levels ...... 74 5-5 Blood Plasma Levels Over 4 and 24 Hours With an Adequate and Inadequate Methadone Dose ...... 75 5-6 SMLs After Single and Split Methadone Dosing in a Fast Metabolizer ...... 76 5-7 Types of Detoxification From Illicit Opioids ...... 80 6-1 Case Study: PatientñTreatment Planning in MAT ...... 97 7-1 Acute Phase of MAT ...... 104 7-2 Rehabilitative Phase of MAT...... 109 7-3 Supportive-Care Phase of MAT ...... 114 7-4 Medical Maintenance Phase of MAT ...... 116 7-5 Tapering Phase of MAT ...... 118 8-1 Resource Materials for Psychoeducational, Skill-Building, and Group Counseling Sessions...... 127 8-2 Strategy for Contingency Management in MAT ...... 129 8-3 Common Strategies for Psychotherapy in MAT...... 131 8-4 Strategies for Psychoeducation in MAT ...... 133 8-5 Patient Goals in Building Relapse Prevention Skills...... 137 9-1 Typical Testing and Confirmation Cutoff Concentrations and Detection Times for Various Substances of Abuse ...... 145 9-2 Common Immunoassays...... 150 9-3 Sample OTP Guidelines for Monitoring Urine Drug Test Specimen Collection ...... 151 9-4 Examples of Onsite Analytical Methods for Drug Tests ...... 156 10-1 Classification of TB ...... 165 10-2 Hepatitis C Evaluation Flowchart ...... 169

Contents vii 10-3 Nonpharmacologic Approaches to Managing Chronic Nonmalignant Pain ...... 177 11-1 Reported Use of Other Substances by Patients Admitted to OTPs ...... 180 11-2 Current Substance Use Disorders in Patients Dependent on Another Substance While Addicted to Opioids and Admitted to OTPs, With and Without Co-Occurring Disorders (N=716) ...... 181 11-3 Drug Combinations and Common Reasons for Use ...... 182 12-1 Common Co-Occurring Disorders in Patients Who Are Opioid Addicted...... 191 12-2 DSM-IV-TR Classification of Diagnoses Associated With Different Classes of Substances ...... 196 12-3 Mutual-Help Groups for People With Co-Occurring Disorders ...... 203 12-4 Topics for Psychoeducational Groups for People With Co-Occurring Disorders...... 204 12-5 Interactions of Some Medications for and With Methadone and Recommended Treatment Response in MAT ...... 206 13-1 Common Medical Complications Among Pregnant Women Who Are Opioid Addicted...... 213 13-2 Laboratory Tests for Pregnant Women Who Are Opioid Addicted...... 214 13-3 Common Obstetrical Complications Among Women Addicted to Opioids ...... 215 D-1 Case Example...... 299 D-2 AATOD Canon of Ethics ...... 303 D-3 Ethical Codes of Selected Treatment-Oriented Organizations and Their Web Sites ...... 304

viii Contents What Is a TIP?

Treatment Improvement Protocols (TIPs), developed by the Center for Substance Abuse Treatment (CSAT), part of the Substance Abuse and Mental Health Services Administration (SAMHSA), within the U.S. Department of Health and Human Services (DHHS), are best-practice guidelines for the treatment of substance use disorders. CSAT draws on the experience and knowledge of clinical, research, and administrative experts to produce the TIPs, which are distributed to facilities and indi- viduals across the country. The audience for the TIPs is expanding beyond public and private treatment facilities to include practitioners in mental health, criminal justice, primary care, and other health care and social service settings.

CSATís Knowledge Application Program (KAP) expert panel, a distin- guished group of experts on substance use disorders and professionals in such related fields as primary care, mental health, and social services, works with the State Alcohol and Drug Abuse Directors to generate topics for the TIPs. Topics are based on the fieldís current needs for information and guidance.

After selecting a topic, CSAT invites staff from pertinent Federal agencies and national organizations to be members of a resource panel that recommends specific areas of focus as well as resources that should be considered in developing the content for the TIP. These recommenda- tions are communicated to a consensus panel composed of experts on the topic who have been nominated by their peers. This consensus panel participates in a series of discussions. The information and recommen- dations on which they reach consensus form the foundation of the TIP. The members of each consensus panel represent substance abuse treat- ment programs, hospitals, community health centers, counseling pro- grams, criminal justice and child welfare agencies, and private practi- tioners. A panel chair (or co-chairs) ensures that the contents of the TIP mirror the results of the groupís collaboration.

A large and diverse group of experts closely reviews the draft document. Once the changes recommended by these field reviewers have been incorporated, the TIP is prepared for publication, in print and on line. TIPs can be accessed via the Internet at www.kap.samhsa.gov. The ix online TIPs are consistently updated and pro- addiction (MAT) that have occurred over the vide the field with state-of-the-art information. most active decade of change since the incep- tion of this treatment modality approximately Although each TIP strives to include an 40 years ago. The TIP describes the nature and evidence base for the practices it recommends, dimensions of opioid use disorders and their CSAT recognizes that the field of substance treatment in the United States, including basic abuse treatment is evolving, and research principles of MAT and historical and regulatory frequently lags behind the innovations pio- developments. It presents consensus panel neered in the field. A major goal of each TIP is recommendations and evidence-based best to convey ìfront-lineî information quickly but practices for treatment of opioid addiction in responsibly. For this reason, recommendations opioid treatment programs (OTPs). It also proffered in the TIP are attributed to either examines related medical, psychiatric, sociolog- panelistsí clinical experience or the literature. ical, and substance use disorders and their If research supports a particular approach, treatment as part of a comprehensive mainte- citations are provided. nance treatment program. The TIP includes a This TIP, Medication-Assisted Treatment for discussion of the ethical considerations that Opioid Addiction in Opioid Treatment arise in most OTPs, and it provides a useful Programs, incorporates the many changes in summary of areas for emphasis in successfully medication-assisted treatment for opioid administering MAT in OTPs.

x What Is a TIP? Consensus Panel

Chair Editorial Advisory Board Steven L. Batki, M.D. John D. Crowley Professor and Director of Research Crowley Associates Department of Elgin, South Carolina SUNY Upstate Medical University Syracuse, New York Herbert D. Kleber, M.D. Professor of Psychiatry Columbia University College of Physicians Co-Chairs & Surgeons Janice F. Kauffman, R.N., M.P.H., New York, New York LADC, CAS Stewart B. Leavitt, Ph.D. Vice President Leavitt Medical Communications Addiction Treatment Services Glenview, Illinois North Charles Foundation, Inc. Cambridge, Massachusetts; Jocelyn Sue Woods, M.A. Director President Addiction Psychiatry Service National Alliance of Methadone Advocates Department of Psychiatry New York, New York Brigham and Womenís Hospital Boston, Massachusetts; Joan Zweben, Ph.D. and Assistant Professor of Psychiatry Executive Director Harvard Medical School 14th Street Clinic & Medical Group, Inc. Boston, Massachusetts East Bay Community Recovery Project Berkeley, California Ira Marion, M.A. Executive Director Division of Substance Abuse Consensus Panelists Albert Einstein College of Medicine Patrick Abbott, M.D. Bronx, New York Medical Director Center on , Substance Abuse, Mark W. Parrino, M.P.A. and President University of New Mexico American Association for the Albuquerque, New Mexico Treatment of Opioid Dependence New York, New York Leslie Amass, Ph.D. Principal Investigator George E. Woody, M.D. Friends Research Institute, Inc. Treatment Research Institute Los Angeles, California University of Pennsylvania/ MIRECC Philadelphia VAMC Hector D. Barreto, M.D., M.P.H. Philadelphia, Pennsylvania Medical Director Center for Drug-Free Living Orlando, Florida

xi Michael D. Couty J. Thomas Payte, M.D. Director Medical Director Division of Alcohol and Drug Abuse Drug Dependence Associates Missouri Department of Mental Health San Antonio, Texas Jefferson City, Missouri Norma J. Reppucci, R.N. Vashti Jude Forbes, R.N., BC., M.S.N., Director LCDC Operations for Eastern MA and NH Associate Director Community Substance Abuse Centers Substance Abuse and Specialized Services Malden, Massachusetts Austin Travis County Mental Health and Mental Retardation Center Yong S. Song, Ph.D. Austin, Texas Assistant Clinical Professor and Program Ron Jackson, M.S.W. Director Executive Director Opiate Treatment Outpatient Program Evergreen Treatment Services University of California, San Francisco Seattle, Washington San Francisco, California

Karol A. Kaltenbach, Ph.D. Jo L. Sotheran, Ph.D. Director Associate Research Scientist Maternal Addiction Treatment Education Mailman School of Public Health and Research Columbia University Jefferson Medical College New York, New York Thomas Jefferson University Philadelphia, Pennsylvania Trusandra Taylor, M.D. Physician Advisor Judith Martin, M.D., FASAM Parkside Recovery Methadone Maintenance Medical Director Philadelphia, Pennsylvania 14th Street Clinic & Medical Group, Inc. Oakland, California

Violanda T. NuÒez, M.S.W. Executive Director Ayudantes, Inc. Santa Fe, New Mexico

xii Consensus Panel KAP Expert Panel and Federal Government Participants

Barry S. Brown, Ph.D. Renata J. Henry, M.Ed. Adjunct Professor Director University of North Carolina at Wilmington Division of Alcoholism, Drug Abuse, and Carolina Beach, North Carolina Mental Health Delaware Department of Health and Jacqueline Butler, M.S.W., LISW, LPCC, Social Services CCDC III, CJS New Castle, Delaware Professor of Clinical Psychiatry College of Medicine Joel Hochberg, M.A. University of Cincinnati President Cincinnati, Ohio Asher & Partners Los Angeles, California Deion Cash Executive Director Jack Hollis, Ph.D. Community Treatment and Correction Associate Director Center, Inc. Center for Health Research Canton, Ohio Kaiser Permanente Portland, Oregon Debra A. Claymore, M.Ed.Adm. Owner/Chief Executive Officer Mary Beth Johnson, M.S.W. WC Consulting, LLC Director Loveland, Colorado Addiction Technology Transfer Center University of MissourióKansas City Carlo C. Di Clemente, Ph.D. Kansas City, Missouri Chair Department of Psychology Eduardo Lopez University of Maryland Baltimore County Executive Producer Baltimore, Maryland EVS Communications Washington, D.C. Catherine E. Dube, Ed.D. Independent Consultant Holly A. Massett, Ph.D. Brown University Academy for Educational Development Providence, Rhode Island Washington, D.C.

Jerry P. Flanzer, D.S.W., LCSW, CAC Diane Miller Chief, Services Chief Division of Clinical and Services Research Scientific Communications Branch National Institute on Drug Abuse National Institute on Alcohol Abuse Bethesda, Maryland and Alcoholism Bethesda, Maryland Michael Galer, D.B.A., M.B.A., M.F.A. Chairman of the Graduate School of Business Harry B. Montoya, M.A. University of PhoenixóGreater Boston President/Chief Executive Officer Campus Hands Across Cultures Braintree, Massachusetts Espanola, New Mexico

xiii Richard K. Ries, M.D. Clarissa Wittenberg Director/Professor Director Outpatient Mental Health Services Office of Communications and Dual Disorder Programs Public Liaison Seattle, Washington National Institute of Mental Health Bethesda, Maryland Gloria M. Rodriguez, D.S.W. Research Scientist Division of Addiction Services Consulting Members to the New Jersey Department of Health and KAP Expert Panel Senior Services Trenton, New Jersey Paul Purnell, M.A. Social Solutions, L.L.C. Everett Rogers, Ph.D. Potomac, Maryland Center for Communications Programs Johns Hopkins University Scott Ratzan, M.D., M.P.A., M.A. Baltimore, Maryland Academy for Educational Development Washington, D.C. Jean R. Slutsky, P.A., M.S.P.H. Senior Health Policy Analyst Thomas W. Valente, Ph.D. Agency for Healthcare Research Director, Master of Public Health Program & Quality Department of Preventive Medicine Rockville, Maryland School of Medicine University of Southern California Nedra Klein Weinreich, M.S. Alhambra, California President Weinreich Communications Patricia A. Wright, Ed.D. Canoga Park, California Independent Consultant Baltimore, Maryland

xiv KAP Expert Panel and Federal Government Participants Foreword

The Treatment Improvement Protocol (TIP) series supports SAMHSAís mission of building resilience and facilitating recovery for people with or at risk for mental or substance use disorders by providing best-practices guidance to clinicians, program administrators, and payers to improve the quality and effectiveness of service delivery and thereby promote recovery. TIPs are the result of careful consideration of all relevant clinical and health services research findings, demonstration experience, and implementation requirements. A panel of non-Federal clinical researchers, clinicians, program administrators, and client advocates debates and discusses its particular areas of expertise until it reaches a consensus on best practices. This panelís work is then reviewed and critiqued by field reviewers.

The talent, dedication, and hard work that TIPs panelists and reviewers bring to this highly participatory process have helped bridge the gap between the promise of research and the needs of practicing clinicians and administrators who serve, in the most current and effective ways, people who abuse substances. We are grateful to all who have joined with us to contribute to advances in the substance abuse treatment field.

Charles G. Curie, M.A., A.C.S.W. Administrator Substance Abuse and Mental Health Services Administration

H. Westley Clark, M.D., J.D., M.P.H., CAS, FASAM Director Center for Substance Abuse Treatment Substance Abuse and Mental Health Services Administration

xv

Executive Summary

Research supports the perspective that opioid addiction is a medical disorder that can be treated effectively with medications when they are administered under conditions consistent with their pharmacological efficacy and when treatment includes necessary supportive services such as psychosocial counseling, treatment for co-occurring disorders, medical services, and vocational rehabilitation. Medication-assisted treatment for opioid addiction (MAT) has been effective in facilitating recovery from opioid addiction for many patients.

This TIP provides a detailed description of MAT, especially in opioid treatment programs (OTPs). MAT includes optional approaches such as comprehensive maintenance treatment, medical maintenance treatment, detoxification, and medically supervised withdrawal. Some or all of these approaches can be provided in OTPs or other settings. With the approval of buprenorphine for physicianís office-based opioid treat- ment, MAT availability is expected to increase.

Growing understanding and acceptance of opioid addiction as a treatable medical disorder have facilitated advances in MAT. The effectiveness of MAT advanced significantly with the development of methadone maintenance treatment in the 1960s and the creation and expansion of publicly funded treatment programs in the 1970s. The first official Federal use of the term ìmaintenance treatmentî (referring to opioid addiction treatment) occurred in the Narcotic Addict Treatment Act of 1974. Perhaps the most important development in MAT during the 1990s was publication of recommendations by a National Institutes of Health consensus panel on Effective Medical Treatment of Opiate Addiction. The panel concluded that opioid addiction is a treatable med- ical disorder and explicitly rejected notions that addiction is self-induced or a failure of willpower. The panel called for a commitment to providing effective treatment for opioid addiction and for Federal and State efforts to reduce the stigma attached to MAT and to expand MAT through increased funding and less restrictive regulation. The implementation of an accreditation system for OTPs further serves to standardize and improve MAT.

xvii Accompanying these improvements in opioid safety considerations, and current availability addiction treatment is an increasing emphasis and restrictions for methadone, levo-alpha on the concomitant treatment of diseases such acetyl methadol (LAAM), buprenorphine, as HIV/AIDS, hepatitis, and tuberculosis, all of and . The information will enable which occur at higher rates among people who treatment providers to compare the benefits inject drugs than in the general population. and limitations of available opioid addiction treatment medications. This TIP addresses a variety of issues and challenges in MAT, including Chapter 4, Initial Screening, Admission Procedures, and Assessment Techniques, ï Drug testing for screening and assessmentó describes screening and assessment procedures how and when (chapters 4 and 9) used with applicants for admission to treat- ï Administrative dischargeóissues of safety ment and with patients in MAT. The chapter and noncompliance (chapter 8) describes components of the screening (or ï Use of other substances with opioids and intake) process that provides a foundation resulting complications for MAT (chapter 11) for treatment and procedures used during the admissions process to ensure thorough, ï Co-occurring mental disorders and their efficient data collection and to gather informa- complications for MAT (chapter 12) tion for ongoing treatment intervention. ï Administration of staffs and procedures Components of substance use, medical, (chapter 14). medication induction, and comprehensive psychosocial assessments are used to determine The following paragraphs summarize chapters MAT eligibility, individualize treatment plans, in this TIP. and monitor changes in patient status. The Chapter 1, Introduction, introduces MAT and chapter also provides information on manag- provides important concepts for understanding ing emergency situations during admission and this TIP. It describes opioid addiction as a treatment. medical disorder with similarities to other dis- Chapter 5, Clinical Pharmacotherapy, explains orders. It outlines the main options for MAT, opioid pharmacotherapy, focusing on the such as choices of medication and optional clinical use of methadone, buprenorphine, services. The chapter concludes by summariz- LAAM, and naltrexone. It details the discrete ing the greatest challenges facing OTPs and stages of opioid pharmacotherapy, each of offering a vision of the future. which requires unique clinical considerations. Chapter 2, History of Medication-Assisted It discusses factors that may affect individual Treatment for Opioid Addiction, provides the responses to treatment medications and key historical context for MAT. It details the histo- considerations in determining individual ry of the use of opioids in the United States; the dosages. For patients who must leave MAT, political, legal, and regulatory responses to opi- either voluntarily or involuntarily, the chapter oid abuse; treatment trends (including logistics explains methods of withdrawal from treatment and strategies); and development of modern medications. It also discusses important consid- medications available in MAT. erations in administering take-home medication.

Chapter 3, Pharmacology of Medications Chapter 6, PatientñTreatment Matching: Types Used To Treat Opioid Addiction, reviews the of Services and Levels of Care, describes a pharmacology and clinical applications of the multidimensional, clinically driven strategy medications used for treating opioid addiction. for matching patients in MAT with the types It focuses on the metabolic activity, dosage of treatment services and levels of care that forms, efficacy, side effects, drug interactions, optimize treatment outcomes, within or in

xviii Executive Summary conjunction with OTPs. Patientñtreatment Most patients need more frequent, intensive matching involves individualizing the choice services in the acute phase, careful monitoring and application of treatment resources to each and diversified services during rehabilitative patientís needs, abilities, and preferences. The and supportive-care phases, and less frequent chapter describes alternative types of treat- services in subsequent phases. ment programs and settings for identified types of patients and recommends elements that Chapter 8, Approaches to Providing should be included in patientñtreatment match- Comprehensive Care and Maximizing Patient ing, including ways to accommodate patients Retention, describes the core- and extended- with special needs. The chapter describes care services essential to MAT effectiveness in elements of a treatment plan and the planning OTPs. It explains how a comprehensive treat- process, including the roles of counselor and ment program improves patient retention in patient, the importance of cultural and linguistic treatment and the likelihood of positive treat- competence, motivation for treatment, and the ment outcomes. Patients who receive regular, need for a multidisciplinary team. frequent, integrated psychosocial and medical services along with opioid pharmacotherapy Chapter 7, Phases of Treatment, describes often realize better outcomes than those who phases of treatment for patients in MAT. These receive only limited services. Counseling phases are conceptualized as parts of a dynam- services are integral to comprehensive mainte- ic continuum of patient progress toward nance treatment and can be behavioral, intended treatment outcomes. Each patient psychotherapeutic, or family oriented. progresses according to his or her capacity and Strategies that target relapse prevention also needs. After an orientation to introduce should be part of any comprehensive treatment patients to the program, successive treatment program. The chapter describes ways to phases include (1) the acute phase, during increase patient retention and avoid adminis- which patients attempt to eliminate illicit-opioid trative discharge. Administrative discharge use and lessen the intensity of other problems usually results in rapid relapse and may lead to associated with their addiction, (2) the rehabili- incarceration or death. Clear communication tative phase, during which patients continue to and awareness on the part of both patients address addiction while gaining control of other and staff members help avoid administrative major life domains, (3) the supportive-care discharge. phase, during which patients maintain their abstinence while receiving other interventions Chapter 9, Drug Testing as a Tool, presents an when needed, (4) the medical-maintenance overview of drug testing in OTPs. Drug testing phase, during which patients are committed to provides an objective measure of treatment continuing pharmacotherapy for the foresee- efficacy and a tool to monitor patient progress, able future but no longer rely on other OTP as well as information for quality assurance, services, (5) the tapering and readjustment program planning, and accreditation. OTPs phase, an optional phase in which patients must ensure the clinical utility of test results gradually reduce and eliminate opioid treat- and protect patientsí privacy. Several drug- ment medication, and (6) the continuing-care testing methodologies are available or in devel- phase, in which patients who have tapered opment, including tests of urine, oral fluid, from treatment medication continue regular blood, sweat, and hair. The chapter describes contact with their treatment program. Phases the benefits and limitations of these tests. Most of treatment address the therapeutic relation- often, OTPs use urine drug testing by ship, motivation, patientsí use of alcohol and immunoassay or thin-layer chromatography illicit drugs, their mental and medical disorders, because these methods are the least costly and legal problems, and basic needs (including best validated of all options, but the Center for housing, education, and vocational training). Substance Abuse Treatment has indicated that

Executive Summary xix oral-fluid testing may be an alternative danger, how to handle emergencies, and the approach in OTPs. The chapter describes effect of co-occurring disorders on behaviors criteria that an OTP should use to collect that increase the risk of infectious diseases. specimens and how treatment providers should respond to test results that indicate Chapter 13, Medication-Assisted Treatment for possible treatment problems. Opioid Addiction During Pregnancy, describes the complications associated with pregnancy Chapter 10, Associated Medical Problems in and opioid addiction and how pregnancy Patients Who Are Opioid Addicted, focuses should be addressed during MAT to reduce the on diagnosis and treatment of the medical potential for harm to a pregnant woman in conditions most commonly seen in MAT MAT and her fetus. Among the main concerns patients. A primary issue in MAT is deciding are those related to HIV/AIDS and hepatitis C. which medical services patients should receive The chapter describes how to adjust methadone in house versus through referral to outside dosage and manage overdose and withdrawal providers. Chapter 10 examines the factors and addresses the postpartum treatment of that influence this determination and reviews mother and child, including topics such as the screening services and protocols OTPs breast-feeding and neonatal abstinence syn- should have in place to evaluate patientsí drome. The chapter focuses on methadone, acute and chronic medical problems and to which has been accepted for treating opioid perform periodic reassessments. addiction during pregnancy since the late 1970s.

Chapter 11, Treatment of Multiple Substance Chapter 14, Administrative Considerations, Use, discusses problems associated with covers the challenging administrative aspects patientsí continued abuse of other substances, of managing and staffing the complex and which is likely to affect patientsí participation dynamic environment of an OTP. Successful in MAT, proper use of medication, and mental treatment outcomes depend on the competence, and physical health. Some substances, such as values, and attitudes of staff members. To alcohol and certain sedatives, have a poten- develop and retain a stable team of treatment tially lethal effect when combined with an personnel, program administrators must opioid agonist or partial agonist medication. recruit and hire qualified, capable, culturally A number of interventions can address the sensitive individuals; offer competitive salaries continued abuse of other substances, includ- and benefit packages; and provide good super- ing increased drug testing and the use of vision and ongoing training. Implementing disulfiram, contingency management, dose community relations and community education adjustments, and counseling. efforts is important for OTPs. Outreach and educational efforts can dispel misconceptions Chapter 12, Treatment of Co-Occurring about MAT and people in recovery. Finally, the Disorders, addresses issues for patients who chapter provides a framework for gathering have substance use and co-occurring mental and analyzing program performance data. disorders. These patients often exhibit Program evaluation contributes to improved behaviors or experience emotions that inter- treatment services by enabling administrators fere with treatment and require special to base changes in services on evidence of what interventions. The chapter describes the works. Evaluation also serves as a way to prevalence of co-occurring disorders, educate and influence policymakers and public screening and diagnosis of these disorders, and private payers. and the effects of such disorders on treatment outcomes. It discusses general issues, specific Appendix D, Ethical Considerations in MAT, psychiatric diagnoses, and a range of inter- explores ethical issues inherent in MAT and ventions (including psychoeducation, provides a structure that administrators psychotherapy, and pharmacotherapy) to and clinicians can use in considering how to treat co-occurring disorders. The chapter resolve them. explores special issues such as acute psychiatric xx Executive Summary 1 Introduction

Opioid addiction is a problem with high costs to individuals, families, and society. Injection drug use-associated exposure accounts for approxi- In This mately one-third of all AIDS cases diagnosed in the United States through 2003 (National Center for HIV, STD and TB Prevention 2005) Chapter… and for many cases of hepatitis C (National Institute on Drug Abuse 2000; Thomas 2001). In the criminal justice system, people who use Purpose of This heroin account for an estimated one-third of the $17 billion spent each TIP year for legal responses to drug-related crime. Indirect costs from lost productivity and overdose also are high (Mark et al. 2001), and people Key Definitions with opioid addictions and their families experience severe reductions in Audience for This their quality of life. The increasing abuse of prescription opioids is TIP another major concern, both for their damaging effects and as gateway drugs to other substance use (see chapter 2). A Decade of Change Remaining Purpose of This TIP Challenges This Treatment Improvement Protocol (TIP) is a guide to medication- The Future of MAT assisted treatment for opioid addiction (MAT) in opioid treatment programs (OTPs). Compared with MAT in other settings, such as physi- ciansí offices or detoxification centers, treatment in OTPs provides a more comprehensive, individually tailored program of medication therapy integrated with psychosocial and medical treatment and support services that address most factors affecting each patient. Treatment in OTPs also can include detoxification from illicit opioids and medically supervised withdrawal from maintenance medications.

This TIP combines and updates TIP 1 (State Methadone Treatment Guidelines, published in 1993), TIP 10 (Assessment and Treatment of Cocaine-Abusing Methadone-Maintained Patients, published in 1994), TIP 20 (Matching Treatment to Patient Needs in Opioid Substitution Therapy, published in 1995), and TIP 22 (LAAM in the Treatment of Opiate Addiction, published in 1995). It incorporates the many changes in MAT that have occurred since the publication of TIP 1, primarily as they are reflected in OTPs, and discusses the challenges that remain.

1 Key Definitions Regulations (CFR), Part 8, to provide super- vised assessment and medication-assisted The glossary (Appendix C) and list of acronyms treatment for patients who are opioid addicted. (Appendix B) at the back of the book provide An OTP can exist in a number of settings, definitions of key words, terms, acronyms, and including, but not limited to, intensive outpa- abbreviations. Particularly important distinc- tient, residential, and hospital settings. Types of tions among selected terms and phrases are treatment can include medical maintenance, discussed below. medically supervised withdrawal, and detoxifi- cation, either with or without various levels of Distinctions between dependence and addiction medical, psychosocial, and other types of care. vary across treatment fields. This TIP uses the term ìdependenceî to refer to physiological The term ìabstinenceî in this TIP refers to effects of substance abuse and ìaddictionî for nonuse of alcohol or illicit drugs (drugs not on and subjective need approved by FDA), as well as nonabuse of and craving for a psychoactive substance either prescription drugs. Abstinence does not refer to experience its positive effects or to avoid to withdrawal from legally prescribed mainte- negative effects associated with withdrawal nance medications for addiction treatment (for from that substance. which ìmedically supervised withdrawalî is the preferred term). MAT is any treat- ment for opioid Terminology continues to evolve for describing addiction that the combination of substance use and mental The intended includes a medi- disorders. In this TIP, ìco-occurringî is the cation (e.g., preferred term, but others use ìcoexisting,î audience for this methadone, ìdual diagnosis,î and ìcomorbidî to describe buprenorphine, the combination of current or former substance TIP is treatment levo-alpha acetyl use disorders and any other Axis I or any methadol [LAAM], Axis II mental disorders recognized by the providers and naltrexone) Diagnostic and Statistical Manual of Mental approved by the Disorders, Fourth Edition, Text Revision administrators U.S. Food and Drug (American Psychiatric Association 2000). Administration (See also TIP 42, Substance Abuse Treatment (FDA) for opioid working in OTPs. for Persons With Co-Occurring Disorders addiction detoxifica- [CSAT 2005b].) tion or maintenance treatment. MAT may be provided in Audience for This TIP an OTP or an OTP medication unit (e.g., phar- The intended audience for this TIP is treat- macy, physicianís office) or, for buprenor- ment providers and administrators working in phine, a physicianís office or other health care OTPs. Other groups that want to understand setting. Comprehensive maintenance, medical the principles and procedures followed in MAT maintenance, interim maintenance, detoxifica- also will benefit. tion, and medically supervised withdrawal (defined under ìTreatment Optionsî below and individually in the glossary) are types of MAT. A Decade of Change An OTP is any treatment program certified Several forces are transforming the MAT field. by the Substance Abuse and Mental Health The implementation of an accreditation system Services Administration (SAMHSA) in (Federal Register 64:39814) is standardizing conformance with 42 Code of Federal and improving opioid addiction treatment (for

2 Chapter 1 details, see 42 CFR, Part 8). Choices of medi- susceptible than others to this derange- cation, including methadone, buprenorphine, ment and whether long-term addicts LAAM, and naltrexone (see chapter 3), now are can recover normal function without available to treat opioid addiction. Each has its maintenance therapy are questions for own benefits and limitations. Continued the future. At present, the most that research on opioid addiction and treatment is can be said is that there seems to be a clarifying what works to improve treatment specific neurological basis for the com- outcomes, with an emphasis on accelerating the pulsive use of heroin by addicts and incorporation of evidence-based methods into that methadone taken in optimal doses treatment. Changes in the health care system can correct the disorder. nationwide (e.g., the growth of managed care and effects of the Health Insurance Portability Similarities to other medical and Accountability Act) are having an effect on OTPs and other types of health care programs. disorders Understanding and acceptance of opioid addic- McLellan and colleagues (2000) compared basic tion as a medical disorder by patients, health aspects of substance addiction with those of care providers, the media, and the public have three disordersóasthma, hypertension, and increased since the publication of TIP 1. diabetesówhich universally are considered ìmedicalî and usually chronic and relapsing and for which behavioral change is an impor- MATóA More Accepted Form tant part of treatment. They found that genet- of Treatment ic, personal-choice, and environmental factors played comparable roles in the etiology and Opioid addiction as a medical course for these disorders and that rates of disorder relapse and adherence to medication were simi- lar, although substance addiction often was Discussions about whether addiction is a medi- treated as an acute, not chronic, illness. Their cal disorder or a moral problem have a long review of outcome literature showed that, as history. For decades, studies have supported with the other disorders, substance addiction the view that opioid addiction is a medical dis- has no reliable cure but that patients who com- order that can be treated effectively with medi- ply with treatment regimens have more favor- cations administered under conditions consis- able outcomes. Fewer than 30 percent of tent with their pharmacological efficacy, when patients with asthma, hypertension, or diabetes treatment includes comprehensive services, adhered to their medication regimens, pre- such as psychosocial counseling, treatment for scribed diets, or other changes to increase their co-occurring disorders, medical services, voca- functional status and reduce their risk of symp- tional rehabilitation services, and case manage- tom recurrence. As a result, 50 to 70 percent ment services (e.g., Dole and Nyswander 1967; experienced recurrent symptoms each year to McLellan et al. 1993). the point of requiring additional medical care Dole (1988, p. 3025) described the medical to reestablish remission. basis of methadone maintenance as follows: Another similarity found between opioid The treatment is corrective, normaliz- addiction and these medical disorders was their ing neurological and endocrinologic outcome predictors (McLellan et al. 2000). For processes in patients whose endogenous example, patients who were older and ligand-receptor function has been employed with stable families and marriages deranged by long-term use of powerful were found to be more likely to comply with narcotic drugs. Why some persons who treatment and have positive treatment results are exposed to narcotics are more than were younger, unemployed patients with less stable family support.

Introduction 3 The concept of opioid addiction as a medical example, Metzger and colleagues (1998) found disorder was supported further by other treat- that substance abuse treatment was associated ment followup studies showing that opioid with a significantly lower risk of HIV infection addiction has a reasonably predictable course, than was nontreatment. Treatment also was similar to such conditions as diabetes, hyper- associated with a significant reduction, but not tension, and asthma. For example, Woody and necessarily cessation, of drug use for many Cacciola (1994) found that the risk of relapse individuals. Similar findings on the positive for a person who was opioid addicted was high- health outcomes associated with maintenance est during the first 3 to 6 months after cessa- treatment of opioid addiction, regardless of tion of opioid use. This risk declined for the whether abstinence was attained, were seen in first 12 months after cessation and continued to studies finding that methadone maintenance decrease but at a much slower rate. Results decreases overdose death. Data on benefits of from other posttreatment studies indicated that partial responses to maintenance treatment roughly 80 percent of patients who are opioid resemble the benefits of treatment for other addicted but leave MAT resume daily opioid chronic medical disorders in terms of symptom use within 1 year after leaving treatment (e.g., alleviation. An analogy with MAT would be the Magura and Rosenblum 2001). desirability of reducing the risk of HIV infec- tion, overdose, and the many psychosocial Similar to patients with other chronic disorders, complications of addiction, which is not as many who are opioid addicted have been found desirable as the benefits of attaining complete to respond best to treatment that combines abstinence from opioids but is associated pharmacological and behavioral interventions. with significantly improved patient health and As detailed throughout this TIP, treatment of well-being. The goal is always reducing or opioid addiction with maintenance medication, eliminating the use of illicit opioids and other along with other treatment services for related illicit drugs and the problematic use of pre- problems that affect patientsí motivation and scription drugs. treatment compliance, increases the likelihood of cessation of opioid abuse. Conversely, dis- The medical community recognizes that opioid continuation of maintenance medication often addiction is a chronic medical disorder that results in dropout from other services and a can be treated effectively with a combination of return to previous levels of opioid abuse, with medication and psychosocial services. An its accompanying adverse medical and psycho- important development in MAT during the social consequences (Ball and Ross 1991). Entry 1990s was the 1997 publication of recommen- into comprehensive maintenance treatment pro- dations by a National Institutes of Health con- vides an opportunity to prevent, screen for, and sensus panel on effective medical treatment of treat diseases such as HIV/AIDS, hepatitis B opiate addiction. After hearing from experts and C, and tuberculosis (see chapter 10) and to and the public and examining the literature, increase compliance with medical, psychiatric, the panel concluded that ì[opioid addiction] is and prenatal care (Chaulk et al. 1995; a medical disorder that can be effectively treat- Umbricht-Schneiter et al. 1994). Recent data on ed with significant benefits for the patient and buprenorphine indicate that treatment with this societyî (National Institutes of Health 1997b, medication, like methadone, has similar positive p. 18). That panel explicitly rejected the notion outcomes (CSAT 2004a; Johnson et al. 2000; ìthat [addiction] is self-induced or a failure of Kakko et al. 2003). willpower and that efforts to treat it inevitably failî (p. 18). It called for ìa commitment to Viewing opioid addiction as a medical disorder offer effective treatment for [opioid addiction] is consistent with the idea that treatment of to all who need itî (p. 2). The panel also called even severe cases improves outcomes, just as in for Federal and State efforts to reduce the other chronic and relapsing medical disorders, stigma attached to MAT and to expand MAT even before abstinence is achieved. For through increased funding, less restrictive

4 Chapter 1 regulation, and efforts to make treatment avail- addiction. Just after the publication of TIP 1, able in all States (p. 24). The consensus panel FDA approved the use of LAAM, although its for this TIP further recommends that access to use has been curtailed treatment with methadone and other FDA- substantially since approved medications for opioid addiction be then (see chapter 3). increased for people who are incarcerated, on In October 2002, parole, or on probation. FDA approved two The medical com- new formulations The trend toward greater acceptance of MAT containing buprenor- munity recognizes as an effective treatment for opioid addiction phine for treatment has resulted in fewer State-mandated restric- of opioid addiction. that opioid addic- tions for treatment. For example, many States Buprenorphine is have removed restrictions on the length of time used to treat individu- tion is a chronic that patients may remain in treatment. als who have been opioid addicted for medical disorder More Treatment Programs and less than 1 year, as well as patients for More Patients in Treatment whom buprenor- that can be treated In 1993, when TIP 1 was published, approxi- phineís unique prop- mately 750 registered OTPs were treating some erties are beneficial effectively... 115,000 patients in 40 States, the District of (CSAT 2004a). The Columbia, Puerto Rico, and the Virgin Islands nal- (CSAT 1993b, p. 1). At this writing, more than trexone is available to 1,100 OTPs operating in 44 States, the District treat people who are of Columbia, Puerto Rico, and the Virgin opioid addicted and have undergone medically Islands are treating more than 200,000 patients supervised withdrawal. These medications are (Substance Abuse and Mental Health Services discussed in chapter 3. Administration n.d.b; Nicholas Reuter, personal communication, June 2004). As of this writing, methadone treatment is not available in six Treatment Options States: Idaho, Mississippi, Montana, North OTPs can provide several treatment options: Dakota, South Dakota, and Wyoming. ï Maintenance treatment combines pharmaco- Most expansion in the treatment system in the therapy with a full program of assessment, past 10 years has occurred in the proprietary psychosocial intervention, and support ser- sector. Historically, most OTPs were funded vices; it is the approach with the greatest like- publicly, whereas proprietary programs were lihood of long-term success for many patients. in the minority. In the 1980s, public funding ï Medical maintenance treatment is provided to for methadone treatment began to be reduced, stabilize patients and may include long-term along with State, Federal, and local budgets, provision of methadone, buprenorphine, and increasingly was replaced by private fee- LAAM, or naltrexone, with a reduction in for-service treatment programs in which clinic attendance and other services. A patients bore more of the costs (Knight et al. patient can receive medical maintenance 1996a, 1996b; Magura and Rosenblum 2001). at an OTP, after he or she is stabilized fully. The patient usually must complete a Choices of Medications comprehensive treatment program first. The decision about whether to provide medical The National Institute on Drug Abuse (NIDA) maintenance must be made by a licensed has been working to broaden the array of effec- practitioner. A designated medication unit tive treatment medications for chronic opioid

Introduction 5 (e.g., physicianís office, pharmacy, long-term points of treatment entry. At this writing, the care facility) affiliated with an OTP can pro- availability of these options varies, often vide some medical maintenance services. To because of individual State regulations. reduce clinic attendanceóa key feature of medical maintenanceópatients must qualify, subject to variations in State regulations Changes in the Federal (which may be more stringent than Federal Regulatory System regulations), to receive 7- to 14-day supplies On May 18, 2001, SAMHSA promulgated a of methadone for take-home dosing after 1 new accreditation oversight system. Its goal year of continuous treatment and 15- to 30- is to ìreduce the variability in the quality of day supplies after 2 years of continuous opioid treatment services, and reform the treatment in an OTP (if additional criteria treatment system to provide for expanded are satisfied [see chapter 5]) (42 CFR, Part 8 treatment capacityî (Federal Register ß 12(h); Federal Register 66:4079). 64:39814). As OTPs meet these national ï Detoxification from short-acting opioids standards, treatment improvement is expected involves medication and, perhaps, counseling to continue along with increased attention to or other assistance to stabilize patients who program evaluation and quality improvement are opioid addicted by withdrawing them in a mechanisms. The consensus panel hopes that controlled manner from the illicit opioids. this TIP will contribute to the movement ï Medically supervised withdrawal treatment toward quality-driven treatment standards. involves the controlled tapering of treatment medication for patients who want to remain abstinent from opioids without the assistance Remaining Challenges of medication. Although important strides have been made, much remains to be done to improve and Based on the framework provided by the Drug expand treatment and to address the stigma Addiction Treatment Act of 2000 (21 United that affects patients and programs. States Code 823(g)), qualified practition- ers are authorized to Administering Appropriate use SubutexÆand Dose Levels SuboxoneÆ(see The consensus panel believes that programs Dosage decisions chapter 3) to treat chronic opioid should monitor and adjust patientsí dose levels of methadone and other opioid treatment medi- should be appro- addiction in an office-based opioid cations to ensure that they receive therapeutic treatment (OBOT) dosages without regard to arbitrary dose-level priate and tailored or other health care ceilings that are unsupported by research evi- setting. dence. Dosage decisions should be appropriate to each patient. and tailored to each patient. Progress has been These alternatives made to ensure that patients receive the thera- are increasing access peutic dosage levels they need to remain stabi- to care as OTPs lized; however, the panel finds it troubling that broaden their range some OTPs still fail to prescribe medication in of treatment options, adequate doses (DíAunno and Pollack 2002). more physicians offer OBOT and become bet- ter trained in MAT principles and methods, and individuals with opioid addiction seek new

6 Chapter 1 Treating Patients Who Have medical maintenance, psychosocial interven- More Complex Problems tions, and moreóand program characteristics that have been demonstrated to improve reten- Complex problems can complicate patientsí tion and outcomes for patients. The consensus diagnosis and treatment. When TIP 1 was panel recommends that program administra- published, the opioid addiction treatment tors and treatment providers compare their system faced two major challengesóthe spread practices with these evidence-based practices of HIV/AIDS and the problem of untreated and make necessary changes where appropri- co-occurring disorders. The consensus panel ate. Moreover, OTPs should measure their believes that the provision of psychiatric ser- outcomes continuously, using appropriate pro- vices at or through OTPs has not kept pace gram evaluation tools, to improve treatment with best practices. It is critical that OTPs be quality (see chapter 14). Finally, OTPs may prepared to diagnose and treat co-occurring want to partner with the research community disorders aggressively, either directly or by to investigate and adopt new interventions for referral. This issue is discussed in chapter 12. improving outcomes.

The treatment system is grappling with the In addition, SAMHSA has established and implications of hepatitis C virus (HCV) infec- funded the Addiction Technology Transfer tion among people who inject drugs, with esti- Center (ATTC) Network, which is dedicated to mates of HCV infection in this group ranging improving the skills and knowledge of sub- from 60 percent on average nationwide stance abuse treatment providers and increas- (National Institute on Drug Abuse 2000) to 90 ing their awareness of research findings. percent in some regions (Thomas 2001). OTPs Regional centers in the ATTC Network seek to face the challenge of how to provide patient accomplish this goal by identifying and advanc- education and HCV testing for people who ing opportunities to improve addiction treat- inject drugs. ment through the dissemination of new infor- mation in response to emerging needs and Patterns of opioid abuse have changed in the developments in the treatment field. (For more past decade. For example, in some areas of the information, visit the ATTC Web site at country, patients are presenting with addiction www.nattc.org.) to pain management medications as a primary admission indication (CSAT 2001a; Office of National Drug Control Policy 2002). OTPs Expanding the Treatment report that patients addicted to pain manage- System ment medications require higher therapeutic methadone levels than other patients. Since the Although the number of patients enrolled in mid-1990s, the prevalence of lifetime heroin OTPs for addiction treatment has almost dou- use has increased for both youth and young bled since 1993, an estimated 898,000 people adults. From 1995 to 2002, the rate among chronically or occasionally use heroin in the youth ages 12 to 17 increased from 0.1 to 0.4 United States (Office of National Drug Control percent; among young adults ages 18 to 25, the Policy 2003). Only about 20 percent of people rate rose from 0.8 to 1.6 percent (Substance who use heroin are being treated. For people Abuse and Mental Health Services who abuse opioid medications normally Administration 2003c). obtained by prescription, the percentage in treatment is even lower. Promoting Evidence-Based Lack of funding for services remains a Treatment Services significant barrier to treatment. In many States, Medicaid does not reimburse MAT Throughout this TIP are many examples of services; accordingly, patients, many of whom types of interventionsócomprehensive MAT,

Introduction 7 have limited financial resources, are compelled NIDA stressed the importance of comprehen- to finance their treatment. sive treatment services by devoting 3 of the 13 principles of effective drug addiction treatment to comprehensive care (see Exhibit 1-1) Making Treatment Available (National Institute on Drug Abuse 1999). to Criminal Justice Populations The consensus panel believes that it is critical Criminal justice populations are in critical need to emphasize the central importance of compre- of opioid addiction treatment, yet most do not hensive care as more physicians begin to use have access to MAT (National Center on buprenorphine to treat chronic opioid addic- Addiction and Substance Abuse 1998; National tion in their private offices. Ideally, a full con- Drug Court Institute 2002; U.S. Department of tinuum of care should integrate the services of Justice 1999). Resistance to MAT by many in primary care physicians who dispense opioid the criminal justice system may be rooted in the treatment medications in private offices and traditional view that medical maintenance other medication units with the services provid- treatment is substitution of one drug for ed by counselors, case managers, and other another (National Center on Addiction and essential staff in OTPs. Substance Abuse 1998). The Rikers Island jail facility in New York City has been providing inmates access to methadone treatment since Combating Stigma 1987 (National Drug Court Institute 2002). For almost a century, the predominant view of Rhode Island jail facilities offer a 30-day opioid addiction has been that it is a self- dose-tapering program. The consensus panel induced or self-inflicted condition resulting understands that few other correctional institu- from a character disorder or moral failing and tions have provided MAT services. that this condition is best handled as a criminal matter (see chapter 2). Use of methadone and Promoting Comprehensive other therapeutic medications has been viewed traditionally as substitute therapyómerely Treatment replacing one addiction with another and the In its 1999 publication, Principles of Drug treatment of choice for those too weak to over- Addiction Treatment: A Research-Based Guide, come temptation. The stigma associated with

Exhibit 1-1

NIDA Comprehensive Care-Related Principles of Effective Drug Addiction Treatment

ï Effective treatment attends to multiple needs of the individual, not just his or her drug use. ï Counseling (individual and/or group) and other behavioral therapies are critical components of effective treatment for addiction. ï Medications are an important element of treatment for many patients, especially when combined with counseling and other behavioral therapies.

Source: National Institute on Drug Abuse 1999.

8 Chapter 1 MAT has been unique in its permeation of com- programs. Fortunately, positive changes are munity institutions, affecting the attitudes of occurring in each area. medical and health care professionals; social services agencies and workers; paraprofession- Positive stories about MAT in the media are als; employers, families, and friends of persons sometimes overshadowed by highly charged who are opioid addicted; and other people negative accounts, for example, stories about who formerly abused substances, as well as patients loitering outside OTPs or diversion of influencing criminal justice policies, creating take-home doses. SAMHSA, recognizing that political opposition, and limiting funding and ì[s]ignificant reduction in stigma and changes space for OTPs. in attitudes will require a concerted effort based on systematic researchî (CSAT 2000b, Although diversion control is an important part p. 4), has undertaken of MAT, public policy sometimes has seemed to a national educational place greater emphasis on protecting society campaign, titled from methadone than on the addiction, vio- Partners for lence, and infectious diseases that these medi- Recovery. Many OTP Managers and cations help alleviate (Institute of Medicine managers and staff 1995; Joseph et al. 2000; Nadelmann and members have isolat- staff members McNeeley 1996). The cost-effectiveness of MAT ed themselves from often has been overlooked (see chapter 2). their communities, should develop which contributes to Stigma affects patients in various ways. It negative stereotypes effective skills for discourages them from entering treatment and and media stories. prompts them to leave treatment early. It cre- Managers and staff ates a barrier for those trying to access other members should working with the parts of the health care system. A striking develop effective skills example is the failure of many medical practi- for working with the media. tioners to medicate pain adequately in this media. The consensus group. In addition, the refusal of some organ panel believes that the transplant programs to provide liver trans- patient advocacy plants to patients maintained on methadone movement also can advance a national educa- may be a result of stigma, as well as a lack of tional campaign about MAT. convincing data on outcomes for methadone patients who receive transplants. Strong efforts are needed to eliminate stigma within OTPs as well. Staff members should Stigma affects programs too. It prevents new treat patients with respect and pay attention programs from opening when community oppo- to the terms they use. The term ìsubstitution sition develops. It can affect a programís inter- treatmentî should be avoided because it incor- nal operations. Staff members who work in rectly implies that long-acting opioid medica- OTPs sometimes absorb societyís antipathy tions act like heroin and other short-acting toward patients in MAT and may deliver pro- opioids. Terms such as ìdirtyî and ìcleanî in gram services with a punitive or counterthera- reference to drug-test specimens should be peutic demeanor. OTPs must guard against replaced by more clinically useful terms such these attitudes through supervision, education, as ìpositiveî and ìnegative,î respectively. The and leadership efforts (see chapter 14). use of criminal justice terms such as ìproba- Several factors have made the destructive force tionary treatmentî should be replaced with of stigma particularly intractable, including the clinically appropriate language (see chapter 14). isolation of MAT from mainstream medicine, Finally, programs should become better neigh- negative media reports about treatment, and bors. Idle, perhaps intoxicated, patients who the public impressions made by poorly run

Introduction 9 remain near an OTP can become, by default, reinforce one another. The consensus panel the programís public representatives and easy hopes that this publication will advance high- targets for complaints from the community. quality care in OTPs by providing up-to-date Frequently, patient loitering is a result of insuf- information on science-based, best-treatment ficient program management. Patient conduct practices and by highlighting sound ethical in and around OTPs should be considered both principles of treatment. Equipped with this a treatment and a community relations concern. TIP, the accreditation standards, and a devel- oping alliance with the general medical commu- nity, OTPs should be able to improve and The Future of MAT expand effective opioid addiction treatment This is an exciting and challenging time for the throughout the country. MAT field, as positive changes accelerate and

10 Chapter 1 2 History of Medication- Assisted Treatment for Opioid Addiction

This chapter describes the history of opioid use and addiction in the United States; changes in the population groups affected by opioid In This addiction disorders; and this countryís social, political, legal, and medical responses. The chapter emphasizes factors affecting the develop- ChapterÖ ment and course of medication-assisted treatment for opioid addiction (MAT) in opioid treatment programs (OTPs). LoremEmergence ipsum dolorof Opioid Addictionsit as Opioid addiction has affected different population groups and socio- a Significant economic classes in the United States at different times. Societyís ProblemSed anddo the response has changed along with changes in the groups or classes most Rootseiusmod of affected, shifts in social and political attitudes toward opioid addiction, ControversyUt enim and the accumulation of more and better information about its causes and treatments (Musto 1999). The consensus panel for this TIP believes Originsad minim of Opioid veniam quis that an appreciation for the roots of opioid addiction and treatment is Maintenance important because attitudes and beliefs about opioid use and addiction DoloreTherapy eu that are rooted in U.S. history over the past 150 years continue to Regulatoryfugiat nulla History influence policies governing MAT. Emergence of Opioid Addiction as a Significant Problem and the Roots of Controversy Many of todayís substances of abuse including the opioidsóprimarily , , heroin, and some prescription opioidsógained their early popularity as curatives provided by physicians, pharmacists, and others in the healing professions or as ingredients in commercial prod- ucts ranging from pain elixirs and cough suppressants to beverages. These products usually delivered the benefits for which they were used, at least initially, such as pain relief, increased physical and mental ener- gy (or ìrefreshmentî), and reduced anxiety. For example, opioids were often the best available substances to relieve pain on Civil War battle- fields. Unfortunately, the uncontrolled use of opioids either for pre- scribed and advertised benefits or for nonmedicinal effects leads to

11 increased tolerance and addiction. Tolerance Consumer Reports (1972, p. 17) attribute to increases the need for larger quantities of opi- ìthe widespread medical custom of prescribing oids, more frequent use, or combination with opiates for menstrual and menopausal discom- other substances to fort, and the many proprietary opiates pre- sustain their effects; scribed for ëfemale troubles.í î Civil War veter- [O]pioids were it also increases the ans who were addicted by medical procedures severity of withdraw- composed another group, but their numbers al when addiction is were dwindling. By 1900, an estimated 300,000 prescribed widely not satisfied. Recog- persons were opioid addicted in the United nition of this prob- States (Brecher and Editors 1972; Courtwright to alleviate acute lem has spurred a 2001; Courtwright et al. 1989). long-running debate and chronic pain, among patients and During the late 19th and early 20th centuries, people who use U.S. society generally viewed iatrogenic addic- other types of dis- opioids, their fami- tion among women and disabled war veterans lies, physicians, sympatheticallyóas an unfortunate medical comfort, and researchers, commu- conditionóand treated these groups with nity leaders, patient tolerance and empathy, particularly because neither group presented major social problems . advocates, and government officials. (Courtwright 2001). Doctors usually prescribed This debate centers more opioids for these patients, and sanatori- on two different ums were established for questionable ìcuresî views: (1) opioid addiction is a generally incur- of the resulting addictions. The chronic nature able disease that requires long-term mainte- of opioid addiction soon became evident, how- nance with medication; or (2) opioid addiction ever, because many people who entered sanato- stems from weak will, lack of morals, other riums for a cure relapsed to addictive opioid psychodynamic factors, or an environmentally use after discharge. In Eugene OíNeillís autobi- determined predilection that is rectified by ographical drama ìLong Dayís Journey Into criminalization of uncontrolled use and distri- Night,î for example, his father refuses to bution and measures promoting abstinence. return OíNeillís mother, who is addicted, to a sanatorium because he is aware of the addictive qualities of morphine and is resigned to the The Changing Face of Opioid inevitability of relapse (Courtwright 2001). Addiction By the end of the 19th century, doctors became Opioid addiction first emerged as a serious more cautious in prescribing morphine and problem in this country during and after the other opioids, and the prevalence of opioid Civil War, when opioids were prescribed widely addiction decreased. Small groups still prac- to alleviate acute and chronic pain, other types ticed opium smoking, but most Americans of discomfort, and stress. Although a smaller regarded it as socially irresponsible and pattern of nonmedical opioid use continued as immoral. It is noteworthy, however, that well, mainly opium smoking among Chinese heroin, introduced in 1898 as a cough suppres- immigrants and members of the Caucasian sant, also began to be misused for its euphoric ìundergroundî (e.g., prostitutes, gamblers, qualities, gradually attracting new types of petty criminals), iatrogenic addiction was much users. This development, along with diffusion more common (White 1998). By the late 19th of the hypodermic technique of drug adminis- century, probably two-thirds of those addicted tration, which gained popularity between 1910 to opioids (including opium, morphine, and and 1920, had a profound effect on opioid use laudanum) were middle- and upper-class White and addiction in the 20th century and beyond women, a fact Brecher and the Editors of (Courtwright 2001).

12 Chapter 2 The size and composition of the U.S. opioid- Another major change in the U.S. opioid- addicted population began to change in the addicted population occurred after World early 20th century with the arrival of waves of War II. As many European immigrants moved European immigrants. Courtwright (2001) from crowded cities, Hispanics and African- portrays most users of opioids of this period as Americans moved into areas with preexisting young men in their 20s: ìdown-and-outsî of opioid abuse problems, and the more suscepti- recent-immigrant European stock who were ble people in these groups acquired the disorder crowded into tenements and ghettos and (Courtwright 2001; Courtwright et al. 1989). acquired their addiction during adolescence or early adulthood. They often resorted to illegal The post-World War II shift in the composition means to obtain their opioids, usually from of opioid-addicted groups coincided with hard- nonmedical sources and specifically for the ening attitudes toward these groups, leading euphoric effects. ìGone was the stereotype of some researchers to conclude that stigmatiza- the addicted matron; in its place stood that of tion of people with addiction disorders and the street criminalî (Courtwright 2001, p. 1). their substances of abuse reflected, at least in part, class and ethnic biases. A portion of U.S. The initial treatment response in the early 20th society appeared to view with disdain and fear century continued to involve the prescriptive the poor White, Asian, African-American, and administration of short-acting opioids. By the Hispanic people with addiction disorders who 1920s, morphine was prescribed or dispensed lived in the inner-city ghettos (Courtwright et in numerous municipal treatment programs al. 1989). (Courtwright et al. 1989). Brecher and the Editors of Consumer Reports Addictive use of opium, cocaine, and heroin, (1972) point out that, by the mid-1960s, the along with drug-related crime, especially in number of middle-class young White Americans poor urban communities, increasingly con- using heroin was on the rise, as was addiction- cerned social, religious, and political leaders. related crime. By the 1970s, U.S. military The tolerance and empathy shown toward Civil involvement in Vietnam also was having an War veterans and middle-aged women evapo- effect. From one-fourth (Brecher and Editors rated; negative attitudes toward and discrimi- 1972) to one-half (Courtwright 2001) of nation against new immigrants probably col- American enlisted men in Vietnam were ored views of addiction. Immigrants and others believed to have used or become addicted to who trafficked in and abused drugs were heroin; however, White (1998) points out that viewed as a threat. As detailed below, societyís the feared epidemic of heroin addiction among response was to turn from rudimentary forms returning veterans did not materialize fully. He of treatment to law enforcement (Brecher and concludes, ìVietnam demonstrated that a pat- Editors 1972; Courtwright 2001; Courtwright et tern of drug use could emerge in response to a al. 1989). For more on trends in the 1920s and particular environment and that spontaneous 1930s, see ìEarly treatment effortsî below. remission could occur when the environment was changedî (p. 303). McCoy (n.d.) refers to a forced decline in opioid addiction during World War II, brought By the 1980s, an estimated 500,000 Americans about by restrictions on shipping and strict used illicit opioids (mainly heroin), mostly poor port security, which produced a marked hiatus young minority men and women in the inner in global opium trafficking and caused the U.S. cities. Although this number represented a opioid-addicted population to drop to a historic 66-percent increase over the estimated number low of about 20,000. Once smuggling resumed of late 19th-century Americans with opioid after the war, the population that had used addiction, the per capita rate was much less opioids resumed the habit. than in the late 19th century because the population had more than doubled

History of Medication-Assisted Treatment for Opioid Addiction 13 (Courtwright et al. 1989). Nevertheless, and physicians had to be licensed, keep records addiction became not only a major medical for inspection, and pay modest fees to the U.S. problem but also an explosive social issue Department of the Treasury, referred to here- (Courtwright 2001; Courtwright et al. 1989). after as Treasury.

By the end of the 1990s, an estimated 898,000 The act permitted physicians and dentists to people in the United States chronically or occa- dispense or distribute opioids ìto a patient . . . sionally used heroin (Office of National Drug in the course of [the physicianís] professional Control Policy 2003), and the number seeking practice onlyî (38 Stat. 786 [1914]). Although treatment was approximately 200,000 (almost this provision permitted physicians to prescribe double the number during the 1980s). The or dispense opioids so long as they kept the abuse of opioids that normally were obtained required records, Treasury interpreted the act by prescription was a growing concern because as a prohibition on physiciansí prescribing opi- of both their damaging effects and their poten- oids to persons with addictions to maintain tial as gateway drugs to other substance use. their addictions. (Treasury was the agency Treatment admission rates for addiction to opi- responsible for enforcing the Harrison Act as oid analgesics more than doubled between 1992 well as prohibition laws.) Treasuryís position and 2001 (Substance Abuse and Mental Health appeared to be that addiction is not a disease Services Administration 2004), and visits to and the person with an addiction, therefore, emergency rooms related to opioid analgesic was not a patient. It followed that any physi- abuse increased 117 percent between 1994 and cian prescribing or dispensing opioids to such 2001 (Substance Abuse and Mental Health individuals was not doing so in the ìcourse of Services Administration 2003b). his professional practiceî (White 1998). In 1919, the United States Supreme Court upheld Treasuryís interpretation. This interpretation Societyís Changing Response and enforcement of the Harrison Act effectively ended, until well into the 1960s, any legitimate The Harrison Narcotic Act of role for the general medical profession in 1914 medication-assisted treatment for Americans The Pure Food and Drug Act of 1906, which who had drug addictions (White 1998). required medicines containing opioids to say so on their labels, was the first national response Early treatment efforts to the changing image of people with addictions Until the 1919 Supreme Court decision uphold- (Brecher and Editors 1972). The Harrison ing Treasuryís interpretation of the Harrison Narcotic Act of 1914 was the earliest significant Act, numerous municipalities with large num- Federal attempt to place strict controls on opi- bers of residents who were opioid addicted oids and other substances (Brecher and Editors were operating treatment clinics in which 1972). Although U.S. mercantile and trade morphine was prescribed or dispensed. Some interests were also at stake, the widely held clinics prescribed heroin and cocaine perception that people with addictions generally (Courtwright et al. 1989). These early OTPs were members of a White criminal underclass varied in how they functioned; some provided or a Chinese minority has been portrayed as detoxification treatment and others adopted a an underlying motivation for the statute maintenance policy (Courtwright 2001; Gewirtz (Courtwright 2001; Courtwright et al. 1989). 1969). Perhaps the best known of these early The Harrison Act was conceived not as a prohi- OTPs were the Department of Health program bition law but as a measure to regulate the in New York City, where those with addictions manufacture, distribution, and prescription of were detoxified with decreasing doses of heroin opioids, coca, and their derivatives. Under the and morphine, and the program established by actís provisions, manufacturers, pharmacists, Dr. Willis Butler in Shreveport, Louisiana,

14 Chapter 2 which not only detoxified patients but also The increase in heroin addiction in New York maintained some of them on morphine City after World War II led, in 1952, to the (Courtwright et al. 1989). establishment of Riverside Hospital for adoles- cents with addiction disorders. This program Courtwright and others state that Treasury also proved to be a failure. A followup study in regarded these clinics as a threat to its anti- 1956 showed a high posttreatment relapse rate maintenance philosophy. By the early 1920s, it (e.g., at least 86 percent of patients admitted in had succeeded in closing them through legal 1955), and the Riverside facility was closed in pressure, critical inspections, and threats. The 1961 (Brecher and Editors 1972). last program to be closed was Dr. Butlerís in Shreveport (Courtwright 2001; Courtwright et al. 1989). Experiment in civil commitment In the 1920s, an increase in crime related to the acquisition of illicit opioids was reported in Civil commitment is portrayed by Brecher and cities throughout the country. In 1929, the Editors of Consumer Reports (1972) and Congress appropriated funds to establish two White (1998) as legislation enabling those with new treatment facilities, initially called ìnar- substance addiction and those ìin imminent cotics farmsî (White 1998), in Fort Worth, danger of becoming addictedî (White 1998, p. Texas, and Lexington, Kentucky. The 250) to be confined in rehabilitation centers Lexington facility, which opened to patients in without having first committed or been convict- 1935, was renamed the U.S. Public Health ed of a crime. Civil commitment was instituted Service Narcotics Hospital in 1936. These insti- in California and New tutions detoxified patients with opioid addic- York in the 1960s to tion who entered voluntarily, and they also allay fears about served as hospitals for prison inmates who had addiction-related Treasuryís posi- opioid addictions and were legally committed crimes against people through a Federal court. The prescribed stay and property in the tion appeared to was about 6 months, although some patients inner cities. People stayed longer. Prisoners could stay for up to 10 with addictions could be that addiction years. These hospitals offered social, medical, be committed to psychological, and psychiatric services in facilities through a is not a disease... addition to detoxification and had a low voluntary process that included a patient-to-staff ratio (about 2 to 1), but the and the personÖ atmosphere was described as prisonlike, espe- medical examination to validate the pres- cially at the Lexington facility (White 1998). not a patient. Two major followup studies showed the pro- ence of an addiction, gram to be a failure. One reported a relapse or they could be rate of 93 percent in 1,881 former patients over committed for 3 years a 1.0- to 4.5-year followup period (Hunt and when arrested on a Odoroff 1962). The second found a relapse rate misdemeanor charge, as an alternative to a of 97 percent in 453 former patients over fol- jail sentence. The civil commitment program lowup periods of 6 months to 5 years (Duvall et instituted in New York in 1966 turned out to be al. 1963). The Lexington hospital facility was exceedingly expensive, and the positive results turned over to the Bureau of Prisons in 1974 were minimal (Brecher and Editors 1972; (Courtwright et al. 1989). Despite the failure of Inciardi 1988). The great majority of those these programs, White credits the research admitted, treated, and paroled to aftercare conducted there with providing ìmuch of the programs dropped out of these programs, and foundation upon which modern treatment they usually could not be located. A review of advances were builtî (White 1998, p. 126). Californiaís civil commitment experience in the

History of Medication-Assisted Treatment for Opioid Addiction 15 1960s showed that five of every six patients people with opioid addictions were arrested for committed for addictions and subsequently drug-related crimes (e.g., possession, sales, placed on aftercare relapsed, were rearrested, robbery, burglary), and overcrowded jails had dropped out of treatment, died, or were no effective method to ease detoxification removed from the program by writs of habeas (Inciardi 1988; Joseph and Dole 1970). By 1968, corpus (Joseph 1988; Joseph and Dole 1970). the Manhattan County Jail for Men (also known as the Tombs) had been wracked by riots Although statutes permitting involuntary com- blamed on poor living conditions, severe over- mitment might remain on the books in some crowding, and lack of medical care for inmates States, such laws rarely have been used to com- with drug addictions. mit people who abuse substances and who are not under criminal justice jurisdiction (Anglin As the incidence of addiction and related crimi- 1988). Court decisions after the 1960s generally nal activity rose dramatically in urban areas, have required that an individual be a danger to concern grew in the legal and medical commu- himself or herself or others before the legal sys- nities because increased incarceration had tem can use involuntary commitment (e.g., failed to stem the tide. The legal and medical OíConnor v. Donaldson, 422 U.S. 563, 1975). professions were perturbed by the post-World War II rise in opioid addiction in the United The search for alternatives States and the ineffectiveness of Federal regula- tory policy. In 1958, a joint committee of the In New York, death rates associated with the American Bar Association and the American injection of heroin increased from 7.2 to 35.8 Medical Association (AMA) issued a report per 10,000 deaths between 1950 and 1961 recommending that an outpatient facility (Frank 2000; Joseph et al. 2000). In the 1960s prescribing opioids to treat addiction be estab- and 1970s, more than 150,000 names were lished on a controlled experimental basis added to the (Brecher and Editors 1972). Narcotics Register in New York City. Other groups voiced support for the concept of Support for opioid (The Narcotics opioid maintenance programs. The New York Register, active Academy of Medicine recommended, in 1955 maintenance grew, from 1967 to 1974, and again in 1963, that clinics be established in was a list of known affiliation with hospitals to dispense opioids in a especially because or suspected persons controlled manner to patients addicted to illicit with addictions.) opioids. In 1956, the AMA advocated a research project to investigate the feasibility of no effective By the middle to dispensing opioids in an OTP. In 1963, the late 1960s, Kennedy administrationís Advisory Commission psychosocial alter- illicitñopioid-related on Narcotic and Drug Abuse also recommended mortality had research to determine the effectiveness of out- native existed to become the leading patient OTPsí dispensing of opioids to people cause of death for addicted to opioids (Brecher and Editors 1972). treat the large young adults from In the early 1970s, faced with increased opioid- ages 15 to 35 in New related drug use and crimes, the Nixon admin- York City. The number of people istration greatly increased funding to stem the number of serum supply of illicit opioids, primarily heroin, hepatitis (now with opioid entering the United States. It also greatly called hepatitis B) increased funding for methadone maintenance, cases related to con- and the number of patients receiving methadone addictions. taminated needles increased from 9,000 in 1971 to 73,000 in 1973 also was increasing. (Courtwright 2001). Support for opioid Record numbers of

16 Chapter 2 maintenance grew, especially because no effec- time for patients to remain stable (Brecher and tive psychosocial alternative existed to treat the Editors 1972). Other short-acting opioids, such large number of people with opioid addictions. as heroin, , , and meperidine (DemerolÆ), showed similar results (Dole 1980, 1988). Origins of Opioid Maintenance Therapy Development of methadone With short-acting opioids eliminated as options Development of Medications for maintenance therapy, research focused on To Treat Opioid Addiction methadone. Methadone appeared to be longer acting and effective when administered orally. Early rationale for It also was selected on the basis of observations of its use in patients withdrawing from heroin methadone maintenance and as an analgesic in the experimental treat- treatment ment of pain (Dole 1980, 1988). In 1964, tech- In 1962, Dr. Vincent P. Dole, a specialist in nology was not available to measure blood levels metabolism at The Rockefeller University, of heroin, morphine, or methadone to assess became chair of the Narcotics Committee of the duration of action. Proof of the efficacy of Health Research Council of New York City. methadone maintenance treatment depended After studying the scientific, public health, and on observation and recognition by researchers. social ramifications of addiction in the city, he In an initial study, methadone was adminis- received a grant to establish a research unit to tered to two patients previously maintained on investigate the feasibility of opioid mainte- morphine. Once tolerance for daily doses of 50 nance. In preparing for this research, he read to 120 mg was established, patients could func- The Drug Addict as a Patient by Dr. Marie E. tion normally without the anxiety associated Nyswander (Nyswander 1956), a psychiatrist with drug craving (White 1998). During this with extensive experience treating patients who research, the following important findings were addicted to opioids. She was convinced about methadone maintenance were noted, all that these individuals could be treated within supporting its efficacy and benefits (Dole 1980, general medical practice. She also believed that 1988): many would have to be maintained on opioids for extended periods to function because a ï Patients did not experience euphoric, tran- significant number of people who attempted quilizing, or analgesic effects. Their affect abstinence without medication relapsed, in and consciousness were normal. Therefore, spite of detoxifications, hospitalizations, and they could socialize and work normally with- psychotherapy (Brecher and Editors 1972; out the incapacitating effects of short-acting Courtwright et al. 1989). Dr. Nyswander joined opioids such as morphine or heroin. Dr. Doleís research staff in 1964. Among others ï A therapeutic, appropriate dose of methadone joining the team was clinical investigator Dr. reduced or blocked the euphoric and tran- Mary Jeanne Kreek. quilizing effects of all opioid drugs examined These researchers realized that morphine, (e.g., morphine, heroin, meperidine, and which is related to heroin, was not a good opium), regardless of whether a patient choice as an opioid maintenance drug because injected or smoked the drugs. patientsí social functioning was impaired by ï No change usually occurred in tolerance morphineís sedating effects (White 1998). Also, levels for methadone over time, unlike for the short half-life of morphine required several morphine and other opioids; therefore, a injections per day, and, as tolerance developed, dose could be held constant for extended increasing amounts were needed over a short periods (more than 20 years in some cases).

History of Medication-Assisted Treatment for Opioid Addiction 17 ï Methadone was effective when administered initiative to treat opioid addiction under the orally. Because it has a half-life of 24 to 36 leadership of Dr. Jerome Jaffe, who headed the hours, patients could take it once a day Special Action Office for Drug Abuse without using a syringe. Prevention in the Executive Office of the White ï Methadone relieved the opioid craving or House in the early 1970s. Dr. Jaffeís office hunger that patients with addiction described oversaw the creation of a nationwide, publicly as a major factor in relapse and continued funded system of treatment programs for illegal use. opioid addiction. ï Methadone, like most opioid-class drugs, caused what were considered minimal side Development of LAAM effects, and research indicated that Like methadone, levo-alpha acetyl methadol methadone was medically safe and nontoxic. (LAAM) was classified as a U.S. Drug Enforcement Administration (DEA) schedule II Expansion of methadone controlled substance (i.e., having a high poten- maintenance from research tial for abuse but also a currently accepted medical use) that creates a pharmacologic project to public health cross-tolerance for other opioids and therefore program blocks their euphoric effects while controlling opioid craving. Whereas methadone suppressed In 1965, the initial research project on symptoms for 24 hours or methadone safety and efficacy was transferred longer, LAAM achieved this effect for 48 to 72 to Manhattan General Hospital in New York hours or longer. City (Brecher and Editors 1972). Because Dole and his colleagues knew that an independent LAAM was first developed in 1948 by German evaluation of this new treatment would be chemists as an analgesic (Finn and Wilcock necessary, a team headed by Dr. Frances Rowe 1997). By the late 1960s, interest arose in Gearing was formed at Columbia University LAAM as an alternative to methadone School of Public Health to evaluate patient (American Association for the Treatment of progress as this treatment expanded. In general, Opioid Dependence n.d.). Between 1969 and the team found that patientsí social functioning 1981, 27 separate studies of more than 6,000 improved with time in treatment, as measured patients established LAAMís safety and efficacy by elimination of illicit-opioid use and better (National Institute on Drug Abuse 1993a). The outcomes in employment, school attendance, U.S. Food and Drug Administration (FDA) and homemaking. Most patients were stabilized approved LAAM for use in OTPs in July 1993 on methadone doses of 80 to 120 mg/day. Most (National Institute on Drug Abuse 1993a). patients who remained in treatment subse- quently eliminated illicit-opioid use. However, Later studies continued to confirm that LAAM 20 percent or more of these patients also had was an effective alternative to methadone and entered treatment with alcohol and polysub- was preferred by some patients (Glanz et al. stance abuse problems, despite intake screening 1997). However, in April 2001, based on that attempted to eliminate these patients from reported LAAM-related disturbances in cardiac treatment (Gearing and Schweitzer 1974). function, FDA and Roxane Laboratories, Inc., Methadone treatment was continued for these manufacturer of ORLAAMÆ, strengthened the patients, along with attempts to treat their warnings in LAAM product labeling (Haehl alcoholism and polysubstance abuse. Further 2001). The American Association for the evaluation, research, and expansion of the Treatment of Opioid Dependence has issued program ultimately were recommended (Joseph clinical guidelines for LAAM (American and Dole 1970) and instituted. Methadone Association for the Treatment of Opioid maintenance became a major public health Dependence n.d.). At this writing, only 3

18 Chapter 2 percent of patients enrolled in maintenance Public Policy Studies and programs in the United States are receiving Reports Since 1993 LAAM (Substance Abuse and Mental Health Services Administration 2002a). Analyses since the publication of TIP 1 have shown that maintenance treatment for opioid In 2003, Roxane Laboratories announced that addiction is effective in both treatment out- it would stop producing LAAM on January 1, comes and costs. 2004 (Schobelock 2003), making LAAMís con- tinued availability doubtful. This TIP contin- California Drug and Alcohol ues to include basic, limited coverage of LAAM in discussions of opioid medications because of Treatment Assessment its clinical significance and relevance in MAT. In 1994, the California Department of Alcohol Development of and Drug Programs AnalysesÖhave buprenorphine published the results of a pioneering large- shown that main- Information on the development of the latest scale study of the successful maintenance medication, buprenor- effectiveness, benefits, tenance treatment phine, is in ìDEA classification of buprenor- and costs of substance phineî below and TIP 40, Clinical Guidelines abuse treatment in for the Use of Buprenorphine in the Treatment California. Using State for opioid addic- of Opioid Addiction (CSAT 2004a). databases, provider records, and followup tion is effective in Development of naltrexone interviews with treat- ment participants, the both treatment Naltrexone is the only pure opioid antagonist of study detailed the the medications described here (see chapter 3). effects of treatment on In the early 1980s, the National Institute on outcomes and participant behavior Drug Abuse (NIDA) completed initial testing of including drug and naltrexone to treat opioid addiction, and FDA costs. alcohol use, criminal approved naltrexone for this use in 1984. In activity, health, health 1995, naltrexone also received FDA approval care use, and income; as a preventive treatment for relapse to alcohol the costs of treatment; and the economic value of use among patients dependent on alcohol. Some treatment to society (Gerstein et al. 1994). opioid treatment providers have found that naltrexone is most useful for highly motivated Among the California Drug and Alcohol patients who have undergone detoxification Treatment Assessmentís findings were the from opioids and need additional support following: to avoid relapse or who desire an expedited detoxification schedule because of external ï Treatment was cost beneficial to taxpayers, circumstances. Naltrexone also may benefit with the cost averaging $7 returned for every some patients in the beginning stages of opioid dollar invested (Gerstein et al. 1994). ìEach use and addiction. Other patient groups day of treatment paid for itself (the benefits frequently have demonstrated poor compliance to taxpaying citizens equaled or exceeded the with long-term naltrexone therapy, mainly costs) on the day it was received, primarily because naltrexone neither eases craving for through an avoidance of crimeî (Gerstein et the effects of illicit opioids when used as direct- al. 1994, p. iv). ìRegardless of the modality ed nor produces withdrawal symptoms when of care, treatment-related economic savings discontinued (Tai et al. 2001). outweighed costs by at least 4 to 1î (Gerstein et al. 1994, p. 90).

History of Medication-Assisted Treatment for Opioid Addiction 19 ï Methadone treatment was among the most ï Encourage programs to provide comprehen- cost-effective treatments, yielding savings of sive services, such as individual and group $3 to $4 for every dollar spent. This was true counseling and medical care for each major methadone treatment modali- ï Emphasize the need for continuing clinical ty, but costs were lower in an outpatient OTP assessment throughout treatment than in a residential or social modality ï End arbitrary restrictions on OTP practices. (Gerstein et al. 1994). ï Patients in methadone maintenance showed the greatest reduction in intensity of heroin National Institutes of Health use, down by two-thirds, of any type of opi- In 1997, a National Institutes of Health (NIH) oid addiction treatment studied. consensus panel called for expansion of ï Patients in methadone maintenance showed methadone maintenance treatment. It identified the greatest reductions in criminal activity such barriers as the publicís misperception of and drug selling, down 84 percent and 86 persons who are opioid addicted not as individ- percent, respectively, of any type of opioid uals with a disease but as ìotherî or ìdifferent,î addiction treatment studied. the misperception ìthat [addiction] is self- induced or a failure of willpower and that ï Health care use decreased for all treatment efforts to treat it inevitably fail,î and overregu- modalities; participants in methadone main- lation of methadone treatment that limits the tenance treatment showed the greatest reduc- flexibility and responsiveness of treatment tion in the number of days of hospitalization, programs (National Institutes of Health 1997b). down 57.6 percent, of any modality. That panel called for the following: Institute of Medicine ï Federal leadership to inform the public that opioid addiction is a medical disorder that In 1995, the Institute of Medicine (IOM) pro- can be treated effectively, with significant duced a study titled Federal Regulation of benefits for the patient and society Methadone Treatment (Institute of Medicine 1995). This study ï Access to methadone treatment for persons concluded that FDA under legal supervision (e.g., probation, regulations were parole, incarceration) For more than inhibiting physicians ï Increase in funding for methadone mainte- from exercising their nance treatment three decades, professional judg- ï Reduction in unnecessary regulation of MAT, ment; isolating including methadoneís use to methadone treat- ment from main- ñ Replacement of FDA regulation and stream medicine, oversight of MAT with more effective, less treat addiction has thereby depriving expensive measures, such as accreditation, patients of important to improve the quality of methadone been subjected to ancillary services; treatment and discouraging ñ Revision of DEA regulations to eliminate extensive Federal, research into new the extra level of regulation placed on medications. This methadone compared with other schedule State, and local IOM study recom- II opioids, thereby encouraging more mended that the physicians and pharmacies to prescribe regulation. Federal and dispense methadone and making regulatory process maintenance treatment available in more be modified to locations

20 Chapter 2 ñ Faster approval of new medications for recognized the use of an opioid drug to treat MAT by FDA and the States opioid addiction as critical and, for the first ñ Expansion of the availability of time in Federal law, defined ìmaintenance maintenance pharmacotherapy to States treatment.î To promote closer monitoring of and programs where it is currently programs that use opioids for maintenance unavailable. treatment, the law required separate DEA registration by medical practitioners who dis- pense opioid drugs in the treatment of opioid Regulatory History addiction. Previously, any physician with a DEA registration could prescribe methadone For more than three decades, methadoneís use for pain management or addiction treatment. to treat addiction has been subjected to extensive This act also increased coordination between Federal, State, and local regulation. (For a the U.S. Department of Health and Human detailed history of Federal regulation of Services (DHHS) and DEA. Under its provi- methadone treatment, see chapter 5 in the IOM sions, before a practitioner can obtain regis- report [1995] edited by Rettig and Yarmolinsky.) tration from DEA, DHHS must determine that the practitioner is qualified according to Laws Related to Controlled established treatment standards. Substances as Addiction The Narcotic Addict Treatment Act also Treatment Medications established NIDA as an institute independent of the National Institute of Mental Health. Congress has enacted several significant Authority to regulate the treatment of opioid statutes since 1970 to limit and control the addiction was split between NIDA and FDA. availability of psychoactive drugs and their use NIDA became responsible for determining to treat addiction. appropriate standards for medical, scientific, and public health aspects of drug abuse treat- Controlled Substances Act ment. FDA received the authority to determine (1970) the safety and effectiveness of drugs and approve new drugs for opioid addiction The Controlled Substances Act of 1970 (Public treatment. Law [P.L.] 91ñ513) requires all manufacturers, distributors, and practitioners who prescribe, dispense, or administer controlled substances Drug Addiction Treatment to register with DEA. A physician seeking Act (2000) registration must meet certain standards estab- The Drug Addiction Treatment Act of 2000 lished by the Secretary of Health and Human (DATA [P.L. 106ñ310 div. B]) amended that Services and must comply with regulations portion of the Controlled Substances Act man- established by the U.S. Attorney General dating separate registration for practitioners regarding security of opioid stocks and mainte- who dispense opioids in addiction treatment. It nance of records. allows practitioners who meet certain qualify- ing criteria to dispense or prescribe schedule Narcotic Addict Treatment III, IV, or V controlled substances specifically Act (1974) approved by FDA for MAT. Chapter 3 describes the specific requirements that physi- In passing the Narcotic Addict Treatment Act cians must satisfy under DATA provisions, of 1974 (P.L. 93ñ281), which amended the including the requirement that physicians must Controlled Substances Act, Congress

History of Medication-Assisted Treatment for Opioid Addiction 21 have the capacity to refer patients for needed practice of medicine, and from addiction counseling and other ancillary services. treatment specialists, who pointed out that proscriptive regulations failed to leave room DEA classification of for treatment innovation. (See comments on the new rules in their proposed form [Federal buprenorphine Register 64:39812ñ39814].) On October 8, 2002, DEA completed its evaluation of buprenorphine, classifying it as a The movement away from a compliance schedule III drug (i.e., having potential for orientation and toward an accreditation abuse and a currently accepted medical use in model was supported by a number of reviews, treatment but less potential for addiction than including the 1997 NIH consensus develop- schedule II drugs). FDA made buprenorphine ment conference on Effective Treatment of the first drug approved for treatment of opioid Opiate Addiction and the review of 1972 FDA addiction in physiciansí offices (CSAT 2004a; regulations by IOM (Institute of Medicine Substance Abuse and Mental Health Services 1995). Interest in accreditation grew because Administration 2003a; see also chapter 3). of its emphasis on self-assessment and improvement and on integration of quality assurance and performance elements devel- History of Methadone oped by expert accreditation organizations. Regulation In addition, trends in national health care fueled movement toward accreditation. Federal regulation Many managed care organizations require all accredited health care practitioners to In 1972, FDA issued regulations governing demonstrate quality care. Several States eligibility, evaluation procedures, dosages, grant exemptions from State licensing take-home medications, frequency of patient requirements (called ìdeemed statusî) to visits, medical and psychiatric services, coun- accredited health care facilities. seling, support services, and related details for methadone treatment Final regulations issued by DHHS and the programs. Several Substance Abuse and Mental Health Services modifications were Administration (SAMHSA) on January 17, The new made to these regula- 2001, effective May 18, 2001, govern the use of tions during the methadone and LAAM in both maintenance regulations 1980s. Until 2001, and detoxification treatments for opioid addic- FDA was responsible tion. The 1972 FDA regulations were repealed, acknowledged that for approving these and a new accreditation-based regulatory programs and ensur- system was created. The new system shifted ing compliance with administration and oversight from FDA to addiction is a FDA regulations. SAMHSA. The new regulations acknowledged that addiction is a medical disorder not medical disorder As experience with amenable to one-size-fits-all treatment. They the effectiveness of recognized that different patients, at different not amenable to methadone grew, times, could need vastly different services. criticism of the 1972 one-size-fits-all FDA regulations Accreditation itself is a peer-review process increased from that evaluates a treatment program against physicians, who SAMHSAís opioid treatment standards and treatment. complained that the accreditation standards of SAMHSA-approved regulations placed accrediting bodies (42 Code of Federal burdens on their Regulations, Part 8). It includes site visits by

22 Chapter 2 specialists with experience in opioid pharma- The consensus panel for this TIP expects the cotherapy and related activities. accreditation process to result in an integrated and individualized approach to services, The new regulations establish an entirely increased patient satisfaction, better staff different regulatory and oversight structure for recruitment, enhanced community confidence MAT. The DEA role remains the same, but and outcomes, and improvements in quality FDAís authority to approve and monitor pro- of care. The shift to accreditation enables grams has been transferred to SAMHSA. SAMHSA to focus its oversight efforts on Instead of detailed proscriptive rules, the new improving treatment rather than ensuring that regulations set forth general certification programs are meeting regulatory criteria. requirements and Federal opioid treatment standards. These are elaborated in best- practice guidelines and in accreditation States ìelementsî (or standards) developed by the The new Federal regulations preserve Statesí SAMHSA-approved accreditation bodies. authority to regulate OTPs. Oversight of treat- SAMHSA has employed a series of expert pan- ment medications remains a tripartite system els to develop guidelines for an accreditation- involving States, DHHS/SAMHSA, and the based certification system. Placing detailed U.S. Department of Justice/DEA. practice criteria in accreditation standards rather than in regulations permits SAMHSA States can monitor the same areas as Federal and the accreditation bodies to update the stan- agencies, but State rules do not always echo dards as needed. Federal regulations. Some States have estab- lished medical recertification requirements for The new regulations provide that, once a continuation of comprehensive, long-term MAT program is accredited, SAMHSA uses accredi- after a specified period. Other State and local tation results along with other data to deter- requirements, such as certificates of need, zon- mine whether the program is qualified to ing, and licensure, can affect the number, size, carry out treatment under the standards in and location of OTPs. These regulations are not the regulations. SAMHSA maintains oversight affected by the change in Federal regulations. of accreditation elements in its review of accreditation bodiesí initial and renewal applications.

History of Medication-Assisted Treatment for Opioid Addiction 23

3 Pharmacology of Medications Used To Treat Opioid Addiction

This chapter reviews the pharmacology and clinical applications of the principal medications used to treat opioid addiction in opioid treatment In This programs (OTPs), including the opioid agonists methadone and levo- ChapterÖIn This alpha acetyl methadol (LAAM), the partial opioid agonist buprenor- Chapter… phine, and the opioid antagonist naltrexone. Coverage of LAAM is brief because its future availability is uncertain. Coverage of buprenorphine is Lorem ipsum dolor short because TIP 40, Clinical Guidelines for the Use of Buprenorphine Pharmacologysit and Pharmacotherapy in the Treatment of Opioid Addiction (CSAT 2004a), discusses its phar- Sed do macology in more detail. Coverage of naltrexone is short because its use Dosageeiusmod Forms in the United States generally has been limited to easing withdrawal symptoms for a small portion of patients undergoing medically super- EfficacyUt enim vised withdrawal after maintenance treatment. Exhibit 3-1 provides ad minim information about these and other medications for opioid addiction Side Effects veniam quis treatment, including the year of their U.S. Food and Drug Interactions With Administration (FDA) approval and their U.S. Drug Enforcement Dolore eu Other Therapeutic Administration (DEA) drug schedule assignment. fugiat nulla Medications The most frequently used medication for opioid addiction treatment in Safety OTPs is methadone, and much of this chapter focuses on methadone pharmacology. LAAM always has been used much less than methadone, and its use was reduced further in 2001, after it was associated with car- diac arrhythmia in some patients. That association led FDA to warn that LAAM be used only for patients not responding well to methadone. That warning and other factors led the manufacturer to cease production of LAAM on January 1, 2004 (Schobelock 2003), making its continued availability uncertain after depletion of existing stocks. Programs were encouraged to transfer patients using LAAM to other treatments. Another pharmaceutical company may manufacture and distribute LAAM in the future.

FDA approved buprenorphine on October 8, 2002, for use in medical maintenance treatment and medically supervised withdrawal. It is the first partial opioid agonist in recent U.S. history available for use by cer- tified physicians outside the traditional opioid treatment delivery system and the strict requirements of the Narcotic Addict Treatment Act of 1974

25 Exhibit 3-1

Pharmacotherapeutic Medications for Opioid Addiction Treatment

Receptor FDA DEA Product Formulations Pharmacology Approval Schedule Treatment Settings Methadone Oral solu- Full mu Never II OTP tion, liquid opioid agonist formally concentrate, approved tablet/ by FDA diskette, and powder LAAM Oral Full mu 1993 II OTP solution opioid agonist Buprenor- Sublingual Partial mu 2002 III Physicianís office, phine tablet opioid agonist OTP, or other health (SubutexÆ) care setting Buprenor- Sublingual Partial 2002 III Physicianís office, phine- tablet mu opioid OTP, or other health naloxone agonist/mu care setting (SuboxoneÆ) antagonist Naltrexone Oral tablet Mu opioid 1984 Not Physicianís office, antagonist scheduled OTP, any substance abuse treatment program

(see chapter 2). In addition, on May 22, 2003, (DATA). (More information about DATA and an interim rule change made buprenorphine waivers can be found at www.buprenorphine. available for use in OTPs that receive certifica- samhsa.gov; also see Boatwright 2002.) tion from the Substance Abuse and Mental Health Services Administration (SAMHSA) to The consensus panel for this TIP expects that dispense buprenorphine. Physicians working in the availability of buprenorphine in multiple medical offices or other appropriate settings settings will increase the number of patients in must obtain a waiver from SAMHSA to use treatment and that its availability in physi- buprenorphine to treat opioid addiction (see ciansí offices and other medical and health Exhibit 3-2). Qualified physicians may dispense care settings should help move medical mainte- or prescribe buprenorphine products for up to nance treatment of opioid addiction into main- 30 patients at a time under the provisions of stream medical practice. the Drug Addiction Treatment Act of 2000

26 Chapter 3 Exhibit 3-2

Requirements for Physiciansí Waivers To Dispense or Prescribe Buprenorphine and Buprenorphine-Naloxone to Patients Who Are Opioid Addicted

ì To qualify for a waiver under DATA 2000 a licensed physician (MD or DO) must meet any one or more of the following criteria:

ï The physician holds a subspecialty board certification in addiction psychiatry from the American Board of Medical Specialties. ï The physician holds an addiction certification from the American Society of Addiction Medicine. ï The physician holds a subspecialty board certification in addiction medicine from the American Osteopathic Association. ï The physician has, with respect to the treatment and management of opioid- addicted patients, completed not less than eight hours of training (through classroom situations, seminars at professional society meetings, electronic communications, or otherwise) that is provided by the American Society of Addiction Medicine, the American Academy of Addiction Psychiatry, the American Medical Association, the American Osteopathic Association, the American Psychiatric Association, or any other organization that the Secretary [of Health and Human Services] determines is appropriate for purposes of this subclause. ï The physician has participated as an investigator in one or more clinical trials leading to the approval of a narcotic drug in schedule III, IV, or V for maintenance or detoxification treatment, as demonstrated by a statement submitted to the Secretary by the sponsor of such approved drug. ï The physician has such other training or experience as the State medical licensing board (of the State in which the physician will provide maintenance or detoxification treatment) considers to demonstrate the ability of the physician to treat and manage opioid-addicted patients. ï The physician has such other training or experience as the Secretary considers to demonstrate the ability of the physician to treat and manage opioid-addicted patients. Any criteria of the Secretary under this subclause shall be established by regulation. Any such criteria are effective only for 3 years after the date on which the criteria are promulgated, but may be extended for such additional discrete 3-year periods as the Secretary considers appropriate for purposes of this subclause. Such an extension of criteria may only be effectuated through a statement published in the Federal Register by the Secretary during the 30-day period preceding the end of the 3-year period involved.î Source: www.buprenorphine.samhsa.gov/waiver_qualifications.html.

Pharmacology of Medications Used To Treat Opioid Addiction 27 Pharmacology and are opioid addicted. Patients with special needs may require split methadone doses given more Pharmacotherapy than once daily. Methadone is metabolized chiefly by the cytochrome P3A4 (CYP3A4) Methadone and LAAM enzyme system (Oda and Kharasch 2001), which is significant when methadone is co- The synthetic opioids methadone and LAAM administered with other medications that also are the only long-acting full opioid agonists operate along this metabolic pathway (see approved for opioid pharmacotherapy at this ìInteractions With Other Therapeutic writing. Opioid agonists bind to the mu opiate Medicationsî below). receptors on the surfaces of brain cells, which mediate the analgesic and other effects of opi- After patient induction into methadone oids. Methadone and LAAM produce a range pharmacotherapy, a steady-state concentration of mu agonist effects similar to those of short- (i.e., the level at which the amount of drug acting opioids. Therapeutically appropriate entering the body equals the amount being doses of these agonist medications produce excreted) of methadone usually is achieved in 5 cross-tolerance for short-acting opioids such as to 7.5 days (four to five half-lives of the drug). morphine and heroin, thereby suppressing Methadoneís pharmacological profile supports withdrawal symptoms and opioid craving as a sustained activity at the mu opiate receptors, short-acting opioid is eliminated from the body. which allows substantial normalization of many The dose needed to produce cross-tolerance physiological disturbances resulting from the depends on a patientís level of tolerance for repeated cycles of intoxication and withdrawal short-acting opioids. associated with addiction to short-acting opioids. Therapeutically appropriate doses LAAM is longer acting than methadone. Unlike of methadone also attenuate or block the methadone, it cannot be administered daily euphoric effects of heroin and other opioids. because its longer duration of action would Goodman and Gilmanís Pharmacological lead to accumulation of toxic levels in the Basis of Therapeutics (Hardman et al. 2001) body that could result in death (Roxane provides a comprehensive description of Laboratories, Inc., 2001). Articles by Oda methadoneís pharmacological effects. and Kharasch (2001) and Walsh and colleagues (1998), as well as the manufacturerís package Methadone is up to 80 percent orally bio- insert for ORLAAMÆ(Roxane Laboratories, available, and its elimination half-life ranges Inc., 2001), provide more information on from 24 to 36 hours. When methadone is LAAMís pharmacology. administered daily in steady oral doses, its level in blood should maintain a 24-hour When given intramuscularly or orally, asymptomatic state, without episodes of over- methadone suppresses pain for 4 to 6 hours. medication or withdrawal (Payte and Zweben Intramuscular methadone is used only for 1998). Methadoneís body clearance rate varies patients who cannot take oral methadone, considerably between individuals. The serum for example, patients in medication-assisted methadone level (SML) and elimination half- treatment for opioid addiction (MAT) who are life are influenced by several factors including admitted to a hospital for emergency medical pregnancy and a patientís absorption, procedures. Methadone should not be given metabolism and protein binding, changes in parenterally in an OTP. urinary pH, use of other medications, diet, Because of its extensive bioavailability and physical condition, age, and use of vitamin and longer half-life, an adequate daily oral dose of herbal products (Payte and Zweben 1998). methadone suppresses withdrawal and drug Measuring methadone via SMLs helps craving for 24 to 36 hours in most patients who determine how much is circulating in patientsí

28 Chapter 3 systems. In a typical 24-hour period after effect in patients may be increased (Eap et al. dosing, SMLs should peak after about 2 to 4 2002; Leavitt et al. 2000; Payte and Zweben hours and decline gradually to trough levels 1998). thereafter (Payte and Zweben 1998). Although researchers have noted a strong correlation Several CYP450 isoforms help metabolize between methadone dosage and serum concen- methadone, including CYP3A4 (the most abun- trations in some patients, the relationship is dant), CYP2B6, CYP2D6, and possibly, but to not necessarily linear, and a high degree of a smaller extent, CYP1A2, CYP2C9, and variation exists among patients (reviewed by CYP2C19 (Cozza and Armstrong 2001; Eap et Leavitt et al. 2000). The rate-of-change ratio al. 2002; Gerber et al. 2004). Different between peak and trough SMLs can be useful enzymes metabolize (R)- and (S)-methadone clinically; Payte and Zweben (1998) suggested differently. Numerous genetic and environmen- that peak SMLs should not exceed twice the tal factors affect these trough levels. enzymes and account for variations in Researchers have found that trough SMLs of methadone [A]n adequate 150 to 600 ng/mL are necessary to suppress metabolism among drug craving (reviewed in Leavitt et al. 2000). individuals. Some daily oral dose Many treatment providers consider that trough enzymes also play a SMLs of $400 ng/mL provide adequate opioid part in metabolizing of methadone cross-tolerance, thereby controlling patientsí other medications, opioid abuse; however, Eap and colleagues such as benzodi- suppresses with- (2002) found no studies that validated these azepines, antidepres- minimum trough levels. sants, anticonvul- drawal and drug sants, antibiotics, and Methadone has two enantiomeric forms, ì(R)-î antiviral agents (e.g., craving for 24 to (also called levo- or L-) methadone and ì(S)-î HIV protease (dextro- or D-) methadone, which have the inhibitors). Through same chemical formula but different spatial their effects on these 36 hours... arrangements. OTPs in the United States use a enzymes, some medi- 50:50 racemic mixture of these two enantiomers. cations can raise or Only (R)-methadone has clinically significant lower patientsí SMLs. Especially during initia- mu receptor agonist activity, and its potency as tion of methadone maintenance, methadone an analgesic is 50 times greater than that of (S)- can increase CYP3A4 activity, thereby acceler- methadone (Eap et al. 2002). (R)-methadone ating its own metabolism in some individuals also has a significantly higher mean clearance (Eap et al. 2002; Leavitt et al. 2000). rate than (S)-methadone (Eap et al. 1999). CYP2D6 selectively metabolizes the (R)- Methadone is metabolized into inactive metabo- methadone enantiomer. Production of this lites, mainly in the liver by CYP450 enzymes, enzyme is affected by genetic factors. A small but probably also by enzymes in the intestines. portion of the population does not produce These metabolites are then excreted. Drugs much CYP2D6, whereas others have very high that induce or inhibit this enzyme activity can CYP2D6 activity. The latter group may require affect methadone metabolism. If these enzymes much higher methadone doses to compensate are stimulated by other medications, the dura- for their high rate of (R)-methadone tion of methadoneís effect and SMLs may be metabolism (Eap et al. 2002; Leavitt et al. lowered, precipitating withdrawal symptoms. If 2000). Individuals also differ considerably in these enzymes are inhibited by other medica- CYP3A4 and CYP1A2 activity, accounting in tions, methadone metabolism may be slowed, part for the wide variations in methadone and the SMLs and duration of methadoneís metabolism (Eap et al. 2002).

Pharmacology of Medications Used To Treat Opioid Addiction 29 Buprenorphine course of buprenorphine-naloxone therapy for detoxification from opioids. Buprenorphine, a derivative of the opium alkaloid , is a synthetic opioid and Buprenorphine is metabolized in the liver by generally is described as a partial agonist at the the CYP3A4 subgroup of CYP450 enzymes mu opiate receptor and an antagonist at the (Kobayashi et al. 1998), and, like methadone kappa receptor. Research has demonstrated and LAAM, its rate of metabolism is affected that buprenorphineís partial agonist effects at by coadministration of other medications mu receptors, its unusually high affinity for metabolized along this pathway. these receptors, and its slow dissociation from them are principal determinants of its pharma- Depending on the dosage, buprenorphine activ- cological profile (Cowan 2003). ity can be viewed as falling between that of full agonists, such as methadone and LAAM, and In the 1990s, researchers determined that, as a antagonists, such as naltrexone (Exhibit 3-3) partial mu agonist, buprenorphine does not (Johnson et al. 2003b). Because it is a partial activate mu receptors fully (i.e., it has low agonist at higher doses, buprenorphine also intrinsic activity), resulting in a ceiling effect can precipitate opioidlike withdrawal symp- that prevents larger doses of buprenorphine toms in patients with high levels of physical from producing greater agonist effects (Walsh dependence on opioids, making it appear to et al. 1994). As a result, there is a greater mar- function more like an antagonist under these gin of safety from death by respiratory depres- conditions (see ìInductionî in chapter 5). sion when increased doses of buprenorphine are used, compared with increased doses of full opioid agonists. Buprenorphine overdose is Naltrexone uncommon, although it has been reported in Naltrexone is a highly effective opioid antago- France, and it is associated almost always with nist that tightly binds to mu opiate receptors. injection of buprenorphine coupled with inges- Because it has a higher affinity for these recep- tion of high doses of benzodiazepines, alcohol, tors than has heroin, morphine, or methadone, or other sedative-type substances (Kintz 2001, naltrexone displaces those drugs from receptors 2002). Another feature of buprenorphine is and blocks their effects. It can, therefore, that it can be used on a daily or less-than-daily precipitate withdrawal in patients who have not basis. Typically, the interdosing interval is been abstinent from short-acting opioids for at extended by doubling or tripling the daily dose least 7 days and have not been abstinent from to permit alternate-day or thrice weekly dosing long-acting ones, such as methadone, for at (Amass et al. 2000, 2001), which is possible least 10 days (OíConnor and Fiellin 2000). because, although larger doses do not increase Naltrexone displaces buprenorphine to a lesser buprenorphineís agonist activity, they do length- degree, but, in high enough doses, it overrides en its duration of action (Chawarski et al. 1999). buprenorphineís activity as well.

Buprenorphine also may be an excellent agent Because naltrexone has no narcotic effect, to facilitate detoxification from illicit opioids there are no withdrawal symptoms when a and abused prescription opioids. Although it patient stops using naltrexone, nor does nal- has a relatively short plasma half-life (about 4 trexone have abuse potential. Early research to 6 hours), buprenorphine has a long duration concluded that tolerance does not develop for of action resulting from its high affinity for and naltrexoneís antagonist properties, even after correspondingly slow dissociation from the mu many months of regular use (Kleber et al. receptor (Cowan 2003). This slow dissociation 1985). A 50 mg tablet markedly attenuates or likely reduces the magnitude of withdrawal blocks opioid effects for 24 hours, and a 100 to symptoms during detoxification (Johnson et al. 150 mg dose can block opioid effects for up to 2003b). Some evidence supports a short-term 72 hours (OíBrien et al. 1975).

30 Chapter 3 Exhibit 3-3

Intrinsic Activity of Full Agonist (Methadone), Partial Agonist (Buprenorphine), and Antagonist (Naloxone) Therapy

Source: Reprinted from Drug and 70(Suppl.) Johnson et al. Buprenorphine: How to use it right. S59ñS77, 2003b, with permission from Elsevier.

The FDA approved naltrexone for maintenance Dosage Forms treatment in 1984 based on its pharmacological effects, without requiring proof of its efficacy in clinical trials for opioid addiction treatment. Methadone Despite its potential advantages, it has had lit- Methadone is provided in various forms, tle impact on the treatment of opioid addiction including diskettes, tablets, oral solution, liq- in the United States, primarily because of poor uid concentrate, and powder. In the United patient compliance (OíConnor and Fiellin 2000). States, methadone used in MAT almost always

Pharmacology of Medications Used To Treat Opioid Addiction 31 is administered orally in liquid form. Federal regulations required OTPs to ensure Parenteral administration is prohibited in that ìdosage forms of LAAM and methadone OTPs. Parenteral abuse of methadone is not are easily distinguishedî (21 Code of Federal widespread, and people rarely inject the Regulations, Part 291 ß 505). Therefore, OTPs methadone dispensed in U.S. OTPs because it color LAAM to distinguish it from methadone. is mixed with substances (e.g., flavored drinks) that make injection unattractive. Buprenorphine Approved forms of Buprenorphine is available in sublingual tablets methadone for oral containing either buprenorphine alone (some- administration are times called monotherapy tablets and marketed In a...study com- supplied in various under the name Subutex) or combined with doses and naloxone (called combination therapy tablets paring the efficacy concentrations, with the trade name Suboxone). For the combi- allowing OTPs to nation therapy tablet, the ratio of buprenor- of LAAM..., choose which to dis- phine to naloxone is 4 mg of buprenorphine to pense on the basis of 1 mg of naloxone. The combination tablet was buprenorphine..., clinic and patient developed because of problems with injection preferences, conve- abuse of buprenorphine reported outside the nience, and cost. and methadone..., United States, where injection of buprenor- The diskette form phine is not permitted for treatment. Injected comprises scored all three medica- alone, buprenorphine precipitates withdrawal tablets, which are symptoms in most patients who are opioid dissolved in water, addicted, and the addition of naloxone increases tions substantially mixed with a fla- this likelihood. The combination tablet may pre- vored liquid, and cipitate acute withdrawal. Withdrawal also may reduced illicit taken orally. be precipitated if too much or too little Advantages are easy buprenorphine is given or if it is administered opioid use. inventory and the while the opioid receptors are highly occupied by ability for patients to an opioid agonist. Therefore, physicians need to see what they are be careful when timing the initiation of taking before water buprenorphine induction. is added. The diskette is not suited, however, for small dose increments and decrements. Methadone tablets, Naltrexone which dissolve in water, can be used in con- Naltrexone was first produced by DuPont junction with diskettes for small dose changes; under the trade name ReviaÆ. However, it is however, tablets normally are used only for now produced by Mallinckrodt under the trade analgesic applications; OTPs favor forms less name DepadeÆand is supplied in 25, 50, and subject to diversion. The liquid concentrate 100 mg tablets. form offers complete dosing flexibility, particu- larly with a computer-assisted dispensing pump system. The powder form can be mixed with Efficacy water into a solution. Methadone LAAM Methadone maintenance has been demonstrated LAAM is supplied to OTPs as a colorless liquid repeatedly to be safe and effective when used to be taken orally. When LAAM was approved, with appropriate safeguards and psychosocial

32 Chapter 3 services (OíConnor and Fiellin 2000). Mainte- that 8 mg of sublingual buprenorphine or 16 nance treatment typically leads to reduction or mg of the tablet per day is equivalent to cessation of illicit opioid use and its adverse approximately 60 mg of oral methadone per consequences, including cellulitis, hepatitis, day. A study by Fudala and colleagues (2003) and HIV infection from use of nonsterile injec- demonstrated the efficacy and safety of the tion equipment, as well as criminal behavior buprenorphine-naloxone combination tablet associated with obtaining drugs. Methadone in office-based settings. pharmacotherapy has been shown to lead to improved overall adjustment, including reductions in psychiatric symptoms, unemploy- Naltrexone ment, and family or social problems. Mattick Naltrexone is highly effective in preventing and colleagues (2003) provide complete reviews relapse when used as directed. However, most of the effectiveness of methadone. studies have indicated very high (70 to 80 per- cent) dropout rates from naltrexone therapy (Stine et al. 2003). A study by Rothenberg and LAAM colleagues (2002) found especially poor retention Controlled clinical trials generally have levels for patients who had received methadone established that LAAM is as effective as before naltrexone treatment (none of them methadone and buprenorphine in reducing completed 6 months of treatment, compared illicit-opioid use and retaining patients in treat- with 31 percent of patients who had not ment when equipotent doses are compared received methadone before naltrexone therapy). (e.g., Johnson et al. 2000; White et al. 2002). Other studies have demonstrated better compli- Appel and colleagues (2001) provide more ance when naltrexone therapy is supported information on LAAMís efficacy. with payment scheduling and vouchers (e.g., Preston et al. 1999b). Buprenorphine The primary efficacy of buprenorphine in Side Effects clinical trials was demonstrated via patient Long-term methadone, LAAM, or buprenor- retention and elimination of illicitñopioid- phine therapy is associated with few side positive drug tests. Compared with equipotent effects. Although patients typically have high doses of both methadone and LAAM, levels of medical and mental disorders, most buprenorphine produced similar rates of result from preexisting problems or the conse- treatment retention and abstinence from illicit quences of addiction, not from the treatment opioids. In a controlled, randomized study medication (Institute of Medicine 1995). comparing the efficacy of LAAM (75 to 115 Chapter 10 provides a review of related medical mg), buprenorphine sublingual solution (16 to problems in patients who are opioid addicted. 32 mg), and methadone (60 to 100 mg), all three medications substantially reduced illicit The most common adverse effects reported by opioid use (Johnson et al. 2000). patients receiving methadone or LAAM are constipation, which is caused by slowed gastric Johnson and colleagues (2003b) reviewed motility, and sweating; a similar side effect numerous studies evaluating the efficacy of profile is seen for buprenorphine. Other side buprenorphine for maintenance treatment last- effects include or early awakening ing up to 1 year. These studies have shown that and decreased libido or sexual performance daily doses of 8 mg of sublingual solution or 8 (Hardman et al. 2001). Possible side effects to 16 mg of the buprenorphine tablet are safe reported after regular use of these medications and well tolerated. Most studies comparing are listed in Exhibit 3-4. buprenorphine and methadone have shown

Pharmacology of Medications Used To Treat Opioid Addiction 33 Exhibit 3-4

Possible Side Effects of Opioid Agonist and Partial Agonist Therapy

Whole Body Effects Respiratory Effects

ï Weakness, loss of energy (asthenia) ï Cough ï Back pain, chills ï Rhinitis ï Fluid accumulation (edema) ï Yawning ï Hot flashes Cardiac Effects ï Flu syndrome and malaise ï Electrocardiogram changes (possible ï Weight gain QT prolongation with LAAM or high Gastrointestinal Effects doses of methadone) ï Postural hypotension ï Constipation ï Slowed heart rate (bradycardia) ï Dry mouth ï Nausea and vomiting Hepatic Effects ï Abdominal pain ï Abnormal liver function tests Musculoskeletal Effects Endocrine Effects

ï Joint pain (arthralgia) ï Hyperprolactinemia ï Muscle pain (myalgia) ï Absence of menstrual periods Nervous System Effects (amenorrhea) Skin and Appendage Effects ï Abnormal dreams ï Anxiety ï Sweating ï Decreased sex drive ï Rash ï Depression Special Sensory Effects ï Euphoria ï Blurred vision ï Headache ï Decreased sensitivity to tactile Urogenital Effects stimulation (hypesthesia) ï Difficult ejaculation ï Insomnia ï Impotence ï Nervousness ï Somnolence

34 Chapter 3 Cardiovascular Effects have led to discontinuation of LAAM therapy for new patients by most American OTPs. Methadone Currently, it is labeled for use only when no other treatment option exists or for continuing Methadone has been shown to increase QT use in patients who already have demonstrated intervals in at least two studies (i.e., Krantz et tolerability for the medication (Roxane al. 2003; Martell et al. 2003). A QT interval is Laboratories, Inc., 2001). that part of a patientís electrocardiogram read- ing that begins at the onset of the QRS complex Before a patient is started on LAAM, providers and extends to the end of the T wave. The QT must follow informed-consent procedures interval represents the time between the start about QT interval prolongation and provide of ventricular depolarization and the end of information about the possibility of arrhythmia ventricular repolarization. The QT interval and sudden death (CSAT 1999b). Patients normally varies depending on heart rate, age, should be screened for cardiac risk factors, and gender. The QT interval may be influenced including preexisting prolonged QT intervals or by electrolyte balance, medications, and other cardiac problems (Food and Drug ischemia. A prolonged QT interval increases Administration 2001; Schwetz 2001). More the risk of developing a cardiac arrhythmia information about LAAM is available from called torsade de pointes. Roxane Laboratories Technical Product Information at 800-962-8364 and in chapter 2. Cases of torsade de pointes have been reported in patients taking high doses of methadone (mean daily doses of approximately 400 mg). Side Effects of Naltrexone Although information about this effect is limit- Approximately 10 percent of patients receiving ed, 6 of 17 patients who developed torsade de naltrexone have gastrointestinal side effects pointes in one study had an increase in their (e.g., nausea and vomiting) that may necessi- methadone dose during the month preceding tate stopping the medication. Most patients, arrhythmia (Krantz et al. 2003). This finding however, experience only mild, transient supported the possibility that methadone con- stomach upset (Stine et al. 2003). Naltrexone tributed to the development of arrhythmia. also can cause anxiety, nervousness, insomnia, Furthermore, Martell and colleagues (2003) headache, joint or muscle pain, and tiredness showed that, regardless of dose, a statistically in some patients (National Library of Medicine significant increase occurred in QT intervals 1997). during the first 2 months of treatment. Practitioners should be aware of potential QT- prolonging effects of methadone, especially at Effects on the Immune high doses, and should be aware of interactions System with other medications that also have QT- prolonging properties or with medications that Short-acting opioids such as heroin and mor- slow the elimination of methadone. phine interfere with the normal activity of the immune system, perhaps through stress hor- LAAM mones such as cortisol, which are known to sup- press immune function. These effects are not LAAM has been associated with prolonged QT seen with methadone, which does not appear to interval in some patients and, in rare cases, affect natural killer cell activity, immunoglobu- with death from torsade de pointes arrhythmia. lin, or T or B cells (Novick et al. 1989). As a result, it has been taken off the market in Europe, and it has been given a ìblack boxî warning (i.e., a required warning on the pack- Effects on the Liver age insert and other product-related materials) Methadone, LAAM, and buprenorphine are in the United States by FDA. These findings metabolized by the liver, but no evidence exists

Pharmacology of Medications Used To Treat Opioid Addiction 35 that they are hepatotoxic (Joseph et al. 2000). have been reported in studies involving more Because the liver is a major storage site for than 5,000 patients, although, like other opi- these medications, patients with liver disease oids, buprenorphine can produce constipation, should be expected to metabolize opioid-based headache, nausea and vomiting, and dizziness medications more slowly, which might raise (Fudala et al. 2003; Ling et al. 1998). Increases blood levels of these medications but lower in liver enzymes (aspartate aminotransferase their stores and shorten their duration of and alanine aminotransferase) were observed action. Abnormal liver functions among in individuals receiving buprenorphine who patients maintained on these drugs usually also were positive for hepatitis C (Petry et are caused by viral infections, most commonly al. 2000). At this writing, 53 cases of hepatitis C acquired from contaminated buprenorphine-associated hepatitis have been needles, or by cirrhosis secondary to alcoholism reported in France since 1996 (Auriacombe et (Marray 1992). Chapter 10 provides informa- al. 2003). One report suggested an association tion on medical conditions commonly seen in between injection buprenorphine misuse and patients who are opioid addicted. liver toxicity, possibly from buprenorphineís increased bioavailability when administered Although the presence of liver disease is not a parenterally (Berson et al. 2001). The direct reason to exclude patients from MAT, severe role of buprenorphine in these abnormalities persistent liver disease in these patients indi- is unclear because many individuals in these cates the need to monitor liver functions regu- studies might have had hepatitis B or C. larly and to use caution in dosage adjustment. Additional studies are needed to clarify this issue. Severe liver impairment might result in toxic serum levels of an opioid medication. Symptoms of toxic levels include poor concentration, Interactions With drowsiness, dizziness when standing, and exces- sive anxiety (sometimes called feeling ìwiredî). Other Therapeutic These effects usually can be managed by dose Medications reduction. The consensus panel and the FDA labels on Subutex and Suboxone recommend Because methadone, LAAM, and buprenor- baseline and periodic liver function testing for phine are metabolized chiefly by the CYP3A4 patients receiving buprenorphine. enzyme system (a part of the CYP450 system), drugs that inhibit or induce the CYP450 system In evaluating naltrexone to treat alcoholism, can alter the pharmacokinetic properties of a Center for Substance Abuse Treatment con- these medications. Drugs that inhibit or induce sensus panel (CSAT 1998a) recommended cau- this system can cause clinically significant tion in using naltrexone for patients who have increases or decreases, respectively, in serum high (three times normal) serum transaminase and tissue levels of opioid medications. levels. OTPs should perform liver function tests before naltrexone therapy and periodically Drugs that induce the CYP450 enzyme system thereafter to ensure healthy liver function. For can precipitate withdrawal in patients receiving the relatively few cases in which liver toxicity methadone, LAAM, or buprenorphine. Most occurs, treatment should be discontinued after notable are certain medications used to treat determining that the liver problem has no HIV infection, such as nelfinavir (McCance- other cause. Katz et al. 2000), efavirenz (Clarke, S.M., et al. 2001b), and nevirapine (Clarke, S.M., et al. 2001a; Otero et al. 1999). Other common Side Effects of Buprenorphine inducers are carbamazepine, phenytoin, and Johnson and colleagues (2003b) reported that phenobarbital (Michalets 1998). buprenorphine in solution or tablet and the Psychiatric medications sharing the same combination buprenorphine-naloxone tablet metabolic pathways as methadone and LAAM were well tolerated. Few serious side effects

36 Chapter 3 include some selective serotonin reuptake Fluvoxamine has been implicated in overseda- inhibitors (SSRIs), which inhibit the isoenzymes tion and respiratory depression when combined that metabolize methadone and might increase with methadone (Alderman and Frith 1999). SMLs (Nemeroff et al. 1996). Hamilton and colleagues (2000), who examined SMLs in Earlier studies showed that methadone increased patients who were depressed, receiving the serum levels of tricyclic antidepressants, indicat- SSRI sertraline, and undergoing methadone ing that the oral doses required for a therapeutic pharmacotherapy, found that sertraline pro- response to tricyclics might be lower than those duced modest increases in SMLs during the needed for a positive response in patients not first 6 weeks of treatment. They concluded that addicted to opioids (Maany et al. 1989). patients who are methadone maintained and Finally, rifampin, carbamazepine, pheno- receiving SSRIs should be monitored for barbital (used occasionally for the treatment of altered SMLs. However, because clinical expe- seizure disorders), and some medications to rience with patients in MAT who take SSRIs treat HIV infection (see chapter 10) also may has not indicated that these alterations are induce liver enzymes that speed the bodyís clinically significant, the consensus panel rec- transformation of methadone. Patients taking ommends careful monitoring of these patients these medications might need increases in but not routine testing of their SMLs. Of all the their methadone dosage or split doses to SSRIs, fluvoxamine likely has the most poten- maintain stability. tial to cause excessive SMLs while patients are receiving it and decreased SMLs after patients Exhibit 3-5 summarizes other reported drug discontinue it (Alderman and Frith 1999). interactions with methadone.

Exhibit 3-5

Reported Drug Interactions With Methadone

Agent Effect on Methadone Possible Mechanism Remarks Decreased clearance Inhibition of one or Clinical relevance unclear several CYP isozymes (1A2, 2C9, 2C19, 2D6, 3A4) Amprenavir Decreased serum Induction of CYP3A Median 65% decrease of levels; possible SMLs in five patients; decreased opioid association of amprenavir effects and abacavir, with ampre- navir the likeliest inducing agent Amylobarbitone Increased clearance Induction of CYP3A Clearance determined in patients receiving methadone for cancer pain

(continued on following page)

Pharmacology of Medications Used To Treat Opioid Addiction 37 Exhibit 3-5

Reported Drug Interactions With Methadone (continued)

Agent Effect on Methadone Possible Mechanism Remarks Ciprofloxacin Increased opioid Inhibition of One case report of sedation, effects CYP1A2 and/or confusion, and respiratory CYP3A4 depression Diazepam Increased opioid Mechanism unclear; Clinical relevance unclear effects probably not a pharmacokinetic interaction Efavirenz Decreased plasma Induction of CYP3A Mean 57% decrease of AUC* levels and opioid in 11 patients; 1 case report effects of reduction of both enantiomers of methadone Ethanol Increased opioid Mechanism unclear Clinical relevance unclear effects and added sedation Fluconazole Decreased Inhibition of Increased AUC by 35% in 13 methadone clearance CYP3A4 patients after 200 mg/day for and increased SMLs 14 days Fluoxetine Increased SMLs Inhibition of CYP2D6 Increased plasma (stereoselectivity for levels (mean increase 32%) (R)-methadone) for (R)- but not (S)- methadone in seven patients Fluvoxamine Increased SMLs and Inhibition of one or One case report of hypoven- increased opioid several CYP isozymes tilation, severe hypoxemia, effects (1A2, 2C19, 3A4, and hypercapnia; two case 2C9) reports of withdrawal symp- toms when fluvoxamine stopped; one case report of fluvoxamine use to decrease methadone metabolism induced by barbiturate Fusidic acid Decreased opioid Induction of CYP3A Reports of withdrawal symp- effects and CYP2C toms after 4-week therapy Moclobemide Increased opioid Inhibition of One case report of withdraw- effects CYP2D6 and/or al symptoms when moclobe- CYP1A2 mide stopped

*Area under the concentration-time curve.

38 Chapter 3 Exhibit 3-5

Reported Drug Interactions With Methadone (continued)

Agent Effect on Methadone Possible Mechanism Remarks Nelfinavir Decreased SMLs Induction of CYP3A; Mean decrease about 55% in possible induction of two patients P-glycoprotein Nevirapine Decreased SMLs and Induction of CYP3A Case reports of very important opioid effects decrease in SMLs and severe withdrawal symptoms

Paroxetine Increased SMLs Inhibition of Increased (R)-methadone CYP2D6 (stereoselec- plasma levels in eight CYP2C6 tivity for (R)- extensive metabolizers (32%) but methadone) not in poor metabolizers (3%) Pheno- Decreased SMLs and Induction of CYP3A One case report with a 31% barbital opioid effects reduction of trough SMLs Phenytoin Decreased SMLs and Induction of CYP3A Mean 2.4-fold decrease of SMLs opioid effects with moderately severe opioid withdrawal symptoms Rifampin Decreased SMLs and Induction of CYP3A Cases of severe withdrawal opioid effects symptoms Ritonavir Decreased SMLs and Induction of CYP3A, Mean 36% decrease of the AUC opioid effects possible induction of in 11 patients after a 14-day P-glycoprotein; induc- treatment; high interindividual tion of CYP2C19 variability of decrease in SMLs and/or CYP2B6 sug- gested to explain greater induction of metabolism of (S)- than (R)-methadone Sertraline Increased SMLs Inhibition of one or No side effects from excess several CYP dosage recorded isozymes (3A4, 2D6, 1A2, 2C9, 2C19) Spirono- Increased clearance Induction of CYP3A Clearance determined in lactone patients receiving methadone for cancer pain

Adapted from Eap et al. 2002, by permission of Adis International.

Pharmacology of Medications Used To Treat Opioid Addiction 39 Exhibit 3-6 provides a list of other substances Strategies To Prevent or that are known to induce or inhibit CYP3A4 Minimize Harmful Drug and potentially could affect levels of methadone, LAAM, and buprenorphine. Interactions in MAT To control patientsí vulnerability to adverse Little information is available on the interac- cardiac and other harmful effects of drug tion of naltrexone with other medications. interactions with methadone or LAAM, the Lethargy and somnolence have been reported consensus panel recommends obtaining a when naltrexone is used along with ThorazineÆ thorough drug and medication history, includ- (chlorpromazine) or MellarilÆ(thioridazine), ing results of drug and other laboratory tests. and caution should be taken when naltrexone In some cases, particularly when patients are is used with other antipsychotic drugs. Patients treated in multiple settings, consolidating this taking naltrexone experience significant block- information can be a challenge. ade of opioid effects from medications taken for analgesia. However, this blockade is present Treatment providers should rely on their only when naltrexone is taken regularly; it will experience, intuition, and common sense to cease 24 to 72 hours after naltrexone is discon- anticipate and circumvent negative drug inter- tinued (OíConnor and Fiellin 2000). actions. The traditional advice when adding drugs to a therapeutic regimen is to start with

Exhibit 3-6

Other Inducers and Inhibitors of CYP450 and CYP3A4

CYP3A4 Inducers Expected To Reduce Opioid Medication Levels Carbamazepine Ethosuximide Rifabutin Dexamethasone Primidone Troglitazone

CYP3A4 Inhibitors Expected To Increase Opioid Medication Levels* Amiodarone Itraconazole Norfloxacin Cannabinoids Ketoconazole Omeprazole (slight) Clarithromycin Metronidazole Quinine Erythromycin Mibefradil Saquinavir Grapefruit juice Miconazole Troleandomycin Indinavir Nefazodone Zafirlukast

*Although clarithromycin and erythromycin are CYP3A4 inhibitors, azithromycin does not inhibit CYP3A4.

Adapted from Michalets 1998, from Pharmacotherapy with permission; with additional information from Gourevitch and Friedland 2000 and McCance-Katz et al. 2000.

40 Chapter 3 low doses, increase slowly, and monitor closely. ï When other medications must be coadminis- In many cases, medication dosages lower than tered with opioid treatment medications, those recommended by the manufacturer may select those that have the least potential for be sufficient for the desired therapeutic effect interaction. (Cohen 1999). This is especially prudent for ï Consider whether significant adverse drug patients receiving agonist medications who have interactions might be ameliorated by admin- a positive diagnosis for cardiac risk factors. istering a medication with or without food or Educating patients about the risks of drug by altering dosing schedules. interaction is essential. The following informa- ï Be aware that, the more complicated the tion should be emphasized: medication regimen, the less likely patients will adhere to it, necessitating increased ï During any agonist-based pharmacotherapy, vigilance on the part of treatment providers abusing drugs or medications that are respi- as the complexity of medication treatment ratory depressants (e.g., alcohol, other opioid increases. agonists, benzodiazepines) may be fatal. ï When potentially interactive medications are ï Current or potential cardiovascular risk coadministered, adjust the agonist or partial factors may be aggravated by opioid agonist agonist dosage based on patient response, pharmacotherapy, but certain treatment rather than prophylactically basing the strategies reduce cardiovascular risk (and dosage on expected interaction, because should be included as needed in patientsí degrees of interaction vary dramatically; treatment plans). prejudging the amount of a necessary dosage ï Other drugsóillicit, prescribed, or over adjustment is unlikely to work. the counteróhave potential to interact with ï When opioid medication dosage must be opioid agonist medications (specific, relevant adjusted to compensate for the effects of information should be provided). interacting drugs, observe patients for ï Patients should know the symptoms of signs or symptoms of opioid withdrawal or arrhythmia, such as palpitations, dizziness, sedation to determine whether they are lightheadedness, syncope, or seizures, and undermedicated or overmedicated. should seek immediate medical attention ï When a potentially interactive drug combina- when they occur. tion must be used and concerns exist about ï Maintaining and not exceeding dosage adverse effects if opioid medication is schedules, amounts, and other medication increased, for example, in patients with regimens are important to avoid adverse drug preexisting cardiovascular conditions, closely interactions. monitor drug serum concentrations or increase testing frequency. Advise patients of Researchers (e.g., Cohen 1999; Levy et al. the physical signs or symptoms of adverse 2000; Piscitelli and Rodvold 2001) have provid- interactions, and tell them what to do if these ed other suggestions for treatment providers to indicators occur. minimize harmful drug interactions in MAT: ï Be aware of concomitant preexisting diseases ï When possible, substitute alternative (e.g., diseases that decrease renal or hepatic medications that do not interact with opioid function) and preexisting cardiovascular treatment medications (e.g., azithromycin for conditions that might influence the potential erythromycin [because the latter is a strong for adverse drug interactions. CYP3A4 inhibitor] or divalproex for carba- Knowledge about medication interactions mazepine [because the latter is a potent with methadone and other medications used in CYP3A4 inducer]). the treatment of opioid addiction is changing

Pharmacology of Medications Used To Treat Opioid Addiction 41 constantly. The reader is advised to check for Buprenorphine overdose deaths reported in the most current information on a regular France generally have been attributed to the basis. A useful Web site is concurrent parenteral abuse of buprenorphine medicine.iupui.edu/flockhart. and benzodiazepines (Kintz 2001; Reynaud et al. 1998; Tracqui et al. 1998a, 1998b). Only two overdose deaths have been attributed to Safety buprenorphine alone (Kintz 2002). The poten- tial for injection abuse with buprenorphine is Methadone and LAAM believed lower than with full agonists because, as a partial agonist, buprenorphine can precip- The safety profiles of methadone and LAAM itate withdrawal in individuals who are opioid are excellent when these drugs are taken as addicted. Moreover, use of combination directed by the manufacturer and, for LAAM, buprenorphine-naloxone tablets in the United when patients are screened carefully for any States should mitigate further the risk of abuse. cardiac risk factors. However, because both As with any agonist-based pharmacotherapy, methadone and LAAM are full mu opioid ago- however, it is extremely important to educate nists, overdose and death can occur if they are patients about the potential lethality of abusing taken in larger amounts than directed and in treatment medication alone or in combination amounts exceeding patientsí tolerance levels. with respiratory depressants, especially Unintended, possibly lethal respiratory depres- benzodiazepines. sant effects also can occur if these medications are used in combination with substances that depress the , such as Naltrexone alcohol and benzodiazepines. Naltrexone generally is safe when used according to the manufacturerís directions. Buprenorphine Hall and Wodak (1999) cautioned that over- dose rates for patients on naltrexone who Like methadone, buprenorphine generally is relapse to heroin use might be higher than safe and well tolerated when used as recom- among patients receiving other treatments mended by the manufacturer, and buprenor- for opioid addiction. Further investigation phineís partial agonist characteristics reduce the is needed to validate this concern. risk of respiratory depression from overdose.

42 Chapter 3 4 Initial Screening, Admission Procedures, and Assessment Techniques

Initial screening or intake procedures determine an applicantís eligibility and readiness for medication-assisted treatment for opioid addiction (MAT) and admission to an opioid treatment program (OTP). Ongoing In This assessment should begin as soon as a patient is admitted to an OTP. It ChapterÖ provides a basis for individualized treatment planning and increases the likelihood of positive outcomes. Initial Screening No single tool incorporates all the important elements for assessing Admission patients in MAT. The Addiction Severity Index (ASI) (McLellan et al. Procedures and 1992), although not comprehensive, can guide collection of the basic Initial Evaluation information needed to measure patient conditions and progress objec- tively. Recent research (e.g., Bovasso et al. 2001) continues to support Medical Assessment the validity of ASI composite scores. The consensus panel recommends Induction that OTPs develop tools and methods for more extensive assessment. Assessment This chapter describes screening and assessment procedures and important considerations that might be made during and shortly after Comprehensive admission to an OTP, as well as assessment techniques and considera- Assessment tions that are important to ongoing MAT.

Initial Screening

First Contact The screening process begins when an applicant or family member first contacts an OTP, often via telephone or a visit to the OTP. This contact is the first opportunity for treatment providers to establish an effective therapeutic alliance among staff members, patients, and patientsí fami- lies. Careful planning for and interaction with new applicants and their families contribute to positive MAT outcomes. Staff members should be prepared to provide immediate, practical information that helps poten- tial applicants make decisions about MAT, including the approximate length of time from first contact to admission, what to expect during the admission process, and types of services offered. A brief exploration of

43 applicantsí expectations and circumstances can Screening of Emergencies and reveal other information they need for consid- Need for Emergency Care ering MAT. The consensus panel recommends that providers develop medically, legally, and Goals of Initial Screening ethically sound policies to address patient The consensus panel recommends the following emergencies. Emergencies can occur at any goals for initial screening: time but are most common during induction to MAT and the acute treatment phase (see ï Crisis intervention. Identification of and chapter 7). In particular, patients who exhibit immediate assistance with crisis and emergen- symptoms that could jeopardize their or othersí cy situations (see ìScreening of Emergencies safety should be referred immediately for inpa- and Need for Emergency Careî below) tient medical or psychiatric care. If possible, ï Eligibility verification. Assurance that an staff members who conduct initial screening applicant satisfies Federal and State regula- and assessment should make appropriate refer- tions and program criteria for admission to rals before applicants are admitted to an OTP. an OTP Identifying and assessing emergencies may require staff familiarity with the components of ï Clarification of the treatment alliance. a mental health status examination (see Explanation of patient and program ìPsychosocial Assessmentî below). responsibilities ï Education. Communication of essential information about MAT and OTP operations Suicidality (e.g., dosing schedules, OTP hours, treat- In a study of population data from the U.S. ment requirements, addiction as a brain National Comorbidity Survey, a significant disease) and discussion of the benefits and association was found between opioid addiction drawbacks of MAT to help applicants make and increased risk of suicide (Borges et al. informed decisions about treatment 2000). Initial screening and periodic assess- ï Identification of treatment barriers. ments should help determine whether those Determination of factors that might hinder indicating risks of suicide need additional an applicantís ability to meet treatment services (e.g., hospitalization for protection or requirements, for example, lack of childcare treatment, outpatient mental treatment, or or transportation. evaluation for antidepressant medication). Exhibit 4-1 lists some indicators of suicidality. Along with these primary goals, initial screen- Exhibit 4-2 lists recommended responses. ing can begin to identify other medical and psychosocial risk factors that could affect Homicidality and threats of treatment, including factors related to mental disorders; legal difficulties; other substance violence use; and vocational, financial, transportation, Threats should be taken seriously. For exam- and family concerns. Cultural, ethnic, and ple, if an individual with knowledge of OTP spiritual factors that affect communication and procedures and schedules makes a threat, pat- might affect treatment planning should be terns of interaction between staff and this indi- noted as early as possible. Staff members vidual should be shifted. It might be necessary should obtain enough information from appli- to change or stagger departure times, imple- cants to accommodate needs arising from any ment a buddy system, or use an escort service of these factors if necessary. (National Institute for Occupational Safety and Health 1996). Counseling assignments can be changed, or patients can be transferred to another OTP.

44 Chapter 4 Exhibit 4-1

Suicide Risk Factors

Behavioral and Circumstantial Indicators of Suicide Risk ï Talk about committing suicide ï Giving away prized possessions ï Trouble eating or sleeping ï History of suicide attempts ï Drastic changes in behavior ï Unnecessary risk taking ï Withdrawal from friends or social activities ï Recent severe losses ï Loss of interest in hobbies, work, or school ï Preoccupation with death and dying ï Preparations for death, such as making a ï Loss of interest in personal appearance will or final arrangements ï Increased use of alcohol or drugs Expressed Emotions That May Indicate Suicide Risk ï Canít stop the pain ï Canít make the sadness go away ï Canít think clearly ï Canít see a future without pain ï Canít make decisions ï Canít see oneself as worthwhile ï Canít see any way out ï Canít get someoneís attention ï Canít sleep, eat, or work ï Canít seem to get control ï Canít get out of depression

Source: Adapted from American Association of Suicidology n.d.

Exhibit 4-2

Recommended Responses to Indicators of Suicidality ï Be direct. Talk openly and matter-of-factly about suicide. ï Be willing to listen. Allow expressions of feelings. Accept the feelings. ï Be nonjudgmental. Donít debate whether suicide is right or wrong or feelings are good or bad. Donít lecture on the value of life. ï Get involved. Become available. Show interest and support. ï Donít dare an individual to do it. ï Donít act shocked. This puts distance between the practitioner and the individual. ï Donít be sworn to secrecy. Seek support. ï Offer hope but not glib reassurances that alternatives are available. ï Take action. Remove means, such as guns or stockpiled pills. ï Get help from persons or agencies specializing in crisis intervention and suicide prevention. Source: Adapted from American Association of Suicidology n.d.

Initial Screening, Admission Procedures, and Assessment Techniques 45 The consensus panel recommends that OTP enter treatment. Prompt, efficient orientation staff members receive training in recognizing and evaluation contribute to the therapeutic and responding to the signs of potential patient nature of the admission process. violence. OTPs should develop policies and procedures for homicide and other violent If a program is at capacity, admitting staff situations. The OTPís policy on violence and should advise applicants immediately of a threats of violence should be explained at the waiting list and provide one or more referrals beginning of treatment. Emergency screening to programs that can meet their treatment and assessment procedures should include needs more quickly. A centralized intake pro- the following: cess across programs can facilitate the admis- sion process, particularly when applicants must ï Asking the patient questions specific to be referred. For example, if an applicant homicidal ideation, including thoughts, accepts referral to another provider, telephone plans, gestures, or attempts in the past year; contact by the originating program often can weapons charges; and previous arrests, facilitate the applicantís acceptance into the restraining orders, or other legal procedures referral program. If an applicant goes willingly related to real or potential violence at home to another program for immediate treatment or the workplace. but prefers admission to the original OTP, the ï Documenting violent incidents and diligent admission process should be completed and the monitoring of these records to assess the applicantís name added to the waiting list. nature and magnitude of workplace violence Patients who prefer to await treatment at the and to quantify risk. When a threat appears original site should be added to the waiting list imminent, all legal, human resource, employ- and contacted periodically to determine ee assistance, community mental health, and whether they want to continue waiting or be law enforcement resources should be readied referred. For individuals who are ineligible, to respond immediately (National Institute staff should assess the need for other acute ser- for Occupational Safety and Health 1996). vices and promptly make appropriate referrals. The consensus panel recommends that each OTP establish criteria to decide which prequal- Admission Procedures ified patients should receive admission priority, and Initial Evaluation especially when a program is near capacity. For After initial applicant screening, the admission example, some programs offer high-priority process should be thorough and facilitate timely admission to pregnant women, addicted spouses enrollment in the OTP. This process usually of current patients, applicants with HIV infec- marks patientsí first substantial exposure to the tion or other serious medical conditions, or treatment system, including its personnel, other former patients who have tapered off mainte- patients, available services, rules, and require- nance medication but subsequently require ments. The admission process should be renewed treatment. designed to engage new patients positively while screening for and assessing problems and needs Interim Maintenance that might affect MAT interventions. Treatment For eligible individuals who cannot be Timely Admission, Waiting admitted to a public or nonprofit program for Lists, and Referrals comprehensive maintenance services within a The longer the delays between first contact, reasonable geographic area and within 14 days initial screening, and admission and the more of applying, 42 Code of Federal Regulations appointments required to complete these proce- (CFR), Part 8 ß 12(j), provides for ìinterim dures, the fewer the applicants who actually maintenance treatment,î in which medication

46 Chapter 4 is administered to patients at an OTP for up to that the following types of information be 120 days without formal screening or admission collected, documented, or communicated to and with only minimal drug testing, assuming patients: the existence of reasonable criteria at the OTP to prioritize admissions. ï Treatment history. An OTP should obtain a new patientís substance abuse treatment history, preferably Denial of Admission from previous treat- Denial of admission to an OTP should be ment providers, based on sound clinical practices and the best including informa- The admission interests of both the applicant and the OTP. tion such as use of other substances Admission denial should be considered, for process should be example, if an applicant is threatening or vio- while in treatment, dates and durations lent. Continuity of care should be considered, designed to engage and referral to more suitable programs should of treatment, pat- be the rule. Due process and attention to terns of success or applicant rights (see CSAT 2004b) minimize failure, and reasons new patients the possibility that decisions to deny admission for discharge or to an OTP are abusive or arbitrary. dropout. Written positively while consent from a patient is required to screening for and Admission Team obtain information OTPs should have qualified, compassionate, from other programs assessing problems well-trained multidisciplinary teams (see (see CSAT 2004b). (See below for chapter 6) that efficiently collect applicantsí and needs... information and histories, evaluate their needs details on other com- as patients, and orient them to MAT. Team ponents to include in members should be cross-trained in treating this history.) addiction and co-occurring disorders. Those ï Orientation to MAT. conducting admission interviews should be All patients should receive an orientation to culturally competent, and their interactions MAT, generally extending over several ses- with applicants should not be stigmatizing. sions and including an explanation of treat- They also should be able to communicate ment methods, options, and requirements OTP policies and services and make and the roles and responsibilities of those appropriate referrals. involved. Each new patient also should receive a handbook (or other appropriate materials), written at an understandable level Information Collection and in the patientís first language if possible, that Dissemination includes all relevant program-specific infor- mation needed to comply with treatment Collection of patient information and dissemi- requirements. Patient orientation should be nation of program information occur by vari- documented carefully for medical and legal ous methods, such as by telephone; through a reasons. Documentation should show that receptionist; and through handbooks, informa- patients have been informed of all aspects tion packets, and questionnaires. Medical of the multifaceted MAT process and its assessments (e.g., physical examinations, blood information requirements, including (1) work) and psychosocial assessments also are the consent to treatment (CSAT 2004b), (2) necessary to gather specific types of informa- program recordkeeping and confidentiality tion. Although collection procedures differ requirements (e.g., who has access to records among OTPs, the consensus panel recommends and when, who can divulge information

Initial Screening, Admission Procedures, and Assessment Techniques 47 without patient con- drugs and alcohol; this multiple substance use sent [see CSAT has definite implications for treatment out- [A]ddressing 2004b]), (3) program comes (see ìSubstance Use Assessmentî below rules, including and chapter 11). Therefore, screening and concerns about patient rights, medical assessment also should identify and grievance proce- document nonopioid substance use and deter- and stressing the dures, and circum- mine whether an alternative intervention stances under which (e.g., inpatient detoxification) is necessary benefits of MAT a patient can be dis- or possible before an applicant is admitted to charged involuntari- the OTP. ...are essential to ly, and (4) facility ï Prescription drug and over-the-counter safety instructions medication use. All prescription drug and (e.g., emergency exit long-term treat- over-the-counter medication use should be routes). OTPs identified. Procedures should be in place to should require ment retention... determine any instances of misuse, overdose, patients to sign or or addiction, especially for psychiatric or initial a form docu- pain medications. The potential for drug menting their partic- interactions, particularly with opioid treatment ipation in the orien- medications, should be noted (see chapter 3). tation process. Also, patients must receive ï Method and level of opioid use. The general and sign a written consent to treatment form frequency, amounts, and routes of opioid use (see Appendix 4-A; see also CSAT 2004b), should be recorded. If opioids are injected, which is kept on file by the OTP. the risk of communicable diseases (e.g., ï Age of applicant. Persons younger than age HIV/AIDS, hepatitis C, endocarditis) in- 18 must meet specific Federal and State creases. Patient reporting helps providers requirements (at this writing, some States assess patientsí substance addiction and tol- prohibit MAT for this group), and an OTP erance levels, providing a starting point to must secure parental or other guardian prescribe appropriate treatment medication consent to start adolescents on MAT (see for stabilization (American Psychiatric discussion below of exemptions from the Association 2000; Mee-Lee et al. 2001a). Substance Abuse and Mental Health Services ï Pattern of daily preoccupation with opioids. Administrationís [SAMHSAís] 1-year A patientís daily pattern of opioid abuse dependence duration rule). should be determined. Regular and frequent ï Recovery environment. A patientís living use to offset withdrawal is a clear indicator of environment, including the social network, physiological dependence. In addition, people those living in the residence, and stability of who are opioid addicted spend increasing housing, can support or jeopardize treatment. amounts of time and energy obtaining, using, ï Suicide and other emergency risks. (See and responding to the effects of these drugs. above.) ï Compulsive behaviors. Patients in MAT ï Substances of abuse. A patientís substance sometimes have other impulse control disor- abuse history should be recorded, focusing ders. A treatment provider should assess first on opioid use, including severity and age behaviors such as compulsive gambling or at onset of physical addiction, as well as use sexual behavior to develop a comprehensive patterns over the past year, especially the perspective on each patient. previous 30 days. A baseline determination of ï Patient motivation and reasons for seeking current addiction should meet, to the extent treatment. Prospective patients typically possible, accepted medical criteria. Many present for treatment because they are in people who are opioid addicted use other withdrawal and want relief. They often are

48 Chapter 4 preoccupied with whether and when they can Medical Assessment receive medication. Because successful MAT entails not only short-term relief but a Medical assessment plays a substantial role in steady, long-term commitment, applicants determining MAT eligibility. Some assessment should be asked why they are seeking treat- tools and methods mentioned briefly in this ment, why they chose MAT, and whether they chapter are explained further in chapter 10. fully understand all available treatment The results of medical assessment, including options and the nature of MAT. Negative atti- toxicology tests, other laboratory results, and tudes toward MAT may reduce patient moti- psychosocial assessment, usually are reviewed vation. However, concerns about motivation by a program physician and then submitted to should not delay admission unless applicants the medical director in preparation for phar- clearly seem ambivalent. In such cases, treat- macotherapy. Programs should minimize delay ment providers and applicants can discuss in administering the first dose of medication the pros and cons of MAT. The consensus because, in most cases, applicants will present panel believes that identifying and addressing in some degree of opioid withdrawal. concerns about and stressing the benefits of MAT as early as possible are essential to long-term treatment retention and maintain- Determination of Opioid ing patient motivation for treatment. Addiction and Verification of ï Patient personal recovery resources. A Admission Eligibility patientís comments also can identify his or her recovery resources. These include com- Federal regulations on ments on satisfaction with marital status and living arrangements; use of leisure time; eligibility problems with family members, friends, Federal regulations state that, in general, significant others, neighbors, and coworkers; opioid pharmacotherapy is appropriate for the patientís view of the severity of these persons who currently are addicted to an opi- problems; insurance status; and employment, oid drug and became addicted at least 1 year vocational, and educational status. Identifi- before admission (42 CFR, Part 8 ß 12(e)). cation of patient strengths (e.g., stable Documentation of past addiction might include employment, family support, spirituality, treatment records or a primary care physi- strong motivation for recovery) provides a cianís report. When an applicantís status is basis for a focused, individualized, and uncertain, admission decisions should be based effective treatment plan (see chapter 6). on drug test results and patient consultations. ï Scheduling the next appointment. Unless the program can provide assessment and Exemptions from SAMHSAís admission on the same day, the next visit should be scheduled for as soon as possible. 1-year dependence duration To facilitate an accurate diagnosis of opioid rule addiction and prompt administration of the If appropriate, a program physician can invoke initial dose of medication when other docu- an exception to the 1-year addiction history mentation of a patientís condition is unavail- requirement for patients released from correc- able, the applicant should be instructed to tional facilities (within 6 months after release), report to the OTP while in mild to moderate pregnant patients (program physician must opioid withdrawal. certify pregnancy), and previously treated patients (up to 2 years after discharge) (42 CFR, Part 8 ß 12(e)(3)).

Initial Screening, Admission Procedures, and Assessment Techniques 49 A person younger than 18 must have under- History and Extent of gone at least two documented attempts at Nonopioid Substance Use and detoxification or outpatient psychosocial treatment within 12 months to be eligible for Treatment maintenance treatment. A parent, a legal The extent and level of alcohol and nonopioid guardian, or an adult designated by a relevant drug use and treatment also should be deter- State authority must consent in writing for an mined, and decisions should be made about adolescent to participate in MAT (42 CFR, whether these disorders can be managed safely Part 8 ß 12(e)(2)). Patients younger than 18 during MAT (see ìSubstance Use Assessmentî should receive age-appropriate treatments, below and chapter 11). ideally with a separate treatment track (e.g., young adult groups). Medical History Cases of uncertainty A complete medical history should include organ system diagnoses and treatments and When absence of a treatment history or with- family and psychosocial histories. It should drawal symptoms creates uncertainty about an cover chronic or acute medical conditions such applicantís eligibility, OTP staff should ask the as diabetes, liver or renal diseases, sickle cell applicant for other means of verification, such trait or anemia, and chronic pulmonary as criminal records involving use or possession disease. Documentation of infectious diseases, of opioids or knowledge of such use by a proba- including hepatitis, HIV/AIDS, tuberculosis tion or parole officer. A notarized statement (TB), and sexually transmitted diseases from a family or clergy member who can attest (STDs), is especially important. Staff should to an individualís opioid abuse might be feasible. note patientsí susceptibility to vaccine- The consensus panel does not recommend use preventable illnesses and any allergies and of a naloxone (NarcanÆ) challenge test (see treatments or medications received for other chapter 5) in cases of uncertainty. Physical medical conditions. Womenís medical histories dependence on opioids can be demonstrated by also should document previous pregnancies; less drastic measures. For example, a patient types of delivery; complications; current preg- can be observed for the effects of withdrawal nancy status and involvement with prenatal after he or she has not used a short-acting care; alcohol and drug use, including over-the- opioid for 6 to 8 hours. Administering a low counter medications, caffeine, and , dose of methadone and then observing the before and during any pregnancies; and patient also is appropriate. Administering incidences of sudden infant death syndrome. naloxone, although effective, can initiate severe withdrawal, which the consensus panel believes Complete Physical is unnecessary. It also requires invasive injec- tion, and the effects can disrupt or jeopardize Examination prospects for a sound therapeutic relationship Each patient must undergo a complete, fully with the patient. The panel recommends that documented physical examination by the pro- naloxone be reserved to treat opioid overdose gram physician, a primary care physician, or emergencies. an authorized health care professional under the direct supervision of the program physi- cian, before admission to the OTP. The full medical examination, including the results of the serology and other tests, must be docu- mented in the patientís record within 14 days following admission. States may have addition- al requirements, and OTPs must comply with

50 Chapter 4 these requirements. The examination should immune system compromised might have a cover major organ systems and the patientís negative purified protein derivative test, even overall health status and should document indi- with active infection. A chest x ray or sputum cations of infectious diseases; pulmonary, liver, analysis should be done if there is doubt. If a and cardiac abnormalities; dermatologic seque- patient has a positive TB test, medical staff lae of addiction; vital signs; general appearance should treat the patient accordingly (see chap- of head, eyes, ears, nose, throat, chest, ter 10) or refer him or her to a primary care abdomen, extremities, and skin; and physical clinic for treatment. evidence of injection drug use and dependence, as well as the physicianís clinical judgment of Hepatitis testing the extent of physical dependence. Women should receive a pregnancy test and a gyneco- People who inject drugs are at high risk for logical examination at the OTP site or by hepatitis virus infection (see chapter 10) and referral to a womenís health center. Again, the should be tested at results of all tests, laboratory work, and other admission to an OTP. processes related to the initial medical exami- Hepatitis A is an important liver nation are to be contained in the patientís file [R]esults of...the within 14 days following admission. infection that affects people who abuse drugs at higher rates medical examina- Laboratory Tests than people who do Although Federal regulations no longer require not. Most patients in tion are to beÖin OTPs to conduct a full panel of laboratory OTPs are seropositive tests, some States do. The consensus panel rec- for surface antigen or the patientís file ommends that laboratory tests include routine antibody to hepatitis tests for syphilis, hepatitis, TB, and recent B virus (HBV) core within 14 days fol- drug use. SAMHSA regulations stipulate ìat antigen, and some least eight random drug abuse testsî annually exhibit signs of lowing admission. per patient, performed according to accepted chronic hepatitis. Any OTP practice (CFR 42, Part 8 ß 12(f)(6)). patients whose tests Given that some drugs are metabolized exten- are negative for hep- sively and excreted quickly, it is important that atitis A virus or HBV analytic procedures provide the highest sensi- infection should be vaccinated for these tivity for substances of interest, such as breath infections at the OTP or by referral. testing for alcohol use. Hepatitis C virus (HCV) accounts for most new hepatitis cases among people who inject drugs, TB testing infects between 70 and 96 percent of this popu- The risk of TB infection and disease is high lation, and is the countryís leading cause of among individuals involved with drugs (Batki chronic liver disease (Sylvestre 2002b). The et al. 2002). Rates of active TB among people consensus panel strongly recommends that who use substances and are HIV infected are HCV diagnosis and referral be an integral com- high (Gourevitch et al. 1999), and cases of ponent of initial MAT assessment. Programs multidrug-resistant TB in this group are that do not offer onsite HCV antibody testing increasing. All patients should undergo screen- should provide appropriate referrals. (A simple ing and medical examination for TB every 12 blood test for hepatitis C antibodies is avail- months. Anergy panel tests should be adminis- able; a positive result does not necessarily tered to anergic patients (those with diminished signal current infections, only that antibodies reactivity to certain antigens). Patients who are have developed.)

Initial Screening, Admission Procedures, and Assessment Techniques 51 HIV testing provided in SAMHSAís Rapid HIV Testing Initiative (www. samhsa.gov/HIVHep/ OTPs are required to provide adequate medi- rhti_factsheet.aspx). As a preliminary positive cal services, and the program sponsor must be test, positive results should be confirmed by sup- able to document plemental HIV testing. In addition, some States that these services have other requirements for laboratory testing are fully and reason- in general and HIV testing specifically. Clinical examina- ably available to patients. HIV testing STD testing tion and an on site or by refer- ral, with pretest and Early testing for STDs in patients receiving posttest counseling, applicantís medi- MAT usually is a State health requirement. is a recommended Persons who inject drugs are at higher risk of medical service. STDs, primarily from increased likelihood of cal history are OTPs should make involvement in sex trading to finance drug use HIV testing part of and the disinhibiting effects of psychoactive keys to determine their medical ser- substances (Sullivan and Fiellin 2004). vices as recommend- Therefore, all patients in MAT should receive the appropriate- ed by the Centers serologic screening for syphilis and, for women for Disease Control and symptomatic men, genital cultures for ness of MAT. and Prevention gonorrhea and chlamydia (Sullivan and Fiellin (2001a). Medical 2004). In the early stages of admission and care and other sup- treatment, patients should be educated about portive services can the effects of STDs and their correlation with be offered if patientsí HIV and HCV statuses other communicable diseases, such as HIV/AIDS are known early in treatment and monitored and hepatitis C, to increase patientsí knowledge continuously. of the ways they can avoid these risks.

Rapid HIV tests have been approved by the For many patients who are opioid addicted, U.S. Food and Drug Administration (FDA) and sexual activities are intertwined with drug use are recommended by the U.S. Public Health behaviors (Calsyn et al. 2000b). Documenting Service to facilitate early diagnosis of HIV the sexual histories of heterosexual and lesbian, infection among at-risk populations involved in gay, and bisexual (LGB) patients, in terms of substance abuse (Centers for Disease Control timing of sexual encounters and partners, is and Prevention 2002a). Rapid tests can detect essential to determine their potential exposure antibodies to HIV in blood obtained by to HCV, HIV, and other STDs, as well as the fingerstick or venipuncture, or in oral fluid and risk of infection for other sexual partners. provide reliable and valid results in 20 minutes Several studies have pointed to increased high- or less. Thus, the rapid HIV test provides a risk sexual behavior among populations that measure of exposure to HIV and requires con- are substance addicted, homeless, and mentally firmatory testing for a diagnosis of HIV infec- ill, in addition to higher levels of psychological tion. In studies by the manufacturer, the blood distress and psychiatric symptoms (McKinnon antibody test correctly identified 99.6 percent et al. 2002; Stoskopf et al. 2001). of people infected with HIV and 100 percent of those not infected, which is comparable to the Additional drug testing results of FDA-approved enzyme immunoassays. FDA expects clinical laboratories to obtain sim- After initial drug testing, subsequent assessment ilar results (Centers for Disease Control and should include further review of urine, blood, Prevention 2003b). OTPs performing rapid oral fluid, or other drug test results. Ideally, HIV tests should comply with the guidelines drug tests should be conducted regularly and

52 Chapter 4 randomly during treatment. The first test is include, but not be limited to, patient especially important because it is part of the recollections of and attitudes about previous initial evaluation and may serve as documenta- substance abuse treatment; expectations and tion of current opioid use. As noted in Federal motivation for treatment; level of support for regulations, the presence of opioids in test a substance-free lifestyle; history of physical results does not establish a diagnosis of opioid or sexual abuse; military or combat history; addiction, and the absence of opioids does not traumatic life events; and the cultural, reli- rule it out. Clinical examination and an appli- gious, and spiritual basis for any values and cantís medical history are keys to determine the assumptions that might affect treatment. This appropriateness of MAT. Chapter 9 discusses information should be included in an integrated drug-testing procedures and Federal regulations summary in which data are interpreted, governing these procedures. patientsí strengths and problems are noted, and a treatment plan is developed (see chapter 6) that matches each patient to appropriate Womenís Health services. Women in MAT should receive information on their particular health needs, for example, Data should be collected in a respectful way, family planning, gynecological health, and taking into consideration a patientís current menopause (see the forthcoming TIP Substance level of functioning. Motivational interviewing Abuse Treatment: Addressing the Specific techniques (Miller and Rollnick 2002) can help Needs of Women [CSAT forthcoming f]). engage applicants early. The information col- Women of childbearing age should be counseled lected depends on program policies, proce- on pregnancy testing during admission before dures, and treatment criteria; State and making decisions about detoxification (42 CFR, Federal regulations; and the patientís stability Part 8 ß 12(e)(3)). Pregnancy testing, along and ability to participate in the process. The with onsite access to or referral for family psychosocial history can reveal addiction- planning services, should be available in all related problems in areas that might be over- OTPs as part of an overall womenís health looked, such as strengths, abilities, aptitudes, initiative (see chapter 13). and preferences. Most information can be ana- lyzed by using standardized comprehensive assessment instruments tailored to specific pop- Induction Assessment ulations or programs, such as those described by Dodgen and Shea (2000). Induction is the riskiest stage of MAT (see chapter 5), and proper medical assessment dur- SAMHSA regulations require that patients ing induction requires an understanding of the ìaccepted for treatment at an OTP shall be pharmacology of treatment medication (see assessed initially and periodically by qualified chapter 3). A patient should be assessed at least personnel to determine the most appropriate daily during induction for signs of overmedica- combination of services and treatmentî (42 tion or undermedication, and dose adjustments CFR, Part 8 ß 12(f)(4) [Federal Register should be made accordingly. 66(11):1097]). Treatment plans should be reviewed and updated, initially every 90 days and, after 1 year, biannually or whenever Comprehensive changes affect a patientís treatment outcomes. Assessment Ongoing monitoring should ensure that services are received, interventions work, new problems Completion of induction marks the beginning are identified and documented, and services of stabilization and maintenance treatment are adjusted as problems are solved. Patientsí and ongoing, comprehensive medical and views of their progress, as well as the treatment psychosocial assessment conducted over teamís assessment of patientsí responses to multiple sessions. This assessment should

Initial Screening, Admission Procedures, and Assessment Techniques 53 treatment, should be documented in the from treatment plan. symptoms and can reveal important clues to effective case management, for example, the need to refer patients for treatment of Patient Motivation and co-occurring disorders. Readiness for Change Chapter 11 discusses treatment methods and Patient motivation to engage in MAT is a pre- considerations for patients with histories of dictor of early retention (Joe et al. 1998) and is multiple substance abuse. Most of these associated with increased participation, positive patients fall into one of three groups, which treatment outcomes, improved social adjust- should be determined during assessment: those ment, and successful treatment referrals (CSAT who use multiple substances (1) to experience 1999a). their psychoactive effects, (2) to self-medicate Starting with initial contact and continuing for clinically evident reasons (e.g., back pain, throughout treatment, assessment should focus insomnia, headache, co-occurring disorders), on patient motivation for change (CSAT or (3) to compensate for inadequate treatment 1999a). OTP staff members help patients move medication (Leavitt et al. 2000). Multiple sub- beyond past experiences (e.g., negative relation- stance use should be identified and addressed ships with staff, inadequate dosing) by focusing as soon as possible because of the risk of possi- on making a fresh start, letting go of old ble overdose for patients who continue to abuse grievances, and identifying current realities, drugs or alcohol during treatment. Continued ambivalence about change, and goals for the substance abuse while in MAT might indicate future. It often is helpful to enlist recovering that another treatment option is more appro- patients in motivational enhancement priate. A challenge in treating patients who activities. TIP 35, Enhancing Motivation for abuse substances for clinically evident reasons Change in Substance Abuse Treatment (CSAT is to determine whether the patients are 1999a), provides extensive information about attempting to medicate undiagnosed, misdiag- stages of change, the nature of motivation, nosed, or undertreated problems. If so, then and current guidelines for enhancing patient effectively addressing these related problems motivation to change. may reduce or eliminate continuing drug or alcohol abuse and improve outcomes. Substance Use Assessment Cultural Assessment As discussed previously, a patientís lifetime substance use and treatment history should be A comprehensive assessment should include documented thoroughly. The following areas patientsí values and assumptions; linguistic should be assessed: preferences; attitudes, practices, and beliefs about health and well-being; spirituality and ï Periods of abstinence (e.g., number, duration, religion; and communication patterns that circumstances) might originate partly from cultural traditions ï Circumstances or events leading to relapse and heritage (Office of Minority Health 2001). Staff knowledge about diverse groups is ï Effects of substance use on physical, important for effective treatment services. Of psychological, and emotional functioning particular importance are experiences and ï Changing patterns of substance use, with- coping mechanisms related to assimilation and drawal signs and symptoms, and medical acculturation of groups into mainstream sequelae. American culture that may affect how they perceive substance abuse and MAT. Gathering Reports of psychiatric symptoms during absti- pertinent information often must rely on nence help treatment providers differentiate subjective sources (e.g., interviews and

54 Chapter 4 questionnaires). Even so, staff members Qualified professionals should train all staff involved in screening and assessment should members involved in screening and assessment be cautioned against making value judgments to recognize signs and symptoms of change in about cultural or ethnic preferences or patientsí mental sta- assumptions about ìaverageî middle-class tus. This training American values and beliefs. (See the forth- should be ongoing. A psychosocial coming TIP Improving Cultural Competence After reviewing their in Substance Abuse Treatment [CSAT observations with the forthcoming b].) program physician, assessmentÖ staff members should A shared staffñpatient cultural identity is refer all patients still identifies the attractive to some patients entering treatment. suspected of To the extent possible, patient preferences for having co-occurring relevant dynamics staff members who share their cultural identity disorders for psychi- should be honored. Multilingual educational atric evaluation. This of patientsí lives materials and displays of culturally diverse evaluation should materials in the OTP help patients feel more at identify the types of and functioning ease when English is not their primary language. co-occurring disor- ders and determine both before the Psychosocial Assessment how they affect patientsí comprehen- The components and objectives of psychosocial sion, cognition, and onset of illness and assessment also are applicable to patients in psychomotor func- MAT. A psychosocial assessment typically iden- tioning. Persistent currently. tifies the relevant dynamics of patientsí lives neuropsychological and functioning both before the onset of illness problems warrant for- (e.g., depression, anxiety) and currently. It mal testing to diag- identifies patientsí specific strengths and nose their type and severity and to guide treat- resources (e.g., employment, supportive family ment. Consultations by psychologists or physi- relationships) as a basis for focused, individu- cians should be requested or referrals made for alized, effective treatment planning. testing. (See chapter 12 for typical methods of psychiatric screening and diagnosis in an OTP.) History of co-occurring disorders and current mental Sociodemographic history status Sociodemographic data about an applicant Mental status assessments identify the threshold should include employment, educational, legal, signs of co-occurring disorders and require military, family, psychiatric, and medical histo- familiarity with the components of a mental ries, as well as current information, and should status examination (i.e., general appearance, be supplemented by documents for identifica- behavior, and speech; stream of thought, tion, such as a driverís license, birth or bap- thought content, and mental capacity; mood tismal certificate, passport, Social Security and affect; and judgment and insight) as out- card, Medicaid card, public assistance card, or lined in Diagnostic and Statistical Manual of identification card from another substance Mental Disorders, Fourth Edition, Text abuse treatment program. Revision (American Psychiatric Association 2000). A mental status assessment also should look for perceptual disturbances and cognitive dysfunction.

Initial Screening, Admission Procedures, and Assessment Techniques 55 Family and cultural back- posttraumatic stress disorder [PTSD]) and ground, relationships, and provide or coordinate immediate services to address it (CSAT 1997b, 2000d). supports Child abuse. All States require mandatory The effect of substance use on a patientís reporting of child abuse by helping professionals family cannot be overestimated, and family including OTP staffóparticularly State- problems should be expected for most patients licensed physicians, therapists, nurses, and entering treatment. The comprehensive assess- social workers (CSAT 2000d). Most States ment should include questions about family require that this reporting be immediate and relationships and problems, including any offer toll-free numbers. Most also require that history of domestic violence, sexual abuse, and reports include the name and address of a par- mental disorders (see below). When possible, ent or caretaker, the type of abuse or neglect, the assessment should include input from rela- and the name of the alleged perpetrator. tives and significant others. Because families Failure to report indications of abuse that with members who abuse substances have results in injury to a child can lead to criminal problems directly linked to this substance charges, a civil suit, or loss of professional abuse, at least one staff member should be licensure. Mandated reporters generally are trained in family therapy or in making appro- immune from liability for reports made in good priate referrals for this intervention. faith that later are found to be erroneous During assessment, program staff should be (CSAT 2000d). sensitive to various family types represented in Staff members who suspect domestic violence the patient population. For example, programs should investigate immediately whether a treating significant numbers of single parents patientís children have been harmed. Inquiries should consider onsite childcare programs. into possible child abuse can occur only after Structured childcare services also enable OTP notice of the limitations of confidentiality in staff to observe and assess a patientís family MAT (42 CFR, Part 8 ß 12(g)) has been given functioning, which can be valuable in treat- to the patient, who must acknowledge receipt of ment planning. this notice in writing. Patients also must be Any counselor or treatment provider who informed, during orientation and when other- might confront emergencies related to child or wise applicable, that substance abuse treatment spousal abuse should be trained in how to iden- providers are required to notify a childrenís tify and report these problems. TIP 25, protective services agency if they suspect child Substance Abuse Treatment and Domestic abuse or neglect. Violence (CSAT 1997b), provides screening, Spousal or partner abuse. Generally, if a assessment, and response guidance when patient believes that she or he is in imminent domestic violence is suspected. TIP 36, danger from a batterer, the treatment provider Substance Abuse Treatment for Persons With should respond to this situation before address- Child Abuse and Neglect Issues (CSAT 2000d), ing any others and, if necessary, suspend the focuses on screening and assessment when screening or assessment interview to do so. patients are suspected of being past victims or Exhibit 4-3 summarizes the steps a treatment perpetrators of child abuse. Staff members provider should follow. He or she should refer should be trained to listen and prepared to a patient to a shelter, legal services, or a domes- hear traumatic stories and handle these situa- tic violence program if indicated. Providers tions, for example, by monitoring any intense should be familiar with relevant Federal, State, symptoms and seeking special assistance when and local regulations on domestic violence (e.g., necessary (CSAT 2000d). Staff should be able the 1994 Violence Against Women Act [visit to identify individuals who exhibit certain signs www.ojp.usdoj.gov/vawo/laws/vawa/vawa.htm]) and symptoms associated with abuse (e.g.,

56 Chapter 4 Exhibit 4-3

Recommended Procedures for Identifying and Addressing Domestic Violence*

ï Look for physical injuries, especially patterns of untreated injuries to the face, neck, throat, and breasts, which might become apparent during the initial physical examination. ï Pay attention to other indicators: history of relapse or treatment noncompliance; inconsis- tent explanations for injuries and evasiveness; complications in pregnancy; possible stress- and anxiety-related illnesses and conditions; sad, depressed affect; or talk of suicide. ï Fulfill legal obligations to report suspected child abuse, neglect, and domestic violence. ï Never discuss a patient without the patientís permission; understand which types of sub- poenas and warrants require that records be turned over to authorities. ï Convey that there is no justification for battering and that substance abuse is no excuse. ï Contact domestic violence experts when battery has been confirmed. *State laws may include other requirements.

and the legal resources available (e.g., restrain- ï Display information about domestic violence ing orders, duty to warn, legal obligation to in public (e.g., waiting room) and private report threats and past crimes, confidentiality). (e.g., restroom) locations.

Romans and colleagues (2000) identified the ï Use opportunities during discussions (e.g., following methods for exploring potential comments about marital conflict situations or domestic violence situations, which can be poor communication with partners) to probe incorporated into effective assessment tools: further. ï Obtain as complete a description as possible ï Always interview patients in private about of the physical, sexual, and psychological domestic violence. violence perpetrated by or on a patient ï Begin with direct, broad questions and move recently; typically, those who commit domes- to more specific ones; inquire how disagree- tic violence minimize, deny, or otherwise ments or conflicts are resolved (e.g., ìDo you obscure their acts. want to hit [him or her] to make [him or her] see sense?î); ask whether patients have trou- History of physical or sexual ble with anger or have done anything when abuse angry that they regret; combine these ques- tions with other types of lifestyle questions. Some patients enter an OTP with a history of ï Ask about violence by using concrete exam- physical or sexual abuse, which frequently ples and specific hypothetical situations causes additional psychological distress (Schiff rather than vague, conceptual questions. et al. 2002). Information about these types of abuse is important in treatment planning but not always easily accessible using specific assessment tools, especially early in treatment.

Initial Screening, Admission Procedures, and Assessment Techniques 57 Some patients with abuse histories might deny Housing status and safety their victimization. Many women are less likely concerns to admit abuse to male counselors. Male staff should know when to request a staff change for Based on year 2000 estimates, approximately counseling about physical or sexual abuse. 10 percent of patients in MAT are homeless or Patients might not be ready to address the living as transients when admitted to treatment problem, think it is unrelated to substance (Joseph et al. 2000). Moreover, those who are abuse, or be ashamed. Gathering information not homeless often live with people who are from them about abuse, therefore, requires addicted or in areas where substance use is extreme care and respect during screening and common. In the opinion of the consensus panel, assessment. Once patients are stabilized and early intervention to arrange safe, permanent their practical needs are addressed, counseling shelter for these patients should be a high pri- by qualified treatment providers can focus on ority, and a patientís shelter needs should be this problem. ascertained quickly during screening and assessment. OTPs should establish special Peer relations and support support services to help patients secure appropriate living arrangements, such as refer- The extent of social deterioration, interpersonal ral agreements with housing agencies or other loss, and isolation that patients have experi- programs to locate housing that addresses the enced should be documented thoroughly during special needs of homeless patients. screening and assessment. Assessment of a patientís support systems, including past Criminal history and legal participation in mutual-help groups (e.g., Alcoholics Anonymous, Methadone Anonymous status [MA]), is critical to identifying peer support Another purpose of screening and assessment is networks that provide positive relationships to identify legal issues that might interrupt and enhance treatment outcomes. Some 12- treatment, such as outstanding criminal Step groups are ill-informed about MAT and charges or ongoing illegal activity to support may be unaware of the treatment goals of MAT substance use; however, pending or unresolved and less than sup- charges are not a contraindication for MAT. portive; in these Assessment may involve exploring personal cases, providers circumstances such as child custody and related [A]ssessment and should help patients obligations. In the consensus panelís experi- identify other ence, many patients ignore legal problems treatment... sources of support during periods of substance use, but these (e.g., MA groups) problems pose a serious threat to recovery. In should focus on and encourage con- addition, a patientís arrest record, including tinued development age at first arrest, arrest frequency, nature of of some type of peer stopping the offenses, criminal involvement during child- support network. In hood, and life involvement with the criminal areas with limited justice system, should be clarified. substance abuse resources, patients may be able to over- Insurance status that interferes come initial discrimi- natory behavior in Patientsí resources to cover treatment costs with patientsí existing groups by should be determined during screening and increasing their assessment. Often they are uninsured or have well-being. knowledge of MAT not explored their eligibility for payment assis- and their ability to tance. The consensus panel believes that OTPs self-advocate. are responsible for helping patients explore

58 Chapter 4 payment options so that they have access to a areas of strength or personal achievement, full range of treatment services, including med- such as the ability to cope under stress, receipt ical care, while ensuring payment to the OTP. of medals for service accomplishments, and honorable discharge; patients can learn to In situations of inadequate funding or patient build on past strengths in current challenging ineligibility for funds, another source of pay- situations and to progress in treatment. If the ment should be identified. OTP staff can assist latter, providers should review patientsí nega- patients in applying for public assistance or tive military experiences, including loss of inquiring whether personal insurance will reim- friends and loved ones, onset of substance use, burse MAT costs. Counselors can help patients war-related injuries, chronic pain, PTSD, and make decisions about involving their insurance co-occurring disorders (e.g., depression). This companies and address fears that employers information might indicate patterns of behavior will find out about their substance use or that that continue to affect recovery. benefits for health care will be denied. Patientsí military history also might reveal Employment history their eligibility for medical and treatment resources through U.S. Department of Another important component of psychosocial Veterans Affairs programs and hospitals or assessment is a patientís employment history. social service agencies. Based on year 2000 estimates, only 20 percent of patients in MAT were employed when admitted to an OTP (Joseph et al. 2000). Until they are Spirituality stabilized, employed patients often experience ìSpiritualityî in this TIP refers to willing substance-related difficulties at the workplace, involvement in socially desirable activities or including lack of concentration, tardiness and processes that are beyond the immediate details absences, inability to get along with coworkers, of daily life and personal self-interest. Attention on-the-job accidents, and increased claims for to the ethics of behavior, consideration for the workersí compensation. Early identification of interests of others, community involvement, these difficulties can help staff and patients helping others, and participating in organized create a more effective treatment plan. religion are expressions of spirituality.

Patients who are employed often are reluctant A patientís spirituality can be an important to enter residential treatment or take the time treatment resource, and persons recovering to become stabilized on medication; however, from addiction often experience increased most of these patients would take medical or interest in the spiritual aspects of their lives. A other leave time if they were hospitalized for study by Flynn and colleagues (2003) of 432 other illnesses, and they should be encouraged patients admitted to 18 OTPs found that those to take their addiction as seriously. A physi- who remained in recovery for 5 years credited cianís note recommending time off work for religion or spirituality as one factor in this out- some period might help, but it should be on let- come. Staff should assess patientsí connections terhead that does not reference drug treatment. with religious institutions because these institu- tions often provide a sense of belonging that is Military or other service valuable in the rehabilitative process. history Miller (1998) found a lack of research explor- A patientís military or other service history can ing the association between spirituality and highlight valuable areas in treatment planning. addiction recovery but concluded that spiritual In particular, was military service generally a engagement or reengagement appeared to be positive or negative experience? If the former, correlated with recovery. In studies reviewed treatment providers can help patients identify by Muffler and colleagues (1992), individuals with a high degree of spiritual motivation to

Initial Screening, Admission Procedures, and Assessment Techniques 59 recover reported that treatment programs that Patientsí ability to manage included spiritual guidance or counseling were money more likely to produce positive outcomes than programs that did not. OTPs should assess Financial difficulties are common among spiritual resources adequately. Counselors and patients in MAT, who often have spent other mental health professionals could benefit considerable money on their substance use that from training in patient spirituality if it is otherwise would have paid for rent, food, and difficult for them to explore. utilities. Financial status and money manage- ment skills should be assessed to help patients Sexual orientation and understand their fiscal strengths and weakness- es as they become stabilized. Patients often history need assistance to adjust to loss of income The assessment and treatment needs of hetero- caused by reduced criminal activity and develop sexual and LGB populations are similar and skills that enhance their legitimate earning should focus on stopping the substance abuse power. Once financial factors are clarified, that interferes with patientsí well-being. patients may be better prepared to devise Assessment of risk factors associated with sexual realistic strategies to achieve short- and long- encounters and partners is essential. What term goals. often differs for an LGB population is the importance of assessing patientsí sexual or gen- Recreational and leisure der orientation concerns, such as their feelings activities about their sexual orientation (CSAT 2001b). OTP staff should pay strict attention to confi- Recreational and leisure activities are impor- dentiality concerns for LGB patients because tant in recovery; therefore, assessment should they may be at increased risk of legal or other determine any positive activities in which actions affecting employment, housing, or child patients have participated before or during custody. Treatment modalities and programs periods of substance use. Identifying existing should be accessible to all groups, and pro- recreational and leisure time preferences and grams providing ancillary services should be gaining exposure to new ones can be significant sensitive to the special needs of all patients steps in developing a recovery-oriented lifestyle. regardless of sexual orientation (CSAT 2001b).

60 Chapter 4 Appendix 4-A. Example of Standard Consent to Opioid Maintenance Treatment

Consent to Participation in Opioid Pharmacotherapy Treatment

Patient’s Name: ______Date: ______

I hereby authorize and give voluntary consent to the Division and its medical personnel to dispense and administer opioid pharmacotherapy (including methadone or buprenorphine) as part of the treatment of my addiction to opioid drugs. Treatment procedures have been explained to me, and I understand that this will involve my taking the prescribed opioid drug at the schedule determined by the program physician, or his/her designee, in accordance with Federal and State regulations.

It has been explained that, like all other prescription medications, opioid treatment medications can be harmful if not taken as prescribed. I further understand that opioid treatment medications produce dependence and, like most other medications, may produce side effects. Possible side effects, as well as alternative treatments and their risks and benefits, have been explained to me.

I understand that it is important for me to inform any medical provider who may treat me for any medical problem that I am enrolled in an opioid treatment program so that the provider is aware of all the medications I am taking, can provide the best possible care, and can avoid prescribing medications that might affect my opioid pharmacotherapy or my chances of successful recovery from addiction.

I understand that I may withdraw voluntarily from this treatment program and discontinue the use of the medications prescribed at any time. Should I choose this option, I understand I will be offered medically supervised tapering.

For Female Patients of Childbearing Age: There is no evidence that methadone pharmaco- therapy is harmful during pregnancy. If I am or become pregnant, I understand that I should tell my medical provider right away so that I can receive appropriate care and referrals. I under- stand that there are ways to maximize the healthy course of my pregnancy while I am in opioid pharmacotherapy.

______Signature of Patient Date of Birth Date

Witness: ______

Adapted with permission from Department of Psychiatry and Behavioral Sciences, Albert Einstein College of Medicine, Division of Substance Abuse, Bronx, NY.

Initial Screening, Admission Procedures, and Assessment Techniques 61

5 Clinical Pharmacotherapy

This chapter describes pharmacotherapy in opioid treatment programs (OTPs), in particular the clinical use of methadone, with limited discus- In This sion of levo-alpha acetyl methadol (LAAM) and buprenorphine. More limited coverage is provided on the opioid antagonist naltrexone, which ChapterÖChapter… is not used widely for opioid addiction treatment in the United States. As explained in chapter 3, at this writing most OTPs have discontinued the Contraindications Lorem ipsum dolor use of LAAM for new patients, and its continued availability is uncer- to Opioid sit tain. TIP 40, Clinical Guidelines for the Use of Buprenorphine in the Pharmacotherapy Sed do Treatment of Opioid Addiction (CSAT 2004a), provides more detailed Stageseiusmod of information about buprenorphine. Pharmacotherapy Ut enim In general, the choice of medication used in medication-assisted treat- adMedically minim ment for opioid addiction (MAT) is based on safety and efficacy, patient veniamSupervised quis preferences, and treatment goals. Methadone maintenance treatment has Withdrawal the longest successful track record in patients addicted to opioids for Dolore eu more than a year and has been shown to control withdrawal symptoms, fugiatTake-Home nulla stabilize physiologic processes, and improve functionality. Studies also Medications have found that methadone maintenance treatment reduces criminality, noncompliance with HIV/AIDS therapy, seroconversion to HIV/AIDS, Office-Based Opioid and mortality associated with opioid addiction (Appel et al. 2001; Ball Therapy and Ross 1991). Since 2001, LAAM, although effective in opioid pharma- cotherapy, has carried a restrictive label precluding its use as the initial medication for MAT. As reviewed in chapter 3, the effectiveness of buprenorphine has been found to be similar to that of methadone and LAAM (Johnson et al. 2000). Sublingual buprenorphine formulations have been approved for use in OTPs and by physicians in office-based and other health care settings. Some patients prefer buprenorphine maintenance in an office-based opioid treatment (OBOT) setting to the daily observed dosing that is part of methadone maintenance in an OTP. However, patients who progress in MAT while in an OTP eventually may qualify for take-home medication lasting up to 30 days at a time, as detailed below, and patients desiring ongoing buprenorphine pharma- cotherapy now can receive buprenorphine on a less-than-daily basis in either an OTP or OBOT setting. For some patients, these options may reduce the attendance requirements for MAT in an OTP.

63 For patients who do not qualify for or do not ï Individuals who abuse opioids but whose prefer opioid maintenance treatment (see conditions do not meet criteria for opioid ìContraindications to Opioid Pharmacotherapyî dependence outlined in the Diagnostic and below), a primary issue during treatment is Statistical Manual of Mental Disorders, what to do about withdrawal symptoms. Fourth Edition, Text Revision (DSM-IV-TR) Naturally occurring opioid withdrawal is almost (American Psychiatric Association 2000). If a never life threatening, but it can produce dis- clear history of opioid abuse or addiction comfort severe enough to warrant urgent inter- exists but a person currently is not addicted, vention. Treatment for withdrawal symptoms regulations allow admission to an OTP in two usually involves administration of a long-acting cases in which a person might relapse without opioid medication such as methadone or treatment: pregnancy and release from incar- buprenorphine, which can be followed by grad- ceration (42 Code of Federal Regulation ual tapering of the medication as withdrawal [CFR], 8 Part ß 12(e)(3)). symptoms diminish. ï Individuals with less than 1 year of opioid Control of withdrawal symptoms often is insuf- addiction and no addiction treatment history, ficient treatment to prevent a relapse to opioid except patients receiving OBOT with abuse, and detoxification alone may yield only buprenorphine. Detoxification might be short-term benefits. Research has shown that attempted with applicants who have a shorter retention in treatment over an extended period history of addiction. Applicants receiving is key to successful outcomes for opioid addic- buprenorphine may be admitted to an OTP tion in many patients, just as it is for other for either medically supervised withdrawal or chronic diseases like hypertension, diabetes, maintenance treatment. and asthma (McLellan et al. 2000). Therefore, ï Applicants who cannot attend treatment when detoxification from short-acting opioids is sessions regularly, especially for medication provided, the consensus panel recommends dosing (unless a clinical exception can be linkage to ongoing psychosocial treatment, with obtained [see chapter 7]); this requirement is or without additional maintenance therapy less of a hindrance for patients receiving with an opioid antagonist such as naltrexone. OBOT with buprenorphine. Comprehensive, long-term opioid agonist main- ï Previous patients who have had allergic reac- tenance remains the treatment with the best tions to methadone, LAAM, or buprenorphine. track record of controlling opioid use and sav- ï For LAAM, applicants with cardiac abnor- ing lives, although opioid partial agonist thera- malities such as prolonged QT interval. py is promising. Access and easy transfer to this care should remain available as part of any In addition, people who are opioid addicted detoxification program. and meet DSM-IV-TR criteria for alcohol or sedative dependence might be problematic can- didates for opioid pharmacotherapy because Contraindications the combined effects of alcohol or sedatives to Opioid that depress the central nervous system (CNS) can cause serious adverse events during MAT Pharmacotherapy (see discussion of drug interactions in chapter The consensus panel believes that few psychi- 3). Some treatment providers require detoxifi- atric or medical diagnoses categorically should cation from alcohol and sedatives before opioid rule out admission to an OTP or access to opi- pharmacotherapy, followed by careful monitor- oid pharmacotherapy. Inclusion rather than ing such as daily BreathalyzerJ tests, ongoing exclusion should be the guiding principle. drug tests, and reduction or withholding of Types of people who possibly should not be medication if a test is positive. The consensus admitted to an OTP and should receive other panel endorses this strategy, provided that interventions include adequate alcohol or sedative detoxification

64 Chapter 5 facilities are readily available. If not, both opi- antidepressants, benzodiazepines, alcohol, or oid addiction and alcohol or sedative depen- other CNS depressants are told in clear lan- dence should be treated concurrently at the guage of the dangers of adverse effects if they OTP site with a combination of psychosocial take these substances while being stabilized or and pharmacological interventions. maintained on methadone, LAAM, or buprenorphine. Stages of Observed dosing. Observed dosing with methadone, LAAM, or buprenorphine should Pharmacotherapy be part of the medical safety procedure and The stages of pharmacotherapy with methadone, diversion control plan in an OTP and is recom- LAAM, or buprenorphine include induction, mended during induction with buprenorphine. stabilization, and maintenance. The stages of Observed dosing is the only way to ensure that naltrexone pharmacotherapy may differ. a patient ingests a given dose and to monitor a patientís Induction response. In observed Regardless of the Induction procedures for methadone, LAAM, dosing, staff members and buprenorphine depend on the unique who dispense medica- medication used, pharmacologic properties of each medication, tion first carefully prevailing regulatory requirements, and patient identify patientsó safety is key characteristics. Regardless of the medication sometimes by requir- used, safety is key during the induction stage. ing them to remove during the hats or dark glasses, General considerations for exampleóand induction stage. then provide the Timing. When to begin the first dose of opioid medication. treatment medication is important. Most treat- ment providers begin treating new patients To ensure that patients swallow oral doses of when there are no signs of opioid intoxication methadone or LAAM, they should be required or sedation and some beginning signs of opioid to speak before and after ingesting at least 2 withdrawal. Administration of the first dose ounces of liquid in which an appropriate dose also should await a physical assessment to rule of medication is dissolved. For buprenorphine, out any acute, life-threatening condition that a sublingual tablet should be observed to have opioids might mask or worsen (see chapter 4 dissolved completely under the tongue. After for more information on medical assessment). the first dose, patients should wait in an obser- For naltrexone, patients should be abstinent vation area and be checked 30 to 60 minutes from all short-acting opioids for at least 7 days later for acute adverse effects. If same-day and from long-acting opioids, such as dosing adjustments must be made, patients methadone, for at least 10 days before begin- should wait 2 to 4 more hours after the addi- ning the medication to prevent potentially tional dosing, for further evaluation when peak severe withdrawal symptoms (OíConnor and effects are achieved. The consensus panel rec- Fiellin 2000). ommends that patients be observed for several hours after the first dose of any opioid treat- Other substance use. The presence of sedatives ment medication. This observation is particu- such as benzodiazepines or alcohol should be larly important for patients at higher risk of ruled out before induction to minimize the overdose, including those naive to methadone, likelihood of oversedation with the first dose. LAAM, and buprenorphine; those receiving OTP staff should ensure that patients known other CNS-depressant medications or known to to abuse sedatives, tranquilizers, tricyclic abuse CNS depressants; and severely medically

Clinical Pharmacotherapy 65 ill, frail, or elderly patients. Naltrexone of medication accumulate in body tissues (see typically is prescribed without observed dosing, below), the effects begin to last longer. but poor patient compliance with ongoing naltrexone therapy has led some investigators Steady state. Initial dosing should be followed to look at using family members to ensure that by dosage increases over subsequent days until patients take their medication (Fals-Stewart withdrawal symptoms are suppressed at the and OíFarrell 2003). peak of action for the medication. Methadone, LAAM, and buprenorphine are stored in body Initial dosing. The first dose of any opioid tissues, including the liver, from which their treatment medication should be lower if a slow release keeps blood levels of medication patientís opioid tolerance is believed to be low, steady between doses. It is important for physi- the history of opioid use is uncertain, or no cians, staff members, and patients to under- signs of opioid withdrawal are evident. Some stand that doses of medication are eliminated former patients who have been released from more quickly from the bloodstream and medi- incarceration or are pregnant and are being cation effects wear off sooner than might be readmitted because they have a history of expected until sufficient levels are attained in addiction might have lost their tolerance. Loss tissues. During induction, even without dosage of tolerance should be considered for any increases, each successive dose adds to what is patient who has abstained from opioids for present already in tissues until steady state is more than 5 days. In general, the safety princi- reached. Steady state refers to the condition in ple ìstart low and go slowî applies for early which the level of medication in a patientís medication dosages in an outpatient OTP. The blood remains fairly steady because that drugís amount of opioid abuse estimated by patients rate of intake equals the rate of its breakdown usually gives only a rough idea of their toler- and excretion. ance and should not be used as a dosing guide for induction, nor should initial dosages be Steady state is based on multiples of the elimi- determined by previous treatment episodes or nation half-life. Approximately four to five patient estimates of dollars spent per day on half-life times are needed to establish a steady opioids. Patients state for most drugs. For example, because transferred from methadone has a half-life of 24 to 36 hours, its other treatment pro- steady stateóthe time at which a relatively grams should start constant blood level should remain present in the bodyóis achieved in 5 to 7.5 days after [T]he safety with medication dosages identical to dosage change for most patients. However, those prescribed at individuals may differ significantly in how long principle ìstart their previous OTPs. it takes to achieve steady state. low and go slowî Dosage adjustments Patients should stay on a given dosage for a in the first week of reasonable period before deciding how it will applies for early treatment should be ìhold.î During induction, patients should be based on how instructed to judge their doses by how they feel during the peak period (the point of maximum medication patients feel at the peak period for their concentration of medication in the blood [for methadone, 2 to 4 hours after taking a dose]), dosages in an medication (e.g., 2 to 4 hours after a rather than during the trough period (the low dose of methadone is point of medication concentration in blood just outpatient OTP. administered), not before the next dose [for methadone, approxi- on how long the mately 24 hours after ingestion]). Patients who effects of a medica- wake up sick during the first few days of opioid tion last. As stores pharmacotherapy might become convinced that

66 Chapter 5 they need a dose increase, when in fact they Since 2001, LAAM has carried a restriction need more time for tissue stores to reach steady that precludes its use as an initial medication state. In contrast, patients who wake up sick for pharmacotherapy because of concerns after the first week of treatmentówhen tissue about its cardiovascular effects. Although stores have reached steady-state levelsómight direct induction with LAAM can be accom- indeed need higher doses. plished with an initial dose of 20 to 40 mg every 48 hours, LAAM has been used almost exclu- In closely monitored settings such as inpatient sively in cases involving transfer of patients programs, multiple split doses can be adminis- from methadone maintenance. LAAM must tered per day based on patientsí symptoms at never be given on 2 consecutive days because peak blood levels. Outpatient programs are its extended duration of action can result in limited in this approach because patients can toxic blood levels leading to fatal overdose. be monitored only when they are at the OTP site. (Split dosing is discussed further below.) Variations in individual response and optimal Because buprenorphineís safety profile makes dosing. Most differences in patient response to overdose less of a concern, some providers opt methadone can be explained by variations in to give even new patients receiving buprenor- individual rates of absorption, digestion, and phine some take-home medication for multiple excretion of the drug, which in turn are caused dosing during induction (CSAT 2004a). by such factors as body weight and size, other substance use, diet, co-occurring disorders and Induction with methadone medical diseases, and genetic factors. Because variation in response to methadone is consider- and LAAM able, the consensus panel believes that the Because methadone overdose deaths have notion of a uniformly suitable dosage range occurred in the first few days of treatment or an upper dosage limit for all patients is (Caplehorn and Drummer 1999; Zador and unsupported scientifically. Whereas 60 mg of Sunjic 2000), it is important to adjust methadone per day may be adequate for some methadone dosage carefully until stabilization patients, it has been reported that some and tolerance are established. Federal regula- patients require much more for optimal effect. tions require that methadone initially be given Treatment providers should avoid thinking of daily under observation for either 6 or 7 days ìhigh dosageî as being above a certain uniform per week. (A take-home dose is allowed for all threshold; however, there are few data on the patients when the OTP is closed on Sunday.) safety of methadone doses above 120 mg/day. LAAM must continue to be given under obser- For example, diversion of very high doses can vation and administered no more than every 2 be associated with significant risk because the to 3 days. tolerance of the person taking the diverted dose may be insufficient to avoid overdose. Initial dosing. For a patient actively abusing opioids, a typical first dose of methadone is 20 The way a person presents at the OTP is often to 30 mg (Joseph et al. 2000) and is limited by the best indicator for determining optimal regulations to no more than 30 mg. If with- dosage. Looking for clinical signs and listening drawal symptoms persist after 2 to 4 hours, the to patient-reported symptoms related to daily initial dose can be supplemented with another 5 doses or changes in dosage can lead to adjust- to 10 mg (Joseph et al. 2000). The total first- ments and more favorable outcomes (Leavitt et day dose of methadone allowed by Federal reg- al. 2000). Exhibit 5-1 illustrates the use of signs ulations is 40 mg unless a program physician and symptoms to determine optimal methadone documents in the patient record that 40 mg was dosages. Generally, the disappearance of opioid insufficient to suppress opioid withdrawal withdrawal symptoms indicates adequate dos- symptoms (42 CFR, Part 8 ß 12(h)(3)(ii)). ing and serum methadone levels (SMLs) within the therapeutic comfort zone.

Clinical Pharmacotherapy 67 Exhibit 5-1

Using Signs and Symptoms To Determine Optimal Methadone Levels

Adapted from Leavitt et al. (2000), modified with permission from Mount Sinai Journal of Medicine.

Research indicates that patients diagnosed with Induction with buprenorphine mental disorders or hepatitis C along with sub- Because buprenorphine has lower abuse poten- stance addiction may need increases of 50 per- tial than methadone or LAAM and is less likely cent or more in methadone dosage to achieve to produce respiratory depression if diverted stabilization (Leavitt et al. 2000; Maxwell and or misused, qualified practitioners can pre- Shinderman 2002). scribe buprenorphine without the control Exhibit 5-2 illustrates how blood levels of structure of an OTP when they meet Drug methadone rise with repeated dosing until steady Addiction Treatment Act of 2000 requirements. state is reached. It is important to understand No stated requirement exists for observed dos- that steady state is achieved after a dosage ing with buprenorphine, although guidelines change. In Exhibit 5-2, because the last change strongly recommend dosage monitoring early in (to 100 mg) occurred on day 5, steady state was treatment (CSAT 2004a). not achieved until approximately day 10.

68 Chapter 5 Exhibit 5-2

Induction SimulationóModerate to High Tolerance

Adapted from Payte 2002, with permission.

Initial dosing. Awaiting signs of withdrawal tablets without naloxone (sometimes called before administering the first dose is especially monotherapy tablets) are recommended during important for buprenorphine induction the first 2 days of induction for patients because, as explained in chapter 3, buprenor- attempting to transfer from a longer acting phine can precipitate withdrawal in some cir- opioid such as sustained-release morphine or cumstances (Johnson and Strain 1999). methadone (Amass et al. 2000, 2001) because Precipitated withdrawal usually is more sudden most of these patients will experience with- and can be more severe and uncomfortable drawal effects from the naloxone in the than naturally occurring withdrawal. The combination tablets. When patientsí tissue typical first dose of buprenorphine is 4 mg. If levels of a full agonist are a factor and the withdrawal symptoms persist after 2 to 4 hours, buprenorphine-naloxone tablet is adminis- the initial dose can be supplemented with up to tered, it may be difficult to determine whether 4 mg for a maximum dose of 8 mg of buprenor- precipitated withdrawal is caused by the par- phine on the first day (Johnson et al. 2003b). tial agonist buprenorphine or small amounts of absorbed naloxone. Three national evaluations of the buprenorphine-naloxone combination tablet For most patients who are appropriate found that direct induction with buprenor- candidates for induction with the combination phine alone was effective for most people who tablet, the initial target dose after induction were opioid addicted. However, buprenorphine should be 12 to 16 mg of buprenorphine in

Clinical Pharmacotherapy 69 a 4-to-1 ratio to naloxone (i.e., 12/3 to 16/4 mg several factors, as discussed elsewhere in this [buprenorphine/naloxone]). Bringing patients TIP. The stabilization stage of opioid pharma- to this target dosage may be achieved over the cotherapy focuses on finding the right dosage first 3 days of treatment by doubling the dose for each patient. The potential for undermedi- each successive day after initial administration. cation or overmedication can be avoided by a An initial dose of 4/1 mg (buprenorphine/ flexible approach to dosing, which sometimes naloxone) is recommended, followed in 2 to 4 requires higher dosages of treatment medica- hours with an additional 4/1 mg if indicated. tion than expected, and by taking into account The dosage should be increased on subsequent patient-reported symptoms (Leavitt et al. 2000). days to the target dosage (ranging from 12/3 to 16/4 mg per day). During dose induction, Dosage determination patients may need to visit their OTP or physi- cianís office daily for dose adjustments and It is critical to successful patient management in clinical monitoring. Further information and MAT to determine a medication dosage that will guidelines for buprenorphine induction and use minimize withdrawal symptoms and craving can be found in TIP 40, Clinical Guidelines for and decrease or eliminate opioid abuse. Dosage the Use of Buprenorphine in the Treatment of requirements for methadone, LAAM, and Opioid Addiction (CSAT 2004a). buprenorphine must be determined on an indi- vidual basis. There is no single recommended dosage or even a fixed range of dosages for all Induction with naltrexone patients. For many patients, the therapeutic The standard procedure for induction to nal- dosage range of methadone may be in the trexone therapy is first to make certain that neighborhood of 80 to 120 mg per day (Joseph there is an absence of physiological dependence et al. 2000), but it can be much higher, and on opioids. This often is done by using a occasionally it is much lower. Narcan challenge after a 7- to 10-day period during which opioids are not used. Then the The desired responses to medication that patient is given 25 mg of naltrexone initially, usually reflect optimal dosage include (Joseph followed by 50 mg the next day if no withdrawal et al. 2000) symptoms occur after the first 25 mg dose. ï Prevention of opioid withdrawal for 24 hours Thereafter, the patient is given 50 mg per day or longer, including both early subjective or up to 350 mg per week in three doses during symptoms and objective signs typical of the week. The first dose usually is smaller to abstinence minimize naltrexoneís side effects, such as nau- sea and vomiting, and to ensure that patients ï Elimination of drug hunger or craving have been abstinent from opioids for the ï Blockade of euphoric effects of self- requisite time (Stine et al. 2003). administered opioids (This is not a true blockade like that achieved by naltrexone but reflects cross-tolerance for other opioids, Stabilization attenuating or eliminating desired sensations The terms ìsteady stateî and ìstabilizationî when illicit or prescription opioids are self- should be differentiated. Steady state is administered in usual ìstreet doses.î The achieved when a treatment medication is elimi- increasing purity of heroin and availability of nated from the blood at the exact rate that highly potent prescription opioids have made more is added. In contrast, a patient is stabi- it increasingly difficult to achieve complete lized when he or she no longer exhibits drug- blockade in patients through cross-tolerance; seeking behavior or craving. The correct consequently, some patients require dosages (steady-state) medication dosage contributes to considerably greater than 120 mg per day to a patientís stabilization, but it is only one of achieve this effect.)

70 Chapter 5 ï Tolerance for the sedative effects of treatment show evidence of opioid abuse or withdrawal, medication, creating a state in which patients the dosage should be increased using the same can function normally without impairment of types of guidelines as for methadone. For perception or physical or emotional response example, if the goal is to suppress opioid with- ï Tolerance for most analgesic effects produced drawal symptoms, then dose increases can be by treatment medication (see ìPain less frequent (e.g., weekly or biweekly) because Managementî in chapter 10). the desired therapeutic response likely will become detectable more slowly. Unfortunately, no exact way exists to determine optimal dosage for each patient. However, the Most patients are likely to remain stable on 12 consensus panel recommends that OTPs avoid to 24 mg per day, although some might need exclusive reliance on drug test results and pre- dosages of up to 32 mg per day. Increasing the conceived notions of correct dosage; instead, buprenorphine dosage OTPs should determine dosage based primarily to 24 mg per day or on patient response. Even when a medication higher has been dosage is controlled for body weight (Leavitt et shown to prolong the Dosage require- al. 2000), patient responses, such as absence of duration of its effects and usually is neces- withdrawal symptoms without oversedation and ments for remission from illicit-opioid use, are the best sary if patients are to indicators of appropriate dosage. In addition, be dosed every other the extent of other drug use and alcohol con- day, which is an methadone, sumption should be considered when determin- option with buprenor- ing dosage adequacy. Finally, a patientís com- phine; however, such LAAM, and plaints (or lack thereof) are also important an increase usually indicators of dosage adequacy. A patient can does not increase buprenorphine experience opioid craving or withdrawal but buprenorphineís manage to abstain from illicit opioids. opioid agonist effects must be deter- to the same degree Methadone. Strong evidence supports the use because of its partial mined on an indi- of daily methadone doses in the range of 80 mg agonist properties or more for most patients (Strain et al. 1999), (Johnson et al. but considerable variability exists in patient 2003b). Because vidual basis. responses. Some do well on dosages below 80 to buprenorphine is a 120 mg per day, and others require significant- partial agonist, ly higher dosages (Joseph et al. 2000). OTPs patients who continue should exercise additional caution with higher to abuse opioids after sufficient exposure to dosages, guarding against diversion of take- buprenorphine treatment and ancillary psycho- home methadone to individuals who are opioid social services or who experience continued intolerant because higher dosages can be lethal symptoms of withdrawal at optimal daily doses for such individuals. of buprenorphine (12 to 32 mg) should be considered for therapy with methadone or Buprenorphine. Buprenorphine dosage should LAAM (CSAT 2004a; Johnson et al. 2003b). be determined in a manner similar to that used for methadone or LAAM. The recommended As with all medications used for MAT, when dosage of buprenorphine to begin stabilization buprenorphine dosage changes are contemplat- is 12 to 16 mg per day for most patients, with ed, the intensity and frequency of other avail- increases provided thereafter as applicable able psychosocial services (see chapter 8) affect (Johnson et al. 2003b). As reviewed by Johnson patientsí ability to refrain from opioid abuse and colleagues (2003b), if patients continue to (Bickel et al. 1997) and should be considered.

Clinical Pharmacotherapy 71 LAAM. Most patients who begin LAAM are Studies of the importance of being transferred from methadone and should dosing have been screened for cardiac risk. Equiv- alency dosing tables for methadone and LAAM Much evidence shows a positive correlation are available in the ORLAAMÆpackage insert between medication dosage during MAT and (Roxane Laboratories, Inc., 2001), and trans- treatment response (e.g., Strain et al. 1999). fer can be done easily. Because of the long- Higher dosages in some studies probably pro- acting nature of LAAM, a patientís reaction duced greater cross-tolerance. Cross-tolerance should be monitored closely during the first occurs when medication diminishes or prevents 2 weeks of treatment and adjustments in dosage the euphoric effects of heroin or other short- made accordingly. acting opioids so that patients who continue to abuse opioids no longer feel ìhigh.î The medi- Patients may request transfer from methadone cation dosage needed for this result depends on to LAAM for various reasons: (1) to avoid the how long and how recently a patient has hardship of methadoneís daily observed dosing, abused heroin or other opioids and how much (2) to provide negative drug test results at work he or she has used, along with individual differ- (LAAM is less likely to show up on screening ences in the level of brain receptor adaptation tests), (3) because they are not doing well on induced by chronic opioid use. methadone (Borg et al. 2002), (4) because LAAM can be less sedating, and (5) because the An Australian study connected the importance patients are rapid metabolizers of methadone of dosage with patient retention in MAT and would benefit from LAAM because it is (Caplehorn and Bell 1991). The importance of longer acting. retention for successful treatment outcomes is discussed further in chapter 8. In addition to LAAM can be given every other day if an OTP the benefits of eliminating illicit opioids (see is open all week or three times per week (i.e., below), reductions in the threats of HIV and two 48-hour doses and one 72-hour dose) if hepatitis B and C make adequate dosing and that is more convenient. Although some treatment retention high priorities and justify patients take the same dose on Monday, additional studies on the safety and efficacy of Wednesday, and Friday, most benefit from an methadone doses exceeding 120 mg. increase on Friday (i.e., 10 to 40 percent more than the Monday and Wednesday doses) with In their classic study, Ball and Ross (1991) or without an additional small dose of clearly demonstrated an inverse relationship methadone to be taken home and used on between frequency of recent heroin use and Sunday. For stable patients, the best option is a methadone dosage. The data in Exhibit 5-3 are regular LAAM dose on Friday and a full based on their study of 407 patients who methadone dose (80 percent of the LAAM dose) received methadone maintenance treatment. as a take-home dose for Sunday. The efficacy These data support the premise that lower of LAAM dosing is determined clinically and by methadone dosages are less effective than high- patient history and examination; an affordable er or adequate dosages in facilitating absti- means to determine blood levels of LAAM and nence from heroin among patients in MAT. The its metabolites is unavailable at this writing. low end of the effective range has been accept- ed widely as about 60 mg for most patients Naltrexone. Naltrexone can be administered (reviewed in Faggiano et al. 2003). either daily (usually at a dosage of 50 mg per day) or thrice weekly. For the latter, the usual Another study (Maxwell and Shinderman 2002) practice is to give 100 mg on Monday and monitored 144 patients who were not doing well Wednesday and 150 mg on Friday (Stine et al. at 100 mg of methadone per day and reported 2003). excellent results after raising dosages based on clinical signs and symptoms. Patients receiving

72 Chapter 5 Exhibit 5-3

Heroin Use in Preceding 30 Days (407 Methadone-Maintained Patients by Current Methadone Dose)

Adapted from Ball and Ross, The Effectiveness of Methadone Maintenance Treatment: Patients, Programs, Services, and Outcome, Appendix B, p. 248, with permission from Springer-Verlag  1991.

more than 200 mg per day (mean 284.9 mg per used more commonly as aids to determine day) had improved responses with no apparent individual methadone dosage requirements. A increase in adverse events. However, additional study in England (Wolff et al. 1991) showed a controlled research is needed to determine the positive correlation between methadone safety of very high doses of methadone or other dosages and concentrations in serum (Exhibit medications used in MAT. 5-4). Moreover, mean SMLs near or above 400 ng/mL are gaining increasing consensus as With the increased availability of blood testing ideal levels for treatment effectiveness (Payte in OTPs, measurements of blood concentra- et al. 2003). Although mean SMLs of 400 ng/mL tions of methadone at peak and trough are

Clinical Pharmacotherapy 73 Exhibit 5-4

Methadone Dose/Mean Plasma Levels

Adapted from Wolff et al. (1991) by permission of the AACC.

generally are considered to be sufficient to resulting SMLs differed widely. Some had block the effects of illicit opioids and prevent relatively low (subtherapeutic) SMLs, even at withdrawal symptoms, some patients may daily doses considerably above 100 mg, which require higher SMLs for stabilization. More would be expected to affect treatment negative- research is needed to understand better the ly (Leavitt et al. 2000). Given these and similar relationship between methadone blood levels data, it is incorrect to conclude that a particu- and cessation of opioid abuse. SML results lar methadone dosage causes a specific SML; should continue to be considered along with many other factors are likely to affect SMLs for patient symptoms. For example, a patient with individual patients. However, measuring SMLs an SML below 400 ng/mL with no symptoms can be useful to determine why a relatively of discomfort would not require a dosage high methadone dosage does not appear to ben- increase, whereas a patient with an SML of efit a patient. In such cases, a blood test may 600 ng/mL but with persisting withdrawal show that a patientís SML remains low and symptoms would. that he or she requires a higher dose.

Okruhlica and colleagues (2002) investigated In their review, Leavitt and colleagues (2000) 69 patients receiving methadone dosages of noted a broad range of SMLs among patients in 10 to 270 mg per day and found a significant MAT. They suggested that individual differ- positive relationship between dosage and mean ences in metabolic enzyme activity and other SMLs, although, at each dosage level, patientsí factors may lead to higher or lower serum

74 Chapter 5 levels of the (R)-methadone enantiomer, levels in a fast metabolizer, illustrating that explaining some of the variation in dosage when a dayís dose is split into two (lower curve), ranges needed for clinical effectiveness. In one the peak SML achieved after each of the two study of the clinical uses of methadone blood split doses is lower than the peak achieved after level measurements, it was suggested that the a single daily dose (upper curve), and the peak level should be no more than twice the trough SML reached just before the next split trough level and that, if it is more, the patient dose is higher than the trough level reached just should be considered a ìfast metabolizerî and before the next single dose. be administered split dosing. When split dosing is used, patients receive two or three doses per The consensus panel recommends that a main- day to achieve the targeted peak-to-trough tenance dosage of methadone not be predeter- ratio in blood level measurements and to avoid mined or limited by policy if that policy does withdrawal symptoms for 24 hours (Payte et al. not allow adjustments for individual patients. 2003). Exhibit 5-5 shows 24-hour SML curves at both inadequate and adequate dosages. Other common dosing issues These curves include peak SMLs at roughly 4 Signs and symptoms associated with lesser hours after dose ingestion (0 hour) and trough degrees of withdrawal and acute opioid over- SMLs at 24 hours after ingestion. Data were dose are well known, but patient changes derived by averaging a series by Inturrisi and associated with overmedicating and undermedi- Verebely (1972) and another one by Kreek cating are less dramatic and often more (1973). Exhibit 5-6 shows an example of plasma subjective.

Exhibit 5-5

Blood Plasma Levels Over 4 and 24 Hours With an Adequate and Inadequate Methadone Dose

Clinical Pharmacotherapy 75 Exhibit 5-6

SMLs After Single and Split Methadone Dosing in a Fast Metabolizer

Certain medical factors may cause a patientís reduced. Patients also might report feeling high dosage requirements to change, including (but or ìloadedî and ask for a reduced dosage. not limited to) starting, stopping, or changing Such a reduction can be helpful for patients the dosage of other prescription medications; committed to abstinence rather than ongoing onset and progression of pregnancy; onset of medication maintenance because they may find menopause; progression of liver disease; signifi- physical reminders of intoxication discouraging, cant increase or decrease in weight; or aging frightening, or relapse triggering. (elderly patients are sometimes more sensitive to drugs such as opioids). Patient complaints of Vomited doses. Patients who report that they opioid craving, withdrawal symptoms, medica- have vomited their medication pose special tion side effects, or intoxication always should problems. The consensus panel recommends be investigated and never should be dismissed. that only doses lost to witnessed emesis be replaced. Emesis 30 minutes after dosing can be Overmedication. Mildly to moderately over- handled by reassuring patients that the full medicated patients might show ìnoddingî dose has been absorbed. Emesis at 15 to 30 and closing of the eyes or might fall asleep at minutes after dosing can be handled by replac- inappropriate times. These patients might ing half the dose, and the whole dose should be scratch their faces continuously, especially their replaced if emesis occurs within 15 minutes of noses. In some cases, sedation might occur but dosing. If vomiting persists, it is important to be unapparent, and some overmedicated remember that only a portion of the gut is patients might feel mildly stimulated. Nausea emptied with forceful emesis; therefore, the also can occur, particularly in newer patients. risk of accumulated toxicity increases with Patients should be told when overmedication repeated dose replacements. Causes of emesisó is suspected, and their dosage should be including pregnancyóshould be explored.

76 Chapter 5 Ingestion of smaller amounts of medication attendance, length of time in treatment, and over a few minutes can be helpful and prudent, overall functioning. An increase in medication as can the occasional use of antiemetic dosage should not be a reward for positive medicines. behavior change, although not everyone in the MAT field shares this viewpoint. For example, “Triggered” withdrawal. Environmental cues, extensive work has demonstrated the effective- including people, places, things, and feelings ness of using increased dosage (as well as extra associated with drug taking, can be associated take-home doses) as an incentive to decrease strongly with opioid craving and withdrawal. substance abuse and increase treatment pro- Such reactions may be identical to opioid with- gram attendance (e.g., Stitzer et al. 1986, 1993; drawal symptoms and can stimulate drug crav- see also Petry 2000). Although the consensus ing and relapse long after opioid use has panel acknowledges important behavioral stopped and physical dependence has been con- aspects of addiction and the value of contingen- trolled (Self and Nestler 1998). Environmental cy management as an aid to behavioral change, changes and other stressors can cause patients using medication dosage as a reward or punish- to perceive that a dose on which they were sta- ment is considered inappropriate. bilized is no longer adequate and to experience increased drug craving. Events that increase the availability of substances of abuse, such as Maintenance another person who uses drugs moving into a Pharmacotherapy patientís home or new sources of illicit drugs, can intensify craving. When their discomfort The maintenance stage of opioid pharma- resumes after a period of abstinence, patients cotherapy begins when a patient is responding might feel that they are weak willed. They need optimally to medication treatment and routine reassurance that this reaction is a condition of dosage adjustments are no longer needed. their brain chemistry, not a weakness of will. In Patients at this stage have stopped abusing animal models, withdrawal symptoms have opioids and other substances and have resumed been conditioned to appear with environmental productive lifestyles away from the people, cues after months of abstinence from opioids places, and things associated with their addic- (Self and Nestler 1998). The consensus panel tions. These patients typically receive scheduled believes that increased medication dosages are take-home medication privileges. Patients who appropriate in such cases, although efforts also continue to abuse substances, do not seek should focus on resolving the troublesome situ- employment, or remain connected to their drug- ations such as developing ways to avoid people, using social networks have not reached this places, and things that trigger opioid craving or stage. Along with continued observed medication relapse. Conversely, diminished triggers and treatment, these latter patients are candidates reduced drug availability can diminish drug for intensified counseling and other services to craving and might indicate the possibility of help them reach the maintenance stage. decreasing medication dosage if a patient prefers. During the maintenance stage, many patients Contingent use of dosage. The consensus panel remain on the same dosage of treatment medi- believes that any manipulation of dosage as cation for many months, whereas others either a positive or a negative consequence of require frequent or occasional adjustments. behavior is inappropriate and has no place in Periods of increased stress, strenuous physical MAT. The only type of contingency contracting labor, negative environmental factors, greater related to medication that should be supported drug availability, pregnancy, or increased drug in MAT is that associated with take-home medi- hunger can reawaken the need for increased cation. Take-home medication is controlled by dosages over short or extended periods. Serious Federal regulations, and access is based on sev- emotional crises may require long-term or eral factors, including drug abstinence, OTP temporary dosage adjustments. Although the counseling relationship and patient interview

Clinical Pharmacotherapy 77 are paramount, drug test reports and medica- Ideally, withdrawal should be attempted when tion blood levels are useful for dosage determi- it is desired strongly by a stable patient who nation and adjustment during and after transi- has a record of abstinence and has adjusted tion from stabilization to the maintenance stage. positively on MAT. However, sometimes dose tapering is necessary for administrative rea- sons, such as a response to extreme antisocial Medically Supervised behavior, noncompliance with minimal pro- Withdrawal gram standards, or a move to a location where MAT is unavailable. In such cases, providers When stable patients in the maintenance stage should refer patients to other programs that ask for dosage reductions, it is important to are more reasonable and practical in terms of explore their reasons. They might believe that the patientsí overall situation (e.g., motivation, they can get by on less medication, or they resource availability, ability to pay). might be responding to external pressures. Patients often perceive that those on lower In a review of research on withdrawal from dosages are ìbetter patients.î These situations MAT, Magura and Rosenblum (2001) noted require physicians or other staff members to that many treatment providers lacked effective educate patients and their significant others ways to improve outcomes for patients who about the importance of adequate dosage and undertook planned withdrawal and that opioid how individual differences in absorption, body craving remained prevalent in this group, even weight, metabolism, and tolerance can affect after successful physiological withdrawal. They the dosage necessary to achieve stability concluded, therefore, that planned withdrawal (Leavitt et al. 2000). from opioid pharmacotherapy should be undertaken conservatively. Voluntary Tapering and Relapse prevention techniques should be Dosage Reduction incorporated into counseling and other support services both before and during dosage reduc- For various reasons, some patients attempt tion. Such structured techniques can be useful reduction or cessation of maintenance medica- safeguards in preventing and preparing for tion. Some studies indicate high relapse rates, relapse. Use of mutual-help techniques (see often 80 percent or more, for this group, chapter 8) is recommended highly, especially including patients judged to be rehabilitated during dosage reduction. before tapering (e.g., Magura and Rosenblum 2001). However, the likelihood of successful Although most data about outcomes after dose tapering also depends on individual fac- tapering from opioid medication come from tors such as motivation and family support. studies of methadone maintenance, the consen- The possibility of relapse should be explained sus panel believes that success rates are likely to patients who want to dose taper, especially to be similar for patients who taper from those who are not stable on their current buprenorphine or LAAM, and similar cautions dosage, as part of the informed-consent pro- and monitoring processes should be in place. cess. Patients who choose tapering should be monitored closely and taught relapse preven- Methadone dosage reduction tion strategies. They and their families should be aware of risk factors for relapse during and The techniques and rates of graded methadone after tapering. If relapse occurs or is likely, reduction vary widely among patients. One additional therapeutic measures can be taken, common practice is to reduce daily doses in including rapid resumption of MAT when roughly 5- to 10-percent increments with 1 to 2 appropriate (American Society of Addiction weeks between reductions, adjusting as needed Medicine 1997). for patient conditions. Because reductions

78 Chapter 5 become smaller but intervals remain about the is longer acting than methadone, withdrawal same, many months may be spent in such grad- should be expected to have a delayed onset and ed reductions. The rate of withdrawal can be protracted course, increased or decreased based on individual although symptoms patient response. A slow withdrawal gives might be less intense patients and staff time to stop the tapering or than with other opi- resume maintenance if tapering is not working oids. Patients tend to Patients who and relapse seems likely. dislike longer periods of withdrawal, choose tapering Regardless of the rate of withdrawal from regardless of symptom methadone, a point usually is reached at which intensity. Special should be moni- steady-state occupancy of opiate receptors is no counseling might be longer complete and discomfort, often with needed to address tored closely and drug hunger and craving, emerges. This point this aspect of with- may occur at any dosage but is more common drawal from LAAM. with methadone when the dosage is below 40 taught relapse pre- mg per day. Highly motivated patients with For patients on good support systems can continue withdrawal LAAM who wish to be vention strategies. despite these symptoms. Some patients appear medication free, to have specific thresholds at which further dosage can be dosage reductions become difficult. reduced gradually at a rate determined by Physicians and other staff members should be their response. Patients who prefer less alert to the possibility of patients attempting protracted withdrawal can be converted to and dose tapering by substituting other psychoac- then tapered from methadone. As with tapering tive substances, such as alcohol, cocaine, from methadone (Moolchan and Hoffman sedatives-hypnotics, or other nonopioid 1994), tapering from LAAM should take into substances for their maintenance medication. account a patientís level of stability, past Some patients might request blind dosage functioning without medication, and fear reduction, that is, withdrawal from medication of withdrawal. without their awareness of dose reductions at each step. Blind dosage reduction is appropri- Medically Supervised ate only if requested by a patient. It should be discussed and agreed on before it is implement- Withdrawal After ed. It is inappropriate, clinically and ethically, Detoxification to withdraw a patient from maintenance medi- For patients who neither qualify for nor desire cation without his or her knowledge and con- opioid maintenance treatment, methadone or sent. The consensus panel recommends that buprenorphine may be used to control with- OTP staff always disclose dosing information drawal from illicit opioids or from abuse of unless patients have given specific informed prescription opioids (detoxification) and then consent and have requested that providers not can be tapered gradually (medically supervised tell them their exact dosages. withdrawal). Regulations specify two kinds of detoxification with methadone: short-term Withdrawal and termination treatment of less than 30 days and long-term from LAAM maintenance treatment of 30 to 180 days. These regulations specify that patients who fail two detoxification Few studies have addressed medically super- attempts in 12 months must be evaluated for a vised withdrawal from LAAM. Because LAAM different treatment (42 CFR, Part 8 ß 12(e)(4)).

Clinical Pharmacotherapy 79 Dosing decisions in medically supervised daily dosing requirements have failed, mainte- withdrawal are related to the intended nance pharmacotherapy no longer may be steepness of tapering. Patients undergoing possible. Treatment decisions should be made short-term withdrawal may never achieve in the patientís best interest. If patient progress steady state, and tapering from methadone is unsatisfactory at a particular level of care, may be too steep if it begins at a dose greater the physician should explore the possibility of than about 40 mg. In long-term withdrawal, increasing that patientís care while maintaining stabilization of dosage at a therapeutic range him or her on methadone. Involuntary taper- is followed by more gradual reduction (see ing and discontinuation of maintenance medi- Exhibit 5-7). cation may be necessary if a patient is unwilling to comply with treatment or tapering or discon- tinuation of medication appears to be in the Involuntary Tapering or patientís best interest. Dosage Reduction If a patient is intoxicated repeatedly with alco- When patients violate program rules or no hol or sedative drugs, the addition of an opioid longer meet treatment criteria, involuntary medication is unsafe, and any dose should be tapering might be indicated although it should withheld, reduced, or tapered. Disruptive or be avoided if possible (see chapter 8). For violent behavior or threats to staff and other example, if many days of dosing are missed and patients might be reasons for dismissal without repeated attempts to help a patient comply with

Exhibit 5-7

Types of Detoxification From Illicit Opioids

80 Chapter 5 tapering or for immediate transfer to another decisions on dispensing take-home medication facility where a patient may be treated under are determined by the medical director in safer conditions. accordance with eight criteria for take-home medication specified in Federal regulations Administrative tapering for nonpayment of fees (42 CFR, Part 8 ß 12(i)): may be part of the structure to which patients agree on admission. It should be noted that, in 1. Absence of recent drug and alcohol abuse addiction treatment, a patientís sudden lack of 2. Regular OTP attendance funds is a marker of possible relapse. 3. Absence of behavioral problems at the OTP LAAM 4. Absence of recent criminal activity 5. Stable home environment and social When involuntary withdrawal from LAAM is relationships unavoidable, patients can be transferred to methadone before withdrawal because clinical 6. Acceptable length of time in comprehensive experience with methadone withdrawal is more maintenance treatment extensive. 7. Assurance of safe storage of take-home medication Incarceration 8. Determination that rehabilitative benefits of decreased OTP attendance outweigh the When patients know that they must serve time potential risk of diversion. in jail or prison, planned withdrawal is the best course of action. At this writing, few correc- Once these clinical criteria are met, maximum tional institutions offer methadone mainte- take-home doses must be further restricted nance to nonpregnant inmates (National Drug based on length of time in treatment as follows: Court Institute 2002). Many jails do not pro- vide methadone for detoxification. When a ï First 90 days (months 1 through 3): one patient in MAT is arrested, program staff take-home dose per week should make every effort to communicate with ï Second 90 days (months 4 through 6): two the criminal justice authorities involved and to take-home doses per week recommend that the patient be withdrawn ï Third 90 days (months 7 through 9): three gradually from medication. Regardless of take-home doses per week which opioid medication is used, maintenance or medically supervised withdrawal is prefer- ï Fourth 90 days (months 10 through 12): 6 able to sudden discontinuation of the medica- daysí supply of take-home doses per week tion. The consensus panel recommends that ï After 1 year of continuous treatment: 2 opioid pharmacotherapy be made available weeksí supply of take-home medication during incarceration for patients who are ï After 2 years of continuous treatment: 1 already in MAT when incarcerated. monthís supply of take-home medication, but monthly OTP visits are still required. Take-Home Additional restrictions are imposed in some Medications States. No take-home doses are permitted for patients in short-term detoxification or interim Take-home medication refers to unsupervised maintenance treatment. doses. Any OTP patient may receive a single take-home dose for a day when the OTP is closed for business, including Sundays and State and Federal holidays. Beyond this,

Clinical Pharmacotherapy 81 Specific Clinical Considerations concurrent disease, to avoid methadone-related in Take-Home Status complications of a concurrent medical disor- der, and to ensure that the pharmacological Demands of a concurrent benefits of administering methadone are main- tained during the course and treatment of the medical disorder concurrent disease. The existence and severity of a concurrent medical disorder (see chapter 10) are additional Enhancement of rehabilitative considerations in determining whether take- potential home medication is appropriate. For patients with concurrent diseases causing impaired Another important issue in take-home ambulation, reduced OTP attendance might medication involves reviewing whether it is be required to aid recovery and prevent likely to help rehabilitate a patient. Take-home complications. In these cases, OTPs should medication may enable patients to engage in consider seeking medical exceptions for employment, education, childcare, or other patients who would not otherwise be permitted important endeavors. to receive take-home doses of medication. These patient exceptions should be requested Emergency circumstances on Substance Abuse and Mental Health During emergency situations or unforeseen Services Administration (SAMHSA) form circumstances such as personal or family SMA-168, Exception Request and Record of crises; bereavement; or medical, family, or Justification. Form SMA-168 is available at employment hardships, the need may arise for dpt.samhsa.gov/Exception168Final.htm. unscheduled take-home medication. An OTP When a new medica- can facilitate emergency or hardship access to tion treatmentósuch medication for a patient by submitting SAMHSA form SMA-168. The OTPís policies should No take-home as rifampin, highly active antiretroviral explain who can request exceptions and how therapy (HAART), it is done. Courtesy dosing at a distant OTP doses are or phenytoinóthat usually can be arranged if unstabilized patients is known to interact are traveling. permitted for with an opioid treat- ment medication is Positive drug tests, diversion patients in introduced, a MAT control, and take-home patient might need a short-term detoxi- dosage adjustment medications (see chapter 3 for The consensus panel believes that take-home fication or interim further discussion of medications are inadvisable for patients who medications that continue to abuse illicit drugs or misuse pre- maintenance interact with opioid scription medications, as evidenced by drug treatment medica- testing or other assessment information, and treatment. tions). Take-home for those whose drug tests do not reflect medi- medication should be cation ingestion. Under the disinhibiting effects avoided until a of other substances, patients might be unable patient is stable on to safeguard or adequately store their take- these new medica- home doses. They should be encouraged to tions and the risks of an undesirable outcome keep their medication in a locked cabinet away have diminished. In these instances, more from food or other medicines and out of the frequent observations are important to monitor reach of children. Some programs require

82 Chapter 5 patients to bring a locked container to the OTP ï Require patients to return all empty dose when they pick up their take-home medication bottles on their next OTP visit after take- to hold it while in transit. This policy should be home dosing. Staff members who accept these considered carefully because most such con- bottles should inspect them to ensure that tainers are large and visible, which might serve they are coming from the indicated patient more to advertise that a patient is carrying during the appropriate period. medication than to promote safety. ï Institute procedures for responding to Methadone is stable and does not need refriger- patients who frequently fail to return or ation when in diskette or tablet form. However, have unverified reasons for failing to return when methadone diskettes are reconstituted or empty take-home bottles. Staff should liquid methadone oral concentrate is used and consider discontinuing take-home medication diluted with juice or some other sugar-based for these patients. liquid, the mixture may not remain stable ï Stay open 7 days a week for dispensing. In beyond a few days without refrigeration. this way, take-home doses can be provided Manufacturer instructions call for adding a only to stable patients with a record of minimum of 30 mL or 1 fluid ounce of liquid adherence to treatment, rather than to all per dose when reconstituting methadone. patients regardless of their status with the program. Although methadone has a significant street value, a National Institutes of Health consensus Behavior, social stability, and statement refers to it as ìa medication that is not often diverted to individuals for recreation- take-home medications al or casual use but rather to individuals with Patients appearing intoxicated; demonstrating opiate dependence who lack access to aggressive, seriously impaired, or disordered [methadone maintenance treatment] pro- behavior; or engaging in ongoing criminal gramsî (National Institutes of Health 1997b, p. behavior are poor candidates for take-home 20). Nevertheless, reported deaths attributed medication. Their home environments also are to methadone have increased significantly in keys to the safety and storage of medication. some States. According to data from the Drug Where social relationships are unstable, a Abuse Warning Network, more than 10,000 significant risk exists that methadone take- emergency room visits related to methadone home doses will be secured inadequately from were reported in 2001 compared with more diversion or accidental use (e.g., by children). than 5,000 in 1999 (Crane 2003). This increase If patients with take-home privileges develop has occurred in the context of overall increases altered mental competency, such as in demen- in abuse of prescription opioids, in particular tia, frequent loss of consciousness, or delusional and oxycodone. Local reports states, then take-home privileges should be indicate that most diverted methadone comes reevaluated. from medical prescriptions because it has gained acceptance as an excellent chronic pain treatment (Belluck 2003). Although the slow Monitoring Patients Who onset of methadone makes it less attractive Receive Take-Home than prescription opioids to potential abusers, Medications it also makes methadone more dangerous because respiratory depression can become Monitoring should ensure that patients with significant hours after ingestion. To guard take-home medication privileges are free of against the possibility of methadone-related illicit drug use and consume their medication as respiratory depression, the consensus panel directed. This goal can be met through random recommends the following diversion control drug testing and periodic interdisciplinary policies for take-home medication: assessment of continuing eligibility. OTPs

Clinical Pharmacotherapy 83 should consider carefully whether to use pill authorized staff may use home delivery and counts or callbacks of dispensed take-home observed-dosing procedures to ensure treat- doses to verify adherence to program rules. In ment continuity. OTPs should evaluate the a pill count or callback, the patient receives an need for continuity of other support services, unannounced phone call and must show up at as well as medication, in these circumstances. the OTP within a reasonable period (e.g., 24 to 36 hours) with all MAT medications. The num- Hospitalization. OTPs are responsible for ber of pills remaining must correspond to the ensuring continuity of treatment when patients number expected based on prescribed inges- are hospitalized for medical or psychiatric tion. A physician should review periodically the problems (see chapters 10 and 12). The best status of every patient provided with take-home practice is for OTP staff to educate and stay in medication. When these strategies are followed, touch with a patientís hospital clinicians about programs should state their policies clearly to MAT. For example, hospital staff might be patients. Callbacks should be used selectively, unaware that certain drugs, such as partial not be applied across the board, and focus on agonists or mixed agonists and antagonists for high-risk patients who have given OTP staff pain management, should be avoided for members reason to be concerned. patients receiving LAAM or methadone for opioid addiction (pain management is discussed in chapter 10). It usually is helpful to provide Issues for review psychiatric consultation to medical or surgical The rationale for providing take-home staff members, especially for patients with co- medication should be reviewed regularly occurring disorders. Written patient consent is and documented to determine whether initial necessary for this kind of program-to-hospital justifications continue to apply. For example, if communication; however, if a medical emergen- employment was a reason for take-home medi- cy poses a threat to a patientís health, the OTP cation, the patientís continued employment should use the medical emergency exception should be verified. If a concurrent medical for treatment when it lacks patient consent. A disorder was the basis, a medical reassessment publication by the Center for Substance Abuse is necessary to determine whether the clinical Treatment (CSAT 2004b) provides a description status of the concurrent medical disease still of the confidentiality regulationsí medical warrants reduced OTP attendance. emergency exception.

Reviewing the original rationale for take-home Hospitalization, particularly of unconscious medication is a necessary but insufficient patients, raises the issue of using identification condition for increased patient monitoring. The (ID) cards. Patients can get OTP-specific Medic monitoring process also should include an Alert ID Cards from Advocates for Recovery assessment of whether medical, psychological, Through Medicine (www.methadonetoday.org/ or social reasons exist to rescind these privileges. armhelp.htm; telephone 615-354-1320), which can include a patientís name, OTP contact Treatment interruptions information, and a list of contraindicated medi- cations. Some large urban OTPs provide Many circumstances, such as work-related patients with a photographic ID card to gain travel, illness, funerals, planned vacations, admittance to the OTP. Their experience has and emergencies, might require patients to miss been that some patients use their OTP cards as OTP visits. Some unstable patients might miss generic photographic IDs in lieu of a driverís days because of chaotic social situations. OTPs license; for example, they use them to cash should have policies to address treatment checks, despite the fact that the cards identify interruptions. them as being in treatment. Smart cards con- Disability or illness. When disability or illness taining a complete medical history are already prevents patients from coming to the OTP, in use in the United States, Israel, and the

84 Chapter 5 Netherlands and may be useful in OTPs. These Office-Based Opioid cards contain electronically encoded informa- tion needed to identify and monitor a patient Therapy without outwardly identifying the cardholder as OTPs should consider assisting with transfer a patient. arrangements for long-term methadone- Missed doses. When doses are missed, it is crit- maintained patients who prefer to use a ical to evaluate patientsí presenting condition. physician in the community for ongoing care. Concerns should include whether a patient has Various forms of this treatment have been stud- been using illicit drugs or taking other medica- ied in the United States and found to be safe tions, has lost tolerance for previous doses (i.e., and efficacious (King et al. 2002; Schwartz et whether a previously tolerated dosage is still al. 1999). safe to administer), or is intoxicated. Patient selection for this treatment option One dose missed. For patients who miss one should focus on a history of negative drug tests, scheduled dose and come to the OTP the next a required length of stability in treatment (at dayófor example, 3 to 4 days after the last least 1 year), social stability, and minimal need LAAM or 2 days after the last methadone for psychosocial services. Methadone can be doseóthe dosage can remain unchanged, and ordered by private physicians, through an affil- dosing should resume on schedule. For patients iation or other arrangement with an OTP, and on LAAM who miss a dose and come to the patients can obtain their medication at special- OTP 2 days later (i.e., 4 to 5 days after their ly registered pharmacies under a SAMHSA- last LAAM dose), the scheduled dose still is approved protocol. Under this arrangement, usually well tolerated. patients on extended take-home-dosing sched- ules (up to 1 month) no longer must ingest their More than 5 days missed. For patients who are doses under observation. Outcomes have been out of treatment for a significant time and uniformly positive, with few relapses and little might have lost tolerance, dosage reduction or or no diversion reported (King et al. 2002; reinduction is advisable. Thereafter, increases Schwartz et al. 1999). Patient satisfaction has of 5 to 10 mg per dose up to the previous level been found to be significantly better compared can be ordered because it is unlikely that the with OTP dosing (Fiellin et al. 2001) but not dosage needed to maintain stability will change significantly different from a comparable in 1 week. Patients might have to be reminded OTP-based monthly medical maintenance and about steady state and that they may not feel take-home schedule (King et al. 2002). back to normal until tissue stores have built up as well.

Clinical Pharmacotherapy 85

6 PatientñTreatment Matching: Types of Services and Levels of Care

This chapter describes a multidimensional, clinically driven strategy for matching patients in medication-assisted treatment for opioid addiction (MAT) with the types of treatment services and levels of care that opti- In This mize treatment outcomes, primarily within or in conjunction with opioid ChapterÖ treatment programs (OTPs). Level of care refers to the intensity of a treatment (in terms of frequency, type of serviceóindividual, group, familyóand medication) and the type of setting needed for treatment Steps in delivery. For information on criteria and methods to determine levels of PatientñTreatment care in substance abuse treatment, see the American Society of Matching Addiction Medicine (ASAM) patient placement criteria (Mee-Lee et al. Patients With 2001b). As explained by Mee Lee and colleagues (2001b), the ASAM Special Needs model conceptualizes opioid pharmacotherapy as a service that can be provided at any level of care, although it is delivered most often in an Treatment Planning outpatient setting (i.e., ASAM level I).

The chapter also provides information on developing a treatment plan with short- and long-range goals for each patient. In some cases, patientñtreatment matching and treatment planning involve changes that can move a patient out of comprehensive MAT to a setting that better meets the patientís needs. Because this TIP is primarily about outpatient MAT in OTPs, other settings and programs are discussed only briefly.

In general, patientñtreatment matching involves individualizing, to the extent possible, the choice and application of treatment resources to each patientís needs. The chapter explains recommended elements of a patientñtreatment-matching process, including ways to accommodate special populations with distinct needs and orientations that affect their responses to specific treatments and settings.

Patients enter OTPs at various points along a continuum of substance abuse and addiction. Many also have co-occurring medical and mental health conditions that can be lifelong. Because of the complexity of patientsí circumstances and needs and the range of services required to address these needs, MAT includes not only opioid pharmacotherapy but also other forms of treatment in a comprehensive treatment program

87 designed to address multiple disorders and offer intensive individual and group counseling needs (see chapter 8). or counseling on a periodic or as-needed basis (De Leon 1994; Margolis and Zweben 1998). The consensus panel believes that OTPs not Ideally, service intensity should depend on the already offering comprehensive MAT services level of care required to help patients achieve and those lacking resources to adjust levels of and maintain successful treatment outcomes. care to patient needs either should augment Most patients in the acute phase of treatment basic opioid pharmacotherapy with services need to see a counselor daily for counseling or that meet the mental health, medical, and case management, just to become stabilized, social needs of patients who are opioid addict- whereas others, who may be highly functioning edóat the level of care each patient needsóor with less severe addiction-related psychosocial should provide referrals to programs that pro- problems, require fewer counseling services. vide such services. Mutual-help programs Steps in Although not a form of treatment, mutual-help PatientñTreatment programs (e.g., 12-Step programs, Secular Organization for Sobriety groups, Women for Matching Sobriety groups) offer effective and motivation for individuals during and after Patient Assessment discontinuation of active treatment. Such pro- grams provide social support from others who Patientñtreatment matching begins with a thor- are in recovery from addiction (Washton 1988). ough assessment to determine each patientís Many patients in MAT participate in mutual- service needs (see chapter 4); then these needs help groups. However, patients with opioid are matched to appropriate levels of care and addiction who are maintained on treatment types of services. Assessment should include medication can feel out of place in some group the extent, nature, and duration of patientsí settings where continued opioid pharmacother- opioid and other substance use and their treat- apy may be misunderstood. Researchers have ment histories, as well as their medical, psychi- described a variety of specialized groups and atric, and psychosocial needs and functional inventive strategies for mutual-help programs status. A comprehensive assessment should that meet the support needs of patients in MAT include a patientís gender, culture, ethnicity, (Zweben 1991). Chapter 8 presents some of language, motivation to comply with treatment, these strategies. and recovery support outside the OTP. Matching Treatment Service Type and Intensity of Needs to Settings Treatment Services Needed After the types and intensities of services that Psychosocial treatment patients need are defined, the next crucial step in patientñtreatment matching is to identify the services most appropriate available setting or settings In a comprehensive MAT setting, patients often for these services. MAT has been offered have access to a variety of psychosocial ser- primarily in a dedicated outpatient OTP. vices, including individual, family, and group However, as the importance of treating counseling, as well as case management (see patientsí varied medical, psychological, social, chapter 8). Some programs may provide psy- and behavioral needs as part of addiction chosocial services to patients in other settings. recovery has become evident, more varied Both residential and outpatient programs may programs and settings have emerged.

88 Chapter 6 Throughout this TIP, the consensus panel rec- Appropriate patients for treatment in outpa- ommends that OTPs lacking the resources to tient OTPs are those who meet Federal and accommodate all their patientsí needs develop State requirements for opioid addiction treat- cooperative relationships with and refer ment (e.g., 42 Code of Federal Regulations, patients to other treatment providers as appro- Part 8), those who have done poorly in other priate. However, OTPs should coordinate these types of programs (e.g., medically supervised services. Based on its assessments of patients, withdrawal or residential treatment programs), the treatment team should collaborate with and those who require opioid pharmacothera- patients to determine the most appropriate py for long-term stabilization. treatment services, intensities of services, and settings needed to meet patient needs. This OTPs in hospital-based outpatient settings may collaboration should continue throughout provide a more enhanced continuum of care MAT, and patient progress should be the basis than freestanding for adjustments in treatment services and OTPs because access intensities. to medical and psy- chosocial services is [S]ervice intensity Patientsí service needs may change throughout readily available. This MAT. For example, one patient may need refer- availability, in turn, should depend on ral to an inpatient program for detoxification increases the likeli- from alcohol or benzodiazepines and then hood that patients in return to the OTP setting. Another may need MAT will engage in the level of care the environment of a residential treatment and adhere to other program while continuing MAT. Therefore, medical and psy- required to help treatment matching in some cases can lead to chosocial treatment multiple settings for an individualís treatment. regimens. patients achieve In most cases, the originating OTP should provide case management and liaison for all Hospital-based MAT and maintain treatment services. programs are appro- priate for some patients who also are successful treat- Types of settings and medically ill and programs offering opioid require coordinated ment outcomes. addiction treatment services services or care by special teams. In The following are examples of treatment pro- addition, because hos- grams and settings that offer some or all of the pitals can provide a one-stop-shopping model comprehensive services recommended in MAT. of care by incorporating some primary care Outpatient OTPs. Outpatient OTPs ideally services with MAT, some patients with histories treat patients who are opioid addicted during of poor treatment compliance may be more all phases of treatment and at most levels of likely to adhere to medical treatment. For care. In reality, many OTPs have capacity or example, one report from a 16-month prospec- resource limitations or payment requirements tive study of nearly 500 persons in a hospital- that cause them to refer at least some patients based outpatient methadone program found to other specialized treatment providers and that 81 percent also used onsite primary care settings, such as those described below, for ser- services (Selwyn et al. 1993). At this writing, vices that match patient needs. Either on site the number of hospital-based programs offer- or through other care providers, OTPs offer a ing MAT is limited in the United States. wide spectrum of treatment services and levels Residential treatment programs. Residential of care for diverse patients. treatment programs offer cooperative living

PatientñTreatment Matching 89 arrangements for patients in recovery, but they treatment programs either offer comprehensive vary in their willingness or ability to accept maintenance services (with medication, collec- MAT patients tion of samples for drug testing, and counseling (Margolis and provided in one or several mobile units) or Zweben 1998). A work in conjunction with fixed-site outpatient residential treatment programs that offer medical care and counsel- The success of setting is indicated ing and other psychosocial services, while for patients who medication is delivered via the mobile units. mobile treatment require residential placement to sup- Appropriate patients for treatment in mobile units...highlights port treatment and treatment units are those in locations where ensure their physical fixed-site programs are unavailable, those with ambulatory disabilities, and those initially sta- the importance or psychological safety and who are bilized in an OTP and then transferred to a mobile unit for continued treatment. Mobile of program unlikely to continue MAT otherwise. units not staffed on weekends are appropriate Such patients gener- only for patients who meet State and Federal accessibility as a ally exhibit high regulations for weekend take-home medications. relapse potential, factor affecting... Office-based opioid treatment settings. After evidenced by an achieving biomedical and psychosocial stabi- inability to control lization in an OTP, some patients might be eligi- positive treatment substance use ble for referral to less intensive physicianís despite active partic- office-based opioid treatment (OBOT) for medi- outcomes. ipation in less inten- cal maintenance. In these settings, patients sive outpatient pro- receive the same level of monitoring and inter- grams (Margolis and vention as patients receiving other types of Zweben 1998). On health care. When available, OBOT programs completion of treat- offer several advantages (Fiellin and OíConnor ment in these settings, patients should return to 2002), including an outpatient setting to continue MAT. ï Less intensive service requirements for stable If a patient in an OTP is referred to a residen- patients (e.g., less restrictive environments, tial program that does not offer or allow onsite focus on maintenance with stable doses of opioid pharmacotherapy (i.e., when other resi- opioid medication, provision of only those dential options are unavailable) or methadone psychosocial services needed to prevent or buprenorphine dispensing or administra- relapse) tion, some programs allow resident patients to travel to the OTP for medication. Some States ï Minimized stigma associated with addiction allow exceptions to regulations governing OTP treatment attendance and take-home medications so that ï Increased opportunity for new treatment concurrent treatment is possible. admissions to OTPs ï Expansion of treatment to geographic areas Mobile treatment units. The success of mobile where there are no OTPs or there are waiting treatment unitsóthat is, mobile vansóin such lists for admission to OTPs. cities as Baltimore, Boston, San Francisco, and Seattle (Greenfield et al. 1996; Schmoke 1995) Criminal justice settings. At this writing, rela- highlights the importance of program accessibil- tively few jails or prisons offer comprehensive ity as a factor affecting length of stay in treat- MAT or selected MAT services, but these num- ment and positive treatment outcomes bers are likely to increase (for information (Greenfield et al. 1996). Mobile substance abuse about substance abuse treatment in criminal

90 Chapter 6 justice settings, see TIP 44, Substance Abuse unique constellations of treatment needs for Treatment for Adults in the Criminal Justice various populations served by OTPs. Findings System [CSAT 2005a]). As a result, MAT for particular groups are summarized below. services are often interrupted or discontinued Other treatment groupings may be identified, when patients are incarcerated. Rikers Island, for example, high-profile persons for whom New York Cityís central jail facility, is an exam- unique treatment schedules and settings may ple of a model program that provides compre- be needed to protect confidentiality (CSAT hensive MAT for this patient group (Magura et forthcoming e). al. 1993). Patients who receive MAT there are guaranteed a slot at a community-based pro- gram in New York City after their incarcera- Patients With Serious Medical tion. Other corrections facilities provide rapid Disorders medically supervised withdrawal from mainte- If a serious medical condition is discovered nance medication to patients. When this with- during medical evaluation or patient assess- drawal is the only option, OTPs should work ment, the patient should receive appropriate with criminal justice institutions to ensure that medical treatment either on site or by referral appropriate dose-tapering procedures are fol- to a medical center. Chapter 10 describes lowed. Patients released from a criminal justice medical conditions commonly encountered setting should be offered referral to an OTP among patients in MAT and provides treatment when referral is desirable and feasible. recommendations. Most OTPs offer only basic Other treatment settings. Numerous other set- medical services. OTPs should develop and tings and specialized programs offer some ser- maintain referral networks for patients who vices and levels of care needed by patients who present for MAT and have other medical condi- are opioid addicted. Any of these programs can tions. Moreover, OTP staff should coordinate be sources of referral by OTPs or can function referrals and follow up as needed to ensure as satellite OTPs to ensure that patients receive compliance with medical treatments and to act services and levels of care they need. as consultants about MAT and medication interactions. Choice of Medications Patients With Serious The consensus panel recommends that OTPs offer a variety of treatment medications. Co-Occurring Disorders Chapters 3 and 5 provide more details about Many studies have focused on the co- the pharmacology and appropriate use of occurrence of substance use and mental methadone, levo-alpha acetyl methadol, disorders (see chapter 12). The existence of buprenorphine, and naltrexone. co-occurring disorders should not prevent patientsí admission to an OTP; however, diagnosis of these disorders is critical to match Patients With Special patients with appropriate services and settings. Therefore, OTPs should include professional Needs staff trained to screen for the presence of co- Effective treatment for opioid addiction should occurring disorders, develop appropriate address the unique needs of each patient referrals to services (e.g., psychopharmacology (OíConnor and Fiellin 2000; Rowan-Szal et al. or psychotherapy) for these disorders, and pro- 2000a). Culturally competent and creative vide coordination of care (CSAT 2005b). Most treatment planning, implementation, and staff members can be trained to recognize and referrals should address the distinct needs of flag major symptoms of co-occurring disorders. patients from different backgrounds. More The OTP should maintain communication and staff training and research are required on the followup with referral resources.

PatientñTreatment Matching 91 Patients With Housing, Family, treatment options for patients with disabilities or Social Problems (Fiellin and OíConnor 2002; Greenfield et al. 1996). OTP staff should address these chal- The following psychosocial problems should be lenges with patients so that barriers to treat- addressed during or directly after admission to ment are overcome. increase the likelihood that patients will engage successfully in treatment: The consensus panel recommends that OTPs engage in discussions with their Federal and ï Lack of stable housing State agencies to develop solutions for treating ï Broken ties with family members; nonexistent patients with disabilities. Such discussions or dysfunctional family relationships should balance the medical needs of these ï Poor social skills and lack of a supportive patients and the safety issues involved in pro- social network viding take-home medications for patients with disabilities who continue to engage in substance ï Unemployment; lack of employable skills. abuse or create a risk of medication diversion. Once these needs are identified during assess- ment, referrals can be made. Although some Adolescents and Young Adults OTPs have social workers on site to manage the assessment and referral processes, most OTPs Adolescents and young adults present a unique rely on counselors to assume this role. Case challenge for MAT. Often, ethnic background, management duties should include arrange- peer affiliations, and aspects of the ìyouth ments for provision of psychosocial care when cultureî require staff training and special indicated. Family members need education expectations from both staff and patients. about MAT, including information on how to Differences in routes of administration for support a partner or loved one in recovery, heroin or prescription opioids and in treatment self-care of family members, signs and symp- needs between adolescents or young adults and toms of active addiction, and support and older adults who are opioid addicted might be assistance from family members willing to attributable in part to generational characteris- participate in family counseling. Programs can tics and life experiences. For example, older offer monthly classes to patients, their families, adults typically present for treatment after and the community, which can reduce the years (sometimes decades) of chronic substance stigma connected with MAT. abuse accompanied by loss of family, health, and employment and deterioration in other psychosocial domains. Youth who are opioid Patients With Disabilities addicted tend to present after only a few years OTPs should try to provide access for patients of addiction and with different attitudes toward with physical disabilities. Treatment interven- addiction and the recovery process and distinct tions for these patients usually include voca- treatment needs. These youth may be more dif- tional rehabilitation, physical therapy, and ficult to evaluate, because, as a result of other social services that help procure prosthetic modes of administration (i.e., intranasally and limbs, wheelchairs, and other assistive devices by smoking), they do not exhibit some physical (CSAT 1998c). Alternative approaches in MAT, markers of opioid use (e.g., track marks). specifically those that reduce OTP visits, Treatment for adolescents and young adults include take-home dosing and requests for should integrate knowledge of their specific medical exceptions through visiting-nurse developmental and psychosocial concerns and services to provide equal access to treatment needs. Some needs are related to identity for- for persons with disabilities (see chapter 10). mation and peer group preoccupation (e.g., the Mobile medication units and office-based or strong desire to be viewed as fearless or to feel home-nursing services may offer viable invincible), legal complications regarding

92 Chapter 6 consent for treatment (see CSAT 2004b), and, capacity to meet the special needs of these often, factors leading them to run away from patients, to address potential biomedical and their homes. TIP 32, Treatment of Adolescents obstetrical complications, and to avoid adverse With Substance Use Disorders (CSAT 1999d), effects of substance use on the fetus (Finnegan provides background information. and Kandall 1992). Chapter 13 offers a detailed overview of MAT for pregnant women Other risk factors for this group include possi- (also see CSAT forthcoming f). ble sexual and physical abuse, young age at first sexual experience, incidents of trading sex OTPs are required by for drugs (Astemborski et al. 1994; Fullilove et regulation or accredi- al. 1990), and co-occurring disorders (Fuller tation standards to et al. 2002; Hawkins et al. 1992). These risk test for pregnancy, Case management factors also can contribute to increased risk but the provision of for HIV infection (Doherty et al. 2000; Fuller prenatal care and ...should include et al. 2001) and other sexually transmitted ancillary services for diseases (STDs). pregnant women arrangements varies depending on The interaction of developmental and psy- the treatment setting. for... chosocial factors affects the ability of adoles- Hospital-based pro- cents and young adults to engage in MAT and grams may be better therefore complicates the recovery process. suited for pregnant psychosocial care OTPs should provide psychosocial services that women in some cases address the unique needs of this age group, because hospitals when especially those needs that affect their sub- offer easy access to stance use and recovery, or they should estab- referrals and links to indicated. lish referrals and links to youth-oriented psy- specialty care (on or chosocial counseling services. off site). Buprenorphine may be a particularly satisfac- tory treatment for some adolescents. Because Sexual or physical abuse buprenorphine can be administered in an Patientsí risks of ongoing abuse in their OBOT setting, it should become more widely current relationships should be addressed, available and offer more privacy and less and appropriate plans or referrals made. Co- stigma for young patients (see CSAT 2004a). occurring disorders such as posttraumatic stress disorder can occur among both women Women and men who have experienced sexual or phys- ical abuse. The best treatment settings to Pregnancy address womenís needs in these cases include OTPs with onsite care provided by psychia- The special needs of women who are opioid trists, psychologists, licensed social workers, or addicted and pregnant should be assessed mental health professionals with special train- thoroughly through a comprehensive medical ing in this area. In lieu of onsite services, OTPs evaluation, as discussed in chapter 13. should establish referral links to programs Treatment matching for pregnant patients in offering such services. Many social service MAT should provide optimal, comprehensive, agencies, as well as agencies responsible for and intensive services related to pregnancy and domestic violence, offer training and support to birth including prenatal care, maternal nutri- OTP staff. TIP 36, Substance Abuse Treatment tion, and psychosocial rehabilitation, along for Persons With Child Abuse and Neglect with MAT. The integration of a womenís overall Issues (CSAT 2000d), provides further details. health initiative into MAT improves an OTPís

PatientñTreatment Matching 93 Complex medical problems patients with children engage successfully in psychosocial services. Where childcare is The complex medical problems commonly unavailable, program staff should offer refer- diagnosed in women in MAT include gynecolog- rals to community daycare agencies. ical infections, amenorrhea, hypertension, and pneumonia (Brown et al. 1992). It is optimal to In most States, OTPs are mandated reporters provide primary care services on site; hospital- of child abuse and neglect. When children are based programs and OTPs with formalized at imminent risk of harm or appear neglected, medical referral systems are best equipped to OTPs are required to notify local childrenís deliver such services. Chapter 10 of this TIP protective services (CPS) agencies so that an and the forthcoming TIP Substance Abuse investigation can be conducted. This require- Treatment: Addressing the Specific Needs ment can create conflict between an OTP and a of Women (CSAT forthcoming f) provide patient, and the OTP should try to address this additional information. issue in a supportive way. Programs and treat- ment providers should not discriminate against patients because they have entered into pre- Parents treatment agreements or have difficulties with Because many patients in MAT are parents, the CPS agencies (see chapter 13). lack of adequate childcare services is often a barrier to OTP attendance and successful treatment. One solution is supervised onsite Lesbian, Gay, and Bisexual childcare services, Patients which also may pro- Just as important as sensitivity to cultural dif- vide opportunities to ferences based on race or ethnicity is providing observe how patients Most patients can a treatment climate that is available and sensi- relate to their chil- tive to lesbian, gay, or bisexual (LGB) patients dren. Problems in by openly acknowledging their heterogeneity be maintained parenting skills and variations in sexual orientation and treat- can be addressed ing these individuals with dignity and respect on their MAT in treatment plan- (CSAT 2001b; Lombardi and van Servellen ning and through 2000). OTP staff should be prepared to assist parenting groups dosage while LGB patients in coping with problems related for patients with to their sexual orientation and the need for children. However, taking short-acting HIV/AIDS and STD risk avoidance. Providers onsite childcare should help patients obtain appropriate medi- services are available opioids for pain cal care and secure their safety if, for example, in few programs they are threatened. OTPs also should acknowl- because of limited relief... edge the unique social support structures of resources and licens- LGB patients, which can provide a way to ing and insurance counteract isolation and separation from com- requirements. These munity, peers, and immediate and extended obstacles might family members (Hughes and Eliason 2002; also cause missed appointments or lack of privacy see CSAT 2001b). Finally, the consensus panel and concentration for parents who must bring recommends that OTPs identify and refer LGB their children to treatment and counseling patients to community counseling, support, and sessions. Insufficient treatment may result. spiritual and religious organizations that are The consensus panel recommends that OTPs sensitive to these groups and address any seek opportunities and funding for onsite child- sexual- or gender-orientation concerns these care where appropriate and feasible to help patients have that could affect treatment.

94 Chapter 6 Aging Patients (Prater et al. 2002). MAT providers should evaluate patient treatment needs for pain MAT treatment planners should consider the management and assist patients directly in stressors common to the aging patient, such as obtaining optimal pain treatment. Medical loss of family, retirement, loneliness, and bore- providers in MAT should work collaboratively dom, which can contribute to high risk of self- with primary care providers and pain and overmedication and addiction to alcohol and palliative-care clinicians to ensure establish- medications. The consensus panel recommends ment of appropriate pain interventions for that OTPs focus on the following areas when patients in MAT. Providers need education working with elderly patients: about maintaining current opioid levels while ï Monitoring the increased risk for dangerous adding sufficient immediate-release treatment drug interactions; elderly patients often are agents to manage acute or chronic pain. More prescribed multiple medications. frequent dosing and short-term increased demand for pain treatment medication should ï Differentiating between co-occurring disorders be expected. Referrals to specialty pain clinics and symptoms and disorders associated with often provide patients a full spectrum of pain aging (including ) (Lawson 1989). care, including pharmacological and psycholog- ï Differentiating between depression and ical or behavioral treatments to alleviate pain dementia. symptoms. These services most often are acces- ï Screening for and treating physical and sible through hospital-based programs or refer- sexual abuse (see chapter 4). ral linkages. Most patients can be maintained ï Developing referral sources that meet the on their MAT dosage while taking short-acting needs of elderly patients. Relationships with opioids for pain relief; however, individualized skilled nursing facilities and nursing homes pain treatment is usually necessary. are particularly important (Lawson 1989). ï Training staff to be sensitive to the elderly Treatment Planning patient population. After patientsí individual needs are assessed ï Providing psychosocial treatment for age- and the best available treatment services and associated stressors and medical screening most appropriate levels of care are determined, and referral for common medical conditions a treatment plan should be developed with the affected by the aging process (see CSAT patient, as required by accreditation guidelines 1998b). (CSAT 1999b). ï Assessing and adjusting dosage levels of medication for the slowed metabolism of many elderly patients. Developing a Treatment Plan Treatment planning for MAT should involve a Patients With Pain multidisciplinary team, including physicians, counselors, nurses, case managers, social work- Patients in MAT often are undertreated or ers, and patients. Based on a thorough patient denied medication for acute or chronic pain history and assessment, a treatment plan management (Compton and Athanasos 2003). should be realistic and tailored to each Health care workers may misperceive pain patientís needs, strengths, goals, and objec- medication requests by patients in MAT as tives. Good treatment plans contain both short- drug-seeking behavior, in part because of and long-term goals and specify the actions patientsí higher tolerance for opioids and, usu- needed to reach each goal. Treatment plans ally, their need for higher doses. Many physi- should indicate which goals and objectives cians who treat pain do not have the necessary require referral to and followup with outside education to treat pain in this population

PatientñTreatment Matching 95 resources and which are provided by the OTP of and sensitivity to a patientís informed itself. Treatment plans should contain specific, choices, cultural background, age, and medical measurable treatment objectives that can be status or disability. evaluated for degree of accomplishment. Other factors in plan Role of the counselor in plan formulation formulation Treatment plans should incorporate an Counselors should ensure that treatment plans assessment of linguistic and cultural factors incorporate strategies to develop therapeutic that might affect treatment and recovery either relationships with patients, based on respect positively or negatively (U.S. Department of for patientsí autonomy and dignity, while Health and Human Services 2001). Treatment motivating patients to become willing partners providers should work collaboratively with in the change process (CSAT 1999a). This role, patients to identify health-related cultural which places great responsibility on the coun- beliefs, values, and practices and to decide how selor, usually incorporates cognitive behavioral to address these factors in the treatment plan approaches in which providers strive to (U.S. Department of Health and Human enhance patient motivation for change by Services 2001). focusing on patient strengths and respecting patient decisions (CSAT 1999a). To engage Motivation for treatment patients in the process of treatment planning, counselors should encourage the inclusion of Patient motivational strategies should be incor- motivational enhancement strategies that high- porated throughout the treatment plan. As part light appropriate, realistic treatment goals (Di of this process, the treatment team can benefit Clemente 1991). Research has shown that con- from an understanding of stages of change and frontational counseling or the use of negative their effects on patient progress. Prochaska contingencies often predicts treatment failure and colleagues (1982, 1986, 1992), who formu- (Miller and Rollnick 2002). lated a useful model that explains how people change, observed five stages of readiness for change during addiction treatment: contempla- Role of the patient in plan tion, determination, action, maintenance, and formulation relapse. An earlier stage (precontemplation) A patient in MAT should be an integral mem- also plays a role. Patients and treatment ber of the treatment team with his or her needs providers ideally should develop recommended and expectations considered respectfully and treatment options in the plan based on each incorporated into the treatment plan. Patients patientís readiness for treatment, which can be who agree with the treatment rationale or ther- determined by identifying the patientís stage-of- apeutic approach tend to experience increased change readiness. The stages-of-change model determination to improve (Hubble et al. 1999). and corresponding counseling responsibilities A patientís participation in treatment planning are described in TIP 35, Enhancing Motivation can enhance motivation to adhere to change for Change in Substance Abuse Treatment strategies, leading to positive treatment out- (CSAT 1999a). comes such as higher rates of abstinence and better social adjustment (CSAT 1999a). When Elements of a Treatment Plan possible, the treatment plan should be written in a patientís own words to describe his or her Because some patients require assistance in unique strengths, needs, abilities, and prefer- many functional areas, treatment plans should ences as well as his or her challenges and address measurable, achievable goals relevant problems. The plan also should contain to the patientís current situation. Short-term mutually approved goals that reflect awareness goals, such as vocational rehabilitation

96 Chapter 6 assessment or computer training, can evolve assessed. Most OTPs have forms to use for from a long-term goal, such as full-time treatment planning, many of which were devel- employment. However, treatment plans should oped to meet regulatory and accreditation be simple and not so comprehensive that they requirements, specifying goals, actions, respon- overpower a patient with the tasks that must be sible parties, and measurable outcomes. The achieved. Although both short- and long-term panel urges that these forms not be overly com- goals should be considered, the patientís plex or overwhelming to the patient. Patients involvement in defining measurable, achievable should receive a copy of the plan. Exhibit 6-1 goals is important. Treatment plans should be provides a case study and an example of a treat- modified periodically when progress can be ment plan.

Exhibit 6-1

Case Study: PatientñTreatment Planning in MAT Patient is a 30-year-old Hispanic mother of two children who has been divorced for 3 years. She dropped out of high school at age 15 when she became pregnant. As a single mother on public assistance, she first began using heroin intranasally at age 17 and began injecting 1 year later.

Patient was born in Puerto Rico, and her family came to the United States when she was 10 years old. She is the youngest of five children. Her father was an unemployed painter and alcoholic who physically abused her mother. He died in Puerto Rico from cirrhosis of the liver. Patientís relationship with her mother always has been strained. Her mother has had numerous relationships that the patient resented. Patient stated that, as the youngest child, she feels that she never received enough attention or love from her mother.

To support her lifestyle, which includes alcohol, cocaine, and heroin use, patient earned money through prostitution, which led to selling drugs, theft, and other criminal activities. Patient married after giving birth to her second child. Patient has an arrest history and a pending case for selling cocaine. After a divorce, patient lived with her mother. An anony- mous call was made to CPS reporting her chronic drug abuse and criminal history. As a result, her children were placed in foster care. After the patientís arrest and the removal of her children, patientís mother asked her to move out of the house; she then lived with whomever she could.

Patient has enrolled in an OTP, motivated by her desire to regain custody of her children. She considers cessation of her cocaine habit secondary to cessation of her heroin abuse. She initially stated that she wanted to change her life, including having her own permanent housing, and she wanted to stop prostituting. Although stabilized on methadone, she continued to use cocaine on a regular basis during her first 6 months in treatment. While in the program, she tested positive for HIV infection. She was assessed as having severe depression, with suicidal ideation, and escalation of cocaine abuse.

Although attempts have been made to motivate patient to stop cocaine use, these attempts have been unsuccessful.

Patientís treatment plan might include the following short- and long-term goals:

(continued on following page)

PatientñTreatment Matching 97 Exhibit 6-1

Case Study: PatientñTreatment Planning in MAT (continued)

Short-term goals 1.Address imminent danger of suicide by developing a service plan in conjunction with mental health provider. ï Objective: To rule out suicide; to overcome patientís depression and assess need for medication. ï Action: Have patient sign a consent form for a psychiatric evaluation and communication between provider and OTP staff; set up appointment with psychiatrist; obtain evaluation, diagnosis, and treatment recommendations from the psychiatrist. ï Target date: Immediately for suicidal ideation; within 1 month for ongoing mental health needs. ï Responsible persons: Patient, counselor or caseworker, and psychiatrist. ï Measurable outcome: Patient is stable and no longer at high risk; medication needs are assessed. ï Long-term goal: Stable mental health status with ongoing treatment plan. 2.Obtain housing for patient, with long-term goal of stable permanent housing. ï Objective: To refer to a shelter. ï Action: Make appointment to apply for housing assistance program. ï Target date: Immediately. ï Responsible persons: Patient, counselor or caseworker, and housing staff. ï Measurable outcome: Copy of lease, patient self-report, or both. ï Long-term goal: Access to stable housing. 3.Obtain HIV counseling. ï Objective: To provide support and education about HIV status. ï Action: Provide education, resources, and counseling about safe sex and spread of HIV. ï Target date: 4 to 6 months. ï Responsible persons: Medical staff, counselor, and patient. ï Measurable outcome: Patient has obtained and integrated accurate information; myths are dispelled; patient reports readiness to explore treatment options. ï Long-term goal: Initiation of antiretroviral treatment. 4.Address cocaine abuse. ï Objective: To educate the patient on the psychological and physiological effects of cocaine abuse; to develop a recovery intervention.

98 Chapter 6 Exhibit 6-1

Case Study: PatientñTreatment Planning in MAT (continued)

ï Action: Assess level of use and readiness for change; develop plan with patient to address use (e.g., motivational groups, Cocaine Anonymous, skill-building interventions, drug testing). ï Target date: 2 to 4 months. ï Responsible persons: Patient, counselor, group leader, and medical staff members. ï Measurable outcome: Patient decreases cocaine use, based on self-report, observable behavior, drug testing, and attendance to counseling plan. Long-term goals 1.Manage or eliminate depression. ï Objective: To stabilize depression; to increase self-esteem and motivation to work on treatment goals. ï Action: Provide regular psychiatric treatment on site or by referral; communicate with providers. ï Target date: 6 months. ï Responsible persons: Patient, counselor, and psychiatric providers. ï Measurable outcomes: Patient regularly attends to psychiatric treatment plan, adherence to medication regimen if prescribed, elimination of or reduction in depression (as assessed by patient report, depression assessment tools, observed behavior). 2.Regain custody of children once in stable housing situation. ï Objective: To reconcile the patient with her family; to maintain a stable living situation. ï Action: Assist patient in obtaining public assistance to ensure stable, safe, appropriate environment for children; access legal assistance for custody issues; obtain permission to communicate with CPS; assist patient in remaining abstinent from substance use. ï Target date: 1 year. ï Responsible persons: Patient, counselor or caseworkers, internal or external social services worker, and lawyer. ï Measurable outcomes: Patient self-report, family and CPS agency reports, rent receipts, progress toward obtaining custody of children. 3.Continue HIV medical care. ï Objective: To obtain ongoing HIV education and treatment. ï Action: Provide access and communication with HIV and primary care providers; provide referral to support group meetings for individuals who are HIV positive. ï Target date: Ongoing. ï Responsible persons: Patient, health care providers, counselor and caseworkers, and group counselor or facilitator. ï Measurable outcomes: Patient self-report, health care providersí report, laboratory reports, and group leader reports about adherence to health care needs.

PatientñTreatment Matching 99 The Multidisciplinary Team staff on all aspects of patient care, particularly Approach drug interactions ï Nonmedical professional staff members (e.g., The complexities of treatment planning for case coordinator, social worker, psychologist, patients who receive MAT require a multi- vocational and educational specialist), who disciplinary treatment team, the composition provide a range of psychosocial services, of which varies with OTP resources and the including counseling and case management, population being treated. The consensus panel psychotherapy and family therapy, psycholog- recommends that the treatment team consist of ical testing and evaluation, health education, the following: and vocational skills assessment and training ï A physician trained in addiction psychiatry, ï A certified or licensed addiction specialist or who provides leadership, health care, and drug counselor medical stabilization; conducts detailed ï Nontreatment and administrative staff mem- evaluations of the patient; monitors medica- bers (e.g., office manager, clerical staff, tions; and provides needed substance abuse receptionist, secretary), who often provide interventions when indicated information to treatment teams and whose ï Nonphysician medical staff members (e.g., responsibilities include operational manage- registered nurse, nurse practitioner, physi- ment, billing, receipt of payments, review of cianís assistant), who administer medications, records, observation of patient interactions, assist in medical evaluations, maintain and telephone coverage records, and facilitate referrals for medical ï Security personnel, who ensure the safety and psychiatric treatments and well-being of patients and staff on site. ï A pharmacist or pharmacy assistant, who dispenses (and sometimes administers) More information on the multidisciplinary team medications, orders controlled substances, approach is presented in chapter 14. maintains records, and consults with program

100 Chapter 6 7 Phases of Treatment

The consensus panel recommends that medication-assisted treatment for opioid addiction (MAT) as provided in opioid treatment programs (OTPs) be conceptualized in terms of phases of treatment so that inter- In This ventions are matched to levels of patient progress and intended outcomes. Chapter… The sequential treatment phases described in this chapter apply primari- ly to comprehensive maintenance treatment, rather than other treatment Rationale for a options such as detoxification or medically supervised withdrawal. When Phased-Treatment MAT is organized in phases, patients and staff better understand that it Approach and is an outcome-oriented treatment approach comprising successive, inte- Duration grated interventions, with each phase built on another and directly related to patient progress. Such a model helps staff understand the complex Phases of MAT dynamics of MAT and the potential sticking points and helps counselors Transition Between organize interventions based on patient needs. Treatment Phases The model described in this chapter comprises either five or six patient- in MAT centered phases for planning and providing MAT services and evaluating Readmission to the treatment outcomes in an OTP, including the (1) acute, (2) rehabilitative, OTP (3) supportive-care, (4) medical maintenance, (5) tapering (optional), and (6) continuing-care phases.

Rationale for a Phased-Treatment Approach and Duration Research on the effectiveness of organizing MAT into phases is limited, partly because MAT is a relatively long-term process, often with no fixed endpoint and with a variety of possible approaches, and partly because patients often leave and then return to MAT, which makes systematic studies difficult. Although research is limited, the consensus panel believes that the notion of phased progression is implicit in treatment and underlies most of a patientís time in MAT. Many OTPs operate according to an informal phased-treatment model, and others use phases at least to develop treatment plans.

101 Hoffman and Moolchan (1994) recognized the individual circumstances. For many patients, value of treatment phases in OTPs and described MAT is the entry point for diagnosis and treat- a highly structured model. This chapter builds ment of, or referral for, other health care and on, adapts, and psychosocial needs. In general, most patients extends their model need more intensive treatment services at entry, as part of an overall more diversified services during stabilization, [T]reatment strategy for matching and fewer, less intensive services after bench- patients with treat- marks of recovery begin to be met (McLellan et phases should not ments. The phases al. 1993; Moolchan and Hoffman 1994). described below are suggested as guide- The consensus panel emphasizes that treatment be viewed as fixed linesóa way of phases should not be viewed as fixed steps with organizing treatment specific timeframes and boundaries but regard- steps with specific and looking at ed as a dynamic continuum that allows patients progress on a care to progress according to individual capacity. timeframes and continuumóand Some patients progress rapidly and some as an adjunct to gradually. Some progress through only some boundaries... the levels of care phases, and some return to previous phases. specified by the Treatment outcomes should be evaluated not American Society of only on how many phases have been completed Addiction Medicine or whether a patient has had to return to an in its patient place- earlier phase but also on the degree to which ment criteria (Mee-Lee et al. 2001a) and the patientís needs, goals, and expectations referred to by accreditation agencies. have been met. As described in chapter 4, assessment of patient readiness for a particular The model is not one directional; at any point, phase and assessment of individual needs patients can encounter setbacks that require a should be ongoing. return to an earlier treatment phase. Therefore, the chapter includes strategies for addressing setbacks and recommendations for handling Duration of Treatment Within transitions between phases, discharge, and and Across Phases readmission. In terms of medication, the model Decisions concerning treatment duration (time includes two distinct tracks, one of continuing spent in each phase of treatment) should be medication maintenance and the other of made jointly by OTP physicians, other members medication tapering (medically supervised of the treatment team, and patients. Decisions withdrawal). The implications of both tracks should be based on accumulated data and are discussed. Although most patients would medical experience, as well as patient partici- prefer to be medication free, this goal is diffi- pation in treatment, rather than on regulatory cult for many people who are opioid addicted. or general administrative policy. Maintaining abstinence from illicit opioids and other substances of abuse, even if that requires ongoing MAT, should be the primary objective. Phases of MAT

Variations Within Treatment Acute Phase Phases Patients admitted for The phase model assumes that, although many patients need long-term MAT, the types and detoxification intensity of services they need vary through- Although the phases of treatment model is struc- out treatment and should be determined by tured for patients admitted for comprehensive

102 Chapter 7 maintenance treatment, some patients may be disorders and medical, social, legal, family, and admitted specifically for detoxification from opi- other problems associated with addiction. The oids (see 42 Code of Federal Regulations [CFR], consensus panel believes that front-loading Part 8 ß 12(e)(4)). These patients usually do highly intensive services during the acute not wish to be admitted for or do not meet phase, especially for patients with serious Federal or State criteria for maintenance treat- co-occurring disorders or social or medical ment. Patients admitted for detoxification may problems, engages patients in treatment and be treated for up to 180 days in an OTP. The conveys that the OTP is concerned about all goals of detoxification are consistent with those the issues connected to patientsí addiction. of the acute treatment phase as described Exhibit 7-1 summarizes the main treatment below, except that detoxification has specific considerations, strategies, and indicators of timeframes and MAT endpoints. Detoxification progress during the acute phase. focuses primarily on stabilization with medica- tion (traditionally using methadone but Goals of the acute phase buprenorphine-naloxone tablets are now available), tapering from this medication, and A major goal during the acute phase is to referral for continuing care, usually outside eliminate use of illicit opioids for at least 24 the OTP. During this process, patientsí basic hours, as well as inappropriate use of other living needs and their other substance use, co- psychoactive substances. This process involves occurring, and medical disorders are identified ï Initially prescribing a medication dosage that and addressed. Patients also may be educated minimizes sedation and other undesirable about the high-risk health concerns and prob- side effects lems associated with continued substance use. They usually are referred to community ï Assessing the safety and adequacy of each resources for ongoing medical and mental dose after administration health care. ï Rapidly but safely increasing dosage to suppress withdrawal symptoms and cravings Patients admitted for detoxification should and discourage patients from self-medicating have access to maintenance treatment if their with illicit drugs or alcohol or by abusing tapering from treatment medication is unsuc- prescription medications cessful or they change their minds and wish to ï Providing or referring patients for services to be admitted for comprehensive MAT. If these lessen the intensity of co-occurring disorders patients meet Federal and State admission cri- and medical, social, legal, family, and other teria, their medically supervised withdrawal problems associated with opioid addiction from treatment medication should end, their medication should be restabilized at a dosage ï Helping patients identify high-risk situations that eliminates withdrawal and craving, and for drug and alcohol use and develop alterna- their treatment plans should be revised for tive strategies for coping with cravings or long-term treatment. compulsions to abuse substances. Chapter 5 details the procedures for determin- Patients admitted for ing medication dosage. comprehensive maintenance Indications that patients have reached the goals treatment of the acute phase can include The acute phase is the initial period, ranging ï Elimination of symptoms of withdrawal, from days to months, during which treatment discomfort, or craving for opioids and focuses on eliminating use of illicit opioids and stabilization abuse of other psychoactive substances while lessening the intensity of the co-occurring

Phases of Treatment 103 Exhibit 7-1

Acute Phase of MAT

Indications for Transition to Treatment Issue Strategies To Address Issue Rehabilitative Phase Alcohol and drug use ï Schedule weekly drug and ï Elimination of opioid- alcohol testing withdrawal symptoms, ï Educate about effects of alco- including craving hol and drugs; discourage their ï Sense of well-being consumption ï Ability to avoid situations ï Ensure ongoing patient dialog that might trigger or per- with staff petuate substance use ï Intensify treatment when ï Acknowledgment of necessary addiction as a problem and ï Meet with program physician motivation to effect lifestyle to ensure adequate dosage of changes treatment medication Medical concerns ï Infectious diseases (e.g., ï Refer patients immediately to ï Resolution of acute medical HIV/AIDS, hepatitis, medical providers crises tuberculosis [TB]) ï Vaccinate as appropriate (e.g., ï Established, ongoing care ï Sickle cell disease for hepatitis A and B) for chronic medical ï Surgical needs, such as conditions skin or lung abscesses Co-occurring disorders ï Psychotic, anxiety, ï Identify acute co-occurring ï Resolution of acute mental mood, or personality disorders that may need imme- crises disorders diate intervention ï Established, ongoing care ï Identify chronic disorders that for chronic disorders need ongoing therapy Basic living concerns ï Legal and financial ï Assess needs ï Satisfaction of basic food, concerns ï Refer patient to appropriate clothing, shelter, and safety ï Threats to personal services needs safety ï Work cooperatively with ï Stabilization of living ï Inadequate housing criminal justice system situation ï Lack of transportation ï Explore transportation options ï Stabilization of financial assistance ï Childcare needs ï Link to legal advocate, case- worker, or social worker ï Resolution of transportation ï Pregnancy and childcare needs ï Advocacy ï Identify financial resources ï Provide ongoing case management

104 Chapter 7 Exhibit 7-1

Acute Phase of MAT (continued)

Indications for Transition to Treatment Issue Strategies To Address Issue Rehabilitative Phase Therapeutic relationship ï Establishing trust and ï Advocate adequate dosage ï Regular attendance at feeling of support ï Remain consistent, flexible, counseling sessions ï Addressing myths about and available; minimize ï Positive interaction with MAT waiting times treatment providers ï Provide incentives and ï Focus on treatment goals emphasize benefits of treatment ï Dispel myths about MAT ï Educate patient about goals of MAT ï Build support system ï Build trust Motivation and readiness for change ï Ambivalent attitudes ï Ensure adequate dosage ï Commitment to treatment about substance use ï Address ambivalence process ï Avoidance of counseling ï Empower patient ï Acknowledgment of (noncompliance) addiction as a problem ï Emphasize treatment ï Negative relationships with benefits ï Lifestyle changes and staff addressing addiction- ï Emphasize importance of related issues ï Inadequate dosage making a fresh start ï Negative attitude about treatment ï Involuntary discharge

ï Expressed feelings of comfort and wellness ï Engagement with treatment staff in throughout the day assessment of medical, mental health, and ï Abstinence from illicit opioids and from psychosocial issues abuse of opioids normally obtained by ï Satisfaction of basic needs for food, shelter, prescription, as evidenced by drug tests and safety.

Phases of Treatment 105 Alcohol, opioid, and other disruptive at the start of MAT and require drug abuse immediate treatment. The course of recovery from substance-induced co-occurring disorders During the acute phase, OTP staff members usually follows that of the substance use dis- should pay attention both to patientsí continuing order itself, and these co-occurring disorders opioid abuse and to their use of other addictive typically do not require ongoing treatment after and psychoactive substances. Patients should the acute phase. Some patients may require receive information about how other drugs, focused, short-term pharmacotherapy, psycho- nicotine, and alcohol interact with treatment therapy, or both. However, many patients medications and why medication must be may have co-occurring disorders requiring a reduced or withheld when intoxication is evi- thorough psychiatric evaluation and long-term dent. When substance abuse continues during treatment to improve their quality of life. (See the acute phase, the treatment team should chapters 4 and 12 for more information on review patientsí presenting problems and revise assessing these conditions and chapter 12 for plans to address them, including changes in more information on psychiatric diagnosis and dosage, increased drug testing, or other intensi- treatment in MAT.) fied interventions. Chapter 11 discusses treat- ment options to address multiple substance use. Medical and dental problems In addition, the consensus panel believes that Patients often present with longstanding, frequent contact with knowledgeable and car- neglected medical problems. These problems ing staff members who can motivate patients to might require hospitalization or extensive become engaged in program activities, especial- treatment and could incur substantial costs for ly in the acute phase, facilitates the elimination people often lacking financial resources. In of opioid abuse. Engaging the patient by addition, many patients in MAT have neglected scheduling extra individual or group counseling their dental health (Titsas and Ferguson 2002). sessions provides additional support and com- Once opioid abuse is stopped, these patients municates staff concern for the patient. often experience pain because the analgesic Intensified treatment in the OTP is an effective effects of the opioids have been removed. Such response and provides improved outcomes conditions must be recognized, assessed, and when compared with more infrequent counsel- treated, either within an OTP or via referral. ing sessions (Woody 2003). (See chapter 10 for discussion of the diagnosis and treatment of medical problems for patients Co-occurring disorders in MAT.) Many people entering OTPs have mental disor- ders. Persistent, independent co-occurring Legal problems disorders (i.e., mental disorders that arise from Most correctional systems do not allow MAT. causes other than substance use and need The consensus panel believes that sudden, ongoing therapy) and substance-induced co- severe opioid withdrawal caused by precipitous occurring disorders (i.e., mental disorders incarceration can endanger health, especially directly related to substance use and addiction that of patients already experiencing comorbid that probably will improve as the addiction is medical illness, and can increase the risk of sui- controlled) should be identified during initial cide in individuals with co-occurring disorders. assessment and the acute phase of treatment so Therefore, it is critical to address patientsí that appropriate treatment or referral can be legal problems and any ongoing criminal activi- arranged. Patients should be monitored closely ty as soon as possible, preferably in the acute for symptoms that interfere with treatment phase. On behalf of those on probation or because immediate intervention might prevent parole or referred by drug courts, program patient dropout. Such disorders can be staff members should work cooperatively with

106 Chapter 7 criminal justice agencies, educating them about these groups support MAT) can be helpful to MAT and, with patientsí informed consent (see patients. OTPs can provide information about CSAT 2004b), reporting patient progress and appropriate meetings and peer support. incorporating continuing addiction treatment into the probation or parole plan. OTPs should The consensus panel recommends that patients work with local prisons and jails to provide as be introduced to key OTP staff members as much support and consultation as possible. early as possible during the acute phase to When medical care is provided in jails or foster an atmosphere of safety, trust, and prisons by contracted health agencies, OTPs familiarity. Patients consistently report that a should establish contacts directly with these strong therapeutic relationship is one of the medical providers to improve the care of incar- most critical factors cerated patients in MAT. (See TIP 44, Substance influencing treatment Abuse Treatment for Adults in the Criminal outcomes and that Justice System [CSAT 2005a].) therapistsí warmth, Patients...report positive regard, and acceptance are major that a strong Basic needs elements in relation- The consensus panel recommends that ship development therapeutic patientsí basic needs such as food, clothing, (Metcalf et al. 1996). housing, and safety be determined during the Treatment providers acute phase, if possible, as discussed in chapter should minimize wait- relationship is one 4, and that referrals be made to appropriate ing times during agencies to address these needs. scheduled appoint- of the most critical ments to demonstrate Patientsí living situations should be relatively that they value factors influencing stable and secure so that treatment can move patientsí time. In beyond the acute phase. Before they transition addition, when treatment to the rehabilitative phase, patients should providers remain flex- begin to develop the coping skills needed to ible and available outcomes... remove themselves from situations of inevitable during the acute substance use. A patientís inability to gain this phase, they contribute control may necessitate revision of the treat- to patientsí sense of ment plan to assist the patient in moving past security. Knowing how the acute phase. The process often includes to reach staff in an emergency can foster meeting directly with the patient to assess moti- patientsí trust in treatment providers. vation and adequacy of dosage and to define treatment goals clearly. Motivation and patient Therapeutic relationships readiness Positive reinforcement of a patientís treatment As discussed in chapter 4, patient motivation engagement and compliance, especially in the to engage in treatment is a predictor of reten- acute phase, is important to elicit a commit- tion and should be reassessed continually. ment to therapy. Chapter 8 addresses the Counselors should explore and address importance of the therapeutic bond between patientsí negative treatment experiences. It patients and treatment providers and reviews might help to acknowledge the weaknesses of practical techniques to address common past staff efforts and to focus on future actions problems in counseling. to move treatment forward. Counseling and motivational enhancement are discussed in Furthermore, participation in peer support detail in chapter 8. services and mutual-help groups (provided that

Phases of Treatment 107 The level of patient engagement during the rehabilitative phase, strategies for addressing acute phase is critical. Research has shown that them, and indicators for subsequent transition patient motivation, staff engagement, and the to the supportive-care phase. trust developed during orientation and the acute phase are linked more closely to treat- As stated for the acute phase, during the ment outcomes than patientsí initial reasons for rehabilitation phase treatment, providers entering an OTP (Kwiatkowski et al. 2000; should continue to assist or provide referrals Marlowe et al. 2001). for patients who need help with legal, educa- tional, employment, medical, and financial problems that threaten treatment retention Transition to the rehabilitative (Condelli 1993). phase Throughout this phase, efforts should increase The panel recommends the following criteria for to promote participation in constructive activi- transition from the acute to the rehabilitative ties such as full- or part-time employment, phase: education, vocational training, child rearing, ï Amelioration of signs of opioid withdrawal homemaking, and volunteer work. As patients attend to other life domains, requirements for ï Reduction in physical drug craving frequent OTP attendance or group participa- ï Elimination of illicit-opioid use and reduction tion should not become barriers to employment, in other substance use, including abuse of education, or other constructive activities or prescription drugs and alcohol medical regimens. Consequently, program poli- ï Completion of medical and mental health cies in areas such as take-home medications and assessment dosing hours should be more flexible in the ï Development of a treatment plan to address rehabilitative phase, especially when patients psychosocial issues such as education, voca- must travel long distances to their OTP or tional goals, and involvement with criminal receive medication at restricted hours. justice and child welfare or other social The consensus panel recommends that informa- service agencies as needed tion about outside support groups, including ï Satisfaction of basic needs for food, clothing, faith-based, community, and 12-Step groups, shelter, and safety. be reviewed with patients in the rehabilitative phase and that patients be urged to participate in such groups, assuming that these groups sup- Rehabilitative Phase port MAT. As discussed in chapter 14, OTPs The primary goal of the rehabilitative phase of also should cultivate direct relationships with treatment is to empower patients to cope with organizations that might lend support for their major life problemsódrug or alcohol patient recovery. Faith-based organizations abuse, medical problems, co-occurring disor- can provide spiritual assistance, a sense of ders, vocational and educational needs, family belonging, and emotional support, as well as problems, and legal issuesóso that they can opportunities for patients to contribute to their pursue longer term goals such as education, communities, and in the process can educate employment, and family reconciliation. community members about MAT. Stabilization of dosage for opioid treatment medication should be complete, although Relapse triggers or cues such as boredom, adjustments might be needed later, and patients certain locations, specific individuals, family should be comfortable at the established dosage problems, pain, or symptoms of co-occurring for at least 24 hours before the rehabilitative disorders might recur during the rehabilitative phase can proceed. Exhibit 7-2 summarizes phase and trigger the use of illicit drugs or the treatment issues addressed during the abuse of prescription drugs or alcohol. Helping

108 Chapter 7 Exhibit 7-2

Rehabilitative Phase of MAT

Indications for Transition Treatment Issue Strategies To Address Issue to Supportive-Care Phase Alcohol and drug use ï Continued opioid use ï Begin behavioral contracting ï Ability to identify and ï Continued abuse of ï Start short-term inpatient manage relapse triggers other substances (e.g., treatment ï Repertoire of coping skills alcohol, cocaine, ï Introduce disulfiram for alco- ï Demonstrated changes nicotine) hol abuse in life circumstances to ï Provide pharmacotherapy and prevent relapse cessation groups for tobacco ï Discontinuation of opioid use and other drug use ï Intensify treatment services ï Absence of problem ï Introduce positive incentives: alcohol use take-home medication, recog- ï Smoking cessation plan nition of progress ï Adjust dosage as necessary to prevent continued opioid use ï Encourage participation in support groups and family therapy Medical concerns ï Chronic diseases (e.g., ï Ensure onsite primary care or ï Compliance with treat- diabetes, hypertension, link to other services ment for chronic diseases seizure disorders, car- ï Provide integrated treatment ï Improved overall health diovascular disease) approach status ï Infectious diseases (e.g., ï Provide routine TB testing as ï Improved dental health HIV/AIDS, TB, hepati- appropriate and hygiene tis B and C, sexually transmitted diseases) ï Provide education on diet, ï Regular prenatal care exercise, smoking cessation ï Susceptibility to ï Stable medical and mental vaccine-preventable ï Provide vaccinations as health status diseases indicated ï Dental problems, ï Adjust other medications that interfere with treatment medi- cation or adjust dosage of ï Womenís health issues treatment medication (e.g., pregnancy, family planning services) ï Assess need and refer patient for pain management

(continued on following page)

Phases of Treatment 109 Exhibit 7-2

Rehabilitative Phase of MAT (continued)

Indications for Transition Treatment Issue Strategies To Address Issue to Supportive-Care Phase Co-occurring disorders ï Psychotic, anxiety, ï Evaluate status ï Stable mental status mood, posttraumat- ï Teach coping skills and compliance with ic stress, or person- psychiatric care ï Ensure early identification and refer- ality disorders ral for co-occurring disorders ï Refer for psychotropic medication or psychotherapy as indicated

Vocational and educational needs ï Unemployment/ ï Identify education deficiencies ï Stable source of income underemployment ï Provide onsite general equivalency ï Active employment ï Low reading skills diploma (GED) counseling or referral search ï Illiteracy ï Provide literacy and vocational train- ï Involvement in produc- ï Learning disabilities ing with community involvement tive activity: school, ï Provide training on budgeting of employment, volunteer personal finances work ï Provide employment opportunities or referral to a job developer

Family issues ï Absence of family ï Involve community or faith-based, ï Social support system support system fellowship, recreation, or other peer in place ï Emergence of family group ï Absence of major problems (e.g., ï Increase involvement in family life conflict within support traumatic family (in absence of family dysfunction system history, divorce, that impedes progress) ï Increased responsibil- other problem ï Provide for well-child care ity for dependents situations) Legal problems ï Criminal charges ï Provide access to legal counsel ï Resolution of, or ï Custody battles ï Encourage patient to take responsi- ongoing efforts to solve, legal problems ï Ongoing illegal bility for legal problems activities ï Identify obstacles to eliminating illegal ï Absence of illegal activities and replace them with con- activities structive activities

110 Chapter 7 patients develop skills to cope with triggers demonstrated a period of abstinence. Patients should be emphasized in this phase (Sandberg also should receive information on the risks of and Marlatt 1991) and might involve individu- smoking, both for their own recovery and for al, group, or family counseling or participation the health of those around them. (See chapter in groups focused on relapse prevention. (For a 11 for techniques to treat continued substance discussion of relapse prevention, see chapter 8.) use during MAT and chapter 8 for counseling and behavior modification strategies.) Many factors that receive emphasis in the acute phase should continue to be addressed in the The frequency of drug testing during the rehabilitative phase: rehabilitative phase and all subsequent phases should depend on a patientís progress in treat- ï Continued alcohol and prescription drug ment. The consensus panel recommends that, abuse and use of illicit drugs once a patient is progressing well and has con- ï Ongoing health concerns sistently negative drug tests, the frequency of ï Acute and chronic pain management random testing be decreased to once or twice per month. The criteria for this should be part ï Employment, formal education, and other of the treatment plan. (See chapter 9 for a income-related areas detailed discussion of drug testing.) ï Family relationships and other social supports ï Legal problems Ongoing health concerns ï Co-occurring disorders As patients advance in the rehabilitative phase, ï Financial problems. they should attend to other medical problems, and OTP staff should help them navigate the Continued alcohol and medical- and dental-care systems, while edu- cating practitioners about MAT. Onsite primary prescription drug abuse and health care is optimal and has been instituted use of illicit drugs successfully in many OTPs and can result in The consensus panel recommends that elimina- better outcomes for patients (Weisner et al. tion of alcohol abuse, illicit-drug use, and inap- 2001), although it requires careful coordination propriate use of other substances be required of activities and staff (Herman and Gourevitch to complete the rehabilitative phase. Evidence 1997). When lack of resources precludes onsite of heavy alcohol use might warrant that a medical services in an OTP, referral arrange- patient return to the acute phase. If a patient is ments with other service providers should be using medications, particularly drugs of poten- in place. tial abuse prescribed by a nonprogram physi- The consensus panel recommends a more cian, the patient should be counseled to advise integrated approach to patient health in the his or her OTP physician of these prescriptions rehabilitative phase. A patientís health needs and should sign an informed consent statement should be diagnosed and treated immediately. permitting OTP staff and the outside physician Education about topics with longer term bene- to discuss these prescriptions. If drug use is fits, such as nutrition, exercise, personal illicit or unapproved by the OTP physician, hygiene, sleep, and smoking cessation, can be then group, family, and individual counseling started. Eventually, patients should demon- should continue, and the patient should remain strate adherence to medical regimens for their in the rehabilitative phase. Patients who con- chronic conditions and address any acute tinue to use illicit drugs or demonstrate alcohol conditions before they are considered for tran- use problems are not eligible for take-home sition from the rehabilitative phase to subse- medication. Take-home medication should quent treatment phases. not be considered until these patients have

Phases of Treatment 111 Acute and chronic pain their status. The panel recommends that management vocational training provided in an OTP include basic education about drug testing, including Patients in OTPs are at high risk of under- the fact that methadone may be detected. treatment for pain (Jamison et al. 2000; Patients should be advised to answer all job Rosenblum et al. 2003; Scimeca et al. 2000). application questions honestly and should be Chapter 10 provides recommendations for pain counseled on ways to manage disclosure of their management. Because acute pain treatment treatment status. Patients with disabilities usually involves opioid medications, programs should be educated about the basics of the should work with patients to recognize the risk Americans with Disabilities Act and any local of relapse and provide supports to prevent it antidiscrimination legislation and enforcement. (Jamison et al. 2000). By the end of the rehabilitative phase, patients Employment, formal should be employed, actively seeking employ- ment, or involved in a productive activity such education, and other as school, child rearing, or regular volunteer income-related issues work. They should have a stable source of legal income, whether from employment, disability The consensus panel believes that some of the benefits, or other legitimate sources, ensuring most difficult obstacles to a stable life for MAT that they can avoid drug dealing or other patients include unemployment and inadequate criminal activities to obtain money. funds to live comfortably and safely. Most such limitations should be addressed during the rehabilitative phase. (See chapter 8 for detailed Family relationships and discussion.) other social supports Individuals who need access to high-quality Broken trust, disappointment, anger, and social services should be identified during the conflict with family members and acquain- rehabilitative phase for educational, literacy, tances are realities that patients should face and vocational programs that will equip them during the rehabilitative phase. Many need to with the skills needed to function independently. reconcile with their families, reunite with or Chapters 6 and 8 discuss such assistance. TIP regain custody of their children, and handle 38, Integrating Substance Abuse Treatment and other family issues. Some patients have had Vocational Services (CSAT 2000c), provides little or no family contact during the period of more information on this topic. their opioid addiction. Counselors need to help patients improve their social supports and rela- Ideally, OTPs should provide onsite GED tionships and begin to rebuild and heal severely counseling and assistance or make referrals to damaged family relationships. Chapter 8 local adult education programs that are sensitive expands on these goals for patients in MAT. to the needs of patients in MAT. Efforts can be made to encourage business, industry, and Transition from the rehabilitative phase should government leaders to create income-generating require that patients have a social support sys- enterprises that provide patients with job skills tem in place that is free of major conflicts and and opportunities for entry into the job market that they assume increased responsibility for and to preclude employment discrimination their dependents (e.g., by reliably providing for patients. child support).

Patients in MAT face unique employment Legal problems challenges, especially as employers increasingly impose preemployment drug testing and The stress associated with patientsí legal patients must wrestle with whether to disclose problems can precipitate relapse to illicit drug

112 Chapter 7 use or abuse of alcohol or prescription drugs. Exhibit 7-3 summarizes the treatment issues Counselors should probe patientsí legal circum- that should be addressed during the supportive- stances, such as child custody obligations, and care phase, strategies for addressing them, and patients should be encouraged to take responsi- indicators for the subsequent transition from bility for their actions; however, counselors the supportive-care phase to medical mainte- should help patients remain in treatment while nance or tapering. resolving pending legal problems. During the rehabilitative phase, counselors should help Patients should have discontinued alcohol and patients overcome guilt, fear, or uncertainty prescription drug abuse and all illicit-drug use, stemming from their legal problems. In addi- as well as any involvement in criminal activities, tion, OTP staff should ensure that patients have before entering the supportive-care phase. access to adequate legal counsel, for instance, Heavy or problem substance use should result through a public defender. All major legal prob- in patientsí return to the acute phase. Patients lems should be in the process of resolution in supportive care should be employed, actively before patients move beyond the rehabilitative seeking employment, or involved in other pro- phase. Drug courtsí referrals of patients can ductive activities, and they should have legal, result in reporting requirements and specialized stable incomes. Even though all treatment protocols (see CSAT 2005a). plans and patientsí progress should be assessed individually, if any requirements largely are unmet, counselors should consider returning Co-occurring disorders these patients to the rehabilitative phase to The consensus panel recommends that, before address areas of renewed concern rather than patients move beyond the rehabilitative phase, advancing them to the medical maintenance or co-occurring disorders be alleviated or stabi- tapering phase. lized. Although symptoms might continue to arise, patients should have adequate coping After patients in supportive care are abstinent skills to avoid relapse to opioid abuse. Chapter from illicit drugs or are no longer abusing 12 provides specific information about co- prescription drugs (as confirmed by treatment occurring disorders in MAT. observation and nega- tive drug tests) for a specified period, they Supportive-Care Phase should be considered After meeting the criteria for transition from for transition to either Heavy or problem the rehabilitative phase, patients should the medical mainte- progress to the supportive-care phase, in which nance or the tapering substance use they continue opioid pharmacotherapy, partici- phase. Opinions vary on the length of time pate in counseling, receive medical care, and should result in resume primary responsibility for their lives. patients should be free from illicit-drug During this phase, patients should begin to patientsí return to receive take-home medication for longer periods use and abuse of pre- and be permitted to make fewer OTP visits. scription drugs before Depending on regulations (State regulations being allowed to move the acute phase. often are more stringent than Federal), these to the next phase. patients might visit their OTP as infrequently as However, to receive every other week. Often, supportive care pro- the maximum 30-day vided in an OTP can be augmented by support- supply of take-home ive activities through mutual-help, community, medication, a patient must be demonstrably faith-based, peer, and acculturation groups. free from illicit substances for at least 2 years of continuous treatment (42 CFR, Part 8 ß 12(i)(3)(vi)). The consensus panel believes that

Phases of Treatment 113 Exhibit 7-3

Supportive-Care Phase of MAT

Treatment Indications for Transition Issue Strategies To Address Issue to Next Phase Alcohol and ï Monitor use ï Discontinued drug use drug use ï Increase frequency of drug screening and no problems with alcohol use Medical and ï Monitor compliance with medical/psychiatric ï Stability mental health regimens concerns ï Maintain communication with patientsí health care and mental health care providers

Vocational ï Monitor vocational status and progress ï Stable source of income and educa- toward educational goals tional needs ï Assist in addressing workplace problems Family issues ï Monitor family stability and relationships ï Stability ï Refer for family therapy as needed Legal issues ï Monitor ongoing legal issues ï Resolution ï Provide needed support

a period of treatment compliance lasting for either medical maintenance or tapering. between 2 and 3 years usually is appropriate. Instead, these patients should continue to However, the length of time a patient remains receive take-home medication for brief periods in supportive care should be based entirely on (e.g., 1 to several days) along with other services his or her needs and progress, not on an as needed. imposed timetable. Patientsí progress in coping with their life domains should be assessed at The criteria for transitioning to the next phase least quarterly to determine whether patients of treatment depend on whether the patient is are eligible and ready for transition from sup- entering the medical maintenance phase or the portive care to either the medical maintenance tapering and readjustment phase. or tapering phase.

In some cases, patients who stop opioid abuse Medical Maintenance Phase and demonstrate compliance with program In the medical maintenance phase, stabilized rules do not make progress in other life patients who continue to require medication to domains. Although such patients might do well remain stable are allowed longer term (up to in MAT, they still need the ongoing support and 30-day) supplies of take-home medication and pharmacotherapy provided by the OTP and, in further reductions in the frequency of treat- the opinion of the consensus panel, should be ment visits, generally without the suite of ser- deemed ineligible or inappropriate candidates vices included in comprehensive MAT. Medical

114 Chapter 7 maintenance with methadone can be adminis- summarizes treatment issues and strategies in tered through an OTP or through the office of the medical maintenance phase of MAT and a qualified physician who operates under provides indicators for transition to physicianís Substance Abuse and Mental Health Services office-based opioid treatment (OBOT) or the Administration (SAMHSA) approval as a tapering or continuing-care phases. ìmedication unitî (42 CFR, Part 8 ß 11(h)) and is linked formally to an OTP. Federal regula- In addition, evaluation of life domains tions (42 CFR, Part 8 ß 12(i)(3)(vi); 42 CFR, including substance use, co-occurring medical Part 8 ß 11(h)) permit various levels of take- and mental problems, vocational and educa- home medication for unsupervised use, with the tional needs, family circumstances, and legal amount linked to the length of time that issues should continue during the medical patients have been abstinent from illicit opioids maintenance phase, regardless of the setting. or have stopped abusing prescription opioids Although patients in medical maintenance may and to other specified conditions. Some State not require psychological services, they may regulations (e.g., New York) further restrict the need occasional dosage adjustments based on amount of take-home opioid treatment medica- their use of other prescription medication or on tion and supersede Federal regulations. such factors as a change in metabolism of methadone (see chapter 5). The consensus panel recommends the following criteria to determine a patientís eligibility for The consensus panel recommends random drug the medical maintenance phase of treatment: testing and callbacks of medication during the medical maintenance phase to make sure that ï 2 years of continuous treatment patients are adhering to their medication ï Abstinence from illicit drugs and from abuse schedules (see chapter 9). Patients in medical of prescription drugs for the period indicated maintenance should be monitored for risk of by Federal and State regulations (at least 2 relapse. Positive drug test results should be years for a full 30-day maintenance dosage) addressed without delay, and patients should be returned to the rehabilitative phase when ï No alcohol use problem appropriate. ï Stable living conditions in an environment free of substance use The consensus panel recommends that, as part ï Stable and legal source of income of the diversion control plan required for all OTPs by SAMHSA (see chapters 5 and 14), ï Involvement in productive activities (e.g., evidence of medication diversion by a patient in employment, school, volunteer work) medical maintenance result in reclassification of ï No criminal or legal involvement for at least that patient to the most appropriate previous 3 years and no current parole or probation phase of treatment and in adjustment of status treatment, other services, and privileges. ï Adequate social support system and absence Reinstatement into medical maintenance of significant unstabilized co-occurring should occur only after the phase-regressed disorders. patient is observed over a reasonable period (at least 3 to 6 months) and has demonstrated During the medical maintenance phase, OTPs required progress. may play various roles in patientsí primary medical and mental health care. OTPs that Considerations for OBOT with provide only limited health care services should integrate their services with those of other methadone health care providers (see chapters 10 and OBOT may be considered for patients receiving 12 about related medical problems and co- methadone in MAT in an OTP who have occurring disorders, respectively). Exhibit 7-4 demonstrated stability in all domains for at

Phases of Treatment 115 Exhibit 7-4

Medical Maintenance Phase of MAT

Indications for Transition to OBOT or Tapering or Treatment Issue Strategies To Address Issue Continuing-Care Phases Alcohol and drug use ï Monitor use ï Continuous stability for ï Perform drug testing 2 years Medical and mental ï Monitor compliance ï Stability health concerns ï Maintain communication Vocational and edu- ï Monitor progress ï Stability cational needs ï Remain available to address work- place problems Family issues ï Monitor family stability ï Stability ï Refer to family therapy as needed Legal issues ï Monitor ongoing legal issues ï Stability ï Provide support as needed

least 2 consecutive years of treatment. If a approach that includes medication and coun- patient in medical maintenance who is receiving seling services. Even for patients who are treatment through OBOT relapses (to opioid, rehabilitated and stable enough to qualify for other drug, or alcohol abuse) or needs the medical maintenance, medication alone often is structure of an OTP for psychosocial reasons, inadequate to treat their opioid addiction the treating physician is responsible for (Joseph et al. 2000). referring the patient back to an OTP. There are some exceptions in which patients, early in treatment, can be transferred from an OTP to Tapering and Readjustment OBOT with methadone (e.g., when travel to an Phase OTP is impossible or there are medical reasons), ì Taperingî and ìmedically supervised with- but these exceptions must be preapproved by drawalî are terms commonly used to describe SAMHSA (see chapter 5). the gradual reduction and elimination of main- Coordination of care is critical in the OBOT tenance medication during opioid addiction model so that patients get the full range of ser- treatment. (The term ìdetoxificationî in this vices needed to remain abstinent. Treatment TIP refers to tapering from illicit drugs, from issues listed in Exhibits 7-1, 7-2, and 7-3 also inappropriate use of prescription drugs, or are applicable to patients who receive OBOT. from alcohol abuse, not to tapering from treat- Regardless of the opioid treatment medication ment medication, to avoid the implication that used, treatment of opioid addiction requires a treatment medications are toxic.) Studies show comprehensive and individualized treatment that most patients who are opioid addicted try

116 Chapter 7 to taper from treatment medication one or Reasons for tapering more times after reaching and maintaining sta- Sometimes decisions to taper are motivated by bility. With proper support systems and skills, the hardships of OTP attendance and other many patients succeed in remaining abstinent requirements or by the stigma often associated from opioids without treatment medication for with MAT. The consensus panel urges OTPs to years or even life, but studies have shown that identify such situational motives and ensure some relapse to opioid abuse (Condelli and that patients who choose medically supervised Dunteman 1993; Hubbard et al. 1989; Kreek withdrawal from MAT are motivated instead by 1987). Chapter 5 describes procedures and legitimate concerns about health and relapse. other key considerations in tapering. In the phased model presented here, tapering is con- Patients and treatment providers might fail to sidered an optional branch. realize or understand that continuing or long- term MAT is the best choice for some patients. It is important that any decision to taper from OTP staff members consciously or inadvertent- opioid treatment medication be made without ly might convey that tapering is more desirable coercion and include careful consideration of a or expected than continuing opioid pharma- patientís wishes and preferences, level of moti- cotherapy, through such practices as celebrat- vation, length of addiction, results of previous ing patientsí tapering but not the accomplish- attempts at tapering, family involvement and ments of others who successfully continue in stability, and disengagement from activities MAT. The consensus panel believes that a basic with others who use substances. A patient con- grounding in MAT pharmacology, the biology sidering dose tapering should understand that of addiction, and the endorphin system helps the chance of relapse to drug use remains patients and treatment providers understand (Magura and Rosenblum 2001) and some level that both successful tapering from and contin- of discomfort exists even if the dose is reduced ued compliance with medical maintenance slowly over months (Moolchan and Hoffman treatment are legitimate goals and commend- 1994). Patients should be assured that they able accomplishments. temporarily can halt the reductions or return to a previous methadone dosage if tapering causes problems. Relapse after tapering The risk of relapse during and after tapering is As medication is being tapered, intensified ser- significant because of the physical and emotion- vices should be provided, including counseling al stress of attempting to discontinue medica- and monitoring of patientsí behavioral and tion (Magura and Rosenblum 2001). The con- emotional conditions. Patients considered for sensus panel recommends that patients be medication tapering should demonstrate suffi- encouraged to discuss any difficulties they cient motivation to undertake this process, experience with tapering and readjustment so including acceptance of the need for increased that appropriate action can be taken to avoid counseling. Tapering from medication can be relapse. Patients should be persuaded to difficult, and patients should understand the return to a previous phase if the need is indi- advantages and disadvantages of both tapering cated at any time during tapering. Patients also from and continuing on medication mainte- should be told that they can taper at their own nance as they decide which path is best for rate, that successful tapering sometimes takes them. Exhibit 7-5 presents treatment issues many months, and that they can stop tapering during the tapering phase, strategies to address or increase their dosage at any time without a these issues, and indicators for return to a pre- sense of failure. Patients should be educated vious phase. about how to reenter MAT if they believe that relapse is imminent.

Phases of Treatment 117 Exhibit 7-5

Tapering Phase of MAT

Indications for Return to a Treatment Issue Strategies To Address Issue Previous Treatment Phase Alcohol and drug use ï Monitor use ï Relapse or concern about ï Increase drug testing relapse to opioid use ï Increase counseling support ï Positive drug test for an illicit substance Medical and mental ï Monitor compliance ï Unstable health issues health concerns ï Maintain communication with health care providers ï Continue education Vocational and educa- ï Monitor progress ï Instability tional needs ï Be available to address ï Loss of employment workplace problems Family issues ï Monitor family stability ï Instability ï Refer to family therapy as ï Death or loss of loved one needed ï Unstable housing Legal issues ï Monitor ongoing legal issues ï New criminal involvement ï Provide support as needed

Readjustment 3), which blocks opioid effects for 2 to 3 days in appropriate doses. Care must be taken Many patients who complete tapering from to initiate naltrexone well after tapering is opioid medication continue to need support completed to avoid precipitating withdrawal and assistance, especially during the first 3 to symptoms. Other patients might benefit from 12 months, to readjust to a lifestyle that is continued counseling to strengthen relapse free of both maintenance medication and prevention skills. Some patients might find the substances of abuse. During this period, treat- support of continued drug testing helpful after ment providers should focus on reinforcing tapering. Other recommended strategies patientsí coping and relapse prevention skills. include problemsolving counseling approaches, Patientsí primary goals should be to increase reinforcement of positive behaviors and atti- self-sufficiency and maintain balanced, stable, tudes, an open-door policy to maximize avail- and productive lifestyles. Participation in ability of counselors and providers, steps to 12-Step or other mutual-help groups is recom- strengthen patientsí own support systems, and mended as reliance on the OTP is gradually development of a relapse prevention plan, reduced. Motivated patients might be helped including how to return to MAT if necessary. by continued naltrexone therapy (see chapter

118 Chapter 7 Reversion to MAT return to a more intensive level of treatment if necessary for continuation of recovery. The consensus panel recommends that all patients attempting tapering be counseled that The panel recommends that appointments with a return to medication and a previous phase the OTP continue to be scheduled every 1 to 3 does not represent failure but simply that medi- months, although many programs prefer that cal maintenance is more appropriate for some patients in continuing care maintain at least patients in general and for others at particular monthly contact. Although many programs times in their lives. curtail this contact after 6 to 12 months, others maintain ongoing contact with patients to assist Indicators for transition them in maintaining their medication-free lifestyle. Some patients might not need Successful discontinuation of medication is a continuing-care services after tapering, prefer- key indicator for transition from the tapering ring instead a complete break from the OTP. phase to the continuing-care phase. Another Others might need more extensive continuing key indicator is a positive self-image as someone care, perhaps including referral to a non-MAT who feels and functions well without medica- outpatient program that more closely fits their tion. Adoption of a socially productive lifestyle needs. without involvement with substances of abuse also is critical to completing this phase and to continued recovery. The absence of signs and Transition Between symptoms of abuse or dependence, as defined by the Diagnostic and Statistical Manual of Treatment Phases in Mental Disorders, Fourth Edition, Text MAT Revision, (DSM-IV-TR) (American Psychiatric Association 2000) indicates successful comple- Characteristics of the recommended treatment tion of tapering. phases are not immutable, and the criteria for transition between phases are not intended to be rigidly interpreted or enforced. The treat- Continuing-Care Phase ment system should be flexible enough to allow Continuing care is the phase that follows suc- for transition according to a patientís progress cessful tapering and readjustment. Treatment and circumstances. The program should modify at this stage comprises ongoing medical fol- treatment based on the best interests of patients, lowup by a primary care physician, occasional rather than infractions of program rules. check-ins with an OTP counselor, and partici- Occasional relapses to drug use might not pation in recovery groups. Ongoing treatment, require that a patient return to the acute phase although less intense, often is necessary but instead that he or she receive intensified because the chronic nature of opioid addiction counseling, lose take-home privileges, or can mean continuous potential for relapse to receive a dosage adjustment. If a patient is in opioid abuse for some patients. the medical maintenance phase or the tapering Patients in continuing care should have a social- and readjustment phase, a relapse often ly productive lifestyle, no involvement with requires a rapid response and change of phase. drugs or problem involvement with alcohol, and In these cases, the patient might be reclassified improved coping skills demonstrated over at into the rehabilitative phase. After providing least 1 year. Significant co-occurring disorders evidence that problems are under control, the should be well under control. People in this patient might be able to return to the phase should continue to participate regularly supportive-care or medical maintenance phase. in mutual-help groups, but regular attendance at an OTP should be unnecessary, except to

Phases of Treatment 119 Readmission to the have close relationships with staff members, should not be allowed to inhibit patients from OTP seeking reentry to treatment. The consensus The consensus panel emphasizes that patients panel recommends that all patients be informed almost always should be encouraged to remain at entry to the OTP that subsequent reentry is in treatment at some level and that pharma- common and can be accomplished more quick- cotherapy should be reinstituted unreservedly ly than initial intake because regulations waive for most previously discharged patients if and documentation of past addiction for returning when relapse occurs or seems likely. Feelings of patients (42 CFR, Part 8 ß 12(e)(3)). All obsta- shame, disappointment, and relapse-related cles to reentry should be minimized. guilt, especially for rehabilitated patients who

120 Chapter 7 8 Approaches to Providing Comprehensive Care and Maximizing Patient Retention

A core group of basic- and extended-care services is essential to the effec- tiveness of medication-assisted treatment for opioid addiction (MAT) in In This opioid treatment programs (OTPs). Numerous studies support the belief that psychosocial interventions contribute to treatment retention and ChapterÖ compliance by addressing the social and behavioral problems and co- occurring disorders affecting patients in MAT (e.g., Brooner and Kidorf Core Services 2002; Joe et al. 2001). The consensus panel agrees that a well-planned Retaining Patients and well-supported comprehensive treatment program increases patient in MAT retention in MAT and the likelihood of positive treatment outcomes.

Counseling and Case Management, Core Services Behavioral Treatments, and Basic-Care Services Psychotherapy The minimum required services for MAT are outlined in Federal regula- Benefits of Family tions (42 Code of Federal Regulations [CFR], Part 8), but individual Involvement program requirements vary according to State standards, accreditation requirements, and local factors. The consensus panel recommends that Integrative OTPs offer at least the following services: Approaches ï Comprehensive psychosocial assessment (see chapter 4) Relapse Prevention ï Initial and yearly medical assessment (physical examination and labo- Referral to Social ratory testing [see chapter 10]) Services ï Medication dispensing (see chapter 5) Involuntary ï Drug tests (see chapter 9) Discharge From ï Identification of co-occurring disorders and neuropsychological prob- MAT lems (see chapter 12) Patient Advocacy ï Counseling to stop substance abuse and manage drug craving and urges ï Evaluation of and interventions to address family problems ï HIV and hepatitis C virus (HCV) testing, education, counseling, and referral for care ï Referral for additional services as needed.

121 Extended-Care Services Managers should provide an appropriate mix of staff for specific patient characteristics and Many patients in MAT have other problems needs and should determine the range of ser- affecting their recovery, including medical, vices that can be provided with available funds. social, family, vocational, and legal problems Unfunded services should be covered by refer- and co-occurring disorders. Assessing and ral to affiliated agencies. Positive, sustained addressing these problems are important to outcomes are more attainable in a therapeutic facilitate recovery from addiction. Various environment with readily available, supportive, strategies have been developed, including psy- qualified caregivers. It is difficult to provide chosocial and biomedical interventions and high-quality care and facilitate favorable treat- peer-support approaches. ment outcomes in a chaotic OTP environment with unqualified or overburdened staff and Managing an OTP To Meet managers and unreasonable caseloads. Service Needs Offsite treatment options Substances of abuse The consensus panel urges OTPs to provide as Increasingly since the 1980s, patients have many basic- and extended-care services as pos- entered OTPs with other addictions, particu- sible on site. OTPs that lack the resources to larly to alcohol, cocaine, marijuana, nicotine, provide or sponsor the comprehensive list of or other sedatives and stimulants. In addition, services recommended in this TIP should adolescent and young adult patients often engage in active case management while work- smoke or snort rather than inject heroin, and ing with other agencies and specialized service more patients are addicted to opioid analgesics, providers and educating these collaborators such as oxycodone, taken orally (see chapter about MAT. Accreditation requirements 11). To manage these developments, OTPs increasingly are motivating OTPs to pursue should evaluate and modify their core sub- these collaborations. stance abuse treatment services continuously, based on the changing needs of their patient populations. Retaining Patients in MAT Medical needs People addicted to opioids are at greater risk Importance of Retention for sexually transmitted diseases (STDs), pneu- Studies of patients who left MAT prematurely monia, and other debilitating conditions that have determined that length of retention was require intensive medical services. Infected the most important indicator of treatment out- injection sites, cellulitis, and abscesses are comes (e.g., Simpson, D.D., et al. 1997b). increasingly common. Bacterial endocarditis Patients who stayed in treatment a year or remains a concern. Long-term tobacco use con- longer abused substances less and were more tributes to other diseases. Chapter 10 details likely to engage in constructive activities and the medical problems of todayís patients in avoid criminal involvement than those who left MAT and the treatment approaches recom- treatment earlier, although all patients benefit- mended in OTPs. ed from treatment, for instance, through less exposure to and transmission of infectious dis- Staffing needs eases (Hartel and Schoenbaum 1998). Their communities benefited as well. Program administrators need to develop comprehensive patient population profiles for planning, staffing, and resource allocation.

122 Chapter 8 Improving Patient Retention Clarify program goals and treatment plans. Treatment providers should explain program Factors affecting patient goals and treatment plans to every patient. retention Inconsistent messages adversely affect patient retention, particular- Patient characteristics, behavior, and other ly when these mes- factors unrelated to treatment have been found sages are about the to contribute relatively little to retention in advisability of MAT. One comprehensive study found that remaining in MAT [R]etention was retention was determined almost entirely by versus tapering from what happened during treatment, not before, medication (Magura determined almost although two factors, older age and less and Rosenblum involvement with the criminal justice system, 2001). Goals related entirely by what predicted longer retention (Magura et al. 1998, to medication should 1999). Another factor found to affect retention be individualized and happened during was motivation or readiness for treatment (Joe respectful of patientís et al. 1998). wishes and goals, but treatment, not they should incorpo- In other studies, how patients entered OTPs, rate knowledge and whether voluntarily or by a court referral, did research about reten- before... not affect treatment retention (Brooner et al. tion in MAT. 1998; Fallon 2001). Rhoades and colleagues Treatment planners (1998) reported that patients who previously should realize that, received methadone were more likely to remain regardless of OTP recommendations, some in MAT than first-time patients. Some patients patients want to taper from maintenance medi- require several attempts at treatment before cation more quickly than seems advisable. Staff becoming stabilized for extended periods should work with these patients to achieve their (Koester et al. 1999). OTPs should not consider goals in a reasonable timeframe. patientsí prior failures indicative of future compliance or retention or use these failures as OTP practices and communication with reasons to reject those seeking readmission. patients should conform to best treatment prac- Some patients may need longer periods of tices. Setting maximum lengths of stay for all adjustment to MAT before making a long-term patients or emphasizing low-dose medication commitment. goals can discourage retention and produce poor outcomes (Magura and Rosenblum 2001). Recommended steps to Rigid operating practices (e.g., requiring improve patient retention extensive travel, inconvenient hours, long waits, frequent pickups) may lower retention Individualize medication dosages. Adequate, and disrupt treatment. Patients have cited individualized medication dosages are probably other factors that discourage retention, such as the most important factor in patient retention staff insensitivity, lack of treatment skills and (Joseph et al. 2000) because they contribute to knowledge, and limited contact. patient comfort and satisfaction by reducing withdrawal symptoms and craving and enabling Simplify the entry process. Shortening more attention to other concerns (reviewed in intake results in better program retention (see Leavitt et al. 2000; Strain et al. 1999). (See chapter 4). chapter 5 for further discussion of prescribing Attend to patients’ financial needs. Patientsí practices in MAT.) inability to pay may limit both treatment entry and retention, especially in States where MAT

Providing Comprehensive Care and Maximizing Patient Retention 123 is not covered by Medicaid, State funds, or pri- OTP administrators increased patient retention vate insurance. One study found that randomly (Magura et al. 1999). Some treatment providers offering prospective patients either cost-free have found that patients are more likely to treatment or moderate fee rates significantly remain in treatment when they are involved in increased treatment entry and retention for the its planning and management. Increased inter- cost-free patients (Kwiatkowski et al. 2000). action with staff increases communication and OTP staff members should work proactively information flow, limits problems, and con- with patients to apply for benefits covering tributes to patientsí sense of well-being. treatment costs, investigate health insurance Unfortunately, funding constraints often and work with existing insurers, and develop reduce communication training for staff and hardship payment plans. opportunities to improve patient-to-staff ratios. Reduce the atten- Improve staff knowledge and attitudes about dance burden. MAT. OTP staff members should understand Attendance require- MAT and appreciate the wealth of science sup- Staff members ments can exert pow- porting it, and they should be aware of recom- erful effects on mended treatment practices so that they can should express retention. Rhoades interact effectively and constructively with and colleagues patients. However, Bell (2000) pointed to stud- confidence in (1998) found that ies showing that staff training, favorable patients who were patient-to-staff ratios, and better facilities did MAT when com- required to visit an not eliminate opioid abuse, and he concluded OTP less frequently that staff attitudes contributed more directly to municating with were less likely to outcomes. Staff members should express confi- drop out of treat- dence in MAT when communicating with patients. ment and no more patients. Attitudes critical of extended pharma- likely to use other cotherapy have been found to be common (even drugs than patients dominant) among many counselors (Kang et al. on a daily atten- 1997) and evoke frequent patient complaints. dance schedule. Provide useful treatment services as early as Counseling and Case possible. Patients were more likely to stay in treatment when they were motivated strongly Management, and engaged earlier in useful activities Behavioral Treatments, (Simpson, D.D., et al. 1997b). In the critical first 90 days of treatment, higher service inten- and Psychotherapy sities, especially for practical services that helped patients achieve basic goals, have been Counseling and Case associated with higher retention. Examples Management include attentive case management, psychiatric services, introduction to peer groups, and Patient counseling in individual, family, or assistance with insurance, transportation, and group sessions offers a venue for many treat- housing (Grella and Wugalter 1997). ment approaches and educational interven- tions. It provides support for a substance-free Enhance staff–patient interactions. Good staff lifestyle and abstinence from substances of attitudes and interactions with patients have abuse. Studies have found that OTPs providing been associated with higher retention. In one regular, structured, substance abuse-focused study, patientsí frequent contact with staff counseling had better outcomes than OTPs members and the involvement and visibility of providing little or no counseling (Kidorf et al.

124 Chapter 8 1999; Magura et al. 1999). Others have first weeks of treatment. Usually, individual concluded that good counseling rapport was sessions during the acute phase (see chapter 7) related to improved abstinence and reductions are more intensive than those that follow, in criminality (e.g., Joe et al. 2001). although individual needs should dictate the frequency and duration of counseling. The consensus panel recommends that counsel- ing in MAT focus on Individual counseling ï Providing support and guidance, especially to As MAT progresses, patients should continue eliminate substance use meeting with counselors in individual sessions, ï Monitoring other problematic behaviors once per month to several times per week ï Helping patients comply with OTP rules depending on need, the phase of treatment, and State regulations. In some States, Medicaid ï Identifying problems that need extended ser- regulations and contracts require or limit coun- vices and referring patients for these services seling frequency. MAT counselors should con- ï Identifying and removing barriers to full tinue to identify patientsí needs and refer them treatment participation and retention to or arrange for other services (e.g., housing, ï Providing motivational enhancement for medical and psychiatric care, legal services). positive changes in lifestyle. A typical individual counseling session, as envi- The standard components of substance abuse sioned by the consensus panel, might include counseling should include any of the following activities:

ï Assistance in locating and joining mutual-help ï Reviewing how a patient feels, is coping with groups or peer support groups such as cravings, or is changing his or her lifestyle Narcotics Anonymous (NA) or Methadone ï Reviewing drug test results and what they Anonymous (MA) mean ï Education about addiction and the effects of ï Identifying emergencies and deciding how to substances of abuse address them ï Education about relapse prevention strategies ï Reviewing the treatment plan ï Identification of unexpected problems need- ï Identifying measurable goals and reasonable ing attention, such as sudden homelessness timeframes ï Assistance in complying with program rules ï Reviewing progress in achieving goals, includ- and regulations ing abstinence and related behaviors ï Information about stress- and time- ï Discussing dosage and take-home medications management techniques ï Discussing legal concerns, such as reporting ï Assistance in developing a healthy lifestyle to probation officers and complying with the involving exercise, good nutrition, smoking terms of probation or parole cessation, and avoidance of risky sexual ï Discussing family concerns practices ï Providing liaison services (e.g., with physi- ï Assistance in joining socially constructive cians, courts, social service agencies) groups such as community organizations and faith-based groups ï Addressing routine issues (e.g., transporta- tion, childcare). ï Continuing education on health issues (partic- ularly HIV/AIDS and hepatitis). Medical staff should educate counselors about patientsí medical problems so that counselors Counseling sessions to relieve patientsí anxiety can help patients understand the importance of about MAT and reassure them about its effica- keeping appointments for and complying with cy are of paramount importance during the

Providing Comprehensive Care and Maximizing Patient Retention 125 medical treatment. Counselors should convey ï Support groups, which buoy members and observations to medical staff about patientsí provide a forum to share pragmatic informa- conditions and information about other aspects tion about maintaining abstinence and man- of patientsí lives that might clarify health prob- aging a day-to-day substance-free lifestyle. lems. Although counselors are not expected to understand medical treatments, pathophysiolo- In some OTPs, group membership is linked to gy, or pharmacotherapy in the same way as the phase of a patientís treatment. Some groups medical professionals do, they should have gen- keep the same membership but stay together eral knowledge of common medical conditions for a short time; others are longer term and affecting patients in MAT and their treat- have a rolling membershipóthat is, frequent mentsóespecially how treatments for these membership changes, with new members conditions can interact with addiction treat- entering when they are ready. Neither type of ment medications. Counselors can help patients group needs a predetermined end point or set cope with hepatitis C and adhere to its treat- timeframe. Using a manual with a structured ment regimens. Many patients have been curriculum enables counselors and other staff exposed to HCV infection (see chapter 10), and members to lead some groups (Exhibit 8-1). effective treatment requires motivation and Manuals increase flexibility in resource-limited support from the entire treatment team. OTPs and the likelihood that groups cover standard information. Manuals for group counseling in MAT are less common than for Group counseling general substance abuse counseling. However, Group counseling has some advantages over the consensus panel believes that the principles individual counseling and therapy (see TIP 41, used for non-MAT groups can be adapted Substance Abuse Treatment: Group Therapy easily to groups in MAT. [CSAT 2005c]). It can reduce patientsí sense of isolation and help them cope with addiction Some patients resist group counseling and and other life problems by providing feedback avoid sessions. Offering smaller groups might from peers, social skill training and practice, ease their concerns while therapists explore the structure, discipline, and encouragement. reasons for their resistance (e.g., fear of talking Through peer interaction, patients contribute in groups or confidentiality concerns). In gen- to one anotherís recovery. Trained individuals eral, an OTP should consider a groupís patient should lead these groups. Some State agencies mix. Some patients with co-occurring disorders offer courses in group process and dynamics. do better in groups with members who have similar conditions. However, some patients The following types of groups are used com- with severe co-occurring disorders cannot par- monly in MAT: ticipate in groups, and some have problems that require individual counseling. ï Psychoeducational groups ï Skill development groups, such as relapse A patientís gender or sexual orientation can be prevention, stress management, and sub- important in choosing individual or group stance use cessation groups, which help counseling. Some women are uncomfortable in patients learn skills to attain and maintain male-dominated groups and do better in abstinence women-only groups. Others feel embarrassed about personal subjects related to their addic- ï Cognitive behavioral groups, in which tion. Gay men, lesbians, and bisexuals might patients learn to alter pervasive thoughts and feel isolated in predominantly heterosexual actions groups. In such cases, the consensus panel ï Interpersonal-process groups, which delve recommends individual, women-only, or into developmental issues contributing to sexual-orientation-specific groups. addiction or interfering with recovery

126 Chapter 8 Exhibit 8-1

Resource Materials for Psychoeducational, Skill-Building, and Group Counseling Sessions

ï Anger Management for Substance Abuse and Mental Health Clients: A Cognitive Behavioral Therapy Manual (Reilly and Shopshire 2002) ï Anger Management for Substance Abuse and Mental Health Clients: Participant Workbook (Reilly et al. 2002) ï Cognitive-Behavioral Coping Skills Therapy Manual (Kadden et al. 1992) ï Cognitive Therapy of Substance Abuse (Beck et al. 1993) ï A Family Like Yours: Breaking the Patterns of Drug Abuse (Sorensen and Bernal 1986) ï National Institute on Drug Abuseís Therapy Manuals for Drug Addiction Series (www.drugabuse.gov) ï Recovery Training and Self-Help: Relapse Prevention and Aftercare for Drug Addicts (National Institute on Drug Abuse 1993b) ï Relapse Prevention Workbook for Recovering Alcoholics and Drug-Dependent Persons (Daley 2002) ï Seeking Safety: A Treatment Manual for PTSD and Substance Abuse (Najavits 2002) ï ìSupportive-expressive dynamic psychotherapy of opiate drug dependenceî (Luborsky et al. 1995) ï Treatment of Opioid Addiction With Methadone: A Counselorís Manual (McCann et al. 1994)

Social services case none of these services. The authors concluded management that social service-focused case management was an important and effective adjunct to Some researchers have investigated the useful- addiction treatment. ness of social service-focused case management in addiction treatment settings such as OTPs. McLellan and coworkers (1999) described a Cognitive and Behavioral system with an active case management compo- Therapies nent to help patients access services for hous- Other interventions, both in use and under ing, medical care, and legal and parenting study, include cognitive-enhanced techniques to assistance. Six months after the systemís imple- increase treatment participation, modify mentation, patients receiving these services behavior, and address patientsí social, emo- showed greater reduction in alcohol use and tional, and behavioral problems, as well as any improvement in medical conditions, family co-occurring disorders. Behavioral treatments relations, and legal status than patients receiving such as contingency management (see below),

Providing Comprehensive Care and Maximizing Patient Retention 127 in which patients enter into agreements that Community reinforcement provide positive incentives for treatment approach compliance, have been especially effective in MAT (see Brooner and Kidorf 2002; Robles et The community reinforcement approach al. 1999). (CRA), originally developed to treat alco- holism, is another effective model for MAT. Behavioral treatments in MAT are derived This multicomponent treatment facilitates from principles of cognitive learning and change in a patientís daily environment. CRA behavioral change developed by psychologists counselors work with patients to identify and behavior scientists. The consensus panel aspects of their lives that reinforce abstinence believes that substance abuse and addiction and to understand how these reinforcers can involve major learning elements and are influ- serve as alternatives to substance use. CRA has enced by patientsí environments and circum- been found to reduce opioid use and produce stances. Many elements of cognitive behavioral other positive outcomes either with or without therapy (CBT)ófor example, emphases on voucher-based incentives (Abbott et al. 2003; identifying high-risk circumstances that may Higgins and Abbott 2001). trigger an event and developing coping re- sponsesóare accepted and incorporated widely Contingency management into substance abuse education and counseling (Ryan 2002). CBT is associated with increased Contingency management reinforces desired treatment compliance and improved treatment behavior with immediate incentives (Griffith et outcomes. al. 2000). Its efficacy has been demonstrated in several well-designed studies (e.g., Rawson et Node-link mapping al. 2002; Robles et al. 1999). Incentives were found to increase such desirable outcomes in Node-link mapping is a cognitive-enhanced MAT as negative drug tests, attendance at technique that uses flowcharts and other visual counseling and medical appointments, working, aids to diagram relationships between patientsí and volunteering. This approach is useful for thoughts, actions, and feelings and their sub- treatment planning because it sets concrete stance use and to increase patient participation goals and emphasizes positive behavioral in counseling (Czuchry and Dansereau 2003). changes. Exhibit 8-2 summarizes this strategy Studies have found that node-link mapping in MAT. encouraged communication about topics such as family, job, and substance use (Dees et al. The consensus panel emphasizes that effective 1997; Pitre et al. 1997) and improved partici- contingencies usually involve positive reinforce- pantsí motivation, self-esteem, and rapport ment. Positive contingencies or rewards are with counselors. Patients with poor attention more effective than negative, punishing contin- stamina were found to have greater success in gencies or threats (Gruber et al. 2000). mapping-enhanced counseling than in standard Negative consequences tend to drive patients counseling (Czuchry and Dansereau 2003). from treatment. In one study, a balance of posi- Less educated patients exposed to mapping- tive and negative , as part of a enhanced counseling also had better 12-month well-constructed contingency management followups than those in standard counseling plan, helped patients reduce their drug use (Pitre et al. 1996). According to Dansereau and (Crowley 1999). Tangible rewards, such as colleagues, ìThe use of node-link mapping take-home medication privileges, should be appears to reduce cultural, racial, and class paired with social reinforcements, such as barriers by providing a visual supplement and praise from the counselor or other patients, to a common language that enhances counselorñ optimize their value. client interchangesî (Dansereau et al. 1996, p. 363).

128 Chapter 8 Exhibit 8-2

Strategy for Contingency Management in MAT

ï Pick a target behavior that can be measured easily (e.g., stopping opioid abuse). ï Select a reward that can be given as soon as the desired behavior (e.g., three con- secutive negative drug test results) is documented. The reward should be non- monetary (e.g., nonrefundable movie passes, take-home medication privileges). ï Specify the link between targeted behavior and the reward. For example, a nega- tive drug test result might earn one take-home medication dose (other treatment and program variables must be taken into account, including Federal and State regulations). ï Put the contract in writing, specifying its duration and any changes over time in contingencies (e.g., after 3 substance-free weeks, the patient can receive take- home privileges).

A popular, effective reward in OTPs is the whose anxiety blocked the benefits of contingen- medication take-home privilege (Chutuape et cy incentives alone. When combined with pro- al. 1998). Other incentives may include special gressive muscle relaxation and desensitization, scheduling for medication administration, meal contingency management had a demonstrated vouchers, gift certificates, entertainment tick- record of effectiveness, whereas systematic ets, or toys for patientsí children. Designing desensitization alone was less effective in such programs requires significant effort, yet eliminating opioid use but reduced fear of with- the rewards can add an important dimension to drawal and general anxiety (Piane 2000). MAT. Kidorf and colleagues (1997, 1998, 1999) demonstrated the effectiveness of behavior- Brooner and Kidorf (2002) described a pro- contingent incentives in OTPs. They used gram of motivational stepped-care levels in take-home medication privileges to increase which clear contingencies were matched with the involvement of significant others and treatment responses. Patients who responded improve patientsí job acquisition. They also poorly were moved to a more intensive level of used behavior-contingent treatment availability care. Those who responded well received less to improve drug test results and counseling intensive care. The authors concluded that this attendance. approach increased treatment participation and that a stepped-care system was effective To be most effective, behavior contingencies and cost sensitive. In another study comparing should be defined clearly and implemented con- contingency vouchers (which had monetary sistently. Contingencies may be individualized value and were exchangeable for goods and ser- based on each patientís targeted areas of vices) with methadone dosage increases, both behavioral change or implemented on a uni- incentives increased negative drug test results, form, programwide basis. Tailoring behavioral but only contingency vouchers increased dura- contingencies to patientsí needs has been found tions of drug abstinence (Preston et al. 2000). to work better (Silverman et al. 1999). Piane Dosage increases should be based on evidence (2000) effectively combined contingency incen- of withdrawal symptoms and other medical tives with systematic desensitization for patients assessments, not good behavior.

Providing Comprehensive Care and Maximizing Patient Retention 129 The consensus panel emphasizes that, when to resolve chronic psychological and social contingency management is used to control use problems. of short-acting drugs, objective measures should provide the basis for withholding incen- Research has shown that psychotherapeutic tives. Testing frequency (both randomly and, interventions enhance the efficacy of MAT ó when feasible, regularly at least once per week) particularly for patients with co-occurring dis- must be adequate to detect short-acting drugs. orders who show little response to counseling (See chapter 9 for a complete discussion of alone (OíBrien et al. 1995; Woody et al. 1995b). drug testing.) Patients in MAT who have benefited from psy- chotherapy include those whose anxiety or depression required more than routine, Motivational enhancement behavior-oriented counseling. Several authors Motivational enhancement has emerged as a have described effective psychotherapeutic component of counseling in MAT, although the approaches for these patients (reviewed by effectiveness of motivational interviewing in Woody [2003]). MAT needs more investigation. One study (Saunders et al. 1995) found that brief motiva- Because many patients are unstable during the tional intervention improved outcomes in MAT. acute phase of MAT, providers usually delay Patients in this study demonstrated greater psychotherapy until later in the acute phase or commitment to abstinence, reported more in the rehabilitative phase, but views differ on positive outcomes and fewer opioid-related when psychotherapy is appropriate. The con- problems, and relapsed less quickly or fre- sensus panel believes that psychotherapy has quently than did the control group. an important role in MAT but that it usually Motivational enhancement interventions influ- should be deferred until patients are stabilized. ence patients to give up secondary substances Exhibit 8-3 summarizes consensus panel recom- of abuse, address health issues, and change mendations for psychotherapy in MAT. their social circumstances. TIP 35, Enhancing Motivation for Change in Substance Abuse Staff qualifications Treatment (CSAT 1999a), provides a thorough Staff members responsible for psychotherapy discussion of motivational therapy. Another should have more specialized training than valuable guide is Motivational Interviewing: those responsible for drug-focused counseling. Preparing People for Change (Miller and Psychotherapists should possess advanced Rollnick 2002). degrees and undergo supervised training. If OTPs lack staff or resources for psychotherapy, Psychotherapy patients should be referred elsewhere. OTPs should verify and document the degrees and Psychotherapy is a form of verbal-expressive licensure of those providing psychotherapeutic therapy in which a trained therapist uses services. psychological principles to modify or remove problematic thoughts, feelings, and behaviors (Kidorf et al. 1999). Whereas counseling focuses Group psychotherapy on the here-and-now, decisionmaking, values, Group psychotherapy and group counseling self-concept, strengths, and goal setting, psy- with an interpersonal, process, or psychody- chotherapy focuses on changes in personality, namic focus can be effective interventions in and psychoanalytic psychotherapy attends to MAT. These groups should be flexibly struc- the subconscious. Both counseling and psy- tured and focus on interpersonal-relationship chotherapy can be short term and solution building, self-insight, reflection, and discussion directed, but psychotherapy more often is used (Vannicelli 1992). Patients should be selected carefully for these groups and should be able to

130 Chapter 8 Exhibit 8-3

Common Strategies for Psychotherapy in MAT

ï Devote part of each session to addressing patientsí most recent successes and fail- ures regarding their substance use. ï Adopt a more active therapist role than typically required for co-occurring disorders. ï Strengthen patientsí resolve to stop substance use (help them visualize or recall life without drugs to replace memories of enjoyable drug use). ï Teach patients to recognize warning signs of relapse and develop coping skills. ï Support patientsí rearranging priorities so that they are not preoccupied with substance use. This might involve their acquiring job skills, developing hobbies, or rebuilding relationships. ï Assist patients in managing painful affects. (From a psychodynamic approach, this involves exploring the causes of such feelings.) ï Help patients enhance interpersonal functioning and social supports so that the rewards of friendship and relationships replace those of substance use. ï Use psychotherapy only after a strong therapeutic alliance has developed with the patient or other supportive structures are in place to guard against relapse.

commit to the process. Group treatment can treatment of sexual abuse for patients during provide a sense that individuals are not alone substance abuse treatment. in addressing problems, even serious ones. Such normalization is often a first step toward Counseling for HIV/AIDS and feeling less isolated and developing new coping strategies. (For a thorough presentation of hepatitis C group therapy in substance abuse treatment, Counseling about the increased risks of HIV see TIP 41, Substance Abuse Treatment: and HCV infection arising from drug injection Group Therapy [CSAT 2005c].) and risky sexual behavior is essential for patients in MAT. TIP 37, Substance Abuse Treatment for Persons With HIV/AIDS (CSAT Other Topics 2000e), thoroughly examines HIV education, which is mandatory for MAT in some States. Effects of sexual abuse Many States require that patients receive spe- The consensus panel recommends specialized cialized HIV counseling before and after they training for counselors and therapists treating receive HIV antibody tests and require that patients who have been sexually abused or patients be encouraged to ask questions about referral of these patients to qualified mental HIV. Pretest HIV counseling should be factual health care providers. TIP 36, Substance and medically based. For patients who test neg- Abuse Treatment for Persons With Child Abuse ative for HIV, posttest counseling should and Neglect Issues (CSAT 2000d), includes address how they can reduce infection risk. information about the effects, symptoms, and Patients with positive HIV test results need

Providing Comprehensive Care and Maximizing Patient Retention 131 referrals for medical care and counseling about when used with other treatment approaches, what the tests mean, coping with problems and increase a patientís ability to function indepen- issues raised by the results, treatment options, dently and meet his or her daily needs outside participation in clinical trials if available, the OTP. Exhibit 8-4 summarizes strategies for support groups, and behaviors to prevent psychoeducation in MAT. infecting others or contracting another HIV strain. Rapid HIV tests have been approved by Recovery Training and Self-Help: Relapse the Food and Drug Administration and are rec- Prevention and Aftercare for Drug Addicts ommended by the U.S. Public Health Service (National Institute on Drug Abuse 1993b) pro- for point-of-care diagnosis of HIV infection in vides educational and public health perspec- settings such as OTPs (see chapter 4). If an tives and educational discussions adaptable to OTP cannot provide onsite testing and coun- MAT. A helpful, straightforward handbook for seling, it should develop referral relationships patients is About Methadone (Lindesmith for outside diagnosis and treatment. The con- Center-Drug Policy Foundation 2000). sensus panel recommends onsite counseling Common topics in patient educational sessions whenever possible. (For further discussion, see include chapter 10.) ï Physical and psychological effects of opioid Coping with patients and other substance abuse who resist counseling and ï Health education information, including med- ical problems related to addiction, smoking psychotherapy cessation, improving nutritional habits Some patients resist counseling, psychotherapy, (including special needs of persons with and other treatments out of fear and distrust. HIV), and exercise, including aerobic and They may perceive that proposed treatments meditative exercises (e.g., yoga) will not meet their needs, or they find staff ï Effects of drug use on family and other insensitive or uneducated. Some patients may relations begin MAT to address other aspects of their lives rather than to stop substance use. Others ï Introduction to mutual-help groups such as have been pressured into MAT by the courts. MA Strategies to engage these patients in treatment ï Effects and side effects of addiction treatment are described in chapter 6. medications and interactions with other drugs Patient Education and ï Symptoms of co-occurring disorders ï Compulsive behaviors besides substance Psychoeducation abuse (e.g., gambling, sexual behaviors) Patient education and psychoeducation are use- ï Skills to attain and sustain abstinence, ful in comprehensive MAT and can be per- such as anger management and coping with formed in group or individual sessions. Both cravings types of education may involve presenting infor- mation about substance abuse and addiction to ï Developing nonñdrug-related leisure activities patients alone, in groups, or with their families. ï Stress management and relaxation Psychoeducation addresses the full range of ï Communication skills and assertiveness patient needs, including education, personal training development, recreation, health, and vocational ï Time management or relationship needs (Stark and Campbell 1991), while addressing patient attitudes and ï Parenting skills feelings to ensure that a message is understood ï Avoidance of STDs and promotion of and internalized. Psychoeducational models, responsible sexual behavior

132 Chapter 8 Exhibit 8-4

Strategies for Psychoeducation in MAT

ï Introduce psychoeducation at the beginning of treatment so that it serves as an orientation to both OTP operational and recovery processes. ï Involve family members and selected friends, with a patientís informed consent. Provide guidance in how to support the patientís recovery efforts. ï Adapt educational strategies and materials to the patientís culture and family. ï Discuss methadone and other treatment medications, and dispel the myths relat- ed to their use (e.g., ìmethadone rots the bones,î ìitís impossible to get off methadoneî). ï Discuss the implications of continuing substance abuse. Question assumptions about alcohol and drug use, and clarify that such use undermines recovery. ï Discuss sexual behaviors that may affect relapse, including exchanging sex for drugs, drug use to function sexually or enhance sex, sexual abstinence, and inti- macy or sex while substance free. ï Discuss the power of triggers with patients and families. For example, merely discussing heroin can be a trigger for resuming its use. ï Incorporate special groups to discuss parenting, childcare, womenís issues, and coping with HIV/AIDS and HCV infection. Use generic names for HIV/AIDS groups (e.g., ìhealth care issuesî group) to avoid stigma.

ï Vocational planning and employment (some- Types of Family Interventions times linked with cognitive testing and Family involvement usually takes the form of conducted with vocational agencies). family counseling or family education. Some OTPs hold short family education sessions Benefits of Family about MAT, substance use disorders and their effects on the family, and family dynamics. Involvement Holding sessions for several families can be cost The consensus panel believes that family effective, supportive, and mutually beneficial. involvement in treatment provides strong Family counseling usually consists of one or support for patient recovery and that family more discussion sessions that provide informa- members also benefit. The concept of ìfamilyî tion and allow participants to express their feel- should be expanded to include members of the ings and concerns. Some OTPs have monthly patientís social network (as defined by the family nights or informal gatherings for ongoing patient), including significant others, clergy, communications between patient families and resource people from the community, and others. counselors. These continuing forums help secure family support for patient treatment and identify acute family problems needing focused therapy.

Providing Comprehensive Care and Maximizing Patient Retention 133 The consensus panel recommends that, because Few OTPs are equipped to address the needs of complex factors affect patientsí families, family children whose family members abuse opioids therapy should be provided only by trained (Dawe et al. 2000). Nunes and colleagues (1998b) staff and reserved for families with serious recommended that treatment providers ask problems with behaviors or attitudes that about the mental health and adjustment of contribute to patientsí addictions, which, if patientsí children and consider routine psychi- unchecked, might affect recovery. Because atric screening and early intervention and many OTPs do not provide family therapy, treatment for these children. Dawe and referrals to community-based services often are colleagues (2000) reported improved needed, and the consensus panel urges that parentñchild relations and positive outcomes such connections be established. Family therapy for children with conduct problems after may be more effective for some patients than behavioral training that provided their parents individual counseling, group therapy, or family with improved parenting techniques. psychoeducation (Stanton and Shadish 1997). TIP 39, Substance Abuse Treatment and Family Therapy (CSAT 2004c), provides Parenting Groups more information. Many patients entering OTPs are in danger of losing custody of their children or already have lost custody. Some patients in MAT might have Children of Patients in MAT separate agreements with childrenís protective Many children of patients in MAT have services (CPS) agencies about what they must emotional and cognitive problems. They are do to keep or regain custody of their children. more vulnerable to physical and sexual abuse OTPs should treat these patients with respect and neglect and may exhibit more behavioral and avoid displaying negative feelings about problems, substance use, criminal involvement, their involvement with CPS agencies. In cases conduct problems, and other social and intel- in which child custody is at issue, the consensus lectual impairments than other children (CSAT panel recommends that, once these patients are 2000d; Dawe et al. 2000). Child assessment stable, treatment focus on concerns about cus- requires trained personnel and may be unreal- tody, children, and parenting. Parenting istic for some OTPs. OTPs can make referrals groups are one useful approach. to appropriate resources and are encouraged to provide parenting support groups, skill devel- Some parenting groups are educational, opment groups, family therapy, or referral for addressing topics such as interacting with CPS child and family therapy (Juliana and agencies, resource availability, daycare ser- Goodman 1997). vices, and breast-feeding during MAT. Skill- building groups for parents in MAT often Counselors should be aware of reporting address process issues, such as setting limits, requirements in their State, and patients appropriate and consistent discipline, divorce, should be advised that confidentiality protec- visitation, noncustodial parenting, and tending tions do not apply if a patient must be reported to sick children. to authorities for child abuse or neglect (see CSAT 2004b). A counselor who determines that Psychodynamic parenting groups take a more a patient is neglecting or abusing young children intensive approach, exploring topics such as is required to report the neglect or abuse. ambivalence about losing child custody, fear of Licensed professional staff members (physi- parenting, and coping with anger, shame, or cians, psychologists, nurses, social workers) are guilt. OTPs should develop parenting groups mandated to report child neglect and abuse. In based on the needs expressed by patients. some States, any person who observes this situ- ation is required by law (42 CFR, Part 2 ß 22) to report it to local authorities (CSAT 2000d).

134 Chapter 8 Domestic Violence the community. Peer support, or mutual-help, programs are the most common such resources Men and women in MAT may be victims of (Chappel and DuPont 1999). OTPs offering domestic violence. It is estimated that at least comprehensive treatment should have the three-quarters of women in MAT experienced flexibility and resources to integrate available, partner violence (El-Bassel et al. 2000, 2001). beneficial services from the community. Counselors should incorporate appropriate assessment procedures, referrals, or treatment responses for violence. They might have to help Peer Support, or Mutual-Help, patients remove themselves from dangerous situ- Programs ations. Counselors should have a broad view of domestic violence that includes female (to male) The most popular, widely used mutual-help aggression, same-sex physical and emotional models are 12-Step recovery programs, such abuse, and issues related to elder abuse. TIP 25, as Alcoholics Anonymous (AA), NA, MA, and Substance Abuse Treatment and Domestic Cocaine Anonymous (CA), which have been Violence (CSAT 1997b), provides a detailed dis- effective in helping people remain abstinent cussion of this subject. Because many patients from substances and can be important augmen- are in domestic violence situations, OTPs should tations to therapy. They are sources for social provide general didactic groups or seminars and support, peer identification, relapse preven- other resources addressing domestic violence. tion, and treatment reinforcement, and they Treatment resources for victims should be provide role models for successful recovery integral parts of treatment strategies. (Chappel and DuPont 1999). Members of sup- port groups gain strength and security from others who understand and share their con- Integrative cerns and who offer practical strategies for surviving ìone day at a time.î McAuliffe (1990) Approaches saw peer support groups as providing the long- Integrative approaches to MAT complement term support necessary to reinforce addiction and enhance OTP efforts with resources from recovery. His program, Recovery Training and

Conflict Between MAT and Some Mutual-Help Programs

Because 12-Step and other mutual-help programs vary widely in attitudes toward medica- tions and some are particularly negative about opioid pharmacotherapy, many patients in MAT feel uncomfortable attending meetings for fear of criticism. If they do attend, some try to hide their participation in MAT (Nurco et al. 1991), and some insist on group acceptance of MAT. Some patients, unable to handle rejection, have chosen not to return, others have chosen prematurely to taper from maintenance medication, and some have used this diffi- culty as justification to self-medicate. Therefore, a decision to encourage patient participa- tion entails some risk. MA groups emerged largely in response to the discrimination per- ceived by patients in MAT from other 12-Step programs. MA has chapters in most States. OTPs lacking an MA group are encouraged to start one. For information, contact the National Alliance of Methadone Advocates (212-595-6262 or www.methadone.org).

Providing Comprehensive Care and Maximizing Patient Retention 135 Self-Help (RTSH), helps people become part of ï Dual Disorders Anonymous a recovery community. He found that partici- ï Dual Recovery Anonymous, pants in RTSH were less likely than controls to www.draonline.org relapse to opioid use, and there were favorable ï Families Anonymous, effects on employment and criminal behavior. www.familiesanonymous.org More information on the above programs is ï Women for Sobriety, available on the World Wide Web: www.womenforsobriety.org ï AA, www.alcoholics-anonymous.org ï Secular Organizations for Sobriety (SOS), www.cfiwest.org/sos ï NA, www.na.org ï SMART Recovery Self-Help Network (Self- ï MA, www.methadonetoday.org Management and Recovery Training), ï CA, www.ca.org www.smartrecovery.org. ï RTSH, www.smartrecovery.org. Other Approaches Decreases in substance abuse among group participants have been associated with attend- In acupuncture, thin needles are inserted ing meetings frequently, obtaining a sponsor, subcutaneously at points on the body for thera- ìworkingî the 12 Steps, and leading meetings peutic purposes. Some believe that acupunc- (American Psychiatric Association 1995, 1996; ture can relieve pain, anxiety, and withdrawal Landry 1997). However, 12-Step groups are symptoms related to substance abuse, although not for everyone. Some groups do not support little empirical evidence exists. Some patients MAT, and many advocate an approach that appear to benefit from acupuncture as an may conflict with a patientís personal beliefs. adjunct to MAT. Its use to treat opioid with- Patients should not be pressured to attend sup- drawal was first reported in 1973. Efficacy, in port groups. Rather, an OTP staff member that case, remained unclear, owing in part to should explain that participation has helped study design limitations (Alling et al. 1990). many patients. Resistance to attendance should However, a National Institutes of Health be discussed and respected. Every effort consensus statement lists addiction as one con- should be made to help a patient find an dition for which acupuncture treatment might appropriate peer support program. Many cre- be useful. Although the mechanism of acupunc- ative strategies have evolved to promote ture is not understood, some researchers have mutual-help programs, such as simulated meet- focused on the analgesic effects of opioid pep- ings to introduce patients to the language, cus- tides released during the procedure (National toms, and rules of groups. Institutes of Health 1997a). Other approaches to self-help and peer support Other Support Groups that might be integrated with MAT include meditation classes; exercise programs; classes Groups also exist for friends and relatives of in diet, nutrition, and health; and trauma persons in recovery (e.g., Nar-Anon) and of groups. More research is needed on the bene- others who refuse treatment. The following fits of these activities and treatments in MAT. groups offer support and teach participants to curb their destructive behaviors:

ï Chemically Dependent Anonymous, Relapse Prevention www.cdaweb.org Because opioid addiction is a chronic relapsing ï Cocaine Anonymous, www.ca.org disease, the consensus panel recommends that strategies specifically directed at relapse pre- ï Double Trouble in Recovery, vention be an important part of comprehensive www.doubletroubleinrecovery.org

136 Chapter 8 MAT in any OTP. A useful manual is Relapse strategy to ensure that a severe relapse is Prevention Workbook (Daley 2002). Exhibit avoided. 8-5 lists consensus panel recommendations for assisting patients in building their relapse pre- vention skills. Relapse Prevention Strategies for Multiple Substance Use Education about relapse is a key part of treat- ment. Educational approaches should teach Patients who abuse multiple substances may concrete strategies to avoid drug relapse and require modified relapse prevention strategies. should address the goals listed in Exhibit 8-5. Patients may use formerly coadministered sub- Additional topics may include cataloging and stances separately, which can increase the avoiding high-risk situations and coping with chance of sequential lapses leading to full drug cravings and slips to prevent full-blown relapse (Kosten 1991). Separate interventions relapses. Relapse prevention strategies often may be necessary for each substance because distinguish between slips and relapses, with the associated risks of relapse are different for slips defined as milder episodes of use. Of each. Perceptions of actual relapse risks for course, no level of opioid use should be con- the same drug can differ among patients. For doned, but when a relatively mild and isolated example, a patient may associate heroin use episode occurs, the consensus panel recom- with socializing and cocaine use with alleviating mends that OTP staff members focus on depression. implementing the best available prevention

Exhibit 8-5

Patient Goals in Building Relapse Prevention Skills ï Understand relapse as a process, not an event. ï Develop new coping skills for high-risk situations. ï Make lifestyle changes to decrease the need for drugs. ï Increase participation in healthy activities. ï Understand and address social pressures to use substances. ï Develop a supportive relapse prevention network (e.g., with significant others). ï Develop methods of coping with negative emotional states. ï Learn methods of coping with cognitive distortions. ï Develop a plan to interrupt a slip or relapse. ï Recognize relapse warning signs, including internal and external triggers and warning signs. ï Combat memories of drug abuse-associated euphoria. ï Reinforce recollections of negative aspects of drug use. ï Overcome the desire to attempt to regain control over use of illicit drugs or abuse of alco- hol or prescription drugs. ï Avoid people, places, and things that might trigger drug use. ï Develop pleasurable and rewarding alternatives to drug use.

Providing Comprehensive Care and Maximizing Patient Retention 137 Some researchers have noted that an absti- treatment for relapse prevention concluded nence violation effect may occur when a patient that these treatments, although studied for abstains from a substance but then relapses years, were ineffective (Conklin and Tiffany and possibly overuses it. The patientís reaction 2002). varies and often is contingent on how much he or she perceives relapse as a personal failure. When a slip or lapse occurs, the patientís self- Patient Followup Strategies esteem can be lowered, which he or she may Patient followup and continuing care have been attempt to repair by continuing or increasing found to be critical to preventing relapse and substance use. Treatment providers should be ensuring that patients remain abstinent (e.g., alert to this phenomenon and educate patients Zanis et al. 1996). When relapse occurs, OTPs about it (Marlatt 1985; Marlatt and Gordon should facilitate reentry into MAT. Followup 1980). and continuing-care services ensure a continu- um of support, and the consensus panel recom- mends that these efforts continue, with neces- Recognizing Relapse Warning sary funding to sustain them. (See the discus- Signs sion of the continuing-care phase of treatment Indications of a patientís mistaken beliefs or in chapter 7.) rationalization might precede relapse and pro- vide intervention points for a therapist. It is critical that a counselor or therapist know Referral to Social these warning signs, including the following Services (Washton 1988): Most patients in MAT need vocational, educa- ï The illusion of feeling cured after a few weeks tional, housing, or other social services. One or months of abstinence review found that an estimated 50 to 80 percent of patients in publicly funded OTPs were ï The belief that one can control his or her unemployed, yet fewer than 5 percent received substance use and can use substances socially employment-related interventions (Zanis and ï Idealized recollections of drug-induced eupho- Coviello 2001). In another study, social services ria; remembering the pleasurable effects but other than Temporary Assistance for Needy selectively forgetting adverse effects Families (Public Law 104ñ193) often were less ï Overreactions to urges and cravings, leading readily available to patients in MAT (Widman to beliefs that treatment is ineffective or et al. 1997). OTPs should be proactive in edu- abstinence is unsustainable cating social service providers about patient ï Denial of vulnerability to and refusal to needs and facilitating these services. Patients in accept the possibility of relapse, leading to OTPs that provide assistance with social ser- overreaction when relapse occurs (causing vices have shown improved outcomes after patients to drop out of treatment) treatment (Rowan-Szal et al. 2000a). ï Entry into high-risk situations, denial of risks, and self-testing or self-sabotage. Involuntary Discharge From MAT Extinction Therapy Unfortunately, involuntary discharge from Behavior therapy using cue exposure treatment MAT, sometimes called administrative dis- (extinction) was designed to reduce drug craving charge, occurs frequently. The consensus panel by repeated exposures to an experience that believes that these discharges are, in many previously triggered drug use (Childress et al. cases, evidence of program shortcomings. A 1992). However, a recent review of cue exposure number of recent changes, including the

138 Chapter 8 Substance Abuse and Mental Health Services Discharge for continued Administration (SAMHSA)-administered OTP substance abuse accreditation system with its emphasis on patient care and rights and requirements for The consensus panel recommends that patients consistent policies and procedures (CSAT receive every chance to continue treatment and 1999b, amended 2001 [Federal Register that treatment last as long as it is effective. 66:4076]), require OTPs to consider and docu- Program effectiveness may be determined by ment the reasons and methods for administrative comparing a patientís discharges far more carefully than in the past. substance use and Other specific details vary from State to State. overall adjustment at admission with his or When discharge is In their review of numerous studies, Magura her current status. and Rosenblum (2001) concluded that patients The Addiction unavoidable, it who were discharged from medical maintenance Severity Index (see or long-term detoxification treatment had con- chapter 4), an assess- sistently worse outcomes than patients who ment tool used in should be handled remained in treatment. Zanis and Woody many substance abuse (1998) found substantial increases in death treatment programs, fairly and rates among those involuntarily discharged for lends itself to such continued drug use. The consensus panel comparisons. Studies humanelyÖ strongly recommends that involuntary discharge have shown significant be avoided if possible, especially when patients improvement in would like to remain in and might benefit from patients even when MAT. When discharge is unavoidable, it should complete abstinence be handled fairly and humanely, following pro- was not achieved (e.g., Strain et al. 1999); cedural safeguards that comply with Federal therefore, caution should be used in judging regulations and accreditation guidelines. patientsí progress in MAT based solely on drug tests. Treatment for other substance use and Reasons for Administrative addiction should be offered to patients coping with dual addictions (see chapter 11). Patients Discharge should understand that the ultimate goals of SAMHSA accreditation guidelines mention treatment are abstinence from heroin and other ìviolence or threat of violence, dealing drugs, illicit drugs and appropriate use of prescription repeated loitering, [and] flagrant noncompli- medications. ance resulting in an observable, negative impact on the program, staff, and other Discharge for nonpayment patientsî as well as ìnonpayment of feesî and An OTP should advise patients to inform the ìincarceration or other confinementî as possi- program of impending financial problems as ble causes for administrative discharge (CSAT soon as possible. OTPs should focus on helping 1999b, pp. 17ñ18). patients who need financial assistance to pay for their treatment, through changes in their Patient and employee safety payment pattern or the identification of addi- OTPs are responsible for the safety and securi- tional funds through Medicare, Medicaid, the ty of both patients and employees and for main- U.S. Department of Veterans Affairs, health taining order in the facilities. Threats of vio- plan coverage, and other possible sources. If all lence should be taken seriously, and interven- of these avenues are exhausted and a patient tions should be rapid. Staff should document must be discharged for inability to pay fees, problem behavior. (For discussion about the then formal notice should precede discharge. ethics of discharging patients, see Appendix D.) Whenever possible, discharge should include

Providing Comprehensive Care and Maximizing Patient Retention 139 referral to a program with a sliding fee scale or administrative discharge. The consensus panel to an OTP receiving funding support through recommends that all OTPs develop, disseminate, its State Authority. To ensure that patients are and consistently enforce guidelines for patient not cut off abruptly from medication, some behavior. Clear communication and awareness OTPs seek payment for both the first and last by both patients and staff members are impor- months at admission. However, this may pre- tant factors in preventing administrative sent serious obstacles for many patients, espe- discharge. cially those in self-pay OTPs. OTPs should assist patients in seeking short-term loans or Staff members should identify behavioral allow payments in smaller, more frequent problems as they emerge and respond to them installments if that will solve the problem. In promptly. Training in interpersonal techniques 2003, the American Association for the to handle aggressive or upset patients in non- Treatment of Opioid Dependence released new provocative ways should be part of training for guidelines for addressing involuntary with- all staff. The first responses to a behavioral drawal from treatment for nonpayment. These problem should be to identify it, review the guidelines can be found at www.aatod.org/ treatment plan, discuss the plan with the policy_otp.html. patient, and modify or intensify treatment to match the patientís treatment status. Remedial approaches to consider include the following: Discharge for incarceration Unfortunately, MAT almost always is discontin- ï Reevaluate medication dosage, plasma levels, ued when patients are incarcerated. When and metabolic responses, and adjust dosage patients face extended incarceration, OTPs for adequacy and patient comfort should work with correctional facilities to ï Assess co-occurring disorders, and provide ensure that appropriate and humane psychotherapy and pharmacotherapy as medication-tapering procedures are followed needed and that medical safeguards are in place. ï Intensify counseling or add other types of Patients should be informed that, on release, counseling or ancillary services they are eligible for readmission to their OTP ï Treat medical or other associated problems without having to demonstrate signs and symp- toms of withdrawal. They should be reassessed ï Consider alternative medications to determine the appropriate treatment phase ï Provide inpatient detoxification from sub- (42 CFR, Part 8 ß 12(e)(3); CSAT 1999b). In stances of abuse, while maintaining patients cases of short-term detention, OTPs should on opioid pharmacotherapy determine whether the correctional system is ï Change counselors if indicated continuing to medicate inmates with prescribed medications and, if it is not, OTPs should con- ï Reschedule dosing to times when more staff sider the practicality of offsite dosing. members are available ï Provide family intervention. Preventing and Finding Dosing should not be a behavioral tooló Alternatives to Administrative patients should not be disciplined by having their medication dosage decreased or withheld, Discharge nor should they be rewarded for good conduct by having their dosage increased. Programs Communicating program are encouraged to develop nonpunitive ways to rules clearly set limits and contain disruptive behavior. Including program rules in patient orientation However, in some cases, involuntary discharge and education is the first step to prevent becomes necessary.

140 Chapter 8 Finding alternative Reviews and appeals treatment arrangements should be handled promptly, with atten- If a decision to Concerns that patients will discontinue medical tion to procedural treatment for or transmit disease (such as regularity and a discharge is made, HIV/AIDS or hepatitis C) may lead staff mem- patientís extenuating bers to ignore noncompliance problems to circumstances and supervised retain patients in a program. At times, such point of view. patients may have to be discharged, and the Procedures should withdrawal of program should make referrals to a more be fair and impartial appropriate level of care or type of treatment because other (CSAT 2000e). patientsí view of the medication should program may be influenced by any begin after the Procedures for Administrative perceived lack of Discharge fairness. review process Ethical criteria for discharge include review and If a decision to appeals processes, a suitable dosage protocol for is complete. discharge is made, withdrawal from medication, and a readmission supervised with- procedure that includes a behavioral contract. drawal of medication Exact procedures depend on the reason for dis- should begin after the charge. For behavioral problems, the approach review process is completed. Involuntary dis- should include escalating warnings and specified charge should be done with the understanding consequences including referral. that, if identified preconditions are met, the patient may return to the OTP within a Review and appeals specified time. Obstacles to reentry should processes be minimized. It is advisable to schedule a date on which the patient may return to talk about CSAT accreditation guidelines recommend, and whether he or she may reenter the program. accreditation body standards require, due pro- cess and documentation during administrative discharge (CSAT 1999b, sections XVI and Medically supervised taper- XVII). OTP policies should include written ing and discontinuation guidelines, including confidentiality guidelines, Whatever the reason for discharge, patients under which cases of involuntary discharge can should be made as comfortable as possible be appealed and examined by treatment and during medically supervised withdrawal. Exact administrative staffs. Some States have devel- schedules require medical determination (see oped regulations to guide this process. OTPs chapter 5), but tapering should be as gradual should have a formal appeal mechanism, and as possible so that patients can find and enter patients should be made aware of their rights. other facilities. Staff members not directly involved with a dis- ciplinary action should conduct a review of Members of the consensus panel agree that that action. OTPs should develop working rela- blind withdrawal (withdrawing a patient from tionships so that, when patients break rules medical maintenance or adjusting dosages and need to be discharged, they can be trans- without his or her knowledge) is unethical ferred to other programs. unless requested by the patient to aid in the withdrawal process.

Providing Comprehensive Care and Maximizing Patient Retention 141 Patient Advocacy At the OTP level, advocacy groups focus on patient education and support, assistance with Advocacy by and for patients in MAT and their practical aspects of treatment, and public edu- supporters has emerged as a force on the treat- cation about the benefits of MAT and construc- ment landscape (Woods 2001). Several national tive roles played by patients in many spheres. and local advocacy groups with slightly differ- OTP-based patient advisory committees are ent emphases have been organized, including becoming increasingly common. Participation the National Alliance of Methadone Advocates in these organizations helps empower patients (www.methadone.org), International Center for and enhance patient skills in social interaction. Advancement of Addiction Treatment Other benefits include practice in group inter- (www.OpiateAddictionRx.info), and Advocates action and problemsolving. Patients gain a for Recovery through Medicine greater understanding of OTP operations and (www.methadonetoday.org/armhelp.htm). perspectives, educate others, identify problems These groups believe that MAT is a lifesaving and misinformation, and provide a channel of treatment, stigma must be reduced, and communication to OTP administration. Because patients should be educated about their treat- accreditation agencies are concerned with input ment and encouraged to participate in it. In from patients, such involvement by patients general, these advocacy groups are made up usually is viewed favorably by these agencies. of stable, long-term patients.

142 Chapter 8 9 Drug Testing as a Tool

Purposes of Drug Testing in OTPs Since the inception of medication-assisted treatment for opioid addiction (MAT), drug testing has provided both an objective measure of treatment In This efficacy and a tool to monitor patient progress. Important changes have Chapter… occurred in current knowledge about and methods for drug testing in opioid treatment programs (OTPs) since the publication of TIP 1, State Purposes of Drug Methadone Treatment Guidelines (CSAT 1993b). Testing now is per- Testing in OTPs formed extensively to detect substance use and monitor treatment com- pliance. Analysis of test results provides guidance for OTP accreditation, Benefits and as well as information for program planning and performance improve- Limitations of Drug ment. In addition, other agencies concerned with patient progress (e.g., Tests child welfare and criminal justice agencies) routinely request and use drug test results with patientsí informed consent (see CSAT 2004b). Drug-Testing Components and Increasing emphasis on treatment outcomes as evidence of program Methods effectiveness has added significance to drug tests in OTPs. Administrators use drug test results in response to quality assurance Development of requirements. For example, an OTP that prescribes adequate mainte- Written Procedures nance medication should report relatively few illicit-opioid-positive drug tests. Ball and Ross (1991) found that the most effective programs had Other less than 10-percent positive tests. However, these findings emerged Considerations in before the purity of heroin markedly increased in recent years and Drug-Testing before the ratio of OTP staff to patients decreased in many programs as Procedures a result of funding cuts. These events have been associated with increases Interpreting and in opioid positive urine tests in most OTPs. Given the regional variability Using Drug Test in factors affecting addiction, for example, differences in heroin purity Results and availability or in prescription opioid abuse, the consensus panel recommends that OTPs develop new measures to improve outcomes if Reliability, Validity, they report an average of more than 20-percent positive drug tests for and Accuracy of patients with at least 1 to 3 years of MAT. Equally important, OTP drug Drug Test Results test results should be nearly 100-percent positive for treatment medica- tion because lower percentages could indicate medication diversion, which requires investigation and a corrective-action plan. (Federal regu- lations require OTPs to maintain diversion control plans as part of their quality assurance efforts [see chapter 14].)

143 Drug test results help policymakers and OTP testing for other drugs (e.g., methamphetamine), administrators detect and monitor emerging depending on local substance use patterns. OTP trends in substance abuse that may signal a administrators should decide whether to test need to redirect resources. Drug use patterns routinely for alcohol and marijuana or only as have changed markedly in recent decades; for needed. Because of the increased depressive example, benzodiazepines, amphetamines, effects of alcohol combined with an opioid such methamphetamine, and cocaine have increased as methadone, it is important for OTPs to avoid in popularity while barbiturate use has dimin- providing opioid medication to patients who are ished. New substances of abuse or combina- intoxicated with alcohol. However, no standard tions of substances and methods of ingestion cutoff scores for permissible alcohol levels exist present new treatment challenges and funding across OTPs. Because urine tests for alcohol are concerns. highly variable (Warner 2003), breath and blood tests are more useful in OTPs to determine the presence or degree of acute alcohol intoxication. Testing for Treatment Because breath tests are much simpler and Compliance faster and are less invasive than blood tests, they At a minimum, most specimens from patients are the most common alcohol testing method maintained on methadone should be tested for used in OTPs. methadone and its metabolites (testing for Exhibit 9-1 summarizes necessary minimum (or metabolites prevents patients from simply cutoff) concentrations for detection of some adding methadone to a sample), which can be illicit and prescription drugs in urine, as well as done efficiently and at reasonable cost. their reliable detection times for both initial Currently, no precise test measures buprenor- patient testing and confirmation of positive phine in a patient specimen, although it can be results. detected in urine, blood, or hair by gas chro- matography/mass spectrometry (GC/MS) (Lisi et al. 1997; Vincent et al. 1999) and, as report- Benefits and ed by Cirimele and colleagues (2003), by enzyme-linked immunosorbent assay in urine. Limitations of Until new, commercially available tests are Drug Tests developed, drug testing of patients receiving buprenorphine primarily should be to detect The consensus panel cautions that drug test substances of abuse. No reagent is commercially results should not be the only means to detect available at reasonable cost to test any specimen substance abuse or monitor treatment compli- type for levo-alpha acetyl methadol (LAAM), ance and that the needs of patients whose test although LAAM can be detected in urine by results show no immediate problems should not thin-layer chromatography (TLC) and GC/MS be overlooked. Too often, overworked coun- (Moody et al. 1995). Therefore, the consensus selors and caseworkers scan drug test results to panel recommends direct monitoring of determine services, without investing time to patients receiving LAAM (American Association develop the trust and concern inherent in a for the Treatment of Opioid Dependence, n.d.), sound counseling relationship. Training and assuming that its availability continues (see educating staff members about the benefits and chapter 3). limitations of drug tests should ameliorate this situation. Staff members should understand, for example, that certain prescribed and over- Testing for Substances of the-counter medications and foods might gener- Abuse ate false positive and false negative results for different substances. Some drug-testing labora- At a minimum, OTPs should test for opioids, tories provide training about drug testing for cocaine, and benzodiazepines and consider

144 Chapter 9 Exhibit 9-1

Typical Testing and Confirmation Cutoff Concentrations and Detection Times for Various Substances of Abuse

Initial Testing Confirmation Cutoff Cutoff Concentrations Analytes Tested in Concentrations Urine Detection Drug (ng/mL*) Confirmation (ng/mL) Time (Days) Amphetamine 1,000 Amphetamine 500 2ñ4 Barbiturates 200 Amobarbital, 200 2ñ4 for short acting; secobarbital, other up to 30 for long barbiturates acting Benzodiaze- 200 Oxazepam, 200 Up to 30 for long pines diazepam, others acting Cocaine 300 Benzoylecgonine 150 1ñ3 for sporadic use; up to 12 for chronic use Codeine 300 Codeine, morphine 300, 300 1ñ3 Heroin 300 Morphine, 6- 300, 10 1ñ3 acetylmorphine Marijuana 100, 50, 20 Tetra-hydro- 15 1ñ3 for casual use; cannabinol (THC) up to 30 for chronic use Methadone 300 Methadone 300 2ñ4 Metham- 1,000 Methamphetamine, 500, 200 2ñ4 phetamine amphetamine 25 Phencyclidine 25 2ñ7 for casual use; up to 30 for chronic use

*ng/mL: nanograms per milliliter.

Adapted from Cone 1997.

OTP staff. Frank discussions of the issues Abuse and Mental Health Services Adminis- involved for patients and for the OTP help tration (SAMHSA) has notified OTPs that they staff members understand the importance of may use oral-fluid testing to satisfy the drug- using test reports appropriately. testing requirements in 42 Code of Federal Regulation (CFR), Part 8, if a programís Urine drug testing remains the most common medical director deems this method adequate method of drug testing in OTPs. The Substance

Drug Testing as a Tool 145 (Clark 2003). As other drug-testing methods and has well-established cutoff levels and other are developed and attain Federal and State laboratory guidelines (Cone and Preston 2002). approval, OTPs should consider using them According to one survey (Jones et al. 1994), as well. most patients accept urine testing in an OTP although many do not like it. Concerns usually Alternatives to urine and oral-fluid testing have relate to the specimen collection process or the benefits and limitations. Some investigators sensitivity and specificity of results, as well as (e.g., George and Braithwaite 1999; Moolchan the possibility of tampering, the need to pre- et al. 2001) have maintained that concentrations serve patient privacy and dignity, risks of col- of methadone in blood plasma are the ìgold lection to staff, and the possibility that sub- standardî to assess treatment compliance in stance interactions may confound results. patients maintained on methadone. However, blood testing is A patientís physical condition can affect test impractical, costly, sensitivity and specificity. Urine testing is not and difficult, and feasible for patients with renal failure (e.g., [U]rine drug the same investiga- those on dialysis) or other bladder control tors recognized that impairments. George and Braithwaite (1999) urine drug testing is found that variations in metabolism and excre- testing is dominant likely to be the domi- tion could affect urine concentrations of nant method in methadone or its metabolites. Moolchan and in OTPs because OTPs for the fore- colleagues (2001) noted that renal methadone seeable future. clearance varies for subjects with certain medi- obtaining speci- cal conditions (e.g., renal disease) and those Some investigators taking other prescribed or illicit drugs. As a mens is relatively evaluating optimal result, urine drug tests for patients on relative- approaches to ly low methadone dosages may be methadone easy and testing is assessing MAT com- negative even though subjects have ingested pliance and deter- medication as prescribed (i.e., a false negative mining continued affordable. result). Furthermore, individuals with parure- substance use have sis (ìshy bladder syndromeî) have a social found patients forth- that may leave them unable to coming about their urinate under observation (Labbate 1996ñ drug use and not 1997; Vythilingum et al. 2002). particularly motivated to avoid detection. Two studies evaluated patientsí self-reports of drug Just as some patients metabolize methadone or use and concluded that they are at least as reli- other treatment medications at different rates able as urine drug tests (Zanis et al. 1994) and and some medications affect the metabolism of sometimes more sensitive (Howard et al. 1995). others (see chapter 3), certain medications, for Both studies suggested that a combination of example, HIV medications, change the self-reporting and urine testing is more useful metabolism of addiction medications and can than either alone. Another study (Katz and affect drug test results. OTP staff members Fanciullo 2002) has challenged these findings. should remain current on these interactions as more data become available (see De Maria 2003). A Web site that provides up-to-date Urine Drug Testing information on the pharmacokinetics of Despite its limitations, urine drug testing is methadone and HIV medications is at dominant in OTPs because obtaining specimens www.hiv-druginteractions.org. is relatively easy (Moolchan et al. 2001) and testing is affordable. In addition, the technique Baker and colleagues (1995) found similar is well studied, has been in use for a long time, urine drug test results regardless of whether

146 Chapter 9 patients were notified of tests in advance. In than in urine. Some drugs remain detectable that study, some patients stated that unan- longer in urine than in saliva. Drug residue in nounced urine tests deterred them from sub- the oral or nasal cavity was found to contami- stance use, but 53 percent said it did not. nate saliva specimens (Swotinsky and Smith Contrary to assumptions by some providers 1999). The consensus panel recommends oral- that substance abuse is more likely over week- fluid testing when drug testing must be ends (presumably resulting in more positive observed because it is more respectful and less drug tests on Mondays), Compton and col- invasive and observation does not require leagues (1996) found that urine drug test watching patients void. Oral-fluid collection results did not vary by day of the week. requires no temperature strips or other devices to ensure that a specimen was just provided. Oral-Fluid Drug Testing Oral-fluid drug testing is an alternative to urine Blood Drug Testing drug testing in OTPs that is approved by OTPs rarely if ever use blood testing routinely; SAMHSA (Clark 2003; for a recent review of most often, they use this method to monitor oral-fluid drug testing, see Kintz and Samyn plasma methadone levels when necessary. 2002), but only when a qualified offsite labora- Testing for the presence of methadone in tory performs the specimen analysis. According serum, although more costly than urine testing, to SAMHSAís interim guidance on the use of is the most accurate method currently available oral-fluid testing in OTPs, sent to OTPs in July to determine whether other prescribed medica- 2003 (Clark 2003), offsite drug testing using tions influence methadone metabolism or a oral fluid may be considered adequate for the patient is a rapid metabolizer. Serum testing is purpose of 42 CFR, Part 8 ß 12(f)(6). The more accurate than other methods to address choice of drug-testing methodology is an issues related to the effects of metabolism on informed medical judgment decision. It is methadone dosage. SAMHSAís view that there is sufficient infor- mation to confirm the adequacy of oral-fluid Blood testing has limitations besides cost. testing in the OTP setting. CSAT noted that Blood offers a smaller drug detection window OTPs still must conform to State laws and than oral fluid or urine; most drugs are unde- regulations in this area (Clark 2003). tectable in blood after 12 hours (DuPont 1999). Trained personnel must obtain blood speci- Many patients in OTPs react more favorably to mens. Concerns about blood-borne pathogens the use of oral swabs than to observed urine make routine blood testing impractical, and, as collection. Researchers have confirmed other discussed in chapter 3, some medications and benefits of oral-fluid testing. Moore and col- diseases affect methadone levels in plasma. leagues (2001) reported that it was highly sensi- tive and specific for methadone and opioids of abuse and that samples could be stored or sent Sweat Drug Testing to a laboratory for analysis. Braithwaite and Sweat patches usually are used as an adjunct to colleagues (1995) noted that oral-fluid testing other forms of testing. They provide a longer ensured privacy and was less susceptible to specimen collection period than either urine or tampering than urine testing and that speci- blood and may be less susceptible to tampering mens required little preparation. than urine. Sweat patches are tolerated well by patients and are considered less invasive and Results of oral-fluid testing generally are less potentially embarrassing. Taylor and col- similar to those obtained by urine drug testing, leagues (1998) found that women were more but differences exist, and OTP staff members likely than men to prefer a sweat patch to urine should understand these differences. Concen- testing. The patch has not been found to deter trations of some substances are lower in saliva substance use (Taylor et al. 1998). Preston and

Drug Testing as a Tool 147 colleagues (1999a) compared the patch method as methadone, providers should discuss the with urine testing for detection of cocaine results with the patient as soon as possible. If and found good concordance between the two the patient insists that a result is inaccurate, an methods. OTP should recheck the existing report via confirmatory analysis or a retest if the labora- Playing-card-sized, waterproof adhesive tory still has the specimen in question. patches are available. Each patch is imprinted Preferably, a different analytical method with with a unique number to track its chain of cus- higher sensitivity is used for confirmation or tody. After a patch is worn for about 1 week, a retesting. A confirmed analysis should be laboratory can extract about 2 mL of sample to viewed as only one basis for modifying a be tested. Compared with urine specimens, patientís treatment plan. sweat yields higher proportions of parent drugs, such as cocaine, heroin, or marijuana. The consensus panel recommends that pro- Drug use is assessed cumulatively, but uniform grams incorporate Federal and State regulatory cutoff levels have not been established, and requirements and their own treatment needs external contamination is a possibility into written policies and procedures for drug (Swotinsky and Smith 1999). testing and integrate these policies and proce- dures into treatment planning and practices. OTP administrators should consider the factors Hair Drug Testing discussed below in establishing and maintaining Hair analysis provides a longer term look at drug-testing procedures that ensure the integri- drug use than other methods because hair ty and utility of results, as well as compliance retains drugs longerófor example, weeks or with regulations. months, compared with the 2 or 3 days that cocaine or heroin is detectable in urine. Collecting hair specimens also is less invasive Specimen Collection than urine or blood sampling. However, drawbacks include expense, possible ethnic Setting and approach bias (Kidwell et al. 2000), and environmental The consensus panel emphasizes that specimen contamination. Studies of hair analysis have collection and testing should be performed in a been hampered by poor design, small specimen therapeutic, humane environment and results size, and lack of confirmation. More research should be used to help guide patient care, mod- is needed. ify treatment plans, and confirm clinical impressions. Specimen collection methods should protect patientsí dignity and privacy Drug-Testing while minimizing opportunities for falsification. Components and The bathrooms used for urine collection should be cleaned frequently and supplied with soap Methods and other toilet articles. Collection procedures Methods and uses of drug tests vary widely should be in writing (see ìDevelopment of among OTPs. Improvements in standards and Written Proceduresî below). Patients should technology have made a variety of testing and be informed during admission and early treat- analytical alternatives available. Drug testing is ment about how drug-testing specimens are col- a multistep process that starts with specimen lected and patientsí responsibility to provide collection. Specimens are analyzed by one of specimens when asked. Patients should receive numerous techniques. The results are recorded a copy of OTP policies on and procedures for and interpreted. When an initial test analysis is drug testing, including whether and when positive for a substance of abuse or unexpect- direct observation is indicated. edly negative for a treatment medication such

148 Chapter 9 Most OTPs assign a staff member to greet regarding the need for direct observation of patients and determine whether a urine urine collection. Temperature strips, adulter- specimen is required before patients can ant checks, and other methods should be used receive medication. This determination may be when possible to ensure test validity. Moran based on staff judgment or a random list gener- and colleagues (1995) determined that unsuper- ated by computer or by OTP managers. In most vised urine collection with a temperature indi- cases, urine specimens should be obtained ran- cator and a minimum 50-mL specimen was domly based on patientsí OTP visit schedules. practical and reliable and ensured individual privacy and dignity. Many OTPs do use direct When indicated, a patient is sent to the bath- observation (Calsyn et al. 1991), but some use room to provide a urine specimen in a labeled one-way mirrors and even video cameras to container. Most programs monitor the bath- ensure reliable sample collection. room to ensure that only one patient uses it at a time and that patients leave parcels outside the OTPs that use observed collection have many bathroom. The person receiving the urine options, including random observation, obser- specimen checks the container to determine vation to ensure treatment compliance before a whether it is a valid specimen. The specimen schedule change, or then is packaged and sent to a laboratory observation because for testing. of suspected drug use. Some OTPs use direct [S]pecimen To ensure patient confidentiality, programs observation only dur- should store specimens and related documents ing initial stabiliza- collection and and material so that only authorized personnel tion. Oral-fluid testing can access and read them. Handling specimens is another option. also raises questions about staff safety Each OTP should testing should be (Braithwaite et al. 1995) and the reliability of decide whether, when, the chain of custody for samples (Moran et al. and how it uses direct performed in a 1995). Universal safety precautions for han- observation in speci- dling urine specimens should be followed; for men collection and therapeutic, example, staff members collecting specimens should include guid- need to wear gloves. ance for direct obser- humane vation in its written Direct observation versus policies and proce- environment... other methods dures. Some States mandate urine drug Collecting urine specimens, especially when col- testing and direct lection is supervised, can be embarrassing for observation of specimen collection. For pro- both subjects and supervisors and raises con- grams that elect unobserved collection, other cerns about patientsí privacy rights (Moran et effective options for sample validation exist, al. 1995). Some patients and treatment such as temperature strips and ambient- providers perceive direct observation of urina- temperature ìgunsî (see below). tion as a violation of trust and respect (Moolchan et al. 2001). In addition, patients with paruresis should not be penalized; Analytical Methods Used in instead, treatment providers should consider Drug Testing unobserved urine testing, oral-fluid testing, or another drug-testing method. Knowledge gained from testing enhances the treatment process and ameliorates some The consensus panel recommends that OTP regulatory concerns and issues facing OTPs. staff members use their clinical judgment However, it is important for practitioners and

Drug Testing as a Tool 149 State and Federal regulators to understand the For urine drug testing, either of two immunoas- limits of the drug testing and analytical meth- say typesóradioimmunoassay (RIA) or EIAó ods used in most OTPs (Moolchan et al. 2001; can be used. RIA uses radioactive markers and Verebey et al. 1998). requires an incubation period and centrifuga- tion of the sample. EIA uses an enzyme as its Because of the volume and cost of urine testing, marker. Currently, no commercially available most OTPs use TLC or enzyme immunoassay EIA tests exist for LAAM, buprenorphine, or (EIA) to analyze test specimens. The Enzyme the buprenorphine-naloxone combination Multiplied Immunoassay Technique (EMIT) is tablet. the EIA method used most often in this country because its costs are lower, it allows for short EIA permits detection of extremely small analysis time, it can be automated for large- quantities of substances but lacks specificity to scale samples, and it can be used on site by determine which drug in a class is present small programs (Hawks 1986; Manno 1986). (Saxon et al. 1990). For example, EIA can detect opioids but cannot distinguish between Immunoassays use antibodies with specific sur- morphine (the metabolite of heroin excreted in face sites to which drugs or metabolites bind. urine), codeine, and other opioids, including

Exhibit 9-2

Common Immunoassays

Immunoassay Brand Name(s) Manufacturer(s) Comments EIA EMIT, CEDIA Syva, Boehringer Used widely; inexpensive; equipment Mannheim/ available for automated, high- Microgenics volume rapid analysis; sensitive to some adulterants Fluorescence Adx, TDx Abbott Diagnostics Resistant to several adulterants; polarization reasonably good quantitative esti- mates of concentrations; slower and more expensive than EIA and KIMS Kinetic OnTrak, Roche Diagnostics Equipment available for automated, interaction TesTcup, high-volume rapid analysis; used by of micropar- OnLine some large laboratories ticles (KIMS) Colloidal Triage Biosite Diagnostics Used in onsite testing metal (CMI) RIA Abuscreen Roche Diagnostics Labor intensive; resistant to several adulterants; not used widely

Adapted from Swotinsky and Smith 1999, with permission of Medical Review Officer Certification Council.

150 Chapter 9 those from poppy seeds used in baked goods. in treatment, periodic assays for its primary EIA does not distinguish oxycodone (e.g., metabolite, EDDP (2-ethylidene-1,5-dimethyl- PercodanÆ, OxyContinÆ). In areas where these 3,3-diphenylpyrrolidine), are advised. Unlike drugs are abused, OTPs should take additional methadone, EDDP is pH independent when steps and use other methods to test for oxy- excreted, so the absence of EDDP from urine codone. Exhibit 9-2 describes several widely may be a more accurate sign of tampering, available immunoassays. substitution, or diversion. GC/MS is a sensitive method that can be used to confirm results from Chromatographic analyses use flows of liquid EMIT or TLC. or gas to separate molecules and isolate any drugs or drug metabolites in specimens. TLC, one of the oldest of these methods, is inexpen- Development of sive but less accurate than EIA, and its accura- cy depends on the skill of the laboratory tech- Written Procedures nician (Hawks 1986). TLC can distinguish Procedures for drug testing in an OTP should between drugs in a class (a limitation of EIA), be described clearly in a written document but it also can produce false negative reports such as that shown for urine specimen collec- because it requires relatively large amounts of tion in Exhibit 9-3. Similar policies can be drugs in specimens before these drugs can be developed for oral-fluid testing. Each OTP detected. Programs working with laboratories should develop policies and procedures for that use TLC should be aware that low doses of drug testing based on its mission, service phi- addiction treatment medication occasionally losophy, and practices. yield negative reports. When methadone is used

Exhibit 9-3

Sample OTP Guidelines for Monitoring Urine Drug Test Specimen Collection

It is the policy of the [name of program] to monitor the use of drugs by collecting random, observed, and/or temperature-monitored urine samples at a frequency determined by clinical staff in accordance with Federal and State regulations. Purpose Urine samples are collected and tested to assist in stabilizing a patient on the proper dosage of methadone or buprenorphine. Drug test results may suggest that a patientís dosage needs adjustment or that a more intensive level of care is need- ed. Positive drug tests alone do not confirm that a patient is not engaged in treat- ment or is not in compliance. The entire clinical picture must be considered. Drug tests are not used to punish patients or as the sole reason to discharge them from treatment. Patients must be assured that the results are confidential and will be released only with their permission or pursuant to a court order (21 CFR, Part 2).

(continued on following page)

Drug Testing as a Tool 151 Exhibit 9-3

Sample OTP Guidelines for Monitoring Urine Drug Test Specimen Collection (continued) General Information and Desired Outcome In accordance with program policy and State and Federal regulations, each new patient is asked to provide one random urine sample per week for the first 6 months and samples less frequently thereafter, based on treatment progress. No patient is monitored less than once a month.

Urine samples are collected randomly. A patient is not told when he or she will be asked to provide a urine sample so that a more accurate assessment of drug abuse patterns can be made.

The urine is tested for several drugs of abuse and for the presence of treatment medication. Testing for EDDP, a methadone metabolite, is a more sensitive mea- sure of the presence of ingested methadone than testing for the parent compound (methadone) alone. This type of testing helps distinguish ingested methadone from methadone that has been added to a urine specimen as an adulterant.

Patients may refuse to provide valid urine specimens for many reasons but are encouraged to provide them. If a patient refuses to provide a specimen, then urine is collected on the next dosing appointment. If a patient fails to provide a valid specimen at the next appointment, a review of take-home dosages and progress in treatment takes place and may result in more frequent required clinic visits. When patients refuse to provide samples, the counseling, nursing, and medical staffs are notified and consulted. Procedure The following guidelines for observing or temperature-monitoring urine specimens help increase the validity of each sample.

ï If a urine specimen is collected with a temperature higher than 99.8F, the patientís temperature is taken (if the patientís temperature is elevated, the temperature of the urine specimen also may be elevated). ï Before a patient enters a bathroom stall, he or she is asked to leave coat, outer garments, purse, and bags outside the bathroom to prevent falsification of the sample. A patient is asked to wash and dry his or her hands before and after giving samples to prevent urine contamination. Bacterial overgrowth invalidates a urine specimen. To the extent possible, staff members ensure that patients do not conceal falsified urine specimens on their persons.

152 Chapter 9 Exhibit 9-3

Sample OTP Guidelines for Monitoring Urine Drug Test Specimen Collection (continued)

ï If collection of a urine sample is observed directly (versus temperature monitored), the following steps are performed to ensure an accurate specimen: ñ The patient is observed to ensure that he or she does not add water to the urine from the toilet or sink to dilute it. (Where health department regulations permit, hot water in the bathroom should be turned off.) ñ Female: A female observer accompanies a female patient into the restroom. The patient is asked to void into a urine container and not to flush the toilet. A wide-mouth collection container may be used and the contents then transferred to a smaller container. The staff member observes collection of the specimen directly. The collection site observer also flushes the toilet. ñ Male: A male observer accompanies a male patient into the restroom. The client uses a urinal and is asked to void into a urine container. This is observed directly. ï The patient provides 50 cc of urine. ï The sample is checked for color, temperature (90.5ñ99.8 F/32.5ñ37.7 C), and any contamination. The temperature is checked 30 seconds after the specimen is provided. ï After a sample is obtained, a staff member verifies the urine temperature and checks the container for pinholes before placing it in a plastic envelope. ï If the urine sample is not sent immediately to the laboratory, it is stored properly in a refrigerator that is used exclusively for laboratory samples. ï Proper security of urine specimens is maintained to prevent loss or switching of urine. Specimens are placed in a locked refrigerator in a locked room. If a patient is unable to provide a urine specimen, he or she is asked to drink plenty of water. Special considerations are given to patients with health problems that interfere with , including renal failure, neurological disorders, and paruresis. Any patient who still is unable to provide a urine sample must be pre- pared to give the sample on the following day.

If a patient refuses to provide a sample, he or she must be referred to a counselor. After a clinical review, the treatment plan and the frequency of clinic visits may be modified.

Source: Adapted from the University of New Mexico Hospitals, Addictions and Substance Abuse Programs.

Drug Testing as a Tool 153 Other Considerations that specific drug-testing methodologies or deci- sion matrices be followed. OTPs must adhere to in Drug-Testing the more stringent of either the Federal or State regulations. In States with no specific require- Procedures ments, Federal regulations are the only applica- ble standard, but, as previously noted, these Frequency of Testing requirements should be considered minimal Given concerns about the cost and reliability of and regulatory. drug tests, some OTPs limit testing and others The consensus panel recommends at least one assume that results are unreliable in many drug test at admission to an OTP. Onsite testing cases. Decisions about how to use drug testing kits are available so that admission can contin- require thought and balance. In addition to ue while test results are pending (see ìOnsite conforming to Federal and State regulations, Test Analysisî below), although some States the frequency of testing should be appropriate may disallow these kits. For patients in short- for each patient and should allow for a caring term detoxification, one initial drug test is and rapid response to possible relapse. Drug required, whereas patients receiving longer tests should be performed with sufficient fre- term MAT are required to have initial and quency and randomness to assist in making monthly random tests. informed decisions about take-home privileges and responses to treatment. Laboratory Selection For patients who continue to abuse drugs or test negative for treatment medication, the con- The laboratory selected by an OTP to analyze sensus panel recommends that OTPs institute patient specimens must comply with Health more frequent, random tests. Increased testing Insurance Portability and Accountability Act provides greater protection to patients vulnera- regulations (CSAT 2004b) and the Clinical ble to relapse because only short periods pass Laboratory Improvement Amendments (CLIA) before a therapeutic intervention can be initiat- (see discussion below). OTPs should under- ed. However, as emphasized throughout this stand a laboratoryís analytical methods and chapter, programs should avoid making treat- know whether and how often the laboratory ment decisions affecting patientsí lives that are confirms positive findings, how long specimens based solely on drug test reports. are retained for testing, and when results are made available to OTPs. A laboratory should SAMHSA requires eight drug tests per year for collaborate with an OTP regarding custody of patients in maintenance treatment (42 CFR, specimens, confidentiality and reporting of Part 8 ß 12(f)(6)). In the opinion of the consen- results, turnaround times for results, and spec- sus panel, this is a minimal requirement. The imen retention for retesting. Programs also actual frequency of testing should be based on should understand a laboratoryís minimum a patientís progress in treatment, and more test- cutoff levels for determining and reporting ing should be performed earlier in treatment positive results. than later, when most patients are stabilized. Most OTPs develop policies and procedures on In a review of requirements for efficient, reli- testing frequency that meet or exceed Federal able urine testing for substances of abuse, requirements and accreditation standards to Braithwaite and colleagues (1995) emphasized assist staff in planning treatment, assessing the importance of quality control in laborato- patient progress, and granting take-home ries. They listed aspects of high-quality assess- privileges. ment, including performing analyses according to manufacturerís instructions, evaluating Some States require more frequent testing than control samples for every analysis, participat- that required by SAMHSA. Some also require ing in external quality assessment, adequately

154 Chapter 9 training and supervising staff, and carefully If an OTP falls under CLIA requirements, it reporting results. They also recommended that must register or seek a waiver to continue its laboratories analyze at least 20 to 30 specimens own laboratory analysis of test specimens. per week from each OTP, have a scientist with expertise in drug addiction and drug testing on Exhibit 9-4 provides a list of commercial staff, and report results confidentially within 2 resources, manufacturers, and contact infor- to 3 days of specimen receipt. mation for onsite analytical methods.

Onsite Test Analysis Interpreting and Using Onsite (also known as near-patient or point- Drug Test Results of-care) drug test analysis can provide rapid Test results should be documented in patient results but may have limitations such as records along with appropriate justifications increased cost or reduced accuracy. Some State for subsequent treatment decisions, particularly regulations disallow onsite test analysis. In an in unusual situations such as when take-home extensive review, D. Simpson and colleagues medications are continued despite test results (1997) found that immediately available drug that are consistently positive for substances. test results improved patient cooperation and OTPs should confirm program management. In their review of avail- positive results when- able commercial analytical methods, they found ever possible, bearing that all were rapid, reliable, and useful but in mind the factors required confirmation of positive results, and that can confound [P]rograms should some lacked sensitivity, specificity, or both. A results (e.g., using more recent review by George and Braithwaite over-the-counter avoid making (2002, p. 1639) concluded that onsite analytical medications, eating devices for drugs of abuse were ìan expensive foods containing and potentially inaccurate means to monitor treatment deci- poppy seeds). patient treatment and drug abuse states.î OTP directors should sions affecting Onsite analysis of test specimens also requires ensure that results are that staff be trained in calibration of the testing not used to force patientsí lives that device and interpretation of results. OTPs patients out of treat- need ongoing quality assessment procedures. ment and that no are based solely on Analyses performed outside a laboratory set- treatment decisions ting require special facilities to ensure safety. are based on a single drug test reports. Onsite specimen analysis also raises questions test result. Patients about the chain of custody, provision, stability, should be informed of and storage of samples (Simpson, D., et al. positive results for 1997). However, the U.S. Department of substances of abuse or Health and Human Services is developing negative results for treatment medication as guidelines for onsite analytical methods in soon as possible and should have an opportuni- workplace drug-testing programs, which sug- ty to discuss these results with OTP staff. A gests that this approach will become more patient who refutes test results should be taken common (Cone and Preston 2002). The use of seriously, particularly when results are incon- onsite specimen analysis for decisionmaking sistent with the treatment profile and progress may subject OTPs to the requirements of of that patient. CLIAóFederal guidelines for any entity doing laboratory analysis of specimens from OTPs should use drug test results clinicallyó humansóand require these OTPs to obtain not punitivelyófor guidance, treatment plan- approval from their State health departments. ning, and dosage determination. OTPs should

Drug Testing as a Tool 155 Exhibit 9-4

Examples of Onsite Analytical Methods for Drug Tests

Test Manufacturer Contact Abuscreen OnTrak Roche Diagnostics, Somerville, New www.roche-diagnostics.com Jersey OnTrak TesTcup Triage Biosite, Inc., San Diego, California www.biosite.com Triage Screening Cassette E-Z SCREEN American Biomedica, Ancramdale, www.americanbiomedica.com New York Bionike One Step Bionike Laboratories, South San Francisco, California AcuSign Drug Test Resources International, [email protected] Boca Raton, Florida Verdict MedTox, St. Paul, Minnesota www.medtox.com Micro Line Casco Standards, Yarmouth, Maine www.microgenics.com

retest (using more sensitive analytical methods Responding to Unfavorable if necessary) when results indicate continuing Drug Test Results problems; monitor carefully the chain of cus- tody for specimens; document results, patient Patients who continue to abuse substances responses, and action plans in the case record; while receiving addiction treatment medication respond rapidly to relapse indications; and create concern among OTP staff members for ensure that positive results for substance abuse their progress in treatment, negative percep- or negative results for treatment medication tions of OTPs, and community concerns that trigger treatment, relapse prevention counsel- may lead to regulatory actions by SAMHSA, ing, HIV counseling, and other intensified accrediting bodies, or the U.S. Drug interventions. Continued use of heroin or other Enforcement Administration. opioids (and possibly other substances) should Most OTPs must review a significant number of generate a review of a patientís addiction medi- unfavorable drug test results. Again, the con- cation dosages. sensus panel emphasizes that results should be used to explore different treatment interven- tions and treatment plans that will reduce and eliminate substance use and improve treatment compliance. Reports indicating substance abuse

156 Chapter 9 should signal the need for a medical review of Patient Falsification of Test medication dosage and for intensification of Results counseling and education aimed at preventing HIV and hepatitis transmission. Also, because False negatives can occur as a result of patient of regulatory concern about medication diver- falsification of drug test results or laboratory sion, reports indicating absence of treatment error. Braithwaite and colleagues (1995) sum- medication should be evaluated carefully. marized some ways in which patients tamper Because dose, pH, and urine concentration can with or obscure the results of urine drug tests, limit detection of treatment medications, staff including substituting urine from another per- members should consider all these areas in con- son, diluting urine specimens, or adding other ducting their medical reviews and deciding on a substances (such as bleach or salt) to samples. plan of action. Strategies to minimize sample falsification When patients deny substance use despite a should be balanced by sound treatment ethics positive laboratory result, a careful history of and the overall goals of the programórecovery their prescribed or over-the-counter drug use and rehabilitation. Common strategies include should be obtained and discussed with a ï Turning off hot water in bathrooms to pathologist or chemist to determine whether prevent patients from heating specimens these drugs might produce false positive results brought from elsewhere (although not feasible or otherwise confound tests. Whenever possi- in States where other regulations prohibit ble, a questionable test should be redone (if the this step) specimen is available) and the result confirmed by another method. If this is impossible, confir- ï Using bathrooms within eyesight of staff to matory analysis should be performed for all preclude use by more than one person at a subsequent tests. More accurate testing meth- time and feeling specimen containers for ods such as RIA or GC/MS can be used to veri- warmth as soon as received (freshly voided fy laboratory reports. Specimens can be col- specimens should be near body temperature lected under direct observation, and a chain of [37 C]) custody can be maintained to assure a patient ï Using temperature and adulterant strips or that every effort is being made to prevent collection devices that include temperature errors and respond to his or her denial. strips Confirmations of positive drug test results gen- ï Using a temperature ìgunî (infrared erally are conducted in a laboratory rather thermometer [visit www.coleparmer.com]) to than at the OTP. D. Simpson and colleagues measure the temperature of urine specimens (1997) emphasized the need to confirm unex- ï Using direct observation by staff of specimen pected negative as well as positive results with collection. additional analyses. Their exhaustive review concluded that TLC is a simple, inexpensive The consensus panel believes that falsification way to confirm the absence of methadone in a is reduced when patients understand that urine urine drug test, but gas chromatography is the test results are not used punitively to lower best choice for rapid, reliable results. GC/MS doses of addiction treatment medication. usually is reserved for confirmation in cases Continued use of drugs requires counseling, with legal implications. High-performance liq- casework, medical review, and other interven- uid chromatography is an improving technolo- tions, not punishment. In the past, some OTPs gy with an increasing role in testing for and reduced medication dosages as a direct result confirming the presence of methadone and its of positive drug tests although this has proved metabolites, as well as other drugs. ineffective and sets up an adversarial relation- ship between patients and the OTP. When it is clear that interventions for substance abuse

Drug Testing as a Tool 157 are ineffective, moving patients to a higher confirmatory GC/MS can be useful. Con- level of care, rather than discharging them, firmatory analysis offsets the limitations is warranted. of single tests.

Patients should be encouraged to discuss their substance use with OTP physicians, casework- False Positive and False ers, or counselors and to trust them with this Negative Drug-Testing Results information. Ideally, once trust has developed, drug test results will confirm what already has Numerous medications and substances can been revealed in individual or group sessions. produce false positive results in urine drug Nevertheless, some patients fear loss of take- tests (see Graham et al. 2003, p. 338). Some home privileges or remain in denial about their researchers have compared quantitative versus drug use and do not disclose their noncompli- qualitative testing, that is, testing to measure ance willingly; drug test results are necessary the amount and frequency of substance use to alert OTPs to these patientsí noncompliance. versus testing to identify the presence or absence of a substance. Wolff and colleagues (1999) noted that false positive results can arise Reliability, Validity, from incorrect identification of a drug or mis- interpretation of a finding. Cone and Preston and Accuracy of Drug (2002) pointed out that EIA analysis lacks the Test Results specificity to distinguish among opioids, and Narcessian and Yoon (1997) reported a case in Another critical concern is the reliability of which consumption of a poppy seed bagel drug testing, which varies by methodology resulted in a positive urine EIA for morphine. (Blanke 1986; Verebey et al. 1998). Accuracy Although EIA can produce some false positive also depends on the choice of laboratory, use of results, TLC may be less sensitive than EIA, proper equipment and methods, quality con- causing more false negative results (Verebey et trol, and adherence to high-quality standards al. 1998). In addition, laboratory and clerical by all involved. As in all laboratory testing, errors and other problems cause inaccuracies. human errors, confounding results, a poorly To check for any of the above problems, controlled chain of custody for samples, and unexpected results should be discussed with other problems lower test reliability. the laboratory before they are conveyed to In the opinion of the panel, urine drug testing the patient. is reliable and valid. A number of studies Cone and Preston (2002) also addressed the have examined the validity and accuracy of pitfalls of qualitative testing, such as the various urine drug-testing analytical methods. increased possibility that with frequent testing Studies generally report that urine analysis by a single drug use episode might trigger multiple EIA techniques is at least 70 percent as accu- positive test results (and result in consequences rate as that for RIA or GC/MS (Caplan and for the patient). In a comparative study, Cone 1997). Preston and colleagues (1997) found that quan- On the basis of cost, the consensus panel titative urine drug testing provided more infor- believes that EIA and TLC usually are ade- mation about patterns and frequency of quate analytical methods in OTP drug testing. cocaine use during treatment than qualitative When results are contested or confusing, con- testing. McCarthy (1994) similarly argued that firmation analyses should be performed. For quantifying the amount and frequency of drug example, when EIA indicates the presence of use (including methadone) is more useful for illicit drugs but the patient denies any drug treatment assessment and decisionmaking than use or has progressed well in treatment, qualitative analysis that simply identifies the presence or absence of a drug.

158 Chapter 9 Responses to Test Results plan into both patient and staff orientations. The diversion control plan must contain specif- Staff members should discuss drug test results ic measures to reduce the possibility of with patients using a therapeutic, constructive diversion and assign specific implementation approach. For example, staff members might responsibility to medical and administrative express concern to patients over any tests that staff (see chapter 14). are positive for illicit drugs and seek additional information to explain these results. If a patient receives medication from a physician Decisions About Take-Home outside the OTP, staff should request informed Medication consent to contact the physician and coordinate treatment, ask the patient to bring in prescrip- Although drug test reports are a key factor in tion bottles, and record these prescriptions in take-home medication decisions, OTPs should patient records. OTP physicians should review consider and docu- prescriptions to determine whether and for ment other considera- how long their use is appropriate, particularly tions, such as employ- when medications have abuse potential. ment and medical problems. Current When results Ultimately, if a positive drug test represents Federal regulations continuing drug use or a relapse after a period (42 CFR, Part 8) out- are contested of abstinence, the counselor and patient should line eight criteria that explore strategies to eliminate future use. the medical director or confusing, Medication dosage and triggers to substance of the OTP must con- use should be examined, motivation for absti- sider when granting confirmation nence should be explored, and the patient take-home privileges should be taught skills to manage triggers and (see chapter 5). The cravings. If drug tests continue to be positive, physician also is analyses should be the medication dosage, amount of counseling, required to reevaluate and number of OTP visits should be evaluated the appropriateness of performed. and may need adjustment. Furthermore, the take-home medica- patient might need the support provided by tions at least every 3 increasing counseling sessions and drug tests. months. These changes should be reflected in an updated treatment plan. Sometimes privileges are revoked simply to prevent possible medication diversion, without a concomitant programmatic response to Medication Diversion address an unfavorable drug test report. When Since methadone treatment gained prominence this occurs without discussion or explanation, in the late 1960s, concerns have existed about OTPs create barriers between themselves and the diversion of medication from legitimate patients and appear to function more as moni- treatment use through theft, robbery, or toring and surveillance units than as treatment patients or staff selling or giving away medica- programs. If patients who are receiving take- tion. SAMHSA-approved accrediting bodies home medications have positive drug test pay particular attention to drug test results and results, OTPs should consider such steps as a whether an OTP appropriately monitors and review of medication dosage and an increase if follows up with patients who receive take-home indicated, revision of the patient treatment medications (see chapter 5). The accrediting plan, or an increase in the level of care, in bodies require all OTPs to develop and imple- addition to cessation or reduction in take- ment a diversion control plan as part of their home doses. quality assurance program and to integrate the

Drug Testing as a Tool 159

10 Associated Medical Problems in Patients Who Are Opioid Addicted

This chapter identifies medical problems commonly encountered in people addicted to opioids, discusses their treatment in opioid treatment In This programs (OTPs), and notes important considerations in deciding which medical services will be provided in an OTP and which can best be per- ChapterÖ formed as a referred service. The chapter also covers medical screening and diagnostic services that are required by Federal and State regulations Integrated Versus or Substance Abuse and Mental Health Services Administration accredita- Referral Services tion guidelines. As such they should be available in or through OTPs.

Routine Testing and Some medical problems are more prevalent and often more severe in Followup for people addicted to opioids than in the general population. Many are Medical Problems infections, including some that can be acutely life threatening, such as Acute, Life- cellulitis, wound botulism, necrotizing fasciitis, and endocarditis. Diseases Threatening that are transmissible pose serious public health threats and are life Infections threatening, such as HIV/AIDS, hepatitis, syphilis, and tuberculosis (TB).

Infectious Diseases Many patients in medication-assisted treatment for opioid addiction (MAT) have chronic diseases such as diabetes, asthma, or hypertension, Patients With as well as conditions such as severe dental problems or seizure disorders, Disabilities which may have been neglected or poorly managed for years. Some patients have chronic obstructive pulmonary disease (COPD), hyperten- Pain Management sion, coronary artery disease, or other illnesses related to long-term Hospitalization of heavy tobacco use. Management of chronic pain for patients in MAT is Patients in MAT particularly challenging because of the role of opioids in pain treatment. In addition, opioid intoxication may result in head trauma or other bod- General Medical ily injury. Criminal activity may produce severe physical injuries such as Conditions and gunshot wounds. The general approach in OTPs for these and other MAT medical problems is to remain alert and knowledgeable, facilitate pre- ventive measures, and provide ongoing medical care and emergency treatment to the extent possible.

161 Integrated Versus studies have shown the public health benefits of this arrangement (e.g., Batki et al. 2002; Referral Services Umbricht-Schneiter et al. 1994). Given that many OTPs lack resources to treat The consensus panel recommends that each acute and chronic medical problems associated OTP clearly define the medical services it with addiction, applicants with these medical offers on site versus by referral. Safety, practi- issues may sometimes be denied treatment cality, and efficacy are important considera- admission for addiction because an OTP can- tions in these decisions. For example, patients not manage their other medical needs. Even needing treatment for acute conditions such as when people with difficult medical problems bacterial endocarditis, those needing treatment are admitted to an OTP, unavailable or frag- for severe liver disease, or those requiring mented medical and psychiatric services may obstetric and gynecologic services generally are cause these patients to leave MAT prematurely, referred to primary or specialty care providers relapse to substance use, or resort increasingly because most OTPs lack the resources to pro- to inpatient, emergency, or other expensive vide those services. The panel recommends that services because proactive care is lacking. OTPs establish sound links with medical The consensus panel believes that many medi- providers and programs skilled in treating cal problems associated with opioid addiction problems that go beyond the direct services of should be treated either within the OTP or the OTPs. through liaisons with outside specialists and It is important for patients to understand an programs. One ran- OTPís policies regarding services provided on domized, controlled site versus by referral. For example, an OTP trial in a large health might offer testing for infectious diseases but OTPs [should] maintenance organi- refer patients for treatment of these diseases. zation showed that Such distinctions, as well as whether and how integrating addiction establish sound staff members will follow up to ensure that treatment and medi- patients comply with offsite treatment, should cal care was cost links with medical be clear. Referral services should be part of a effective and patientís opioid addiction treatment plan. The improved patient providers and pro- consensus panel recommends that primary care outcomes (Weisner et responsibility be established either on site or al. 2001). Integrating through a community provider because special- grams skilled in medical and addic- ists are more likely to accept patients if their tion treatments is primary care responsibility has been assigned. treating problems both a challenge and OTPs also should inform local hospitals about an opportunity to their services and willingness to provide medi- that go beyond the match strategies for cal information (e.g., dosage information for more cost-effective addiction treatment medications, assuming a direct services of interventions. patientís informed consent) when a patient in Medical services for MAT is admitted to a hospital for medical at least the most treatment. the OTPs. common problems (such as soft-tissue In many cases, patients need help to under- infections, hepatitis, stand their testing and treatment experiences at HIV infection, other sites, and they may feel uncomfortable hypertension, diabetes, and COPD) should be asking offsite providers questions. OTP staff provided at the OTP with expansion to other should be ready to help patients understand medical services as resources permit. Several

162 Chapter 10 procedures and care received off site and what The most common of these life-threatening these experiences mean for their overall care. conditions are discussed below.

Routine Testing and Endocarditis Followup for Medical Endocarditis is an infection, usually bacterial, of the inner lining of the heart and its valves. A Problems diagnosis of possible endocarditis should be Because medical problems associated with considered in any patient with recent injection opioid abuse sometimes emerge or are resolved marks and fever or a newly appearing heart during MAT, OTPs should establish protocols murmur. A history of previously treated endo- for both assessment of acute problems and carditis might produce persistent heart mur- periodic reassessments. The consensus panel mur. Patients who have survived endocarditis recommends periodic (every 6 to 12 months) by having a valve replacement are at increased testing for hepatitis A, B, and C; syphilis and risk of recurrent endocarditis. Fever in other sexually transmitted diseases (STDs); patients with a heart murmur always merits TB; HIV infection; hypertension; and diabetes. careful clinical investigation. Liver and kidney functions also should be evaluated routinely. With the exception of HIV Soft-Tissue Infections testing, these tests can be performed during routine evaluation. HIV testing requires a Soft-tissue infections, such as abscesses and patientís written permission, along with coun- cellulitis, involve inflammation of skin and seling before and after the test (see TIP 37, subcutaneous tissue, including muscle. Substance Abuse Treatment for Persons With Contaminated injection sites often swell and HIV/AIDS [CSAT 2000e]). Some OTPs repeat become tender. When swelling and tenderness physical examinations annually, and others do persist, infection is likely. A fluctuant abscess so every 2 years. The consensus panel believes might need incision and drainage. Depending that physical examinations of patients in MAT on its severity, cellulitis may require treatment should be performed at least annually. with intravenous antibiotics. Patients with Tuberculin skin tests should be performed abscesses or cellulitis might not have fever. every 6 to 12 months, depending on the epi- demiology of the region and recommendations Necrotizing Fasciitis from public health authorities. Necrotizing fasciitis, sometimes called flesh- eating infection, usually is caused by introduc- Acute, Life-Threatening tion of the bacterium Streptococcus pyogenes into subcutaneous tissue via a contaminated Infections needle. It is uncommon, and cases caused by OTP medical staff, in particular those perform- other bacteria also have been reported (Noone ing intake assessments, should recognize most et al. 2002). The infection spreads along tissue potentially life-threatening infections related to planes and can cause death from overwhelming opioid abuse. Some of these conditions can sepsis within days without much evidence of mimic opioid or intoxication withdrawal. In inflammation. Some patients may lose large many cases, patients may be unaware of the areas of skin, subcutaneous tissue, and even severity of their conditions or may attribute muscle, requiring grafting. Case fatality rates their symptoms to withdrawal. Because patients from 20 to more than 50 percent have been are focused on avoiding withdrawal, their reported (Mulla 2004). This infection should be descriptions of their histories may be unhelpful. considered when pain at an injection site is more severe than expected from the redness or

Associated Medical Problems 163 warmth at the site. Edema (fluid accumulation as well as some immigrant groups. Intensive and swelling), fever, hypotension, and high public health efforts decreased reported cases white blood cell counts are additional clues. of syphilis from the 1990s through 2000, but Treatment includes extensive debridement reported cases increased 2.1 percent in 2001 (cutting away of infected tissue) and intravenous (Centers for Disease Control and Prevention antibiotics. Earlier ingestion of antibiotics, espe- 2003c). Reported TB cases continued to cially if these antibiotics were unprescribed, decrease during the same period (Centers for may result in partial treatment of necrotizing Disease Control and Prevention 2002b). fasciitis and modify its diagnosis and course (Smolyakov et al. 2002). TB Public health statutes in all States require that Wound Botulism the U.S. Public Health Service be notified of all Botulism is caused by the neurotoxin of cases of known or suspected active TB. State Clostridium botulinum, a bacterium usually and Federal laws mandate appropriate fol- found in contaminated food. Botulism causes lowup and treatment of anyone whose TB might loss of muscle tone, including respiratory mus- have been acquired from known exposure to an cle weakness, making it life threatening. The individual with active TB. presenting symptoms and signsódifficulty swallowing (dysphagia), difficulty speaking Frequency and types of (dysphonia), blurred vision, and impaired body movements (descending paralysis)ómay mimic testing signs of intoxication (Anderson et al. 1997). An The consensus panel recommends that patients epidemic of botulism poisoning among people in MAT be screened for TB every 12 months who injected drugs occurred in the 1990s in unless local epidemiology and transmission pat- several areas, particularly California (Werner terns and the recommendations of local health et al. 2000). Several cases in people who injected authorities indicate that more frequent testing drugs have been reported in Europe and Great is needed. High-risk groups, for example, Britain (Jensen et al. 1998; McGarrity 2002). patients still injecting drugs and health care workers who must treat them, should be screened more frequently (e.g., every 6 Infectious Diseases months). New staff members should be Some infectious diseases that are prevalent screened for TB, and all staff members should among patients in MAT, including TB, viral be retested regularly, depending on local preva- hepatitis, HIV infection, and STDs, are lence. Patients should receive a purified pro- monitored closely by the Centers for Disease tein derivative (PPD) skin test for TB both on Control and Prevention (CDC), which provides admission and annually, unless local health recommendations about testing, evaluation, authorities indicate that more frequent testing classification, and treatment and publishes is needed or patients are known to be PPD pos- surveillance data. This information changes itive. In addition, treatment providers should periodically, and the most recent data can be look for and question patients about other obtained from CDCís Web site (www.cdc.gov) symptoms of active TB, such as persistent and its publications. cough, fever, night sweats, weight loss, and fatigue. OTPs should use the Mantoux test, The incidence of reported cases of TB and which injects five tuberculin units of PPD syphilis in the general population in the United intradermally. Patients who are HIV positive States peaked in 1992. Groups identified to be are considered PPD positive if an induration of at high risk included individuals who were 5 mm or more appears. Those who are HIV homeless, incarcerated, or infected with HIV, negative are considered PPD positive if an

164 Chapter 10 induration of 10 mm or more appears. The (Centers for Disease Control and Prevention standard classification system for TB is shown 2002b). Patients with class 2 TB do not transmit in Exhibit 10-1. the disease. Those who have a history of exposure (e.g., when a family member has TB) Positive PPD. The PPD skin test detects the but remain uninfected (i.e., their skin tests are immune response when a patient has been negative) are considered to have class 1 TB and infected with TB. However, patients who have sometimes are treated prophylactically. received a Bacillus Calmette-Guerin (usually called BCG) vaccination will have a positive The consensus panel recommends following PPD, and a chest x ray is indicated. Infections CDC guidelines on frequency of chest x rays for need not be active to be detected. Earlier patients in MAT who are PPD positive. The infections controlled by the immune system are medical staff should facilitate referrals for such inactive, but they cause positive test results. In patients to be evaluated at appropriate facilities these cases, patients do not have symptoms of (e.g., county TB clinics, affiliated or local hos- TB, and chest x rays show no evidence of active pitals, patientsí private physicians) and should TB. These patients are considered to have class ensure necessary followup. 2 TB and should receive prophylaxis with isoni- azid to prevent later activation of infection

Exhibit 10-1

Classification of TB

Class Type Description 0 No TB exposure No history of exposure; negative skin test for TB 1 TB exposure; no History of exposure; negative skin test for TB evidence of infection 2 TB infection; no disease Positive skin test for TB; no clinical, bacteriologic, or radiographic evidence of active TB 3 TB infection; clinically Mycobacterium tuberculosis-positive culture (if done); active clinical, bacteriologic, or radiographic evidence of active TB 4 TB infection; not History of TB episodes clinically active now; or clinically active in past Abnormal but stable radiographic findings; negative bacteriologic studies (if done); positive skin test for TB and No clinical or radiographic evidence of active disease 5 TB suspected Diagnosis pending

Source: Centers for Disease Control and Prevention 2000, p. 15.

Associated Medical Problems 165 Negative PPD. A negative PPD means one of resistant TB. Some patients may benefit from three things: there is no TB infection (class 0), receiving their TB medication under direct the infection is in the incubation period, or the observation along with their addiction treat- patient is unable to respond to the skin test ment medication (Batki et al. 2002; Gourevitch (i.e., is anergic) (see Exhibit 10-1). Because et al. 1996). However, directly observed treat- many patients who are immunocompromised ment for eligible patients should be optional. and HIV infected are immunologically anergic, Addiction treatment medications should not be chest x rays are considered a routine part of withheld to ensure adherence to TB medications. their HIV care. Isoniazid is effective in TB prevention but can cause liver toxicity (Centers for Disease Control Prevention of TB in MAT and Prevention 2000). In view of the high Adequate room ventilation is important for TB prevalence of liver disease and hepatitis among prevention (Centers for Disease Control and patients in MAT, liver enzymes should be moni- Prevention 2000). tored during isoniazid therapy. A significant Special attention increase (i.e., doubling or more) in one or more should be paid to liver enzymes (alanine aminotransferase or [T]reatment waiting rooms, cor- serum pyruvic transaminase, aspartate amino- ridors, and offices. transferase, or lactate dehydrogenase) suggests providers should Patients with active liver toxicity and warrants a thorough medical TB who are cough- evaluation. look for ing in an unventilat- ed room are most If rifampin is used to treat TB in patients likely to spread the receiving MAT, their addiction treatment medi- and question disease and should cations should be adjusted carefully because receive masks or rifampin accelerates clearance of methadone patients about... special precautions and other drugs metabolized by the liver (see should be taken to chapter 3). Rifabutin can be used as an alter- symptoms of active prevent transmis- native in patients receiving methadone. The sion pending medi- methadone dose may need to be increased, TB... cal evaluation. OTP split, or both. staff should be edu- cated about this STDs risk. Patients diag- nosed with active TB are quarantined in a hos- Syphilis pital when treatment begins and generally are not released until their sputum tests revert to The consensus panel recommends that all negative. Undiagnosed cases of TB increase the patients admitted to OTPs be tested at intake exposure risk in communities; therefore, for syphilis with one of the serologic blood tests aggressive evaluation and screening are crucial. described by CDC (Centers for Disease Control and Prevention 2002c), including the rapid plasma reagent or the Venereal Disease Treatment of TB during MAT Reference Laboratory test. Because false Isoniazid is used with vitamin B6 for prophylaxis positive results are common with nontrepone- to prevent active TB. Isoniazid is combined mal serologic tests in people who inject drugs, with other medications when patients have all positive tests should be confirmed with a active TB (Centers for Disease Control and treponemal antigen test such as fluorescent tre- Prevention 2000). In either case, OTP staff ponemal antibody absorption or Treponema members should monitor medication compliance pallidum particle agglutination. Patients with a actively to prevent the emergence of multidrug- confirmed positive serologic test for syphilis

166 Chapter 10 need to receive treatment either on site or by HBV infection, both active and carrier states referral to a local clinic, hospital, physicianís are marked by persistent surface antigen office, or health department. Treatment of expression. A chronic carrier is someone who syphilis is particularly important because remains positive for serum hepatitis B surface syphilis has been shown to facilitate sexual antigen for 6 months or more. Recovery is transmission of HIV. marked by the disappearance of surface anti- gen, which is replaced by surface antibody. Chlamydia and gonococcus Core antibody (antibody to HBV core proteins) is present whenever patients are infected with infections HBV, regardless of outcome. If patients are not Genital chlamydia and gonococcus infections exposed to HBV, tests for the core antibody will often go undetected and may facilitate the be negative, but these patients remain suscepti- sexual transmission of HIV. One cross-sectional ble to infection if exposed. study found that 7.9 percent of all adults between ages 18 and 35 had untreated gonococ- Testing is important to identify individuals with cal or chlamydial infections (Turner et al. acute hepatitis B, those in chronic HBV carrier 2002). Although testing for sexually transmitted states, and those who are untreated but symp- genital infections is recommended in OTPs, it tomatic for chronic active hepatitis B, as well often is ignored because it requires a full pelvic as those unprotected from HBV infection who and genital examination. Increased availability can be immunized (Centers for Disease Control of urine testing for STDs might enhance access and Prevention 2002c). All patients in MAT to their treatment in patients receiving MAT. should be tested on admission via blood tests Additional information is available in TIP 6, for both anti-HBV core antibody and HBV Screening for Infectious Diseases Among surface antigen. If patients are positive for the Substance Abusers (CSAT 1993a). surface antigen, further medical evaluation and counseling about avoiding transmission to oth- ers is important. Medical evaluation, including Hepatitis liver function testing, needs to be done on site or by referral. Hepatitis A Patients who are negative for core antibody Hepatitis A is an important viral liver infection and surface antigen should be advised of their that affects people who abuse drugs at higher susceptibility to HBV infection and vaccinated rates than rates found in the general popula- at the OTP if possible, although cost is a factor tion. Hepatitis A can cause serious morbidity in most OTPs. Patients who are positive for and mortality in patients already infected with HBV surface antibody either have been infected hepatitis B virus (HBV) or hepatitis C virus or were vaccinated and probably are protected. (HCV). OTPs should screen for hepatitis A virus (HAV) and provide vaccination services All staff members risk exposure to HBV or referral to such services for individuals who infection, especially those who do physical are unexposed. examinations or handle urine or blood specimens, and they should receive hepatitis Hepatitis B B vaccine, according to Occupational Safety and Health Administration standards for Fifty to seventy percent of people who begin blood-borne pathogens (29 Code of Federal injecting drugs contract hepatitis B within 5 Regulations [CFR], Part 1910 ß 1200). years, accounting for 17 percent of all new cases in 2000 (Centers for Disease Control and Prevention 2003d). This prevalence is Hepatitis C particularly disturbing because vaccination can An estimated 70 to 90 percent of people who prevent HBV infection. In people with chronic inject drugs have serologic evidence of

Associated Medical Problems 167 exposure to HCV (National Institutes of Health damage, as well as encouragement to be evalu- 2002), which indicates that OTPs will treat ated further. These patients should know that some patients with chronic HCV infection. alcohol ingestion significantly worsens hepatitis The most appropriate intervention depends C (Regev and Jeffers 1999). They also should on HCV stereotype liver disease, alcohol be tested and receive vaccinations for HAV and consumption, and HIV status. HBV infections if they have not been vaccinated. Because acute hepatitis A can be severe among Testing for HCV. The consensus panel recom- HCV-infected patients, hepatitis A vaccination mends that patients be tested by enzyme is recommended for all persons who are HCV immunoassay for exposure to HCV. Testing infected. Many standard ìhepatitis panelî should be simple and accessible on site. When blood tests include a test for HAV antibody. In HCV antibody test results are negative, it is addition, patients who are HCV-antibody posi- important to educate patients about HCVís tive should avoid high doses of acetaminophen high transmissibility. The main method of because it can cause liver damage, and their transmission in this group is injection drug use HCV antibody status should be communicated (National Institutes of Health 2002). Hepatitis to any physician prescribing medication so that C is transmitted more than hepatitis A or B liver-toxic drugs are avoided (Thomas et al. or HIV/AIDS. In one study, most subjects 2000). became infected with HCV within the first 2 years of injection drug use (Thomas et al. In contrast to HIV, the viral load of HCV does 1995). Hepatitis C also can be acquired not correlate with its liver disease severity. For through sexual transmission. However, this is patients who have quantitative HCV, a complete much less efficient than the parenteral route. evaluation of liver disease includes determina- Sexual transmission of HCV occurs more fre- tion of liver enzymes and a liver biopsy (Saadeh quently in HIV-infected individuals than in et al. 2001). Virus genotyping is important if other individuals. pharmacotherapy is considered because the results indicate the optimal length of treatment. Determination of HCV disease activity. A Treatment decisions are not based on patientsí positive HCV antibody test indicates patient symptoms but on HCV genotype, level of liver exposure to HCV. Further evaluation should disease, co-occurring illnesses, and willingness determine whether HCV infection has self- to undergo treatment. A decision flowchart for resolved (cleared) or is chronic. Approximately evaluating patients for HCV exposure is given 15 to 25 percent of patients exposed to HCV in Exhibit 10-2. clear their infections. To determine whether HCV infection still is present, a test for HCV Treatment of hepatitis C. The decision to treat ribonucleic acid is required. This test uses patients in MAT for chronic hepatitis C infec- polymerase chain reaction and is costly, pre- tion is complex because it must include many senting a significant barrier for patients with- factors, such as presence of co-occurring disor- out health insurance. Detection of liver ders, motivation to adhere to a 6- to 12-month enzymes is a cheaper test but is insufficient to weekly injection schedule, and medication side detect the virus. Twenty-five to fifty percent of effects. Results of HCV genotyping (another people with HCV infection have normal liver expensive blood test) and a liver biopsy also enzymes (Inglesby et al. 1999). Patients with must be considered. Counselors in OTPs can chronic hepatitis C infection may have few or support patients who are deciding whether to no symptoms, so they have little incentive to undergo hepatitis C treatment. Patients with incur further expense and visit their physicians. HCV infection who do not need treatment (minimal liver disease) may be concerned about The consensus panel recommends that OTPs liver disease progression. They should be provide patients who are HCV positive with informed that liver disease progresses to cir- advice on minimizing their risk of liver rhosis in 10 to 15 percent of cases and that its

168 Chapter 10 Exhibit 10-2

Hepatitis C Evaluation Flowchart

progression is more likely with alcohol con- The duration of hepatitis C treatment depends sumption. Co-infection with HIV or other types on the virus genotype. Most patients are of hepatitis also may be associated with higher infected with genotype 1 virus and require risks of disease progression (National Institutes approximately a year of treatment, consisting of Health 2002). of polyethylene glycol (PEG) interferon-alpha combined with ribavirin. In genotype-2 and

Associated Medical Problems 169 genotype-3 patients, 6 months of treatment usu- Sylvestre and Clements 2002). Patients ally is sufficient. The most effective interferon at required moderate increases in methadone dur- this writing is pegylated interferon alpha-1 or ing treatment, perhaps related to the discom- alpha-2a. Treatment combines one interferon fort of side effects (Sylvestre 2002a). Support injection per week with ribavirin taken twice groups met twice per week, led by both a coun- daily in capsule form for up to 1 year depend- selor and a peer; educated patients about HCV; ing on viral subtype. Side effects include flulike and provided a forum to share fears, crises, symptoms and depression. Ribavirin also can problems, and successes (Sylvestre 2003). A have numerous adverse effects, most notably National Institutes of Health consensus state- anemia and neutropenia. Therefore, co- ment (National Institutes of Health 2002) also occurring disorders and anemia should be encouraged hepatitis C treatment for patients evaluated carefully before initiating hepatitis C who inject drugs: treatment. Pretreatment with Many patients with chronic hepatitis C antidepressants can have been ineligible for trials because Treatment be helpful to control of injection drug use, significant alcohol treatment-induced use, age, and a number of comorbid medical and neuropsychiatric condi- effectiveness is depression. Some selective serotonin tions. Efforts should be made to increase the availability of the best cur- measured by reuptake inhibitors can increase plasma rent treatments to these patients. levels of methadone absence of Treatment effectiveness is measured by absence or levo-alpha acetyl of detectable HCV after the treatment course methadol (LAAM) detectable HCV and at 24 weeks after completion of treatment (see chapter 3); (sustained virologic response [SVR]). In one therefore, patients after the treatment study, combination treatment with pegylated receiving these medi- interferon and ribavirin produced an SVR in cations should be more than 40 percent of patients (Manns et al. course and at 24 observed for seda- 2001). Most patients (75 percent or more) had tion or other effects genotype 1 HCV infection, which is associated weeks after of overmedication. with worse response (Manns et al. 2001). In Many treatment studies of all patients receiving these treatments completion of providers are reluc- (i.e., not just patients who abused substances), tant to treat patients pegylated interferon and ribavirin produced treatment... who are opioid higher response rates for HCV genotypes 2 and addicted for HCV 3 after only 6 months of treatment, whereas infection, but their regular interferon was less effective (Manns et concerns are unsup- al. 2001). From approximately 50 (Lau et al. ported by evidence (Edlin et al. 2001). 1998) to more than 90 percent (Fontaine et al. Sylvestre (Sylvestre 2002a, 2002b) and 2000) of patients with an SVR in these studies Sylvestre and Clements (2002) reported excel- remained virus free. Treatment had partial lent treatment results for HCV in patients on benefits for those who did not clear the virus, methadone maintenance, using a model that such as reduced liver disease (Baffis et al. 1999; included pretreatment with antidepressants Poynard et al. 2000). when necessary and weekly group support Treatment choices are complex for patients who meetings, a key element in treatment success. have not responded to hepatitis C infection Success in treatment did not require absti- treatment, have dropped out of treatment, or nence, although patients who used illicit drugs have been judged too ill or behaviorally dis- daily did not respond well (Sylvestre 2002b; turbed for treatment. There is no consensus

170 Chapter 10 on whether treatment reinstatement might be with untreated groups and that these rates beneficial or medical maintenance should be continued to decrease with time in treatment continued for partial responders. (e.g., Ball et al. 1988; Novick et al. 1990). These lifesaving benefits of MAT have contributed sig- Liver transplant. Transplantation is a last nificantly to the respect MAT is accorded with- recourse for patients with hepatitis C infection in the medical community. with end-stage liver disease. The consensus panel recommends that MAT providers become TIP 37, Substance Abuse Treatment for Persons familiar with the policies of regional transplant With HIV/AIDS (CSAT 2000e), provides infor- centers and their acceptance requirements. mation on the natural history or course of Success in obtaining a transplant may depend HIV/AIDS and treatment for HIV/AIDS. A pub- on timeliness of action by a patientís extended lication from the Center for Substance Abuse treatment team. Patients receiving methadone, Treatment (CSAT 2004b) provides information LAAM, or buprenorphine for opioid addiction on confidentiality issues related to substance may be barred from transplant programs or abuse treatment programs. accepted only if they taper from their mainte- nance medication before transplantation (Koch Testing for HIV infection and Banys 2001). OTP medical staff members can serve as advocates for patients needing The U.S. Public Health Service and many State transplants. A common concern is that patients health departments recommend that HIV coun- will be unable to comply with complicated care seling and testing be routinely offered in drug after their transplant. On the contrary, limited or alcohol prevention and treatment programs, reports on transplantation in patients receiving especially where most patients have injected MAT have shown excellent compliance with drugs and therefore are at increased risk aftercare, although their outcomes were not (Centers for Disease Control and Prevention compared with patients with no history of sub- 2001a). ìRoutinely offeredî means providing stance use (Kanchana et al. 2002; Koch and these services to all patients after informing Banys 2002). them that the test can be done either on site or through referral. CDC also recommends that pretest counseling be required for all patients HIV/AIDS (Centers for Disease Control and Prevention Since the early 1990s, the prevalence of HIV 2001a) and that HIV testing be recommended infection has increased substantially in most of strongly and viewed as a routine procedure. the United States among people who inject Individuals should be informed that they may drugs (Hartel and Schoenbaum 1998). A 1998 decline this testing without losing health care or survey by the American Methadone Treatment other services. Counseling and testing also Association (now the American Association for should be made available to patientsí acquain- the Treatment of Opioid Dependence) reported tances who might have been exposed to HIV. that approximately 25 to 30 percent of patients The consensus panel further recommends that receiving methadone treatment in the United HIV counseling and testing be provided by the States were infected with HIV (Gourevitch and OTP at no cost. Either a trained employee or Friedland 2000). In practical terms, these someone from an outside agency can provide statistics mean that OTPs should be prepared counseling and testing services. Some States to care for many patients who are HIV positive may have certification requirements. Many or have AIDS. State health departments, as well as CDC, pro- Relatively early in the AIDS epidemic, it was vide training or training materials for HIV shown that rates of needle use and conversion counseling and testing. Standard tests include to HIV seropositivity decreased in patients enzyme immunoassay for antibodies to HIV-1 receiving methadone maintenance compared and HIV-2 and confirmation by Western blot

Associated Medical Problems 171 analysis (Centers for Disease Control and HIV medications and Prevention 2001a). Several other tests are methadone approved by the U.S. Food and Drug Administration (FDA), including tests using Gourevitch and Friedland (2000) summarized urine and saliva and rapid tests that give interactions between methadone and commonly results in 10 to 60 minutes (see chapter 4). used HIV medications. Some medications, such These newer tests are for HIV-1 only, and posi- as fluconazole, increase methadone levels, and tive tests are reconfirmed by Western blot. others, such as nevirapine, efavirenz, and OraQuick also tests for HIV-2. Although HIV-2 ritonavir, lower them. These authors pointed is rare in the United States, testing for it still is out that decisions about raising or lowering recommended for blood bank donations and in methadone dosages for patients in MAT who special populations, such as immigrants from are HIV positive should be based on observa- West Africa. There also is an FDA-approved tion during the first month of any treatment home collection kit that allows a sample to be change because some patients react differently sent from home for testing (Branson 1998; than indicated by published information Centers for Disease Control and Prevention (Gourevitch and Friedland 2000). If necessary, 2001a). TIP 37, Substance Abuse Treatment peak and trough blood levels can be drawn and for Persons With HIV/AIDS (CSAT 2000e), split dosing provided accordingly. provides additional information about patients infected with HIV. Neurologic complications of AIDS and its treatment Prevention of HIV infection Pain from neuropathy is difficult to control Universal precautions to prevent the spread of with opioids alone, and some patients do better HIV through contaminated bodily fluids with gabapentin or antidepressants instead of, (Centers for Disease Control 1988a) should be or in addition to, an increased methadone followed in any OTP. The consensus panel rec- dosage or the addition of another opioid for ommends that staff members be educated about breakthrough pain (see ìPain Managementî how HIV is transmitted both to avoid exposure below). Patients with AIDS-related dementia or and to reduce generally unfounded fears of loss of balance may become erratic and difficult contamination during daily interactions with to monitor in an OTP. For them, a referral for patients such as counseling or shaking hands. neuropsychological evaluation may be helpful Prevention should include a factual under- to identify any cognitive deficits and effective standing of the highly charged, often panic- ways to provide supportive care. As dementia laden beliefs surrounding AIDS. worsens, patients with take-home privileges may lose methadone bottles or mistakenly take The panel believes that having an AIDS coordi- more than one daily dose. Patients who fall or nator on staff as the resident expert, communi- are unsteady might be assumed erroneously to ty liaison and educator, and patient resource is be intoxicated. Close cooperation between OTP optimal in areas with high HIV prevalence. staff and providers treating these patients for Education about HIV should be part of the AIDS is key to managing patients with neuro- intake process for all patients and should logic complications of AIDS. include a description of the modes of transmis- sion (stressing sexual as well as needle-sharing transmission), assessment of risk status, guide- Referral for treatment lines for prevention, and the importance of Most OTPs offer no onsite treatment for HIV HIV testing in prevention and intervention. because of its complexity and their limited resources. Referral usually should be made for medical assessment of patients who are HIV positive. A standard assessment may include a

172 Chapter 10 baseline CD4 T-cell count, viral load, and Home Dosing for Patients tuberculin skin test, along with updated immu- With Disabilities in MAT nizations. Based on the results, physicians should discuss the potential utility of antiviral Home dosing is an important option for therapy (Krambeer et al. 2001). Depending on patients whose disabilities preclude daily OTP the availability of medical services, referrals visits. However, some patients are ineligible. can be made to private physicians, infectious For example, those with AIDS or other medical disease specialists, HIV early-intervention problems that affect neurological functioning treatment programs, hospital-based clinics, or may be unable to community health centers. TIP 37, Substance manage their medica- Abuse Treatment for Persons With HIV/AIDS tion without supervi- (CSAT 2000e), provides suggestions regarding sion. Others who are Patients in medical-care referrals. medically compro- mised and continue to methadone Benefits of early intervention abuse substances usu- ally are ineligible for maintenance... The benefits of early intervention to control take-home dosing. HIV and opportunistic infections should be These patients pose have high levels stated clearly to patients. Patients and treat- major challenges for ment staff, including drug counselors, should OTPs, and treating of tolerance for discuss the importance of notifying patientsí them requires cre- sex and needle-sharing partners, and staff ative planning. members should offer help in this. Encourage- the analgesic ment to continue in MAT or another form of Solutions vary from addiction treatment is extremely important program to program effects of opioids. because addiction treatment participation may and in different foster adherence to HIV treatment and lead to areas. For patients reductions in the spread of HIV. with disabilities who do not meet take-home eligibility criteria, home dosing sometimes can be negotiated under the Patients With emergency dosing provisions of Federal or State regulations. For example, some OTPs Disabilities identify a responsible family member or signifi- OTPs increasingly must address the needs of cant support person to assist with dosing. With disabled patients. TIP 29, Substance Use patient permission, these individuals can be Disorder Treatment for People With Physical educated about addiction treatment medica- and Cognitive Disabilities (CSAT 1998c), dis- tions and made responsible for picking them up cusses the requirements of the Americans with from the OTP, ensuring safe storage (e.g., Disabilities Act of 1990. Many patients with locked boxes, limited key access), and adminis- AIDS have disabilities such as visual impair- tering them daily to these patients. For patients ment, or they lack the strength to visit an OTP. who cannot identify such people, OTPs might Other patients may have hearing impairments negotiate medication support through the or other disabilities, some since birth and some Visiting Nurses Association or comparable caused by trauma or other events. In one programs that can assist in this process. study, prevalence of illicit drug use was higher for persons with disabilities than for others. Some OTPs deliver medication directly to dis- The types of drugs used varied with age (Gilson abled patientsí homes, but such arrangements et al. 1996). may be impractical when patients live far from their OTPs, and delivery often is expensive.

Associated Medical Problems 173 Switching from methadone to LAAM might ease specialists more familiar with the use of the accessibility problem somewhat, but, as methadone in pain treatment, and they also indicated elsewhere are more likely to understand that methadone in this TIP, the should be continued if patients receiving MAT future availability of are hospitalized. Reluctance to provide ade- Home dosing is an LAAM is doubtful. quate pain treatment to patients in MAT Buprenorphine, with usually is based on the mistaken belief that a its longer duration of maintenance dose of opioid addiction treatment important option action, also might be medication also relieves acute pain. In fact, considered. long-term opioid pharmacotherapy produces for patients whose substantial tolerance for the analgesic effects Regardless of the of opioid treatment medications; therefore, a disabilities pre- strategy, meeting the usual maintenance dose affords little or no needs of homebound pain relief. clude daily OTP patients is a chal- lenge. Home dosing Patients receiving methadone maintenance can be time consum- treatment were shown to be hyperalgesic, visits. ing and expensive, meaning that they experienced pain more and it introduces severely than those not receiving methadone safety and security (Doverty et al. 2001b). Patients in methadone problems. maintenance also were shown to have high Consideration should be given to negotiating levels of tolerance for the analgesic effects of with pharmacies or interested physicians who opioids, suggesting that conventional doses of can work directly with OTPs to provide home morphine may be ineffective in managing dosing in geographically remote areas. The con- episodes of acute pain in this patient group sensus panel encourages OTP administrators to (Doverty et al. 2001a). engage in discussions with their State agencies, the U.S. Drug Enforcement Administration Another common concern is that opioid- (DEA), FDA, and other Federal and local containing analgesics aggravate addiction agencies to develop creative solutions. disorders. In fact, relapse to illicit opioid use has occurred when opioid analgesics are given to people in recovery. Such patients generally Pain Management should not be given the drugs they abused previously, and patients with current or past Patients in MAT have been shown to have high opioid addiction should be monitored more rates of acute and chronic pain (Rosenblum et closely than those without these problems. al. 2003). Medical treatment providers, accred- Relapse occurs most often when practitioners iting bodies, and the popular press have are unaware of their patientsí opioid focused considerable attention on the need for addiction history. adequate pain treatment, particularly to relieve chronic, nonmalignant pain or pain at the end Occasionally some patients do not meet of life, including palliative care with large doses Diagnostic and Statistical Manual of Mental of opioids. Pain in MAT patients can sometimes Disorders, Fourth Edition, Text Revision be managed with nonopioid medications, as (DSM-IV-TR) (American Psychiatric well as nonpharmacologic approaches, but Association 2000), criteria for addiction, but often the pain is severe and refractory to they believe they are addicted to pain medica- nonopioid analgesics or nonpharmacologic tion because they are dependent physically as a treatments. result of chronic use of these medications. A patient or physician who lacks education about Increased attention to pain control has made MAT might interpret physical dependence even physicians who are not addiction alone (i.e., not psychological addiction) or drug

174 Chapter 10 seeking for poorly managed chronic pain as Acute pain addiction. Ideally, such patients should be Patients occasionally require medical, surgical, referred to pain management specialists. and dental procedures that must be performed However, the consensus panel recommends that away from the OTP. In their guidelines for they also be accepted for MAT. Disadvantages treating pain in patients receiving methadone, of this approach are that regulations and Scimeca and colleagues noted that these requirements for observed dosing may be oner- patients often required large doses of opioids at ous and that these patients receive treatment relatively short intervals for pain control where most patients are opioid addicted, which because they had developed tolerance for might not be therapeutic for patients not opioids. One recommended approach to pain addicted in the usual sense. If these patients management for this group was to prescribe are treated in OTPs, the new regulatory frame- adequate doses of an alternative mu opioid work allows for up to 1 month of take-home agonist, such as morphine, , or medication, provided evidence of stability and oxycodone, while maintaining the maintenance absence of unprescribed drug use exist (see dose of methadone or LAAM (Scimeca et al. chapter 5). This option could reduce markedly 2000). Partial agonists such as buprenorphine, the burdens imposed by the earlier, more rigid tartrate, and should regulatory framework of OTPs. In smaller be avoided because they can cause opioid with- communities with no OTPs, such patients might drawal in patients receiving MAT (Rao and be ostracized from pharmacies or from primary Schottenfeld 1999). Whenever possible, pain care offices for insisting on proper pain con- management should be discussed with care trol. Effort should be made to find physicians providers before surgery or dental procedures. who will help them manage their pain. Some physicians are willing to accept patients after Several principles provide the basis for manag- they have been stabilized by the OTP. ing acute pain in hospitalized patients also receiving opioid addiction pharmacotherapy Types of Pain (Compton and McCaffery 1999; Savage 1998; Scimeca et al. 2000): Examples of conditions, either foreseeable or unplanned, that produce acute pain include ï Methadone should be continued at the same traumatic injury, dental procedures, and labor daily dose, whether by oral or intramuscular and delivery. A dying patient with lung cancer routes, although it can be divided. For exam- probably has chronic malignant pain. Patients ple, 50 percent of the usual dose can be given with arthritis or disc disease might have chronic before surgery and 50 percent after. If nonmalignant pain. In addition, patients in methadone must be given parenterally, the MAT might have withdrawal-related pain, injected dose should be 50 percent of the usually as aches in bones and joints along with oral dose, because it is absorbed twice as other withdrawal signs and symptoms. Various efficiently by injection. types of pain are not mutually exclusive. For ï LAAM patients can be treated temporarily example, withdrawal, anxiety, and depression with equivalent daily methadone doses (usu- make chronic pain worse, and patients with ally the 48-hour LAAM dose divided by 1.2), chronic pain may have acute exacerbations of taking into account the timing of the last their pain. The most therapeutic intervention LAAM dose and its longer acting effects. for pain depends on its type, community ï Buprenorphine treatment may have to resources, patient preferences, and the extent be suspended temporarily because it can of services available. attenuate or block the effects of opioids. ï Hospital physicians should be aware that methadone can be prescribed by any physi- cian with a DEA registration for treating

Associated Medical Problems 175 nonaddiction problems and that mainte- than ìtwice dailyî (or ìb.i.d.î) or ìthree nance treatment can be continued without a times dailyî (ìt.i.d.î) (Savage 1998). special registration throughout hospitaliza- Increasing the drug testing frequency also tion, provided that a patient is being treated may be advisable to verify that only pre- in a certified and accredited program. For scribed medications are taken. example, when a patient in MAT is admitted ï Hospital physicians should communicate for treatment of any disorder other than clearly with OTPs about discharge dates and addiction, Federal regulations indicate that a times and the amounts of final methadone hospital physician may continue to prescribe doses given in the hospital, to allow mainte- maintenance doses of methadone (21 CFR, nance pharmacotherapy to be resumed Part 1306 ß 07(c)). effectively without interruption and to avoid ï Pain management should be discussed overmedication. with affected patients, and they should receive assurances that they will be afforded Chronic pain adequate relief. Patients who complain of chronic pain first ï Patientsí levels of pain should be monitored need a thorough examination to determine and and, if increases are evident, pain should treat the cause of the pain. Some patients may be treated promptly. Doses of short-acting need referral to specialists for testing and treat- opioids might have to be administered in ment. Several options should be tried before a addition to maintenance treatment, which is patient receives opioids for pain. Nonopioid preferable to increased methadone doses for pain treatments may be tried, including patients in MAT with acute pain. The doses medications, for example, nonsteroidal anti- of opioid analgesic required to interrupt pain inflammatory drugs (which are not without in these patients can be larger and more fre- risksógastrointestinal bleeding is a well-known quent than for persons not in MAT because side effect of chronic use), COX-2 inhibitors, or of the higher tolerance of patients in MAT. A other pharmacotherapies and physical therapy patientís previous drug of abuse should not or surgery. Exhibit 10-3 lists nonpharmacologic be prescribed for pain treatment. Patient- approaches to managing chronic, nonmalignant controlled analgesia can be successful to treat pain. Unfortunately, many pain centers that postoperative pain in patients who are opioid provide these treatments hesitate to accept addicted, although the increments used patients taking opioid treatment medications. should be monitored to minimize the rein- forcing properties of the medications Special consideration is needed to provide opi- (Savage 1998). oid therapy for patients in MAT who have ï Partial agonist or agonist antagonist drugs chronic, intractable, nonmalignant pain. such as , butorphanol tartrate, Studies of patients receiving methadone have nalbuphine hydrochloride, and buprenor- found that 37 to 60 percent have chronic pain phine should be avoided in methadone- (Jamison et al. 2000; Rosenblum et al. 2003). maintained patients because these agents Use of opioids to treat chronic pain in this can precipitate withdrawal symptoms. group is controversial because of potential side effects and hyperalgesia (Compton et al. 2001). ï Changeover to nonopioid agents should occur However, withdrawal of patients with chronic as soon as practical. pain from maintenance opioids is rarely appro- ï Take-home opioids should be monitored for priate and often results in failure to treat both appropriate use and amounts limited. the addiction and the pain disorder. A pain Patients should be seen at shorter intervals management expert and an addiction specialist for refills, and prescriptions should specify a should coordinate treatment of patients in fixed schedule rather than ìas needed.î The MAT, following an extended team approach. actual time of day should be specified, rather

176 Chapter 10 Exhibit 10-3

Nonpharmacologic Approaches to Managing Chronic Nonmalignant Pain

Physical Interventions Psychological Interventions Cold and heat Deep relaxation Ultrasound Biofeedback Counterstimulation (TENS*) Guided imagery Massage and manipulation Cognitive behavioral therapy Stretching and strengthening treatment Orthotics, splints, and braces Posttraumatic stress disorder treatment Positioning aids (pillows, supports) Family/relationship therapy

* Transcutaneous electrical nerve stimulation. Source: Adapted with permission from Savage 1998.

Some OTPs restrict take-home dosing for necessitates a take-home schedule for the patients also receiving opioids for pain. The remaining daily doses. When possible, program consensus panel believes that such policies are guidelines should require that an OTP staff unfair and counterproductive. When a patient member witness the first dose of the day. in MAT uses opioid pain medications only as prescribed, informs his pain treatment physi- cian of his or her addiction history and partici- Additional Opioids pation in MAT, and refrains from abusing Some patients with chronic pain have variable substances, long-term use of opioid pain medi- levels of pain or bursts of acute pain as well. cation should not disqualify the patient from For them, prescribing additional doses (or take-home dosing in MAT. Drug testing can be ìrescueî doses) of opioid analgesics to manage useful in evaluating the degree to which such breakthrough pain may be indicated as part of patients are complying with treatment regimens a comprehensive approach. If so, the amount although it is not foolproof; urine drug tests, of rescue medication should be calculated for example, identify only the presence or prospectively based on a patientís history absence of substances, not the amount taken (Savage 1999). The rescue medication should (see chapter 9). be monitored, and unannounced drug testing may be indicated to prevent abuse or diver- sion. A primary care physician or a pain spe- Adjustment of Methadone cialist can prescribe rescue medication. If a Schedule patient needs frequent rescue medication, then The methadone-dosing schedule to treat pain is his or her substance abuse treatment medica- three or four times daily or every 6 to 8 hours. tion probably should be increased in lieu of Some patients in MAT with chronic pain might prescribing increasingly higher doses of short- benefit from having their daily methadone acting opioids. Certain types of pain respond dosage split for better pain control, which well to anticonvulsant adjuvant medications

Associated Medical Problems 177 such as carbamazepine or phenytoin, both of Some patients in MAT are hospitalized fre- which are potent CYP450 3A inducers that can quently. For example, a patient on dialysis lead to a sharp reduction in serum methadone might require repeated shunt revisions, a levels. Gabapentin, which also is effective in patient with chronic lung disease might have neuropathic pain, does not alter CYP450 3A pneumonia several times a year, or a patient isoenzymes and therefore does not change with cirrhosis might have episodes of variceal methadone levels. bleeding. In such cases, OTP staff members who dispense medications may be in a position to monitor patients to facilitate early treatment. Hospitalization of Patients in MAT General Medical During a medical crisis requiring hospitalization of a patient in MAT, it is important that the Conditions and MAT OTP physician communicate with the attending As patients become engaged in MAT, they are physician and other members of the patientís more likely to take better care of themselves, hospital health care team. The hospital team modify their lifestyles, and participate in the should be informed of the patientís methadone medical followup needed to manage common dosage, the date on which methadone was chronic illnesses. In general, their medical care last administered, and the patientís medical, co- for other conditions should be identical to that occurring, or social problems. given patients not in MAT. Primary care for common medical conditions such as diabetes, During hospitalization, it is extremely impor- hypertension, and COPD can be provided easi- tant for the treating physician to understand ly in an OTP by nurse practitioners and other that a patient in MAT probably will require staff members working in collaboration with larger doses of medication for anesthesia and primary care physicians or internists. In some that adequate pain relief might require the cases, medications for these medical conditions patient to receive a normal methadone dose might need adjustment because of interactions (or its equivalent) plus additional medication, with opioid addiction treatment medications as described earlier in this chapter. Communi- (see chapter 3). cating these facts to the hospital team ensures appropriate care. Failure to provide sufficient General advice on diet, exercise, smoking pre- baseline opioid medication in accordance with vention, and stress management should be inte- previous daily use plus additional medication grated into MAT, especially if nurse practition- for anesthesia can lead to inadequate pain ers or physicianís assistants are on staff. A relief, even with additional opioids. comprehensive approach addressing all aspects of patient health facilitates treatment of In addition, the hospital team should be neglected medical problems. Age- and risk- advised to institute appropriate controls to pre- appropriate medical screening, such as mam- vent a patient from obtaining and using illicit mograms, sigmoidoscopy, prostate checks, or substances or abusing prescription drugs while exercise stress tests, should be discussed with in the hospital. These controls are especially patients during regular examinations. The important for unstable patients in the acute counseling staff can use printed educational phase of MAT. Such controls include limiting material or videotapes to present this informa- visitors, preventing a patientís tion. Some programs have developed health- through the hospital, and conducting regular related educational videotapes that are played drug tests. It usually is helpful to provide psy- in the waiting room so patients can receive chiatric consultation to medical or surgical staff information during daily OTP visits. treating patients in MAT, especially for patients with co-occurring disorders.

178 Chapter 10 11 Treatment of Multiple Substance Use

Concurrent opioid and other substance use is a serious problem in opioid treatment programs (OTPs). Patients in medication-assisted treatment for opioid addiction (MAT) commonly use alcohol, amphetamines, benzodi- In This azepines and other prescription sedatives, cocaine, and marijuana (THC Chapter… [delta-9-]). Patterns of use range from occasional low doses to regular high doses that meet dependence criteria. Central Prevalence of nervous system (CNS) depressants such as alcohol, benzodiazepines, and Multiple Substance barbiturates are especially dangerous when used with opioids. Use in MAT Except for naltrexone, which is used to treat alcohol dependence, the Common Drug treatment medications used in MAT do not address nonopioid substance Combinations Used use directly, although patients stabilized on adequate treatment medica- by Patients in MAT tion are less likely to abuse other substances than patients who are undermedicated. Because multiple substance use during MAT may Effects of Other complicate treatment greatly, the consensus panel recommends that staff Substance Use members be trained to recognize the pharmacologic and psychosocial Management of effects of both opioid and nonopioid substances of abuse. OTPs should Multiple Substance have treatment options available to address multiple substance use either Use in MAT directly or by referral.

Inpatient An essential purpose of preliminary assessment is to determine whether Detoxification and new patients are abusing or are dependent on substances other than opi- Short-Term oids (see chapter 4). If one of these problems is identified, OTPs should Stabilization adjust treatment plans and the types of services provided accordingly. OTPs should not exclude patients automatically from MAT who test posi- tive for illicit drugs other than opioids. Treatment providers should treat patients for their concurrent substance abuse aggressively or refer them appropriately. Providers should try to understand and address the underlying causes of concurrent substance use.

179 Prevalence of Multiple abuse treatment programs in the United States. According to TEDS, 42.7 percent of patients Substance Use in MAT entering substance abuse treatment in OTPs in 2000 reported using only heroin (Substance Patients Entering OTPs Who Abuse and Mental Health Services Administration 2002d). Exhibit 11-1 presents Abuse Other Substances TEDS data on heroin and other substances The Treatment Episode Data Set (TEDS) used by people admitted to OTPs in 2000. summarizes data on admissions to substance Proportions of patients using additional drugs

Exhibit 11-1

Reported Use of Other Substances by Patients Admitted to OTPs

Primary Substance of Abuse Heroin Other Opioids Total number of admissions 243,523 25,839 Average number of substances used (per admission) 1.8 1.8 Substance Used in Addition to Primary Substance Percent Percent None 42.7 44.4 Alcohol 23.3 24.4 Marijuana/hashish 12.1 14.2 Nonsmoked cocaine 22.2 7.2 Smoked cocaine 12.1 5.4 Methamphetamine/amphetamine 2.8 3.2 Other stimulants 0.2 0.3 Heroin NA 7.8 Other opioids 4.3 1.3 Hallucinogens 0.3 0.4 Tranquilizers 3.0 10.2 Sedatives 0.7 4.0 Phencyclidine 0.2 0.1 Inhalants <0.5 0.1 Other 0.7 1.5

Percentages sum to more than 100 because 1 patient could report more than 1 additional substance. NA, not applicable.

Source: Substance Abuse and Mental Health Services Administration 2002d.

180 Chapter 11 and the types of drugs used varied by locality, other institutions that report admissions for depending primarily on drug availability. substance use and drug-related deaths. In Although not shown in Exhibit 11-1, rates of 2001, 93,064 nonfatal admissions mentioned cigarette smoking in this population reportedly heroin use. Of these, 5 percent mentioned con- range from 85 to 92 percent (Clarke, J.G., et current alcohol use only, 25 percent mentioned al. 2001; Clemmey et al. 1997). concurrent use of another drug but not alco- hol, and 15 percent mentioned concurrent use Exhibit 11-2 summarizes results of a large-scale of alcohol and another drug or other drugs as study of co-dependence in 716 patients admit- well as heroin (Substance Abuse and Mental ted to OTPs in Baltimore, Maryland, over a Health Services Administration n.d.a). Nearly 5-year period (1989 to 1994). Patients with 90 percent of heroin-related deaths may co-occurring disorders had higher rates of sub- involve concurrent use of other substances stance co-dependence than patients without (Substance Abuse and Mental Health Services co-occurring disorders. Rates were substantial- Administration 2002b). ly higher for lifetime co-dependence, even among patients not co-dependent during the study (Brooner et al. 1997). Common Drug Combinations Used by Emergency Room Admissions Patients in MAT and Fatalities Involving Exhibit 11-3 summarizes reasons patients in Concurrent Opioid and Other MAT give for using particular combinations of Substance Use substances, based on the consensus panelís The Drug Abuse Warning Network tracks data experience. A common reason is that patients from hospital emergency departments and have become dependent on the substance along

Exhibit 11-2

Current Substance Use Disorders in Patients Dependent on Another Substance While Addicted to Opioids and Admitted to OTPs, With and Without Co-Occurring Disorders (N=716)

With Co-Occurring Without Co-Occurring Substance Disorders (%) Disorders (%) Cocaine 48.5 32.7 Marijuana 16.8 15.7 Alcohol 31.5 18.6 Sedatives 21.8 12.5

Percentages sum to more than 100 because 1 patient could report more than 1 additional substance.

Adapted from Brooner et al. 1997.

Treatment of Multiple Substance Use 181 with their opioid addiction. Another common regimens that vary throughout the day, for reason is the need to self-medicate withdrawal example, using stimulants in the morning, anxi- symptoms or uncomfortable affects (e.g., anxi- olytics in the afternoon, and hypnotics at night. ety, depression, anger, loneliness) related to nonñsubstance-induced mental disorders or difficult life situations. Patientsí initial sub- Effects of Other stance use experiences and continued attrac- Substance Use tion to drugs may indicate enhancementñ avoidance reactions. That is, substances may be used to enhance an experience (e.g., use of Alcohol alcohol as a social lubricant or cocaine to The acute effects of alcohol are well known, heighten sexual pleasure) or to avoid or neu- including sedation, as well as impairment of tralize strong feelings (e.g., incest survivorsí judgment, coordination, psychomotor activity, substance use before sex to numb their feelings reaction time, and night vision. Overdose or adolescentsí substance use before sex to deaths can occur when alcohol is used alone in avoid accepting responsibility for their high doses or in lower doses with opioid treat- actions). Some patients develop unique drug ment medication or sedatives (Hardman et al.

Exhibit 11-3

Drug Combinations and Common Reasons for Use

Combination Reasons Heroin plus alcohol Enhance a high; create euphoria or sedation Heroin followed by alcohol Medicate opioid withdrawal; medicate cocaine overstimulation (e.g., anxiety, paranoia) Heroin plus cocaine (ìspeedballî) Enhance or alter cocaine euphoria Heroin followed by cocaine Medicate opioid withdrawal Cocaine plus alcohol Enhance high; reduce cocaine overstimulation (e.g., anxiety, paranoia) Cocaine followed by heroin Reduce cocaine overstimulation (e.g., anxiety, paranoia); modulate the cocaine crash Methadone plus alcohol Create a high; sedate Methadone plus cocaine Reduce cocaine overstimulation (e.g., anxiety, paranoia); moderate the cocaine ìcrashî Methadone plus benzodiazepines Create a high; sedate Any opioid plus any nonbenzo- Create a high; sedate diazepine sedative Any opioid followed by any Medicate opioid withdrawal nonbenzodiazepine sedative Any opioid plus amphetamine Create a high

182 Chapter 11 1996). The effects of concomitant alcohol and Treatment for alcohol dependence involves a methadone, levo-alpha acetyl methadol (LAAM), comprehensive approach combining detoxifica- or buprenorphine use are additive and more tion if needed, counseling, medications such as sedating than either alcohol or treatment medi- disulfiram, and participation in mutual-help cation alone. Alcohol abuse can aggravate liver groups (Fuller and Hiller-Sturmhofel 1999). damage from hepatitis C, which is common Many groups do not support use of mainte- among patients in MAT. Alcohol-related factors nance medication. Other interventions have are a major cause of death among patients in met with limited success. A pilot study provid- MAT, both during and after treatment, and of ed intensive education for staff members at administrative discharges from OTPs (Appel et OTPs in which 220 patients receiving al. 2000). On average, patients in MAT who are methadone also were treated for alcohol depen- alcohol dependent have more medical and men- dence. Eighty percent of these patients com- tal disorders, greater criminality, and poorer plied with treatment requirements and com- social and family functioning and peer relations pleted treatment (Kipnis et al. 2001). than patients who are not alcohol dependent (Chatham et al. 1995b). Benzodiazepines Alcohol abuse among patients in MAT can Benzodiazepines such as diazepam (ValiumÆ) affect treatment compliance (Bickel and Amass and clonazepam (KlonopinÆ) have antianxiety 1993) and outcomes adversely. Continuous use and sedative effects. They are schedule IV may induce enzyme activity that increases the drugs, signifying relatively low abuse liability. metabolism of treatment medication, reducing However, people with other addiction disorders medication plasma levels and resulting in symp- are more likely to abuse benzodiazepines than toms of undermedication that further compli- are members of the general population (Ross cate treatment. and Darke 2000). In an early study, patients Research is limited or conflicting on alcohol receiving opioid treatment medication who also disorder treatment for patients in MAT. Many abused benzodiazepines typically took the lat- studies comparing alcohol use before OTP ter within 1 hour of the former and reported admission and after 1 year have found little or that benzodiazepines increased the effects of no improvement (e.g., Fairbank et al. 1993; the medication (Stitzer et al. 1981). These Hubbard et al. 1997). However, one study effects likely result from an interaction in found that short-term MAT reduced alcohol which each drug potentiates the sedative consumption significantly in patients who did aspects of the otheróknown on the street as not meet alcohol-dependence criteria (Caputo ìboosting.î When used in prescribed doses, et al. 2002), and a 10-year study found that less benzodiazepines are not dangerous for patients than 6 percent of patients in MAT reported in MAT, except when they cause patients to alcohol problems in the previous 6 months seek other drugs with sedative effects. High- (Appel et al. 2001). dose benzodiazepines can cause serious prob- lems, including severe intoxication and higher Lubrano and colleagues (2002) found an associ- risk of injuries or fatal overdoses. These risks ation between inadequate methadone doses and are potentiated when high doses of benzodi- increased cravings for both heroin and alcohol. azepines are mixed with methadone or other Others noted that continued alcohol consump- drugs that produce sedation and respiratory tion among patients dependent on alcohol was depression, even among patients in MAT who associated with smaller increases in methadone have developed tolerance for the respiratory- doses during MAT (El-Bassel et al. 1993). depressant effects of opioids. Stastny and Potter (1991) found that many patients in MAT who abused alcohol also In the experience of the consensus panel, abused benzodiazepines. patient use of benzodiazepines negatively affects attendance at treatment sessions and

Treatment of Multiple Substance Use 183 progress in MAT. Regular benzodiazepine use respiratory effects (perforation of nasal septum, for 3 months or more may be associated with bronchial irritation) if inhaled or smoked, or physiologic dependence, even when benzodi- mental effects (anxiety, depression, anger, azepines are taken in prescribed doses. paranoia, psychotic symptoms). Patients in Patients who are abusing or dependent on ben- MAT who abuse stimulants may be disruptive zodiazepines usually need detoxification and if the stimulants have severe mental effects, more intensive treatment interventions to and these patients may have problems with remain safely in MAT. mood swings and compliance with group or individual therapy. TIP 33, Treatment for Stimulant Use Disorders (CSAT 1999c), Nonbenzodiazepine Sedatives provides more information. Nonbenzodiazepine sedatives such as interme- diate- or short-acting barbiturates or Another concern for patients in MAT who use glutethimide are more likely than benzodi- cocaine is concurrent alcohol use. The combi- azepines to produce lethal overdose because nation of alcohol and cocaine is popular people who abuse them develop tolerance for because it can create a more intense high and their sedative and euphoric effects but not for less intense feelings of inebriation than either their respiratory-depressant effects. Therefore, substance alone. Individuals also use alcohol to as these people increase their dosages to get temper discomfort when they come down from high, they suddenly can overdose to respirato- a cocaine-induced high. Patients in MAT who ry depression. People who are opioid addicted abuse both alcohol and cocaine are significantly and abuse nonbenzodiazepine sedatives usually more difficult to engage and retain in treatment need inpatient detoxification before starting than patients who do not abuse all three sub- MAT or may do better with referral to a long- stances (Rowan-Szal et al. 2000b). In addition, term, residential program such as a therapeutic cocaethylene, a psychoactive derivative of community. Nonbenzodiazepine sedatives cocaine formed exclusively during the combined induce cytochrome P450 3A, an enzyme administration of cocaine and alcohol, can involved in methadone, LAAM, and buprenor- increase the cardiotoxic effects of either sub- phine metabolism (see chapter 3), and can stance alone. The combination of alcohol and make stabilization difficult. cocaine tends to have exponential effects on heart rate and may increase violent thoughts The consensus panel recommends that OTPs and tendencies (Pennings et al. 2002). The mix- withhold treatment medication for patients who ture of opioids, cocaine, and alcohol can be appear intoxicated with a sedative-type drug lethal and has been identified as a leading cause until intoxication has cleared and patients are of accidental overdose (Coffin et al. 2003). either detoxified from sedatives or confirmed not to be sedative dependent. Nonbenzo- Tennant and Shannon (1995) found that diazepine sedative and barbiturate abuse is cocaine use appeared to lower the methadone rare in most areas. These medications are less concentration in blood. In addition, some widely abused than in the past, because benzo- patients reduced their cocaine use when their diazepines are less dangerous and easier to methadone dosages were increased. Borg and obtain in many areas. colleagues (1999) found that adequate doses of methadone seemed to reduce cocaine use even though methadone does not target cocaine Cocaine and Other Stimulants directly. More focused treatments and research Stimulant abuse, especially cocaine, is another on these interactions are needed. serious problem in many OTPs (see Exhibit Traditionally, disulfiram has been used to treat 11-1). Adverse effects of these substances alcohol dependence (chapter 3). Because include cardiovascular effects (hypertension, cocaine often is used with alcohol, Petrakis and stroke, arrhythmias, myocardial infarction),

184 Chapter 11 colleagues (2000) evaluated disulfiram treatment that drug tests be free of THC before patients for , with and without can qualify for take-home medication. Unlike alcohol abuse, for patients in MAT. Patients people addicted to nonopioid substances, who were treated with disulfiram significantly patients in MAT who are opioid addicted rarely decreased the quantity and frequency of their seek treatment for THC dependence. There- cocaine use, whereas those treated with a fore, it has received less attention in OTPs than placebo did not. Related studies found that the in other substance abuse treatment programs. positive effects of disulfiram on cocaine use among patients in substance abuse treatment remained evident after 1 year (Carroll et al. Nicotine 2000) and that disulfiram also was promising Tobaccoñsmoking-related illnesses are a major for patients treated with buprenorphine cause of morbidity and mortality among (George et al. 2000). More research on the patients in MAT as they are in the general benefits of disulfiram therapy for cocaine population. For example, 40 percent of deaths dependence during MAT is needed. over 15 years in one physicianís office-based MAT program were related to cigarette smoking, which was more than deaths from HIV/AIDS, Marijuana hepatitis C, and violence combined (Salsitz et In general, THC use is not as prevalent as al. 2000). Frosch and cocaine or amphetamine use among patients colleagues (2000) in MAT (see Exhibit 11-2). Some studies have found that patients in concluded that THC use in MAT does not MAT who smoked [S]moking inter- affect MAT outcomes adversely. For example, heavily were more Epstein and Preston (2003) found that THC likely to abuse cocaine ventions neither was not associated with either poor treatment and opioids than were retention or problem use of other substances patients who did not detract from such as cocaine. One study (Wasserman et al. smoke heavily, sug- 1998) showed that, for patients committed to gesting an association nor interfere opioid abstinence and doing well, positive tests between nicotine and for THC could predict relapse, but this finding other substance use. has not been replicated (Epstein and Preston In other research, with addiction 2003). patients receiving methadone who recovery... OTPs vary in whether they require THC-free reduced their tobacco drug tests before patients can qualify for or use also reduced continue take-home medication privileges. The cocaine use, although consensus panel recommends that OTPs cocaine was not addressed directly in treatment address patient THC use because, as with other (Shoptaw et al. 1996). substances of abuse, THC increases the proba- bility that patients will engage in activities that Many OTPs avoid addressing nicotine depen- put them at higher risk of relapse to opioid use, dence because it may create additional stress other health problems, other related illicit for patients. Research has shown that smoking activities, and legal problems. interventions neither detract from nor interfere with addiction recovery and that patients who Patients in MAT sometimes use THC to self- attempt nicotine cessation are at the same risk medicate for anxiety or insomnia. Approaches for relapse as other patients (Ellingstad et al. to address THC use in these patients include 1999; Hughes 1995). Furthermore, many increased counseling, treatment of their anxiety patients in MAT want to stop smoking disorders with standard psychotropic medica- (Clemmey et al. 1997). tions and psychotherapy, and requirements

Treatment of Multiple Substance Use 185 The consensus panel believes that OTPs should these patients are taking the places of people address nicotine dependence routinely. In addi- who would benefit more from MAT. Patients tion, because effective medications are available, who continue using illicit drugs sometimes tobacco cessation should be a regular part of erode the morale of other patients, who may patientsí treatment plans. The forthcoming TIP conclude that treatment compliance and absti- Detoxification and Substance Abuse Treatment nence are optional. (CSAT forthcoming a) contains information on medications and other interventions for nicotine Policies favoring treatment termination for cessation. patients who use substances negate a funda- mental principleóthat longer retention in treatment is correlated highly with increased Management of treatment success (Hubbard et al. 1997, 2003). In fact, substantial remission from all sub- Multiple Substance stance use is a common and positive outcome of Use in MAT MAT, particularly when treatment includes reg- ular drug counseling and other psychosocial Although some studies have indicated that services (McLellan et al. 1993). Consensus patients in MAT reduce other substance use sig- panel members have found that, if patients with nificantly when they secondary substance use problems remain in receive adequate MAT and staff members address overall sub- doses of methadone, stance abuse patterns for these patients, many OTPs should have LAAM, or patients stop using nonopioid and nonpre- buprenorphine, scribed substances. clear policies none of these medi- cations reliably and Changing staff attitudes can be helpful to both declaring the consistently stopped patients and staff. Abuse of other substances nonopioid abuse in along with opioid addiction presents many studies reported by problems and challenges for treatment desirability of Borg and colleagues providers and patients. Without treatment, a (1999) and by person with these problems may continue crim- cessation of all Tennant and inal activity; remain obsessed with substance Shannon (1995). A use; experience severe financial, vocational, substance use. major concern is and personal problems; and be at increased how to determine risk for overdose death. what level of other substance abuse by Given the importance of retention in MAT for patients indicates that MAT is insufficient and positive outcomes, the consensus panel agrees other treatments should be tried or that MAT that a policy of discharge for other substance should be stopped, perhaps against patient use is seldom appropriate. Instead of setting wishes. standard timetables for discharge, limits should be determined on a case-by-case basis. Patient Some have argued for early treatment dis- discharge should be done with great caution for charge if patients continue using multiple sub- reasons stated elsewhere in this TIP (e.g., stances. In addition, some State regulations set chapter 8) and only when staff members have specific timetables for compliance, although the exhausted all reasonable alternatives. When requirement is unsupported by research. Some grappling with these difficult problems, OTP staff members may feel that patientsí con- providers should keep in mind where patients tinued use of alcohol and illicit drugs, despite started, how far they have progressed, the progress in recovery from opioid addiction, degree to which they are engaged in treatment, reflects negatively on OTP credibility and that whether all available interventions have been

186 Chapter 11 tried, the riskñbenefit ratio of keeping these effective to treat legitimate, diagnosed condi- patients in treatment versus discharging them, tions. OTPs should encourage abstinence from and a realistic expectation for patients, given alcohol and nicotine, but it is difficult to the resources available. If discharge must require it because these are legal substances. occur, staff members should work with patients However, OTPs may withhold medication if to arrange transfer to another program where patients have consumed alcohol shortly before a treatment slot is open and they can obtain or are intoxicated during treatment and should more benefit. address alcohol problems.

The consensus panel believes it is helpful, both Other Procedures when patients are admitted to an OTP and A key element in treating multiple substance throughout treatment, to maintain the position use in an OTP is the need for intensified ser- that opioid use is only the most obvious part of vices and heightened structure and supervision patientsí problems and that the role of all (see chapter 8). Because few chronic diseases intoxicants (both licit and illicit) in patientsí respond to a single care model, OTPs need a lives and their overall substance-using lifestyle variety of techniques for patients who abuse are other important issues. Patients in MAT multiple substances. These techniques should should recognize that use of any intoxicant incorporate available medical, mental health, undermines their progress. and social services. Usually patients who abuse multiple substances require a more intensive Dosage Adjustments level of care for a limited period. Treatment providers also should have referral agreements During the dosing period (see chapter 5), OTPs with inpatient facilities for brief detoxification should ensure that patientsí dosages suppress from nonopioid substances, extended stabiliza- withdrawal and produce significant cross- tion before reentry into an OTP, or admission tolerance for opioids of abuse. Patients may be to a therapeutic community, residential treat- abusing other drugs to self-medicate withdraw- ment, or other long-term, more structured and al symptoms caused by inadequate dosages or controlled environment. OTPs can enter into other factors that affect medication agreements with residential treatment pro- metabolism. In this case, raising the dosage or grams to allow continued MAT along with treat- splitting doses may lessen other substance use. ment for other .

A common problem is that some OTP staff Increased Counseling and members and patients assume that stopping Other Psychosocial Services opioid and injection drug use is the sole objec- Numerous studies have shown that regular tive of treatment. Use of cocaine and other sub- counseling is associated with a reduction in stances should cause concern because it under- opioid and other substance use by patients in mines patient stability. Nonetheless, use of MAT (Villano et al. 2002; see chapter 8 in this some substances such as THC may be viewed TIP). In a study of patients who abused multi- as less serious unless clear evidence exists of ple substances and had co-occurring disorders impaired functioning. Many people entering an or criminal histories, those who received more OTP regard alcohol use as acceptable because intensive cognitive behavioral treatments it is legal. Changing such attitudes and behav- reduced their cocaine use more than those in iors requires patience and effort. OTPs should less intensive treatment (Rosenblum et al. have clear policies declaring the desirability of 1995). In another study of patients in MAT cessation of all substance use. These policies who received additional cognitive behavioral should clarify any ambiguity about abstinence therapy for cocaine abuse and patients who from nonprescribed medications but encourage received standard methadone treatment, therapeutic use of medications that are

Treatment of Multiple Substance Use 187 cocaine use declined significantly for both loss of consciousness, life-threatening with- groups (Magura et al. 2002). drawal reactions, and increased risk of lethal overdose (Baskin and Morgan 1997). This type of withdrawal is not treatable with methadone Increased Drug Testing (Sporer 1999; White and Irvine 1999). Signs One obstacle to detecting other substance use and symptoms of withdrawal from CNS depres- during MAT is that infrequent drug tests pri- sants include elevated body temperature, marily identify only those patients who use hypertension, rapid pulse, confusion, halluci- substances frequently, for example, daily. nations, and intractable seizures. When a Early detection and intervention requires occa- patient in MAT abuses a CNS depressant, the sional periods of more intensive, random drug depressant should be withdrawn medically testing. OTPs, however, should have objective from the patientís system, and the opioid treat- policies that require combining increased drug ment medication should be continued with con- testing with more intensive counseling. Testing sideration of the need for a dosage increase. frequency might be used as a contingency, with more negative tests for illicit drugs resulting in The patient may require inpatient detoxifica- less frequent testing (see chapter 8). tion from CNS depressants and should contin- ue MAT during the inpatient stay. In addition, a history of seizures or toxic during Inpatient withdrawal from a sedative-hypnotic or anxi- olytic drug or from alcohol is an absolute Detoxification and indication for inpatient detoxification. The Short-Term forthcoming TIP Detoxification and Substance Abuse Treatment (CSAT forthcoming a) con- Stabilization tains more information on detoxification from Use of alcohol or other CNS depressants with substances of abuse. opioids may cause depression of respiration,

188 Chapter 11 12 Treatment of Co-Occurring Disorders

Many people who are opioid addicted have co-occurring mental disor- ders. However, mental health and addiction treatment systems often are In This separated. This situation may result in patientsí being treated at one location for addiction and at another for mental disorders. Some mental ChapterÖ health care facilities do not accept patients in medication-assisted treat- ment for opioid addiction (MAT), forcing these patients to choose which Prevalence of disorder to treat. These problems, along with uncertainties about effec- Co-Occurring tive interventions for patients with both addiction and mental disorders, Disorders have stimulated research in this area. This chapter summarizes current Motivation for thinking and consensus panel recommendations on screening, diagnos- Treatment and ing, and treating these patients in opioid treatment programs (OTPs). Co-Occurring The term ìco-occurring disorderî in this TIP means a mental disorder Disorders that coexists with at least one in an individual. Etiology of The consensus panel acknowledges that other types of disorders also Co-Occurring occur with substance use disorders, such as cognitive and medical disor- Disorders ders and physical disabilities. These conditions also require individual- ized treatment approaches, and, for patients who are opioid addicted, Screening for other chapters in this TIP present discussions of treatments for other Co-Occurring types of disorders that occur with substance use disorders. Chapter 6 Disorders discusses patients with physical disabilities. Chapter 8 discusses patients with cognitive disorders. Chapter 10 discusses patients with other Making and medical disorders. Confirming a Psychiatric TIP 42, Substance Abuse Treatment for Persons With Co-Occurring Diagnosis Disorders (CSAT 2005b); Report to Congress on the Prevention and Treatment of Co-Occurring Substance Abuse Disorders and Mental Prognosis for Disorders (Substance Abuse and Mental Health Services Administration Patients With 2002c); and Strategies for Developing Treatment Programs for People Co-Occurring With Co-Occurring Substance Abuse and Mental Disorders (Substance Disorders Abuse and Mental Health Services Administration 2003d) provide addi- Treatment Issues tional information on co-occurring disorders in substance abuse treat- ment. This chapter focuses on co-occurring disorders in patients with opioid addiction.

189 Patients in MAT who have co-occurring disor- (1997), nearly half of patients in MAT had ders often exhibit behaviors or feelings that co-occurring disorders during their lifetimes. interfere with treatment. These symptoms may indicate either underlying co-occurring disorders that would be present regardless of substance Factors Affecting Prevalence use (i.e., independent or primary disorders) or of Co-Occurring Disorders co-occurring disorders caused by substance use Some factors found to increase the prevalence (i.e., substance-induced or secondary disorders). of co-occurring disorders among people with Symptoms may also indicate the presence of substance use disorders include older age, both independent disorders and self-induced dis- lower socioeconomic status, and residence in orders along with substance use disorders. urban areas (Kessler et al. 1994); homelessness Patients may have identifiable co-occurring dis- (North et al. 2001); and incarceration (Robins orders on admission to an OTP, or disorders et al. 1991). Certain mental disorders (e.g., may emerge during MAT. antisocial [APD], Unless MAT providers distinguish co-occurring ) and some affective and anxiety disorders accurately by type and address them disorders (, bipolar depression) have appropriately, these disorders likely will com- been found to be more prevalent among per- plicate patientsí recovery and reduce their sons with substance use disorders than in the quality of life. Numerous studies have indicated general population (Regier et al. 1990). that rapid, accurate identification of patientsí However, some of these studies did not co-occurring disorders and immediate interven- determine whether symptoms of co-occurring tions with appropriate combinations of psychi- disorders were related to the pharmacological atric and substance addiction therapies improve effects of substances or to an underlying MAT outcomes. The consensus panel for this nonñsubstance-related disorder. TIP 42, TIP endorses this view. Many standard treat- Substance Abuse Treatment for Persons ments for mental disorders can be modified With Co-Occurring Disorders (CSAT 2005b), readily for patients with co-occurring disorders discusses factors affecting the prevalence of in MAT. co-occurring disorders.

Prevalence of Gender Differences in Prevalence of Co-Occurring Co-Occurring Disorders Disorders Exhibit 12-1 lists the most common co- Rates of co-occurring disorders have been occurring disorders among patients in MAT, found to differ between men and women. For based on representative studies (e.g., Brooner example, Ward and colleagues (1998b) found et al. 1997; Mason et al. 1998). They are that more women than men who were opioid grouped into Axis I and II disorders, as defined addicted had affective and anxiety disorders, in Diagnostic and Statistical Manual of Mental whereas more men than women who were opi- Disorders, Fourth Edition, Text Revision oid addicted had APD and were dependent on (DSM-IV-TR) (American Psychiatric alcohol. A study by Brooner and colleagues Association 2000). (1997) found women were more likely than men Studies comparing patients in MAT with the to have Axis I diagnoses, particularly major general population have confirmed higher rates depression; seven times more likely to have of co-occurring Axis I and II disorders in these borderline personality disorders; only half as patients (e.g., Calsyn et al. 1996; Mason et al. likely to be diagnosed with APD; and less likely 1998). In a study by Brooner and colleagues than men to manifest problems with other

190 Chapter 12 Exhibit 12-1

Common Co-Occurring Disorders in Patients Who Are Opioid Addicted

Axis II Categories Axis I Categories (Personality Disorders and (Clinical Disorders and Other Conditions) Mental Retardation) ï Mood Disorders ï Personality Disorders Major depressive disorder APD Dysthymic disorder Borderline personality disorder Bipolar disorder Narcissistic personality disorder ï Anxiety Disorders Generalized anxiety disorder Posttraumatic stress disorder (PTSD) Social Obsessive-compulsive disorder Panic disorders ï Attention Deficit/Hyperactivity Disorder (AD/HD) ï Schizophrenia and Other Psychotic Disorders ï Cognitive Disorders ï Eating Disorders ï Impulse Control Disorders: Pathological Gambling ï Sleep Disorders

substances, including alcohol. Another study seek treatment. Community surveys from both indicated that female patients receiving the Epidemiologic Catchment Area study and methadone were more likely than male patients the National Comorbidity Study found that, to have psychotic and affective disorders among respondents with substance use disor- (Calsyn et al. 1996). Another study of patients ders, those with co-occurring disorders were in MAT found that women were more likely more likely to obtain treatment (Kessler et al. than men to have PTSD (Villagomez et al. 1995). 1994, 1996; Regier et al. 1990).

Motivation for Etiology of Treatment and Co-Occurring Disorders Co-Occurring Disorders Mueser and colleagues (1998) identified four common models to explain the relationship Some studies have found that co-occurring dis- between co-occurring and substance use orders motivated people who were addicted to disorders:

Treatment of Co-Occurring Disorders 191 ï Primary substance use disorder and factors, such as poverty, social isolation, drug secondary co-occurring disorder. This availability, or lack of accountability by adult ìdisease modelî holds that substance use dis- caregivers, also contribute to both substance orders cause most co-occurring disorders in use and co-occurring disorders through a patients. Appropriate treatment, by this the- complex interaction between environment ory, focuses on the underlying substance use. and genetic susceptibility. The bidirectional ï Primary co-occurring disorder and sec- model has not been evaluated systematically. ondary substance use disorder. This ìself-medicationî model, proposed by Khantzian (1985), argues that preexisting Screening for mental disorders are a significant cause of Co-Occurring Disorders substance use disorders. People who are drug The consensus panel believes that admission addicted choose drugs that lessen painful and ongoing assessment routinely should incor- feelings caused by their mental disorders, porate screening for co-occurring disorders. for example, opioids or alcohol to alleviate This screening should yield a simple positive or anxiety or cocaine or other stimulants to negative result, depending on whether signs or relieve depression. By extension of this view, symptoms of co-occurring disorders exist. A adequate treatment of the psychopathology negative result generally should rule out imme- resolves the substance use disorder. diate action, and a positive result should trigger ï Common pathway. This model holds that detailed assessment by a trained professional shared genetic or environmental factors may (see chapter 4). cause both substance use and co-occurring disorders. For example, accumulating evi- To identify patients in MAT with co-occurring dence indicates that disorders, treatment providers must decide childhood conduct disorders that per- ï When and how to screen patients [A]dmission and sist to become adult ï How to integrate psychological screening with antisocial or border- standard intake assessment ongoing assess- line personality dis- ï Which instruments to use for screening and orders are signifi- confirming co-occurring disorders cant risk factors for ï What qualifications are needed by staff who ment routinely substance abuse conduct screenings (e.g., Compton et al. should incorporate 2000; Mueser et al. ï How to classify symptoms and other evidence 1999). Other studies ï How to determine the most appropriate screening for (e.g., Ahmed et al. treatment methodology and level of care. 1999; Nunes et al. co-occurring 1998b) have found that relatives of Specific Screening Procedures disorders. patients who were OTPs should establish specific screening opioid addicted had procedures for co-occurring disorders and higher rates of major train counselors and intake workers to perform depression, alco- these procedures, including how to recognize holism, and substance use disorders, indicat- the presenting symptoms of the most commonly ing that genetic factors increase susceptibility encountered co-occurring disorders. Few to both addiction and co-occurring disorders. significant differences in symptoms of mental ï Bidirectional model. This model emphasizes disorders exist between patients who are that socioenvironmental and interpersonal addicted to opioids and other people who are not; therefore, the symptoms described in

192 Chapter 12 DSM-IV-TR are applicable during admission determine whether a co-occurring disorder is screening. When possible, screening for co- substance induced or independent. occurring disorders should be linked with other ï The applicantís current co-occurring disor- assessments to avoid duplicate efforts by staff der symptomatology based on DSM-IV-TR and unnecessary burdens on patientsí time. An criteria, including whether any psychotropic OTPís screening procedures for co-occurring medications have been prescribed or are disorders should specify being used (usually included on a screening ï Questions or instruments to be used questionnaire). ï When and where to conduct screening ï Trauma history (e.g., physical or sexual segments (e.g., address all safety-related abuse, living through a natural disaster or questions during initial intake and defer war, witnessing death or tragedy). Questions other questions until applicants are no longer about trauma should be brief and general, intoxicated or in withdrawalóbut wait no without evoking details that might precipitate longer than a specified period after admission) stress. Several screening instruments for PTSD are described in other TIPs (see the ï Who conducts screenings forthcoming TIP Substance Abuse and ï How to record results Trauma [CSAT forthcoming d]; TIP 25, ï Cutoff scores or other indicators of positive Substance Abuse Treatment and Domestic results for co-occurring disorders Violence [CSAT 1997b]; and the Modified PTSD Symptom Scale: Self-Report in TIP ï Exactly how to handle positive results (e.g., 36, Substance Abuse Treatment for Persons whom to inform, how, and when; what con- With Child Abuse and Neglect Issues [CSAT stitutes a psychiatric emergency and how to 2000d]). address it) ï Any history of mental disorder-related symp- ï How extensively a patientís self-reported toms among immediate relatives and their information must be corroborated with infor- diagnoses, treatments, or hospitalization. mation from other sources (e.g., family and friends, caseworkers, previous treatment ï Any unusual aspects of an applicantís records) appearance, behavior, and cognition. If indications of a cognitive impairment are ï Which staff members to consult if questions present, a mental status examination should arise about these procedures or the results. be conducted. Screening for co-occurring disorders usually entails determining Screening for cognitive ï An applicantís immediate safety and self- impairment control, including any suicide risk, aggres- The accuracy of instruments to screen for sion or violence toward others, or domestic co-occurring disorders may be compromised if or other abuse or victimization and the administered to patients with cognitive impair- ability to care for himself or herself (see ments. A brief preexamination of cognitive ìHandling Emergency Situationsî below). functioning during a mental status examination ï Previous diagnosis, treatment, or hospitaliza- is recommended for individuals who are disori- tion for a mental disorder and, if applicable, ented with respect to time, place, or person; why, when, and where, as well as the treat- have memory problems; or have difficulty ment received and its outcome. Questions understanding information in their first lan- about the relationship of mental disorders guage. TIP 29, Substance Use Disorder to substance useófor example, whether a Treatment for People With Physical and mental disorder was present during absti- Cognitive Disabilities (CSAT 1998c), contains nence or before the substance use disorderó an 18-item screening instrument for cognitive

Treatment of Co-Occurring Disorders 193 impairment and functional limitations. TIP 33, but procedures to use and reimburse these Treatment for Stimulant Use Disorders (CSAT resources should be well established. 1999c), lists nine brief screening tools to deter- mine cognitive impairment and reproduces the The most widely used systems to classify mental Repeated Memory Test. Treatment providers and substance use disorders are provided in who prefer the familiar Mini-Mental State DSM-IV-TR and the International Classification Examination (Folstein et al. 1975) can order of Diseases, 10th Edition (ICD-10), either the standard or extended version via the Classification of Mental and Behavioural World Wide Web at www.minimental.com. Disorders: Clinical Descriptions and Diagnostic Guidelines (World Health Organization 1992). Both systems present Screening Tools diagnosis criteria accepted by national (DSM- Many States require specific screening or IV-TR) or international (ICD-10) experts. assessment instruments, such as the Addiction Severity Index (ASI), to document baseline DSM-IV-TR Criteria patient data. Other important considerations in selecting a screening tool for co-occurring dis- Although many insurance companies require orders include its psychometric properties and International Classification of Diseases diag- cultural appropriateness and, if the test is self- nostic codes for reimbursement purposes, administered, the literacy level required. The clinicians and researchers in the United States consensus panel believes that no instrument in traditionally use the DSM classification system. an OTP can identify co-occurring disorders As this system has evolved over several edi- satisfactorily, and many of the most thoroughly tions, its authors have made important changes tested are not in the public domain. The ASI in definitions for substance-related disorders. records symptoms of mental disorders but does Specifically, the DSM-IV-TR divides these dis- not diagnose. More information on the ASI and orders into two types: substance use disorders other screening instruments, including Mental and substance-induced co-occurring disorders. Health Screening Form III, the Mini Interna- tional Neuropsychiatric Interview (M.I.N.I.), Substance use disorders and some proprietary instruments, is in TIP DSM-IV-TR divides substance use disorders 42, Substance Abuse Treatment for Persons into abuse and dependence with or without With Co-Occurring Disorders (CSAT 2005b). physiological features such as tolerance or with- Other tools focusing on particular disorders drawal. It also makes distinctions pertaining to or pathologies (e.g., suicide danger, PTSD, early or sustained remission; programs offering AD/HD, depression) can be accessed through agonist, partial agonist, or agonist/antagonist the Web sites listed in Appendix 12-A. therapy; and treatment while living in a con- trolled environment (e.g., jail). Making and Confirming Substance-induced a Psychiatric Diagnosis co-occurring disorders After a possible co-occurring disorder is identi- fied during screening, an experienced, licensed Substance-induced co-occurring disorders are mental health clinician (e.g., psychiatrist, associated with intoxication, withdrawal, and psychologist, clinical social worker) should per- the persistent effects of substances of abuse. form additional evaluation to make or confirm Substance-induced persisting disorders are a diagnosis. Ideally, this expertise is available those in which substance-related symptoms at the OTP. When it is not, appropriate consul- continue long after a person stops using a drug tants and referral resources must be substituted, (e.g., prolonged flashbacks from hallucinogen use, substance-induced persistent dementia,

194 Chapter 12 substance-induced persistent amnesia). Exhibit or withdrawal. Substance use can magnify 12-2 shows the association between substance- symptoms of independent co-occurring induced co-occurring disorders and substances disorders. For example, substance use can of abuse. It is noteworthy that different drugs heighten the mood have been associated with different types swings of bipolar dis- of co-occurring disorders and that some order; intensify the (such as opioids) have relatively few or no hallucinations and [I]ndependent and reported psychotoxic effects, whereas others paranoid delusions have many. of schizophrenia; or substance-induced increase the risk of suicide, violence, and co-occurring Structured and Semistructured impulsive behaviors Interview Formats for among individuals with disorders differ in Psychiatric Diagnoses antisocial or borderline personality disorders their course. A number of carefully designed and tested (American Psychiatric instruments are available to determine DSM-IV Association 2000). or ICD-10 diagnoses, although a careful clinical interview usually can serve this purpose. Not The accuracy of differential diagnosis has all instruments have been updated for DSM- treatment implications because independent IV-TR diagnoses, but DSM-IV diagnoses are and substance-induced co-occurring disorders similar. Examples include the differ in their course. Independent disorders tend to follow a typical course for each diagno- ï Structured Clinical Interview for DSM-IV sis and require specific, long-term treatment Axis I and II Disorders, Clinical Versions (e.g., pharmacotherapy, psychotherapy). ï Composite International Diagnostic Substance-induced disorders tend to follow Interview, Core Version 2.1 the course of the substance use disorder and to ï Psychiatric Research Interview for Substance dissipate with abstinence, although persistent Abuse and Mental Health Disorders disorders can deviate from this sequence. Substance-induced symptoms can be disruptive ï Diagnostic Interview Schedule, Version 4 at the start of MAT, but they typically do not ï Alcohol Use Disorder and Associated require ongoing psychiatric treatment (Woody Disabilities Interview Schedule. et al. 1995a). TIP 42, Substance Abuse Treatment for Persons With Co-Occurring Disorders (CSAT Timing for confirming a 2005b), discusses these and other screening and diagnosis assessment instruments and their sources at Accurate diagnosis of independent co-occurring greater length. disorders is difficult during the early phases of MAT because substance-induced symptoms also Differential diagnosis usually are present. A definitive diagnosis often Careful assessment including a family history must wait until a patient is stabilized on treat- is critical to determine whether presenting ment medication for a minimum of 5 to 7 days symptoms indicate independent co-occurring (but preferably 2 to 4 weeks) and any continu- disorders or disorders induced by substance ing substance use is eliminated. Although use or a general medical or neurological several weeks of abstinence may improve the condition. In many cases, people who abuse accuracy of diagnoses, symptoms of severe multiple substances have both an independent co-occurring disorders (e.g., suicidality, co-occurring disorder and various substance- psychotic reaction) need prompt attention and induced symptoms precipitated by intoxication might require more immediate pharmacological

Treatment of Co-Occurring Disorders 195 Exhibit 12-2

DSM-IV-TR Classification of Diagnoses Associated With Different Classes of Substances Dependence Abuse Intoxication Withdrawal Intoxication Withdrawal Delirium Dementia Amnestic Disorder Psychotic Disorders Mood Disorders Anxiety Disorders Sexual Dysfunctions Sleep Disorders Alcohol X X X X I W P P I/W I/W I/W I I/W

Amphetamines X X X X I I I/W I I I/W

Caffeine X I I

Cannabis X X X X I I I

Cocaine X X X X I I I/W I/W I I/W

Hallucinogens X X X I I* II

Inhalants X X X I P I I I

Nicotine X X

Opioids X X X X I I I I I/W

Phencyclidine X X X I I I I

Sedatives, hypnotics, or anxiolytics X X X X I W P P I/W I/W W I I/W

Polysubstance X

Other X X X X I W P P I/W I/W I/W I I/W

*Also Hallucinogen Persisting Perception Disorder (flashbacks). Note: X, I, W, I/W, or P indicates that the category is recognized in DSM-IV-TR. In addition, I indicates that the specifier With Onset During Intoxication may be noted for the category; W indicates that the specifier With Onset During Withdrawal may be noted for the category (except for Withdrawal Delirium); and I/W indicates that either With Onset During Intoxication or With Onset During Withdrawal may be noted for the category. P indicates that the disorder is Persisting.

Source: Reprinted from DSM-IV-TR. Copyright 2000, American Psychiatric Association.

196 Chapter 12 treatment or hospitalization (Woody et al. opioid withdrawal, paranoid delusions 1995a). OTPs should be aware that even symp- after low-dose marijuana use) toms of less severe co-occurring disorders can ñ Substance use or another medical disorder prevent a patientís stabilization and should be cannot account better for the symptoms addressed quickly. ï Consider the mental disorder secondary Guidelines for distinguishing (substance induced) if nonñsubstance-induced ñ Symptoms developed only during periods of active substance use or within 1 month from substance-induced of intoxication or withdrawal co-occurring disorders ñ Symptoms are consistent with intoxication To assist with a differential diagnosis, the or withdrawal from substances used following information (Woody et al. 1995a) ñ Other features (e.g., age at onset) are atyp- should be collected and reviewed: ical for primary co-occurring disorder ï Previous history of mental disorders and ñ Another co-occurring or medical disorder treatment, focusing on temporal relationship does not account better for the symptoms. of symptoms to substance use and response to previous treatment Prognosis for Patients ï Type, quantity and frequency, and time of last use of illicit substances or prescribed psy- With Co-Occurring chotropic drugs (each substance class pro- duces specific physiological and behavioral Disorders effects, especially during acute intoxication or Patients with co-occurring disorders generally withdrawal after prolonged, high-dosage use) have been found to have poorer prognoses and to be more difficult to treat than those with ï Family history of mental disorders. diagnoses of either a substance use or mental DSM-IV-TR (American Psychiatric Association disorder (Dausey and Desai 2003; Kessler 2000) offers the following procedures to ascer- 1995). Research has suggested that persons tain whether a co-occurring disorder is primary with co-occurring disorders are at higher risk or secondary: of suicide, psychiatric hospitalization, legal difficulties and incarceration, homelessness, ï Label the disorder according to predominant life-threatening infectious diseases, domestic symptom pattern and specified criteria (e.g., violence, abuse or neglect of their children, mood, anxiety, psychotic disorder) unemployment, and other interpersonal problems (e.g., Dausey and Desai 2003; ï Consider the co-occurring disorder primary Room 1998). (not substance induced) if

ñ Symptoms developed before the substance Effects of Co-Occurring use disorder Disorders on Treatment ñ Symptoms have persisted during 30 days or more of abstinence (depending on the Outcomes characteristic withdrawal course for each The conventional view, which has considerable substance) empirical support, is that unidentified, untreat- ñ Symptoms are inconsistent with or exceed ed co-occurring disorders impede progress for those produced by the abused substance at patients in MAT and lead to difficulties in the dosage used (e.g., hallucinations after engaging patients in treatment, establishing a

Treatment of Co-Occurring Disorders 197 therapeutic alliance between patients and time (Belding et al. 1998). In another study, treatment providers, maintaining adherence patients in MAT for at least 90 days who had to treatment regimens, eliminating substance co-occurring disorders and high levels of symp- abuse and other risky behaviors, and prevent- tom severity had positive treatment responses ing premature dropout or early relapse. (Joe et al. 1995). Patients with more than one Conversely, a review by Drake and Brunette co-occurring disorder engaged in treatment (1998) concluded that substance abuse compli- more readily than those who were addicted cates co-occurring disorders, often precipitat- only, and both groups were similar in average ing relapse to psychopathological symptoms, incidence of drug use or criminal activity. hospitalization, disruptive behavior, familial Patients with depression, anxiety, suicidal problems, residential instability, decreased ideation, and other pathologies at intake were functional status, HIV infection, or medication twice as likely to attend individualóbut not noncompliance. groupócounseling sessions and significantly more likely to discuss psychological problems Because research on treatment outcomes for than those reporting none of these symptoms. patients with opioid addiction and co-occurring disorders usually examines small groups of sub- Consequently, caution is advised in predicting a jects and because patients in these groups are simple, stable correlation between symptom not homogeneous, the general applicability of severity of co-occurring disorders and treat- current findings is limited. Many confounding ment outcomes. However, the consensus panel factors exist (Room 1998). Despite these limita- believes that co-occurring disorders can tions, numerous studies have found that many improve substantially but that outcomes patients with co-occurring disorders did well depend heavily on additional treatment being when appropriate psychiatric and substance provided for these disorders and that patients abuse treatments were delivered. The consen- with severe symptoms may require longer, sus panel recommends more intensive and more intensive treatment. psychiatrically specific treatment for these patients. Prognosis for Specific Co-Occurring Disorders Effects of Symptom Severity Studies disagree on whether the severity of co- Effects of co-occurring APD occurring disorder symptoms in patients who on progress in MAT are addicted is a useful predictor of treatment outcomes. Early studies found that the severity APD has been estimated to affect 24 to 39 per- of co-occurring disorder symptoms, particular- cent of people seeking treatment for opioid ly in patients with anxiety or depression, addiction (Brooner et al. 1997; Darke et al. strongly predicted treatment outcomes and that 1996; King et al. 2001). Some studies have the most severely symptomatic patients had the found that people with APD and opioid addic- heaviest substance use and most impaired tion had more criminal activity, more history of adjustment, whereas the least symptomatic did early violent and aggressive behaviors, greater best in addiction treatment (McLellan et al. likelihood of engaging in activities that risked 1993; Rounsaville et al. 1986). However, later HIV transmission, more extensive and severe studies have found that higher symptom severi- polydrug abuse, and earlier onset of opioid use ty, although associated with higher levels of than persons who were opioid addicted without substance use and worse overall adjustment, APD (Brooner et al. 1997; Darke et al. 1996). did not predict treatment response. In one However, agreement is lacking on the study, drug test results for patients with severe significance of a diagnosis of APD in MAT. psychopathology improved significantly over Some studies have found that patients with

198 Chapter 12 co-occurring APD had less favorable outcomes Effects of co-occurring AD/HD than those without this disorder, even if the on progress in MAT former group received additional psychothera- py (e.g., Alterman et al. 1998; Galen et al. King and associates (1999) studied 125 people 2000). Others have found that patients with admitted to OTPs over a 1-year period to APD in MAT improved to the same extent, on determine the relationship of AD/HD to cur- average, as those without APD (e.g., Cacciola rent attention problems, other co-occurring et al. 1995; Darke et al. 1996), although the and substance use former group had more severe symptoms at disorders, and other both entry and followup. This lack of consis- outcome variables. Nineteen percent of tent findings has led some researchers to [P]atients with question the clinical utility, reliability, or valid- patients had a history ity of DSM-IV-derived APD diagnoses in MAT of AD/HD, and 88 patients (Alterman et al. 1998; Cacciola et al. percent with lifetime severe symptoms 1995). Darke and colleagues (1998) expressed AD/HD diagnoses concern that people addicted to opioids might had current symp- may require be diagnosed with APD as a reflection of their toms of AD/HD. risk-taking and drug-dealing lifestyles rather Although patients longer, more than actual existence of their underlying with AD/HD showed personality disorders. poorer attention intensive during continuous Patients with APD can improve in MAT, and performance testing treatment. OTPs should be prepared to manage and limit and more concurrent aggressive, impulsive, or criminal behaviors by Axis I and II disor- patients, regardless of whether the behaviors ders (e.g., , are related to a DSM-based diagnosis of APD. anxiety disorders including social phobia, APD) than those Effects of co-occurring PTSD without AD/HD, the AD/HD diagnosis was not on progress in MAT a significant predictor of decreased treatment retention, poor treatment compliance, or Increasing attention has been paid to the high continuing substance abuse. prevalence and negative effects of PTSD on patients in MAT, especially women (Villagomez et al. 1995). Hien and colleagues (2000) found Treatment Issues that women with symptoms of PTSD at admis- sion were significantly less likely than those General Treatment without such symptoms to adhere to treatment requirements, including abstinence from sub- Considerations for Patients stances during the first 3 months of MAT. In With Co-Occurring Disorders another study, patients with current PTSD Clearly, co-occurring disorders should not symptoms had greater drug abuse severity exclude people with opioid addiction from (Clark et al. 2001). These patients may need admission to an OTP. The consensus panel special attention paid to depression and suici- believes that the best strategy is to stabilize dal ideation (Villagomez et al. 1995). TIP 36, these patientsí opioid addiction with Substance Abuse Treatment for Persons With methadone, buprenorphine, or levo-alpha Child Abuse and Neglect Issues (CSAT 2000d), acetyl methadol (LAAM) while assessing their and TIP 42, Substance Abuse Treatment for co-occurring disorder symptoms and choosing Persons With Co-Occurring Disorders (CSAT the most appropriate treatment course. 2005b), provide more information on PTSD Although OTP staff members often focus on and substance abuse treatment.

Treatment of Co-Occurring Disorders 199 the condition that is most severe and threaten- oxazepam (SeraxÆ) rather than lorazepam, ing, it usually is best to address all of a patientís clonazepam, alprazolam or diazepam. disorders simultane- ï Patients resistant to being psychiatrically ously because each diagnosed should be assured that it is not can influence the shameful but is likely to provide a better [C]o-occurring others. TIP 42, understanding of their problems and aid in Substance Abuse treatment. Educating patients about co- disorders should Treatment for occurring disorders helps. Persons With Co- ï Therapy for patients with co-occurring not exclude people Occurring Disorders (CSAT 2005b), pro- disorders should be more intensive, on aver- age, than for patients without co-occurring with opioid addic- vides information about treatment disorders. The primary goal is abstinence planning and imple- from substances. Remission of co-occurring tion from admis- mentation for this disorder symptoms should be an important group. secondary goal. sion to an OTP. The consensus panel believes that the fol- Co-Occurring Disorders and lowing principles are Treatment Planning essential to manage patients with co-occurring Because patients in MAT exhibit a wide range disorders in an OTP: of co-occurring disorders, the consensus panel believes that early treatment planning and ï Treatment of co-occurring disorders should resource management should include classifying be integrated or closely coordinated with sub- patients, at least tentatively, into categories stance abuse treatment when the former is based on types and severity of co-occurring not available on site. disorders, although treatment always should be ï Staff members, whether primarily from the tailored individually. substance abuse treatment or mental health fields, should be knowledgeable about treat- ments for both disorders. Patients in acute psychiatric ï Psychotropic medications should be pre- danger scribed only after patients are stabilized on Patients presenting with suicidal or homicidal the treatment medication (which in the ideation or threatsówhether resulting from panelís experience takes an average of 3 to 7 acute intoxication or withdrawal or from an days for buprenorphine and 3 weeks to a independent co-occurring disorderóor those month for methadone), unless an indepen- manifesting psychotic symptoms (e.g., halluci- dent co-occurring disorder is evident from nations, paranoia) that may interfere with their past records or clinical examination or signif- safety and ability to function should be assessed icant impairment associated with the symp- and treated immediately. Although their symp- toms of a co-occurring disorder exists. toms may be short lived, admission to a psychi- ï All medications used by patients and patientsí atric unit for brief treatment may be necessary adherence to medication regimens should be if outpatient care is too risky or problematic. monitored carefully, for example, via drug Immediate administration of antipsychotic testing. Physicians should be careful about drugs, benzodiazepines, or other sedatives may prescribing substances with abuse potential, be required to establish behavioral control such as benzodiazepines. If such medications (Minkoff 2000). A physician, physicianís assis- are prescribed, the less abusable drugs in a tant, or nurse practitioner on staff can pre- class should be chosen, for example, scribe medications at the OTP. Otherwise,

200 Chapter 12 referral is warranted. In emergencies, OTPs Patients with less severe, pre- should send patients to affiliated hospital emer- sumptively substance-induced gency rooms (see ìHandling Emergency Situationsî below). co-occurring disorders The consensus panel recommends that patients Patients with established, in MAT with symptoms of Axis I disorders but severe co-occurring disorders no history of primary co-occurring disorders receive no new psychotropic medications until Patients in MAT who are not in acute danger they are stabilized on MAT because their symp- but have been diagnosed or treated for severe toms might remit or significantly diminish after co-occurring disorders (e.g., schizophrenia, a period of substance abuse treatment (Joe et bipolar disorder) should receive medication al. 1995). Exceptions include patients who have with the lowest abuse potential for their condi- acute, substance-induced disorders such as tion. If an OTP is staffed appropriately and extreme anxiety or paranoia that are likely to prepared to treat patients with severe co- be transitory but require temporary sedation occurring disorders, these patients can be treat- or antianxiety medication. ed on site. Otherwise, they should be referred to an OTP with these qualifications. If there is no such OTP, patients may need to remain in a less Effects of Co-Occurring optimal OTP but receive psychiatric treatment Disorders on HIV Risk at another facility. For referrals, effective com- Behaviors and Comorbidity munication between OTPs and mental health providers is necessary to coordinate treatment. King and colleagues (2000) found that patients with co-occurring disorders in MAT were at Patients with less severe, higher risk for contracting and transmitting HIV than those without these disorders. In persisting or emerging another study, patients who were HIV seroposi- symptoms of co-occurring tive and had co-occurring disorders were more disorders likely than those without co-occurring disor- ders to continue using drugs, less likely to be Patients in MAT with nondisabling symptoms prescribed HIV medications or to adhere to of less severe co-occurring disorders (e.g., medication regimens, and more likely to devel- mood, anxiety, and personality disorders), op AIDS (Ferrando et al. 1996). People with psychiatric treatment histories, or verified co-occurring disorders, particularly depression diagnoses and current prescriptions for medi- or dysthymia, were more likely than those with- cations to treat such disorders (regardless of out Axis I disorders to continue needle sharing whether they are used) should continue or and other high-risk behaviors (Camacho et al. begin medication, psychotherapy, or both for 1996). Patients in MAT who injected drugs and their co-occurring disorders. These patients had APD were at higher risk for contracting should continue in MAT if the OTP is staffed to and spreading HIV (Brooner et al. 1993). To treat them. Although it is desirable for patients decrease the spread of HIV, it is important to to be stabilized on methadone, buprenorphine, treat both substance use and co-occurring dis- or LAAM before other pharmacotherapy is ini- orders and provide education and support for tiated, newer medications with relatively benign patients who inject drugs. More information on side effects can be initiated sooner (e.g., selec- HIV/AIDS and substance abuse treatment, tive serotonin reuptake inhibitors [SSRIs]) if a including the combined treatment of HIV/AIDS, primary mental disorder is indicated. Such substance abuse, and mental illness, can be medications may facilitate engagement in MAT found in TIP 37, Substance Abuse Treatment and addiction recovery (Minkoff 2000). for Persons With HIV/AIDS (CSAT 2000e).

Treatment of Co-Occurring Disorders 201 Models of Care Risk factors and predictors for Although it is not always feasible to provide suicidal ideation and threats more specialized services on site, patient adher- People who are opioid addicted have high rates ence to medical treatment was found to drop of suicide and attempted suicide, ranging from dramatically when such services were provided 8 to 17 percent in some studies with even higher through offsite referral (Batki et al. 2002). Even rates among certain groups (Krausz et al. when referrals are to services near an OTP, 1996). or withdrawal noncompliance may have significant conse- can cause or exacerbate suicidal ideation or quences for personal, social, and public health. threats, and the presence of co-occurring disor- If a program cannot provide onsite ancillary ders further increases the risk. Chapter 4 dis- services, it is important that staff members cusses risk factors for suicide and recommend- identify co-occurring disorders early so that ed treatment responses. Risk factors do not they can refer patients to appropriate predict individual behavior, but a high-risk resources. It is essential to monitor patient profile merits immediate and ongoing attention progress and compliance with offsite treatment, (Chatham et al. 1995a; Hall et al. 1999). In one which can be done by a counselor, case manag- study of suicidality among patients in an OTP, er, nurse, or physicianís assistant or by assign- the strongest predictors of suicide risk were ing one staff member to coordinate and moni- psychosocial dysfunction (e.g., depression, tor all referrals. Offsite referrals also may be social withdrawal, hostility toward friends and necessary to obtain psychotropic medications family), help-seeking behaviors (e.g., previous and evaluate patientsí reactions to them. treatment episodes, attendance at mutual-help meetings, self-referral), and perceived lack of support from others (Chatham et al. 1995a). Handling Emergency At least two studies of patients in MAT who Situations overdosed on opioids concluded that overdoses A high percentage of patients with co-occurring usually were accidental and not predictive of disorders in MAT have reported suicide subsequent suicide attempts. In an early work, attempts or difficulty controlling violent behav- Kosten and Rounsaville (1988) found that acci- ior during their lifetimes (Cacciola et al. 2001). dental overdoses were three times more likely Patients who present an acute danger to them- than suicidal ones. More recently, Darke and selves or others or have psychotic symptoms or Ross (2001) reported that 92 percent of disordered thinking that could interfere with patients who overdosed characterized the their safety or that of others should receive overdose as accidental. In that study, of the 40 immediate, aggressive intervention on admis- percent who acknowledged a previous suicide sion and throughout treatment. Staff members attempt, only 10 percent deliberately overdosed should be trained to notice indications of with heroin compared, for example, with 21 suicidal or homicidal risks. These observations percent who deliberately overdosed with should be documented and communicated to benzodiazepines. designated staff members who can take neces- sary action, including appropriate medication, Protocol for identifying notification of family members and involved agencies (e.g., probation office, childrenís and handling suicide and protective services), or transfer of patients to homicide risk more secure or protective settings. Staff mem- All intake workers, certified addiction coun- bers should understand thoroughly and be selors, and clinicians should be alert to risk prepared to act on an OTPís ìduty to warnî factors for suicide and homicide and should (CSAT 2004b) about potentially violent question at-risk patients routinely about suici- behavior by patients. dal or homicidal thoughts or plans. This is

202 Chapter 12 important for patients who appear withdrawn, other mood stabilizers or antidepressants take depressed, angry, or agitated or are known to hold, which can take several weeks. Medication- have experienced a recent significant loss or assisted treatment of acute suicidality should be other source of stressóespecially if a co- on an inpatient basis unless family members or occurring disorder is suspected or diagnosed or friends are willing to be responsible for adminis- if a patient still is intoxicated or withdrawing tering the drugs regularly, keeping the at-risk from a psychoactive substance. Although the patient safe, and monitoring his or her reactions. consensus panel believes such screening is help- ful, the research evidence supporting its effec- Patients identified as being at imminent risk tiveness is limited (Kachur and DiGuiseppi of committing suicide or homicide might need 1996). hospitalization for short-term observation. Some key factors in this decision are clearly To aid in screening and referral for suicidality expressed intent, specific and lethal plans, and homicidality, all programs should have accessible means, limited social or familial protocols in place that specify resources, severe symptoms of mental illness or psychosis, command hallucinations, hopeless- ï Who asks what questions or uses what ness, and previous suicide or homicide attempts. specific tool to identify these types of risk If a referral is made, the patient should not be ï How identified risks are documented left alone until responsibility for monitoring ï Who is informed about risks and is responsi- safety is transferred to the referred facility. ble for taking actions and what resources he or she can use (e.g., medications, Counseling, Psychotherapy, referral/transfer, family involvement). and Mutual-Help Groups for Any patient suspected of suicide or homicide People With Co-Occurring risk should be referred immediately to a mental health clinician for further evaluation. If the Disorders in MAT OTP has no psychologist, clinical social work- Chapter 8 discusses counseling, case manage- er, or psychiatrist on staff, it should have ment, and psychotherapy for patients in MAT. arrangements for rapid consultations. Programs should encourage participation in Decisions should be made about using antipsy- mutual-help groups that focus on the needs of chotic medications, benzodiazepines, or other people with co-occurring disorders. Exhibit 12- sedatives to establish behavioral control rapid- 3 lists some of the best known of these groups, ly (Minkoff 2000). Such medications may be along with contact information. needed to alleviate or control symptoms until

Exhibit 12-3

Mutual-Help Groups for People With Co-Occurring Disorders

ï Double Trouble in Recovery (www.doubletroubleinrecovery.org) ï Dual Recovery Anonymous (www.draonline.org) ï Dual Disorders Anonymous (847-781-1553 or P.O. Box 681268, Schaumburg, IL 60168) ï Dual Diagnosis Recovery Network (www.dualdiagnosis.org) (active mostly in California)

Treatment of Co-Occurring Disorders 203 Psychoeducation for Patients used when indicated. Most medications are With Co-Occurring Disorders more effective when used with counseling or psychotherapy in comprehensive MAT. in MAT In many ways, an OTP is an optimal setting Group sessions presenting information about to initiate and monitor psychiatric pharma- topical issues can help patients with co-occurring cotherapy for co-occurring disorders because disorders and their families. Patients can patients attend daily (at least in the early stages explore relevant themes by emphasizing positive of treatment) and onsite physicians and other coping strategies and sharing experiences. staff can observe their reactions to psychotropic Possible topics for psychoeductional groups are medications as well as to methadone or other presented in Exhibit 12-4. addiction treatment medications.

Pharmacotherapy for Patients When psychotropic medications are used in an OTP, they should be prescribed With Co-Occurring Disorders in MAT ï In a comprehensive program that integrates medical, psychiatric, and social interventions Several pharmacological treatments for co- and supports patient compliance with occurring disorders are available and should be medication dosing schedules.

Exhibit 12-4

Topics for Psychoeducational Groups for People With Co-Occurring Disorders

ï Causes, symptoms, and treatment for substance use and co-occurring disorders ï Medical and mental effects of co-occurring disorders ï Psychosocial effects of co-occurring disorders ï The recovery process for co-occurring disorders ï Medications to treat co-occurring disorders, their side effects, and medication management ï Coping with cravings, anger, anxiety, boredom, and depression ï Changing negative or maladaptive thinking ï Developing a sober support system ï Addressing family issues ï Learning to use leisure time constructively ï Spirituality in recovery ï Joining 12-Step and co-occurring disorder recovery mutual-help groups ï Risk factors in ongoing recovery ï Understanding and getting maximum benefits from psychotherapy and counseling

Adapted from Daley 2000.

204 Chapter 12 ï In the context of a multidisciplinary-team OTPs should consider a hierarchical approach approach in which regularly scheduled team to treating patients with co-occurring disorders, meetings ensure that all members are aware starting with psychosocial interventions such as of the patientís progress in treatment. increased counseling or psychotherapy (unless ï With careful selection of medications because the patient has a disorder clearly needing medi- some patients may attempt to get high on any cation). Depending on severity and acuity of medication prescribed. Some medications symptoms, treatment providers may be able to (e.g., amitriptyline, , benzodi- use nonpharmacological approaches such as azepines) have little abuse potential in other psychotherapy, either alone or with psychiatric populations but pose a significant risk of medications. If these psychosocial approaches abuse in this population (Cicero et al. 1999). are ineffective or of limited benefit, providers should select psychiatric medications with the If patients in an OTP are prescribed other lowest abuse potential that are likely to be medications in addition to addiction treatment effective. TIP 37, Substance Abuse Treatment medications, the consensus panel recommends for Persons With HIV/AIDS (CSAT 2000e, pp. the following procedures: 83ñ84), provides a summary of abuse potential for psychiatric medications. The psychiatric ï All prescribed psychotropic medications medications should be, in most instances, should be to treat suspected or confirmed adjunctive to other ongoing interventions, not a co-occurring disorders, not to alleviate nor- substitute for them. However, other factors to mal discomfort (Minkoff 2000). consider include ï Fixed, rather than ìprnî or ìas needed,î doses of psychotropic medications should be ï The potential effect of medication side effects prescribed because, especially early in MAT, on compliance patients addicted to opioids have difficulty ï Potential negative interactions with addiction regulating medications of any kind (Minkoff treatment medication or other drugs 2000). Whenever possible, given resource ï Lethality if the drug is used impulsively or availability, potentially abusable medications intentionally for suicide should be dispensed by OTP staff along with addiction treatment medication. ï Potential effects on a patientís physical con- ditionófor example, whether the drug might ï Patients receiving psychotropic medications injure an already damaged liver or increase should be educated about each drugís blood pressure in a hypertensive patient. expected benefits, potential disadvantages and limitations, side effects, implications for Some studies have found that methadone may, pregnancy and breast-feeding, length of time by itself, relieve some symptoms of mood and before full effects should begin, and potential anxiety disorders but not Axis II personality to cause tolerance and withdrawal. This disorders (Calsyn et al. 2000a; Musselman and education can be done individually or in a Kell 1995). From a practical viewpoint and group, but all information should be commu- assuming sufficient time to observe patients nicated both in writing and orally. before further intervention, the consensus ï An onsite (full- or part-time) physician or panel believes that the best approach is careful psychiatrist should have regular contact with observation during the first weeks of MAT to each patient with a co-occurring disorder to determine whether symptoms of co-occurring review medication response and compliance. disorders diminish before psychiatric medica- This professional also should supervise coun- tions are considered. selor interactions with these patients and participate in team meetings to discuss treatment plans.

Treatment of Co-Occurring Disorders 205 Medications for major depres- in MAT with co-occurring disorders should be sion and bipolar disorder used to determine which patients diagnosed with major depression or bipolar disorder may The hierarchical approach described in the benefit from antidepressant medication. previous two paragraphs for treating patients Exhibit 12-5 summarizes interactions of some

Exhibit 12-5

Interactions of Some Medications for Depression and Bipolar Disorder With Methadone and Recommended Treatment Response in MAT

Medication Type Recommended Treatment and Examples Action With Methadone Response SSRIs Some SSRIs inhibit metabolism of Observe patients carefully for fluvoxamine methadone and increase signs of methadone overmedication methadone blood levels (Eap et al. during the first weeks of treatment (LuvoxÆ), 1997). Fluoxetine and sertraline with SSRIs. Methadone withdrawal fluoxetine do not increase methadone levels symptoms may occur after discon- (ProzacÆ), significantly. Fluvoxamine is the tinuation of fluvoxamine. sertraline most dangerous SSRI and should be avoided for patients in MAT. (ZoloftÆ) Carbamazepine Carbamazepine speeds production Avoid carbamazepine and use (TegretolÆ) of liver enzymes that metabolize alternatives such as valproate methadone and can cause severe (DepakoteÆ). Increase and/or split opioid withdrawal symptoms (Eap the methadone dosage to increase et al. 2002). its blood levels. Tricyclics Methadone impairs the metabolism Adjust doses of tricyclic , of tricyclics and can cause medications as needed; monitor increased tricyclic medication blood levels if clinically indicated. , blood levels (Maany et al. 1989). , doxepin Monoamine MAO inhibitors may have Use extreme caution in prescrib- oxidase (MAO) dangerous interactions with ing these medications in MAT. inhibitors certain foods and substances of abuse (Kleber 1983). Lithium None. Monitor closely because window between therapeutic and toxic dose is narrow.

206 Chapter 12 antidepressant medications with methadone The well-documented abuse potential of and recommended treatment response. benzodiazepines has led to a common belief Antidepressants have been used successfully that they are contraindicated in patients to treat depression in patients in MAT. One receiving methadone. However, evidence sug- example is a study of patients with chronic gests major differences in the abuse liability of depression who were treated with the tricyclic benzodiazepines. Those with a slower onset of imipramine or a placebo. Fifty-seven percent of action such as oxazepam rarely are mentioned imipramine-treated patients showed both signifi- as substances of abuse, have a wide margin of cant improvement in mood and some decreases safety, and are effective in reducing anxiety, in illicit drug use according to self-reports, com- even over extended periods (Sellers et al. 1993). pared with only 7 percent of placebo patients Several case reports have indicated that benzo- who reported results (Nunes et al. 1998a). diazepines, particularly those with low abuse However, no significant reductions in substance liability, may be used safely for patients with use were found between the two groups based substance use disorders (Adinoff 1992; Sellers on drug testing. There is no theoretical reason et al. 1993). Sellers and colleagues also found a to presume that tricyclic medications are ìserious pattern of nontherapeutic benzodi- unique among antidepressants improving azepine use . . . among opiate-dependent mood, and SSRIs are much safer and may be persons, particularly those in methadone main- the preferred treatment. Antidepressants also tenance treatment programsî (1993, p. 72), may be helpful for anxiety disorders. leading these authors to recommend that ìif benzodiazepine is used [with this group], those Bipolar disorder in patients in MAT can be with an apparently low abuse potential are treated with antipsychotic or mood-stabilizing generally preferable.î medications. Mood stabilizers shown to be effective include lithium, valproate, and The consensus panel believes that patients who carbamazepine (Hellewell 2002). Lamotrigine have a history of benzodiazepine abuse should (LamictalÆ) also has been shown to be effective. not be disallowed from receiving previously prescribed benzodiazepines, provided that they Anxiety disorders are monitored carefully and have stopped the earlier abuse. They may be attempting to Anxiety disorders, including , reduce symptoms of co-occurring disorders, PTSD, and others, can be treated with and, when they receive a prescribed medication psychotherapy, pharmacotherapy, or both. with low abuse liability and are monitored for These disorders can be treated effectively with their co-occurring anxiety and substance use antidepressant medications such as the SSRIs, disorders, improvement and cessation of other Æ venlafaxine (Effexor ), and the tricyclics. benzodiazepine use may occur naturally. Some Patients sometimes respond better to one drug drug-testing laboratories can determine specific class or a specific drug in a class. Therefore, types of benzodiazepines used. If such a another antidepressant should be considered if resource is available, testing can determine patients do not respond to their first one after a whether patients are using only their prescribed 4- to 8-week trial. Some antidepressants also benzodiazepines or supplementing them with have sedative effects (e.g., others obtained illicitly. The latter would indi- Æ [Remeron ], trazodone, and some tricyclic cate a need to change patientsí treatment plans. antidepressants), which might be beneficial for patients with insomnia when these drugs are taken before bedtime, or for patients with high AD/HD levels of anxiety. Nonsedating antidepressants Stimulants such as methylphenidate (RitalinÆ) might be especially useful for patients with are the treatment of choice for childhood psychomotor inhibition. AD/HD. Stimulant treatment in adulthood also is potentially effective but carries the obvious

Treatment of Co-Occurring Disorders 207 risk of abuse by patients in MAT. Use of cocaine cases, and should be considered as the initial could be an attempt to control symptoms of treatment for some patients or as a second AD/HD (Levin et al. 1998). If AD/HD is severe, option for those not responding to more tradi- treatment providers should consider treatment tional medications. TIP 42, Substance Abuse with medications such as methylphenidate, Treatment for Persons With Co-Occurring amphetamine, or atomoxetine (StratteraÆ) Disorders (CSAT 2005b), provides more because these medications reduce AD/HD information. symptoms and address cocaine or other stimu- lant use. However, they should be monitored carefully because some patients have abused Collaboration Between them by injection, and medical complications Counselors and Physicians can result from long-term injection use. Many counselors have little or no psychiatric Tricyclic antidepressants also are effective for background and need training in some patients in MAT with co-occurring AD/HD and depression (Higgins 1999), and these drugs ï Working with patients who may have co- carry no addiction liability. Recently, the non- occurring disorders but who resist evaluation stimulant atomoxetine was approved to treat or respond only partially to treatment AD/HD and may prove advantageous for ï Exploring stereotypes and feelings about what patients in MAT with co-occurring AD/HD. it means to have a co-occurring disorder However, because atomoxetine is metabolized by the cytochrome P450 system of liver ï Helping patients keep physician appoint- enzymes, the potential for interaction with ments, understand information, and follow methadone exists, and it should be used cau- physician recommendations tiously until more information is available. ï Supporting patients to try medication if recommended Schizophrenia ï Supporting patients to tolerate side effects long enough to determine whether Patients in MAT who have schizophrenia often medications help have profound impairment in thinking and behavior and are unlikely to fit in well in many ï Providing guidance about when to contact a OTPs. Antipsychotic medication, along with physician to report side effects or lack of psychosocial intervention, is the mainstay of relief from or worsening symptoms treatment. Newer atypical antipsychotic medi- ï Supporting patients to continue taking cations for schizophrenia are preferred over medication, even when they feel better. older ìtypicalî agents, which carry a risk of movement disorders such as tardive dyskinesia, Physicians need training or guidance in a neurological syndrome caused by long-term ï Providing education to OTP staff about co- use of neuroleptic medications (National occurring disorders and medications Institute of Neurological Disorders and Stroke 2001). ï Recognizing common misunderstandings about and resistances to medication in Newer antipsychotic medications (clozapine addiction treatment [ClozarilÆ, olanzapine [ZyprexaÆ], risperidone ï Creating protocols that make good use [RisperdalÆ]), quetiapine, ziprasidone of counselor ability to provide detailed [GeodonÆ], and aripiprazole [AbilifyÆ]) have observations and ongoing feedback on fewer side effects, are more effective in many patientsí conditions (Zweben 2003).

208 Chapter 12 Appendix 12-A. Internet Resources for Accessing Psychiatric Instruments

ï Comorbidity and Addictions Center: George ï National Institute on Alcohol Abuse and Warren Brown School of Social Work Alcoholism (www.niaaa.nih.gov/ (www.gwbweb.wustl.edu/Users/cac/ publications). Provides access to information measurescollection.htm). Lists 175 instru- first published in Assessing Alcohol ments for measuring aspects of substance use Problems: A Guide for Clinicians and and psychopathology with hyperlinks to Researchers (Allen and Columbus 1995). The descriptions. Information for each measure site specifies useful measures for screening, or scale includes purpose, authors, key diagnosing, and planning treatment for references, target populations, variables, alcohol-related and other psychoactive sub- administration and scoring options, and time stance use disorders, as well as co-occurring estimates as well as copyright, cost, and disorders. The site also includes information ordering information. on administration and scoring options, ï Medical Outcomes Systems, Inc. estimated times for administration, key (www.medical-outcomes.com). Contains a variables, groups on which normative data description of the Mini International for the instrument were based, psychometric Neuropsychiatric Interview as well as down- properties, and ordering costs. loadable versions of all M.I.N.I. instruments, ï University of Adelaide (Australia) Library including the screen version and standard Guide (www.library.adelaide.edu.au/guide/ and expanded (Plus) 5.0.0 editions (January med/menthealth/scales.html). Contains a list 2002). Although materials are protected by of psychiatric rating scales and information copyright, researchers and clinicians working about where copies and descriptions of these in nonprofit or publicly owned settings (e.g., instruments can be obtained, hyperlinks to universities, teaching hospitals, government electronic versions, and references on devel- institutions) may make copies for clinical or opmental history and psychometric properties research purposes. of each instrument.

Treatment of Co-Occurring Disorders 209

13 Medication-Assisted Treatment for Opioid Addiction During Pregnancy

Little information exists on the prevalence of opioid use by pregnant women, but there is some information about opioid use by pregnant In This women entering substance abuse treatment programs. Of the 400,000 Chapter… women admitted to programs in 1999, 4 percent were pregnant when admitted. Opioids were the primary substance of abuse for 19 percent of Acceptance of both pregnant and nonpregnant women who entered these programs Methadone (Office of Applied Studies 2002). Maintenance as the Standard of Care Acceptance of Methadone Diagnosing Opioid Addiction in Pregnant Maintenance as the Patients Standard of Care Medical and Obstetrical Methadone has been accepted since the late 1970s to treat opioid addic- Concerns and tion during pregnancy (Kaltenbach et al. 1998; Kandall et al. 1999). In Complications 1998, a National Institutes of Health consensus panel recommended Methadone Dosage and methadone maintenance as the standard of care for pregnant women Management with opioid addiction (National Institutes of Health Consensus Development Panel 1998). Methadone currently is the only opioid medi- Postpartum Treatment cation approved by the U.S. Food and Drug Administration (FDA) for of Mothers in MAT medication-assisted treatment for opioid addiction (MAT) in pregnant Breast-Feeding patients. Buprenorphine is classified as a category C drug by FDA (i.e., one lacking adequate, well-controlled studies in pregnant women) and, at Effects on Neonatal this writing, is not FDA approved to treat pregnant women, although Outcome several studies have found it safe and effective in this group (e.g., Use of Buprenorphine Fischer et al. 2000; Lacroix et al. 2004). Even though it is a category C During Pregnancy drug, buprenorphine may be used with pregnant patients in the United States under certain circumstances (see ìUse of Buprenorphine During Importance of Pregnancyî later in this chapter). Integrated, Comprehensive Services Effective medical maintenance treatment with methadone has the same benefits for pregnant patients as for patients in general. In addition, Nutrition Assessment, methadone substantially reduces fluctuations in maternal serum opioid Counseling, and levels, so it protects a fetus from repeated withdrawal episodes Assistance

211 (Kaltenbach et al. 1998). Comprehensive (Finnegan 1991); inducing even mild withdrawal methadone maintenance treatment that can cause premature labor or other adverse includes prenatal care reduces the risk of fetal effects. obstetrical and fetal complications, in utero growth retardation, and neonatal morbidity and mortality (Finnegan 1991). Medical and Obstetrical Concerns Diagnosing Opioid and Complications Addiction in Pregnant Pregnant women who abuse substances, including alcohol and nicotine, have a greater- Patients than-normal risk of medical complications. In the consensus panelís experience, some These women should be monitored regularly women who are opioid addicted do not for signs of anemia, poor nutrition, increased acknowledge pregnancy readily, or they misin- blood pressure, hyperglycemia, sexually trans- terpret early signs of pregnancy, for example, mitted diseases (STDs), hepatitis, preeclampsia, fatigue, headaches, nausea and vomiting, and and other complications of pregnancy or health cramps, as opioid withdrawal symptoms. problems related to addiction. Good nutrition, Consequently, onset of pregnancy may cause including vitamin supplements, should be these patients to increase their use of illicit encouraged. Pregnant women should be edu- opioids or other substances that do not alleviate cated about the potential adverse effects of their perceived withdrawal symptoms but substance use on their fetuses, such as fetal expose their fetuses to increased serum levels alcohol syndrome and premature labor associ- of these substances. ated with opioid withdrawal or stimulant use. Patient use of prescribed medications other than Many women who are opioid addicted confuse methadone should be monitored for compliance the amenorrhea caused by their stressful, with usage directions and for adverse effects. unhealthful lifestyles with infertility. They might have been sexually active for years Chronic substance use in pregnancy can cause without using contraceptives and becoming medical complications (some are listed in pregnant. The consensus panel has noted that, Exhibit 13-1), depending on how substances are because methadone normalizes endocrine func- administered and when or whether problems tions, it is not unusual for women in the early are identified and treated. Infections account phases of MAT to become pregnant uninten- for a high percentage of these complications in tionally, especially if they receive no counseling pregnant women who are opioid addicted, as for this possibility. they do in all people who abuse opioids (see chapter 10). Infections can be profoundly Procedures for diagnosing opioid and other harmful to both women and their fetuses, par- addictions in pregnant women should incorpo- ticularly if infections remain unrecognized and rate information from their medical and sub- untreated during gestation. Hepatitis B and C, stance use histories, physical examinations, drug bacterial endocarditis, septicemia, tetanus, test reports, and observed signs or symptoms of cellulitis, and STDs are especially frequent withdrawal. Other indications of addiction may (Finnegan 1991). include evidence of diseases associated with drug use (e.g., hepatitis, bacterial endocarditis, The rate of vertical perinatal transmission of cellulitis), poor attendance for prenatal care, hepatitis B virus (HBV) is high (ranging from and unexplained fetal growth abnormalities 70 to more than 90 percent [Centers for Disease (e.g., intrauterine growth retardation). Using an Control 1988b; Ranger-Rogez et al. 2002]), opioid antagonist to diagnose addiction in preg- especially if a pregnant woman has active nant women is absolutely contraindicated infection (determined by a positive

212 Chapter 13 Exhibit 13-1

Common Medical Complications Among Pregnant Women Who Are Opioid Addicted

Anemia STDs Bacteremia/septicemia Chlamydia Cardiac disease, especially endocarditis Condyloma acuminatum Cellulitis Gonorrhea Depression and other mental disorders Herpes Edema HIV/AIDS Gestational diabetes Syphilis Hepatitis (acute and chronic) Tetanus Hypertension/tachycardia Tuberculosis Phlebitis Urinary tract infections Pneumonia Cystitis Poor dental hygiene Pyelonephritis Urethritis

Adapted from Finnegan 1979.

hepatitis B antigen test) in the third trimester performed if an anti-HCV antibody test is posi- or within 5 weeks postpartum. If a new motherís tive. The results facilitate referral for further hepatitis B antigen test is positive, the neonate evaluation, staging, and treatment of liver dis- should receive both hepatitis B vaccine and ease after delivery. Infants whose mothers have hepatitis B immune globulin (Kaltenbach et al. hepatitis C should receive HCV RNA testing 1998). The rate of perinatal transmission of along with antibody testing for HCV between hepatitis C virus (HCV) is lower than that of ages 2 and 6 months and again between 18 and HBV, as discussed below; however, vaccines 24 months (Roberts and Yeung 2002). exist for hepatitis A virus and HBV but not for HCV. Recommended laboratory tests for During pregnancy, HCV can be transmitted pregnant women who are opioid addicted are vertically from mother to fetus. However, listed in Exhibit 13-2. multiple studies have shown low overall HCV vertical transmission risk and greater risk from factors such as HIV co-infection or high HCV HCV viral load (Roberts and Yeung 2002). Vaginal Pregnant women with a history of injection delivery and breast-feeding do not appear to drug use are at high risk for HCV infection and increase the risk of neonatal HCV infection sig- should be screened for anti-HCV antibody. nificantly (Dinsmoor 2001; Roberts and Yeung HCV ribonucleic acid (RNA) testing should be 2002). Available treatments to prevent vertical

MAT During Pregnancy 213 Exhibit 13-2

Laboratory Tests for Pregnant Women Who Are Opioid Addicted

ï Complete blood count with differential and ï Urine tests platelets Urinalysisóroutine and microscopic ï Chemistry screen (K, Na, Cl, Ca, P, CO2, Urine culture and sensitivity creatinine, blood glucose, blood urea Urine drug screen nitrogen, total bilirubin, total serum protein albumin) ï Tuberculin skin test (Mantoux) ï Hepatic panel (liver function tests) ï Alpha-fetoprotein between 15 and 21 weeksí gestation (optimal, 16 to 18 weeks) ï Hepatitis B surface antigen (full panel if positive) ï 1-hour, 50 mg glucose challenge test at 24 to 28 weeksí gestation (at initial visit if ï Hepatitis C antibody risk factors) ï Rubella titer ï Repeat complete blood count and serology ï Serology (Venereal Disease Research at 24 to 28 weeksí gestation Laboratory or Rapid Plasma Reagin tests) ï Group B Strep vaginal-rectal culture at ï Sickle prep (if appropriate) 35 to 37 weeksí gestation ï Blood type; Rh and indirect Coombs Varicella (if unsure of history) ï HIV (with counseling)

Reprinted from Obstetrics and Gynecology Clinics of North America, 25(1), Kaltenbach et al., Opioid dependence during pregnancy. Effects and management, pp. 139ñ151, 1998, with permission from Elsevier.

transmission, however, are limited by the fetal additional studies are completed. Studies on toxicity of the medications currently available the combined effects of HIV antiretroviral for HCV infection. treatment and methadone especially are needed. HIV/AIDS During the early 1990s, before effective pre- Pregnant women who are opioid addicted vention treatments were available, studies in and HIV positive present a unique treatment North America and Europe found mother-to- problem. A limited number of studies with child or perinatal HIV transmission rates of 16 small numbers of patients have examined the to 25 percent. However, between 1996 and 2000, relationship of HIV, methadone, and immune after the implementation of new guidelines, function (e.g., Beck et al. 2002; Siddiqui et al. studies in the United States found transmission 1993). These studies have not been replicated rates of 5 to 6 percent, and more recent studies widely. Therefore, it is difficult to conclude any have found rates below 2 percent when antena- significant relationship involving HIV, tal antiretroviral drugs or zidovudine (AZT) is methadone, and immune function until combined with cesarean section (Centers for

214 Chapter 13 Disease Control and Prevention 2001b). meet the demands of caring for a newborn. Although AZT prophylaxis reduces the risk of Breast-feeding by HIV-infected women has perinatal HIV infection, monotherapy often is been associated with an increased risk of HIV inadequate to treat a motherís HIV disease. transmission and should be discouraged Combination antiretroviral therapy is now the (Nduati et al. 2000). standard of care (Paul et al. 2001). Studies in the United States and Europe have Obstetrical Complications found that pregnancy has no effect on HIV Obstetrical complications in pregnant women progression (Burns et al. 1998; Saada et al. who are opioid addicted are the same as those 2000). Studies before the availability of seen at increased rates in all women who lack antiretroviral therapy showed no increase in prenatal care (see Exhibit 13-3). These compli- prematurity, low birth weight, or intrauterine cations may be difficult to diagnose in patients growth restriction associated with HIV infec- who are opioid addicted because they often tion. These data are difficult to interpret deny the existence of complications or avoid because of relatively high rates of adverse medical settings. When obstetrical complica- events in the control groups attributed to tions are confirmed, standard treatments, other conditions such as substance abuse including use of medications to arrest preterm (Brocklehurst and French 1998; Bucceri et al. labor, can be initiated safely. 1997). Studies have not found increases in birth defects or fetal malformation related to HIV infection (Brocklehurst and French 1998). Methadone Dosage The consensus panel recommends that women and Management who are opioid addicted and HIV infected The pharmacology of methadone in pregnant receive additional counseling and support dur- women has been evaluated thoroughly. ing the postpartum period to improve their Methadone is distributed widely throughout adherence to antiretroviral therapy and to

Exhibit 13-3

Common Obstetrical Complications Among Women Addicted to Opioids

Abruptio placentae Postpartum hemorrhage Chorioamnionitis Preeclampsia Intrauterine death Premature labor/delivery Intrauterine growth retardation Premature rupture of membranes Intrauterine passage of meconium Septic thrombophlebitis Low Apgar scores Spontaneous abortion Placental insufficiency

Reprinted from Obstetrics and Gynecology Clinics of North America, 25(1), Kaltenbach et al., Opioid dependence during pregnancy. Effects and management, pp. 139ñ151, 1998, with permission from Elsevier.

MAT During Pregnancy 215 the body after oral ingestion, with extensive Brown et al. 1998; Kaltenbach and Comfort nonspecific tissue binding creating reservoirs 1997). The consensus panel knows of no com- that release unchanged methadone back into pelling evidence supporting reduced maternal the blood, contributing to methadoneís long methadone dosages to avoid NAS. On the con- duration of action (Dole and Kreek 1973). trary, higher dosages have been associated with Peak plasma levels occur between 2 and 6 increased weight gain, decreased illegal drug hours after a maintenance dose of methadone is use, and improved compliance with prenatal ingested, with less than 6 percent of the ingest- care by pregnant women in MAT and with ed dose in the total blood volume at this time. increased birth weight and head circumference, Lower sustained plasma concentrations are prolonged gestation, and improved growth of present during the remainder of a 24-hour infants born to women in MAT (De Petrillo and period (Stine et al. 2003). Rice 1995; Hagopian et al. 1996). Moreover, reduced methadone dosages may result in con- As pregnancy progresses, the same methadone tinued substance use and increase risks to both dosage produces lower blood methadone levels, expectant mothers and their fetuses (Archie owing to increased 1998; Kaltenbach et al. 1998). The consensus fluid volume, a larg- panel recommends that methadone dosages for er tissue reservoir pregnant women be determined individually to [M]ethadone for methadone, and achieve an effective therapeutic level. altered opioid dosages for metabolism in both the placenta and Induction and Stabilization pregnant women fetus (Weaver 2003). Methadone dosages for pregnant women should Women who are be based on the same criteria as those for methadone main- [should] be deter- women who are not pregnant. Women who tained often experi- received methadone before pregnancy should ence symptoms of mined individually be maintained initially at their prepregnancy withdrawal in later dosage. However, if pregnant women have not stages of pregnancy been maintained on methadone, the consensus to achieve an and require dosage panel recommends that they either be inducted increases to maintain in an outpatient setting by standard procedures effective therapeu- blood levels of or be admitted to a hospital (for an average methadone and stay of 3 days) to evaluate their prenatal health tic level. avoid withdrawal status, document physiologic dependence, and symptoms (Jarvis et initiate methadone maintenance if possible. al. 1999; Kaltenbach et al. 1998). The For pregnant women being inducted in an out- daily dose can be increased and administered patient setting, a widely accepted protocol is to singly or split into twice-daily doses give initial methadone doses of 10 to 20 mg per (Kaltenbach et al. 1998). day, with exact dosage based on a patientís opi- oid use history. A patient should be asked to Historically, treatment providers have based return at the end of the day for followup evalu- dosing decisions on the need to avoid or reduce ation, and the initial dose may be followed by the incidence of neonatal abstinence syndrome regular adjustments of 5 to 10 mg based on (NAS) (Kaltenbach et al. 1998; Kandall et al. therapeutic response (Archie 1998). Twice 1999) rather than to achieve an effective thera- daily observation should continue until the peutic dosage. This low-dose approach, which patient is stabilized. If evidence of intoxication emerged from several 1970s studies (e.g., or withdrawal emerges, treatment providers Harper et al. 1977; Madden et al. 1977), has should adjust the patientís dosage immediately. been contradicted by more recent studies (e.g., Most pregnant women can be stabilized within

216 Chapter 13 48 to 72 hours (Kaltenbach et al. 1998). In Management of Acute Opioid outpatient settings, where fetal monitors Overdose in Pregnancy usually are unavailable, it is crucial that patients record measures of fetal movement at Opioid overdose in pregnancy threatens both set intervals (Jarvis and Schnoll 1995). pregnant women and their fetuses. Naloxone, a short-acting, pure opioid antagonist, is the pharmacological treatment of choice for opioid Split Dosing overdose but should be given to pregnant Split-dosing methadone regimens are accepted patients only as a last resort (Weaver 2003). widely for pregnant patients, but little empirical Patients should receive naloxone (0.01 mg/kg investigation has been done of its effects on of body weight) intravenously after an airway fetuses or maternal plasma levels (Jarvis et al. is established to ensure adequate respiration. 1999). Although split dosing may improve Patients can receive additional naloxone doses maternal compliance with treatment and every 5 minutes after they regain conscious- decrease cocaine use (De Petrillo and Rice ness. Naloxoneís duration of action is from 30 1995), traveling to an opioid treatment program minutes to 2 hours, depending on the dose and (OTP) twice a day or, for unstable or newly type of substance that was used, whereas that admitted patients, qualifying for take-home of most opioids is from 6 to 8 hours and that medication doses may be difficult. of methadone or other long-acting opioids (e.g., morphine sulfate contin, OxyContinÆ) is from 12 to 48 hours (or more for levo-alpha Managing Polysubstance Use acetyl methadol). Therefore, symptoms are A large percentage of pregnant women in likely to recur within 30 minutes to 2 hours MATóup to 88 percent in one studyócontinue of naloxone treatment, and treatment to use other substances including alcohol, nico- providers should continue administering tine, heroin, cocaine, barbiturates, and tran- naloxone intravenously or intramuscularly quilizers (Edelin et al. 1988). The risks of other at intervals until the effects of illicit opioids substance use for both maternal and fetal markedly diminish, which may take 2 to 3 health are well documented (Reid 1996). It is days. Special care is needed to avoid acute essential that patients be monitored for use of opioid withdrawal that can harm a fetus. both licit and illicit drugs and alcohol to man- Treatment providers should titrate the nalox- age appropriately the perinatal care of both one dose against withdrawal symptoms and mothers and infants (Kaltenbach et al. 1998). use a short-acting opioid to reverse acute withdrawal symptoms (Archie 1998). Polysubstance use is a special concern during pregnancy because of the adverse effects of cross-tolerance, drug interactions, and potenti- Managing Withdrawal From ation (Kaltenbach et al. 1998) and the serious Methadone maternal and fetal health risks from continued Withdrawal from methadone, called medically substance use and lack of adequate prenatal supervised withdrawal (MSW) or dose taper- care (Svikis et al. 1997a). Chapter 11 provides ing, is not recommended for pregnant women. more information about treatment of multiple When MSW is considered, however, a thorough substance abuse in MAT; the forthcoming TIP assessment is important to determine whether a Substance Abuse Treatment: Addressing the woman is an appropriate candidate for MSW Specific Needs of Women (CSAT forthcoming f) because the procedure frequently results in contains additional information on the effects relapse to opioid use. Appropriate patients for of different substances on pregnant women. MSW during pregnancy include those who

MAT During Pregnancy 217 ï Live where methadone maintenance is Breast-Feeding unavailable Mothers maintained on methadone can breast- ï Have been stable in MAT and request MSW feed if they are not HIV positive, are not before delivery abusing substances, and do not have a disease ï Refuse to be maintained on methadone or infection in which breast-feeding is con- ï Plan to undergo MSW through a structured traindicated (Kaltenbach et al. 1993). Hepatitis treatment program (Archie 1998; Kaltenbach C is no longer considered a contraindication for et al. 1998). breast-feeding. A patient who elects to withdraw from The American Academy of Pediatrics has a methadone should do so only under supervision longstanding recommendation (1983) that by a physician experienced in perinatal addic- methadone is compatible with breast-feeding tion treatment, and the patient should receive only if mothers receive no more than 20 mg in fetal monitoring. MSW usually is conducted in 24 hours. However, studies have found minimal the second trimester because the danger of mis- transmission of methadone in breast milk carriage may increase in the first trimester and regardless of maternal dose (Geraghty et al. the danger of premature delivery or fetal death 1997; Wojnar-Horton et al. 1997). McCarthy may increase in the third trimester (Kaltenbach and Posey (2000) found only small amounts of et al. 1998; Ward et al. 1998a). However, the methadone in breast milk of women maintained consensus panel has found no systematic stud- on daily doses up to 180 mg and argued that ies on whether withdrawal should be initiated available scientific evidence does not support only during the second trimester. If MSW is dosage limits of 20 mg a day for nursing undertaken, methadone should be decreased by women. 1.0 to 2.5 mg per day for inpatients and by 2.5 to 10.0 mg per week for outpatients. Fetal movement should be monitored twice daily in Effects on Neonatal outpatients, and stress tests should be per- Outcome formed at least twice a week; MSW should be discontinued if it causes fetal stress or threatens to cause preterm labor (Archie 1998; NAS Kaltenbach et al. 1998). Infants prenatally exposed to opioids have a high incidence of NAS, characterized by hyper- activity of the central and autonomic nervous Postpartum Treatment systems that is reflected in changes in the gas- of Mothers in MAT trointestinal tract and respiratory system. Infants with NAS often suck frantically on their Current treatment practices include continuing fists or thumbs but may have extreme difficulty methadone after delivery either at dosages simi- feeding because their sucking reflex is uncoor- lar to those before pregnancy or, for women who dinated (Kaltenbach et al. 1998). Withdrawal began methadone maintenance during pregnan- symptoms may begin from minutes or hours cy, at approximately half the dosages they after birth to 2 weeks later, but most appear received in the third trimester. However, no within 72 hours. Preterm infants usually have empirical data support these approaches, and milder symptoms and delayed onset. Many fac- any decrease should be based on signs of over- tors influence NAS onset, including the types medication, withdrawal symptoms, or patient of substances used by mothers, timing and blood plasma levels (Kaltenbach et al. 1998). dosage of methadone before delivery, charac- teristics of labor, type and amount of anesthesia or analgesic during labor, infant maturity and

218 Chapter 13 nutrition, metabolic rate of the infantís liver, with phenobarbital considered (American and presence of intrinsic disease in infants. Academy of Pediatrics Committee on Drugs NAS may be mild and transient, delayed in 1998). onset or incremental in severity, or biphasic in its course, including acute neonatal withdrawal When control is achieved, the dosage should be signs followed by improvement and then onset continued for 72 hours before pharmacological of subacute withdrawal (Kaltenbach et al. weaning begins, in which dosage is decreased 1998). Although NAS can be more severe or 10 percent daily or as tolerated until 0.2 prolonged with methadone than heroin because mg/kg/day is reached, when medication may be of methadoneís longer half-life, with appropri- discontinued. Decisions about dosage decrease ate pharmacotherapy, NAS can be treated sat- rate during pharmacological weaning should be isfactorily without any severe neonatal effects. based on Neonatal Abstinence Scores and daily weight and physical exams. Onset of NAS may be delayed by other neonatal illnesses. In addition, various other conditions may mimic NAS, such as hypoglycemia, Maternal Methadone Dosage hypocalcemia, sepsis, and neurological illness- and Extent of NAS es. To rule out such conditions, infants suspect- The relationship between maternal methadone ed of having NAS should have a complete blood dosage and NAS has been difficult to establish, cell count with differential, electrolyte and and the consensus panel believes no compelling calcium levels, comprehensive neurological evidence shows that methadone reduction consultation, and head ultrasound if indicated. avoids NAS. Although a number of investiga- An abstinence scoring system should be used to tors have reported significant relationships monitor opioid-exposed newborns to assess the between neonatal withdrawal and maternal onset, progression, and diminution of symp- methadone dosage (e.g., Malpas et al. 1995; toms (Kaltenbach et al. 1998). The Neonatal Mayes and Carroll 1996), most have found no Abstinence Score (Finnegan and Kaltenbach such relationship (e.g., Berghella et al. 2003; 1992) is used widely to estimate NAS severity, Brown et al. 1998). determine whether pharmacotherapy is need- ed, and monitor the optimum response to ther- Perinatal Outcomes apy. All infants of mothers with an opioid use history should be scored every 4 hours. Another area of concern is the intrauterine Control is achieved when the average Neonatal growth of infants born to women maintained on Abstinence Score is less than 8, infants exhibit methadone. Early research yielded somewhat rhythmic feeding and sleep cycles, and infants inconsistent findings, have optimal weight gains. and not much new has been added since the If pharmacological management is indicated, 1980s. Studies com- ...NAS can be infants should be treated with neonatal opioid paring infants born to solution (0.4 mg/mL of morphine-equivalent women addicted to treated satisfacto- solution; starting dosage, 0.4 mg/kg/dose given heroin but not receiv- orally in six to eight divided doses [timed with ing methadone with rily without any the feeding schedule]). Dosage should be infants born to increased by 0.4 mg/kg/dose as needed until women receiving control is achieved or a maximum dosage of 2.0 methadone found dif- severe neonatal mg/kg/day is reached. If Neonatal Abstinence ferential effects, with Scores remain high but daily doses approach reduced fetal mortali- effects. the maximum, the infantís symptoms should be ty and greater birth reassessed and concurrent pharmacotherapy weights indicated for

MAT During Pregnancy 219 infants of women maintained on methadone visual stimuli and reduced alertness among (Connaughton et al. 1977; Kandall et al. 1977). infants exposed to opioids (Strauss et al. 1975). Some studies comparing infants born to women not using opioids with infants of women in Important aspects of these behavioral charac- methadone treatment found lower birth weights teristics are their implications for motherñ in the latter group (Chasnoff et al. 1982; infant interactions. In the consensus panelís Lifschitz et al. 1983), whereas others found no experience, these infants are frequently diffi- differences in birth weights (Rosen and cult to nurture, causing poor motherñinfant Johnson 1982; Strauss et al. 1976). bonding, which Hoegerman and colleagues (1990) suggested might be the most devastating A study by Kaltenbach and Finnegan (1987) legacy of perinatal addiction. with 268 infants found that those exposed to methadone had lower birth weights and smaller head circumferences than those not exposed to Developmental Sequelae drugs. However, the infants exposed to Research on developmental sequelae associated methadone were not small for their gestational with in utero methadone exposure has found age, and there was a positive correlation that infants through 2-year-olds function well between head circumference and birth weight within the normal developmental range (e.g., in both groups. These data suggested that Kaltenbach and Finnegan 1986; Rosen and infants born to women who are opioid addicted Johnson 1982). Lifschitz and associates (1985) and maintained on methadone may have lower found no significant developmental differences birth weights and smaller head circumferences between children of mothers maintained on than nonñdrug-exposed comparison infants, methadone and children of mothers still using but the former are not growth restricted. heroin or using no opioids, when sociodemo- graphic, biological, and other health factors Researchers (e.g., Chasnoff et al. 1984; Jeremy were considered. Other data have suggested and Hans 1985) who used the Brazelton that maternal drug use is not the most impor- Neonatal Behavioral tant factor in how opioid-exposed infants and Assessment Scale children develop but that family characteristics (Brazelton 1984) to and functioning play a significant role (Johnson [I]nfants born to investigate neuro- et al. 1987). More information is needed to behavioral charac- update or extend these findings from the 1970s women who are teristics in newborns and 1980s. undergoing opioid opioid addicted withdrawal have found differences Use of Buprenorphine and maintained on consistently in behavior between During Pregnancy these infants and methadone may Buprenorphine use for pregnant women has infants born to not been approved in the United States, women not opioid although it may be used with pregnant patients have lower birth addicted. Infants under certain circumstances (see below). It exposed to opioids may be a safe and effective treatment for some weights and were more irritable, pregnant women who are opioid addicted, but exhibited more more research is needed. Several animal stud- smaller head tremors, and had ies have been conducted. However, only limited increased muscle prospective and open-label studies using sub- circumferences... tone. Several studies lingual buprenorphine tablets in pregnant have reported less women have been reported, and these repre- responsiveness to sent the most closely controlled data (e.g.,

220 Chapter 13 Johnson et al. 2001; Lejeune et al. 2002). of Opioid Addiction (CSAT 2004a). For a com- Several case studies have been reported, main- prehensive review of buprenorphine use in ly in France, of buprenorphine use during pregnant patients and its effects on the pregnancy (e.g., Marquet et al. 1997, 1998). neonate, see the article by Johnson and col- Johnson and colleagues (2003a) provided a leagues (2003a). Current data indicate that complete review of these reports. The studies buprenorphine probably is safe and effective all found that buprenorphine was well accepted for some women who are pregnant and opioid by mothers and infants during the early neona- addicted, but more research is needed. tal stage and appeared useful to treat pregnant women who were opioid addicted. Buprenorphine Effects on NAS In view of incomplete data and the absence of Johnson and colleagues (2003a) reviewed 21 FDA approval for use of buprenorphine in reports of buprenorphine use during pregnan- pregnant patients, the consensus panel recom- cy, most from Europe, and found that NAS was mends that buprenorphine be used only when reported in 62 percent of approximately 309 the prescribing physician believes that the infants exposed to buprenorphine, with 48 potential benefits justify the risks. For exam- percent requiring treatment and 40 percent ple, patients already maintained and stable on confounded by other drug use. Another study buprenorphine who become pregnant probably of 100 infants of mothers maintained on should continue on buprenorphine with careful buprenorphine found NAS in approximately 67 monitoring. Pregnant women who are opioid percent (Johnson et al. 2001). Of these, 53 per- addicted but cannot tolerate methadone, those cent required treatment for withdrawal, and for whom program compliance has been diffi- approximately 7 percent were admitted to a cult, or those who are adamant about avoiding neonatal intensive care unit. Similar to infants methadone may be good candidates for born to women receiving methadone, infants of buprenorphine. In such circumstances, it women receiving comprehensive prenatal care should be clearly documented in the patientís plus buprenorphine had improved birth out- medical record that she has refused methadone comes compared with those whose mothers maintenance treatment or that such services received no comprehensive prenatal care. are unavailable; that she was informed of the risks of using buprenorphine, a medication Buprenorphine-associated NAS generally that has not been thoroughly studied in preg- appears within 12 to 48 hours, peaks at 72 to nancy; and that she understands these risks. 96 hours, and lasts 120 to 168 hours, although When treating pregnant patients, treatment some reports have indicated buprenorphine- providers should use buprenorphine monother- related NAS lasting 6 to 10 weeks. apy tablets (SubutexÆ) because no work has Buprenorphine-associated NAS was found to been done on the effects of fetal exposure to be less intense than that associated with sublingual naloxone in buprenorphine- methadone (Johnson et al. 2003a). If controlled naloxone combination tablets (SuboxoneÆ) randomized trials confirm that newborns of during pregnancy. Consensus panelists have mothers treated with buprenorphine have less found that a patient already maintained on NAS than those of mothers treated with buprenorphine-naloxone combination tablets methadone, it may be appropriate to switch who becomes pregnant can be transferred patients from methadone to buprenorphine directly to buprenorphine monotherapy tablets. during early pregnancy to reduce chances for marked withdrawal syndromes in newborns. A more detailed discussion on buprenorphine use in the treatment and management of pregnant patients and its effects in newborns can be found in TIP 40, Clinical Guidelines for the Use of Buprenorphine in the Treatment

MAT During Pregnancy 221 Breast-Feeding During and helping new parents cope with their Buprenorphine Treatment environment. Research has indicated that only small amounts Integrated services, whether on site or through of buprenorphine and buprenorphine-naloxone linkages to other community-based agencies, pass into breast milk, with little or no effect on encourage prospective patients to enter a infants (Johnson et al. 2001; Schindler et al. treatment program and continue treatment. 2003; CSAT 2004a). These data are inconsis- Services should be woman centered and tent with product labeling, which advises directly address traumatic events. The array of against breast-feeding in mothers treated with services may include buprenorphine or the buprenorphine-naloxone ï Special groups to address problems of preg- combination. Based on research data, particu- nant women who are opioid addicted larly findings that buprenorphine is likely to be poorly absorbed by infants via the oral route, ï Available treatments for women addicted to the consensus panel recommends that women opioids, including pharmacotherapies maintained on buprenorphine be encouraged to ï Education and discussion groups on parent- breast-feed because of the benefits to infants ing and childcare and motherñchild interaction. The panel rec- ï Special groups and services for children and ommends more research, particularly to con- other family members firm that infants absorb little buprenorphine during breast-feeding. ï Couples counseling ï Case management and assistance in locating safe, affordable housing. Importance of The forthcoming TIP Substance Abuse Integrated, Treatment: Addressing the Specific Needs of Comprehensive Women (CSAT forthcoming f) has more detailed information on the psychosocial Services components of women-centered treatment. Pregnant women who are opioid addicted need comprehensive treatment services, including Psychosocial Barriers individual, group, and family therapy to address both the physiological and psychologi- Women addicted to opioids typically face finan- cal effects of substance use and psychosocial cial, social, and psychological difficulties that factors. Psychosocial complications may affect their options and treatment progress. include disruption of the motherñchild relation- Many have histories of negative experiences ship, guilt over the adverse effects of addiction with the legal system or childrenís protective on the family, and family adjustment when a services that may cause them to be resistant to newborn is retained in the hospital. Problems or noncompliant with treatment. Guilt and associated with domestic violence, financial shame coupled with low self-esteem and self- support, food, housing, and childcare issues efficacy can produce behaviors difficult for can be overwhelming to women in recovery and some staff members to tolerate, such as late- should be addressed. AIDS prevention, coun- ness, missed appointments, continued illegal seling, testing, and educational services should drug use, and demanding or provocative be available during prenatal and parenting behaviors. For successful treatment, care classes. Services should be aimed at eliminating should be provided in a gender-specific, non- substance use, developing personal resources, punitive, nonjudgmental, nurturing manner, improving family and interpersonal relation- with attention to each patientís fears and cul- ships, eliminating socially destructive behavior, tural beliefs (Kaltenbach et al. 1998; Ward et al. 1998a).

222 Chapter 13 Contingency Management Many pregnant women who receive MAT dis- Treatment Strategies continue treatment prematurely, with the high- est dropout rates occurring on transfer from As discussed in chapter 8, contingency manage- residential to outpatient treatment. A related ment strategies offering positive reinforcement series of controlled, randomized studies (Jones for behavioral change have been effective in et al. 2000, 2001; Svikis et al. 1997b) examined treating a range of substance use disorders. whether brief voucher incentives improved Voucher-based reinforcement therapy (VBRT) patient participation and decreased substance has been particularly effective in increasing use during this transition phase. In pregnant abstinence from substances and strengthening women maintained on methadone, low-value behaviors such as compliance with treatment incentives did not influence substance use plans and participation in vocational training (Jones et al. 2000). However, greater incentives, (Kidorf et al. 1998; Petry 2000; Silverman et using an escalating al. 1996). These and other studies also have reinforcement proce- suggested that VBRT may help manage poly- dure, both decreased Integrated substance abuse and improve retention for substance use and pregnant women in MAT. increased full-day outpatient treatment services... Although few systematic studies have been done attendance (Jones et with pregnant women who are opioid addicted, al. 2001). encourage available evidence has indicated that positive- contingency rewards for abstinence or treatment Overall, these studies prospective attendance can improve pregnancy outcomes have suggested that (Chang et al. 1992; Jones et al. 2001). contingency manage- patients to enter a Contingency management incentives for this ment using positive population have ranged from cash (Carroll et rewards for desired al. 1995; Chang et al. 1992) to vouchers behaviors may be an treatment program exchangeable for goods and services (Jones et important adjunct to al. 2000, 2001; Svikis et al. 1997b). MAT for pregnant and continue women. It is notewor- Carroll and colleagues (1995) compared the thy that interventions treatment. effectiveness of an enhanced treatment program such as VBRT not for pregnant patients that included a contingen- only are compatible cy management component, in which clients with MAT but could earn $15 weekly for three consecutive address both continued substance abuse and negative drug tests, with an unenhanced treat- poor program attendance. ment program. The group receiving enhanced treatment had better neonatal outcomes, but the two groups did not differ in percentages of Nutrition Assessment, positive drug tests. The authors attributed these results primarily to more frequent prena- Counseling, and tal care in the contingency management group. Assistance However, results of the study were limited by the small sample size (seven women in each People with substance use disorders often are group), the inability to discern which compo- poorly nourished. Substances themselves may nents contributed to improved outcomes, and impair usersí metabolism, interfere with nutri- use of a demanding contingency procedure that ent availability, and affect appetite. However, reinforced continuous abstinence (e.g., three other lifestyle factors associated with substance consecutive negative drug tests) but not discrete use play a significant role, including poverty, abstinence (each negative drug test). poor eating and exercise habits, lack of concern

MAT During Pregnancy 223 about nutrition and health, and diets restricted Association (800-366-1655 or www.eatright.org) by physiological conditions. refers inquirers to registered dietitians in the local area who provide individual or group Pregnancy is an opportune time to help women counseling or program information about diet improve their health-related attitudes and during pregnancy. Another useful resource, behaviors. The consensus panel recommends Pregnancy and Nutrition, a seven-page pam- that all pregnant patients in MAT receive phlet developed by the National Womenís ï An assessment of nutritional status, eating Health Information Center (www.4women.gov/ habits, and weight faq/preg-nutr.htm), covers recommended dietary allowances for pregnant women, diet ï Education on appropriate diet and weight to changes and weight gain, cravings, exercise, meet optimal targets for the pregnancy dietary supplements, diabetes, morning ï Counseling to ensure that special nutrition- sickness, and nausea. related medical and psychosocial problems are addressedówith high priority given to OTPs wishing to assess patientsí knowledge stopping or substantially reducing cigarette, about nutrition might be interested in the U.S. alcohol, and other substance use with known Department of Agricultureís 22-page survey adverse effects on fetuses forms (www.barc.usda.gov/bhnrc/foodsurvey) to ascertain respondentsí knowledge of nutri- ï Supplemental nutrients when nutritional tion, food composition, labeling requirements, needs cannot be met by diet changes and serving sizes, as well as eating habits and ï Information about and referral to food assis- attitudes. tance programs.

Nutritional Education for Food Program Assistance for Pregnant Patients in MAT Pregnant Patients in MAT Most pregnant women in MAT can benefit from Pregnant women in MAT who are nutritionally nutritional guidance that encourages them to at risk or financially needy may be eligible for have wholesome, well-balanced diets consistent supplemental food assistance. Their school-age with their ethnic or cultural backgrounds and children also might qualify for school breakfast financial situations. Such guidance helps them and lunch programs, as well as summer food understand how diet and substance use affect programs. OTP counselors should be familiar the fetus, pregnancy, labor and delivery, and with the services and requirements of each type breast-feeding. of program and make appropriate referrals. Facts about food stamps can be found at Some OTPs have trained nurses or other staff www.fns.usda.gov/fns. Information about the members who facilitate a nutrition education Federal Women, Infants, and Children pro- program. In addition, the National Center for gram can be accessed at www.fns.usda.gov/wic Nutrition and Dietetics of the American Dietetic or www.nal.usda.gov/wicworks.

224 Chapter 13 14 Administrative Considerations

This chapter describes policies, procedures, and considerations that make opioid treatment program (OTP) administrators and managers In This more effective, therefore contributing to improved treatment outcomes. OTPs are complex, dynamic environments, and their staffing and ChapterÖ management are challenging. OTP directors influence patient outcomes positively by providing sound leadership and staff management (Magura Staffing et al. 1999). Managers are responsible for keeping staff members focused Medication on patient care and improved treatment outcomes. Conflict or misunder- Diversion Control standing about treatment goals can increase the stress of working in an Plans OTP (Bell 1998). Managers should set clear staff guidelines, supply the needed resources, and create a culture that nurtures professional growth The Community and staff retention. Effort OTPs and National Staffing Community Education How . . . interactions [between OTP staff and patients] are Initiatives conducted, and particularly the attitude of staff members, is probably the next most important determinant of treatment Evaluating effectiveness after an adequate dose of methadone. (Bell 1998, Program and Staff p. 168) Performance Successful treatment outcomes depend on staff competence, values, and attitudes. To develop a stable group of competent personnel, OTP administrators should recruit qualified, capable, culturally competent people; offer competitive benefit packages; and provide careful supervi- sion and ongoing training. Employees then can increase their under- standing of medication-assisted treatment for opioid addiction (MAT).

Qualifications Licensing, certification, and credentialing The complexities of treating patients who are opioid addicted demand highly trained caregivers who can provide direct patient care and coordinate access to other services that their OTP cannot provide. To ensure these qualifications, OTPs should hire individuals who are 225 licensed or credentialed under State regulations Sensitivity to cultural, gender, and age issues. and have a record of working effectively with In a review of the literature on culturally rele- the types of patients served by the OTP. vant health care interventions and their effect Licensed and credentialed staff members also on treatment outcomes, Kehoe and colleagues may be viewed as having more legitimacy by (2003) found that treatment provider knowl- State regulators, community members, and edge of cross-cultural principles significantly third-party payers. improved outcomes for patients with drug addictions. OTP staff members should be Staff interpersonal willing to work with people from diverse back- grounds, explore and accept other value sys- characteristics tems, and understand how culture and values In addition to hiring licensed or credentialed can relate to patientsí behavior. Support staff staff, administrators should employ people with should be accepting and understanding of empathy, sensitivity, and flexibility, particular- patients from diverse groups because these staff ly regarding patients in MAT. Empathic staff members often are the first people a new members create a patient sees at the OTP and those with whom therapeutic milieu the patient interacts most. If possible, manage- (Joe et al. 2001). In ment should recruit employees who reflect [A]dministrators addition, staff mem- patient demographics and should consider bers should main- hiring people who are recovering from addic- should recruit tain appropriate tion (see below). professional bound- qualified,...cultur- aries with patients. People working with diverse groups should remember that diversity also exists within cul- ally competent Transference and tures. It is important to be sensitive to cultural countertransfer- differences but to avoid acting on cultural ence. Some patients assumptions. Understanding both a patientís people; offer with addictions cultural influences and his or her individuality project feelings or requires taking time to know the patient. competitive benefit emotions onto their treatment providers Treatment staff should be sensitive to other packages; and or cast providers in factors that can affect recovery, such as unintended roles, a patientsí sexual orientations or ages, but should provide careful phenomenon known avoid generalizing about patients based on as transference. these factors. Correctly identifying such factors supervision and Countertransference requires an effort to see the world through each occurs when treat- patientís eyes. Information on cultural compe- tence and diversity is available at Web sites of ongoing training. ment providers pro- ject their feelings the National Association of Social Workers onto patients, which (www.socialworkers.org/diversity) and can interfere with Substance Abuse and Mental Health Services treatment and be destructive to therapeutic Administration (SAMHSA) (www.samhsa.gov/ relationships. OTP supervisors should ensure search/search.html) and in ìCultural that staff members avoid countertransference Competence for Social Workersî (Center for (e.g., displaying anger toward patients or dis- Substance Abuse Prevention 1995) and the appointment with them). TIP 36, Substance forthcoming TIP Improving Cultural Abuse Treatment for Persons With Child Abuse Competence in Substance Abuse Treatment and Neglect Issues (CSAT 2000d), contains a (CSAT forthcoming b). detailed discussion of these topics. Multicultural and multilingual representation. The consensus panel is aware of no published

226 Chapter 14 data demonstrating improved outcomes from people in MAT, sometimes use counterthera- ethnic matching of patients and substance peutic language, for example, the phrase ìdirty abuse treatment providers. Sterling and col- urineî to describe an unsatisfactory urine drug leagues (2001) noted the existence of ìequivocal test (ìpositive testî is less judgmental). Staff findings of the effect that therapist and patient should avoid terms suggesting the criminal similarity plays in treatment outcomeî (p. justice system, such as ìprobationî or ìproba- 1015) in substance abuse treatment programs tionary,î to refer to the status of patients doing and concluded that more research is needed. poorly in treatment. ìTerminationî should be However, the panel believes that, when pro- avoided in reference to patient discharge. gram staff generally reflects the demographics Other preferred expressions in MAT include of the population served, patients are more ìpatientsî not ìclientsî and ìdose taperingî or likely to feel comfortable in the OTP. When ìmedically supervised withdrawalî not ìdetoxî multicultural representation among staff is in reference to withdrawal from treatment limited, OTPs should find ways to communi- medication. Applying words derived from cate acceptance of diverse cultures and groups. ìtoxinî to treatment medication suggests that the medication is a toxin; ìdetoxificationî Programs with nonñEnglish-speaking patients should refer only to withdrawal from substances should provide information in patientsí first of abuse. languages by employing staff members or inter- preters who can communicate with patients. Inclusion of recovering patients. The consen- Federal and State resources are available for sus panel believes that employing treatment programs seeking literature in languages other professionals and support staff who are in than English. Community colleges, universities, recovery also adds valuable perspectives to and other institutions or agencies might assist treatment and provides role models for in translating forms and pamphlets. Information patients. OTP policies on hiring people who are about translation services is available via the in addiction recovery should be in writing and Internet (visit www.atanet.org/bin/view.fpl/ include procedures for addressing staff mem- 52076.html). bers who relapse. State regulations may estab- lish a minimum abstinence period before an Flexibility in thinking, behavior, and attitudes. OTP can hire someone in recovery. Policies Staff attitudes about MAT and opioid addiction also must comply with Federal and many State can affect patient outcomes. Administrators laws prohibiting discrimination against people should seek staff members who are free of rigid who are addicted (CSAT forthcoming b). Staff biases, are not judgmental, and do not have members who are in recovery and their col- punitive attitudes toward patients (Bell 2000). leagues who have no addiction history should OTP staff members sometimes hold negative be treated similarly. attitudes toward patients (Caplehorn et al. 1997) or MAT (Forman et al. 2001). At least Staff Retention one study has associated such attitudes with lower rates of patient retention and poorer Retaining staff is important for several reasons: patient outcomes (Caplehorn et al. 1998). OTP ï Stability of treatment staff may affect managers should be vigilant about monitoring treatment outcomes. staff attitudes and conduct inservice training to create or sustain appropriate attitudes about ï High staff turnover can undermine relations patients and MAT. with the community, funders, and others. ï Investment in recruitment and training is lost The verbal expressions used by OTP staff when staff members leave. members can reflect how they feel toward ï Unfilled staff positions result in longer patients. Treatment staff members, who might patient waiting lists. have absorbed societyís antipathy toward

Administrative Considerations 227 ï Reducing staff turnover minimizes disruption ï Establish objective performance standards to patientsí treatment. derived from job descriptions, and conduct ï Accreditation standards place importance on regular performance evaluations that include the stability of OTP staff. feedback based on patient outcomes. ï Establish regular consulting sessions among Factors that may contribute to high staff counselors, their supervisors, and other staff turnover include low salaries and benefits, members. Supervisors should be well trained negative stereotypes of MAT and its patients, and supported. job stress, excessive counselor workload, unreasonable operating hours, and unsafe OTP ï Provide opportunities for professional locations. Staff members can experience training, either by onsite training or by burnout when they work in isolation with permitting staff members to attend offsite difficult patients and inadequate support or training during work hours. feedback. Managers should take concrete steps ï Encourage professional development by to retain staff, including the following: supporting staff certifications. ï Establish personnel policies that demonstrate ï Establish and maintain clear policies and concern for staff well-being, including flexible procedures, and apply them consistently. work schedules to reduce stress. ï Avoid excessive caseloads. Even the most ï Offer routine praise and recognition for staff professional, committed counselor struggles contributions and achievements. when the caseload is too large. Managers can use a monitoring system that focuses on the The forthcoming TIP Substance Abuse: number of counseling hours a caseload Administrative Issues in Outpatient Treatment requires, which can differ dramatically from (CSAT forthcoming c) provides more informa- the number of cases assigned per counselor, tion on supervision, and Newman (1997) pro- depending on the requirements of individual vides information on the therapeutic alliance patients. between patients and treatment providers. ï Encourage a team approach. Staff members usually feel less isolated and overwhelmed when a team makes treatment decisions. Training When a lack of cohesion exists, staff members Training should be offered for all staff mem- risk burnout, disillusionment, or cynicism. A bers, including secretaries, nurses, counselors, well-coordinated team also reduces the level supervisors, and managers, to ensure a strong of intrastaff disagreements about patient care knowledge base so that staff members do their and decreases the likelihood of ìstaff split- best and to affirm that all staff members are ting,î when patients pit staff members against valued members of the treatment team. The one another. importance of training has increased because ï Encourage a culture of mutual respect accreditation standards require OTPs to pro- through team cooperation, clear and effective vide continuing staff education, with many communication, and inclusive, interdepart- States requiring such education for OTPs to mental decisionmaking. Managers should maintain licensure. OTPs should help profes- hold regular staff meetings. Staff cooperation sional staff members acquire education credits also can be fostered through training and to maintain their licensure by offering onsite retreats. The program director or manager training, collaborating with other agencies for should mediate disputes among staff members. reciprocal training, or paying for educational leave or tuition. ï Establish job descriptions that clearly delineate roles, responsibilities, and lines of At minimum, training should focus on the communication (Bell 1998), and review them following areas: annually with personnel.

228 Chapter 14 ï Facts about MAT and the health effects of of addiction and effects of medications. A treatment medications. Educating OTP staff psychiatrist might distinguish primary mental about the health effects of MAT medications disorders from those that are substance related and the value of remaining in treatment is and provide information on psychotropic medi- essential. Some studies have revealed a high cations. Therapists and social workers might level of misinformation among OTP staff teach behavior management techniques, par- members about the health effects of mainte- enting, and resource allocation. Nurses might nance medications (e.g., Kang et al. 1997). provide training on gender and wellness, as Other studies have shown that many staff well as the side effects of pharmacologic regi- members hold negative attitudes about MAT mens. Consistent inservice training can help (e.g., Caplehorn et al. 1997), which negative- staff members understand the programís ly affect patient outcomes (Caplehorn et al. mission and the effects of MAT. 1998). One way to address negative staff attitudes is to include successful patients in Federal and State training (Bell 2000). agencies and profes- sional associations The importance of ï Up-to-date information about medications. offer seminars, Staff should be able to discuss medications courses, and work- training has with patients. Medical staff members should shops. SAMHSAís be able to assess patients and determine, with Addiction Technology increased because input from other treatment team members, Transfer Centers which medication is most appropriate. (ATTCs) offer an accreditation stan- ï Up-to-date information about drugs of array of training abuse. Training should ensure that staff events and resource dards require members are knowledgeable about drug materials abuse trends in the community. (www.nattc.org). OTPs to provide ï Up-to-date information about communicable Some States offer diseases. Training should focus on both training leading to diseases commonly experienced by patients certification for continuing staff in MAT, such as hepatitis C, and emerging addiction specialists diseases in the community, possibly including and counselors. education... tuberculosis or HIV/AIDS. Hospitals and large OTPs sometimes ï Skills training. Staff members should have allow staff from access to generic skills training such as crisis smaller programs to attend their sessions. management, communications, and problem- Professional societies, such as the American solving, as well as new evidence-based MAT Society of Addiction Medicine, American treatments. They should have access to Academy of Addiction Psychiatry, and training about the populations the OTP Osteopathic Academy of Addiction Medicine, serves, including cultural information and offer training for medical personnel in vari- information about specific disorders. ous therapeutic techniques. National counsel- ï Patient sensitivity training. The importance ing organizations, such as the Association for of emphasizing sensitivity to patient needs Addiction Professionals, and professional should be reviewed periodically. No matter nursing societies also offer treatment courses. how creative and naturally sensitive a staff member may be, factors such as burnout can OTP administrative, financial, clerical, affect how he or she responds. maintenance, and custodial staff may lack direct treatment responsibilities, but they are A large OTP can tap into its own staff to very much part of the team. Reception staff provide training. A program physician might members, often the first to speak with patients, educate staff members about the etiology play an important role. They should receive an

Administrative Considerations 229 orientation about MAT to ensure that they with the OTP ìname, address, and telephone understand how the OTP operates so that they number andÖpackaged in a manner that is develop favorable attitudes about patients. If designed to reduce the risk of accidental inges- possible, all staff members should receive tion, including child-proof containersî(42 CFR, annual training in such areas as confidentiality Part 8 ß 12(i)(5)). requirements, cultural competence, prevention of workplace violence, and patient rights. Callbacks (see chapter 5) help prevent patient diversion of take-home medication. Callbacks require OTPs to select patients at random to Medication Diversion return to the OTP with their remaining take- home medication. A random-callback policy Control Plans avoids patient complaints of being unfairly Federal opioid treatment standards state that ìpicked onî by staff members. Programs also an OTP must maintain a current diversion can require patients to undergo drug tests when control plan (DCP) that includes measures to they bring in their medications. OTPs should reduce the possibility of medication diversion document that patients have been informed and assigns responsibility for control measures of their responsibilities regarding callbacks to medical and administrative staff members (e.g., how much notice they will receive before- (42 Code of Federal Regulations [CFR], hand) and about the consequences of failure to Part 8 ß 12(c)(2)). respond or of discrepancies in medication amounts. The OTP callback policy should be A DCP should address diversion of medication stated clearly in the program DCP. both by patients, who might sell or give their take-home medication to others, and by staff, A no-loitering policy is part of an effective who might steal medication or spill or otherwise DCP. The policy should be clarified at the waste it. beginning of treatment and enforced consistent- ly. Extending OTP hours helps eliminate overcrowding and loitering. The OTP should Reducing the Possibility of include routine meetings with community lead- Diversion by Patients ers, attendance at neighborhood civic associa- tion meetings, and open communications with Patients considered for take-home medication local law enforcement officials to help resolve must meet Federal criteria. The medical direc- community concerns. tor makes decisions about take-home [A]n OTP must medications (42 Reducing the Possibility of CFR, Part 8 ß Diversion by Staff Members 12(i)(2)), and these maintain a decisions and their OTPs rely on the integrity of employees who basis must be docu- handle U.S. Drug Enforcement Administration diversion control mented (42 CFR, (DEA)-scheduled substances. Even so, proto- Part 8 ß 12(i)(3)). cols should be in place to reduce the risk that plan...to reduce Staff should ensure staff will divert medications. All scheduled that patients can substances should be accounted for rigorously the possibility of store medications and inventoried continuously. Receipt and safely in their homes dispensing should be noted in logbooks. medication (42 CFR, Part 8 ß Working stocks should be logged and tracked 12(i)(2)(vii)). All from receipt through dispensing and measured at the beginning and end of each workday. diversion... take-home medica- tion must be labeled Measurements and daily reconciliations should be monitored by supervisors and checked

230 Chapter 14 periodically by dispensary managers. Any Despite progress, MAT remains stigmatized and significant discrepancy should prompt an inves- controversial in many U.S. communities tigation. The dispensary manager, executive (Joseph et al. 2000). The association of MAT director, and medical director should follow up with substantial improvements in individual on investigation findings. The security of com- health and employment and with reductions in puterized records and systems also should be HIV risk and criminal behavior has been vali- ensured to prevent employee theft of medica- dated by research (e.g., Krantz and Mehler tion. Spills and other accidents should be 2004; Mueller and Wyman 1997), but MAT reported immediately. Within the dispensary, remains misunderstood even among some employees should open the safe or work with health care professionals. scheduled substances only in the presence of other staff members. In matters of medication Sensationalized media coverage and successful dispensing, OTPs must consult and comply NIMBY-type opposition have continued to with DEA regulations (Drug Enforcement delay or preempt the siting of new facilities Administration 2000). (Lawmakers may restrict 2000; Shepard 2001; Sissenwein 2000; Zoning fight over Michigan 1998). Introducing MAT into communities is The Community Effort difficult without community support. However, the consensus panel believes that, since the early 1990s, the willingness of treatment profes- Community Opposition, sionals and patients; government officials; Stigma, and the Importance agencies representing health, mental health, of Community Relations addiction treatment, research, and criminal justice; and the general public to learn more Community resistance to MAT has been chroni- about MAT and opioid addiction has increased. cled for decades (e.g., Genevie et al. 1988; Organizations appear more willing to include Joseph et al. 2000; Lewis 1999; Lowinson and OTPs in community health planning as well- Langrod 1975). The consensus panel believes regarded community services, but this effort that this resistance has been reduced since TIP remains a work in progress. 1, State Methadone Treatment Guidelines (CSAT 1993b), was published, particularly through efforts to improve scientific clarity Good Community Relations about opioid addiction, to affirm the efficacy Good community relations are part of good and benefits of MAT, and to educate profes- treatment. When TIP 1 was published in 1993, sionals and the public about MAT. The expand- Federal regulations guiding the operation of ing patient advocacy movement effectively may OTPs did not mandate efforts to improve be countering some stereotypes and misunder- community relations or educate the community. standings about MAT. Some treatment Transition in Federal oversight of substance providers have overcome community opposi- abuse treatment from the U.S. Food and Drug tionósometimes called not-in-my-backyard Administration (FDA) to SAMHSA altered the (NIMBY) syndromeóthrough outreach and Federal regulatory perspective, as reflected in educational efforts (e.g., Weber and Cowie SAMHSA regulations guiding OTPs (21 CFR, 1995). Many prevention and treatment pro- Part 291, and 42 CFR, Part 8 [Federal grams are becoming increasingly responsive to Register 66:4076ñ4102]). In the panelís view, the needs of cultural and ethnic groups (i.e., this change in oversight is bringing OTPs into more culturally competent). These successes the medical mainstream, under the purview of provide models for effective community SAMHSA, by establishing an OTP accredita- relations in other settings. tion system similar to the requirements of other medical services. Furthermore, the new rules have codified SAMHSAís earlier guidelines for

Administrative Considerations 231 OTP accreditation (CSAT 1999b), which treatment options can affect community recognize community relations, education, and perceptions positively because patients stigma reduction as necessary operational ele- involved in MAT are less likely to loiter near ments. SAMHSAís approved OTP-accrediting the OTP. organizationsóincluding at this writing the Commission on Accreditation of Rehabilitation Facilities for onsite patient activities to limit Facilities, Council on Accreditation for outside loitering are beneficial. Having ade- Children and Family Services, Joint quate onsite staff is equally important in avoid- Commission on Accreditation of Healthcare ing and resolving community problems. Glezen Organizations, National Commission for and Lowery (1999) provide other practical Correctional Health Care, State of Missouri guidelines for addressing community concerns Department of Mental Health Division of about substance abuse treatment facilities. Alcohol and Drug Abuse, and Washington Community opposition can be triggered when State Department of Social and Health Services community groups believe that they have been Division of Alcohol and Substance Abuseó informed or consulted insufficiently. OTP require that MAT providers demonstrate administrators should meet regularly with effective community relations and stigma- community leaders to ensure that all parties reduction efforts. are heard. The physical appearance of facilities OTPs serve both patients and the community. should be conceived carefully. The OTP should They affect public health, education, and be clean and orderly to distinguish it as a pro- citizensí sense of well-being. Publicly funded fessional, responsible facility. Surrounding OTPs often rely on community support. property (e.g., entrances, sidewalks, fencing, Moreover, MATís placement within the medical trash receptacles, signs) and OTP hours should and behavioral spectrum of health care affects not impede pedestrian or vehicle traffic. The relations with the payer community (Edmunds availability of public transportation is impor- et al. 1997), including government and private tant when considering an OTPís location insurers and managed care organizations. These (Glezen and Lowery 1999). connections increase the need for effective out- Some communities have found mobile treat- reach to other community services and entities. ment facilities more acceptable than fixed-site OTPs. Mobile services allow more people Overcoming Negative addicted to opioids to be treated without con- fronting NIMBY reactions. Pilot studies have Community Reactions to OTPs confirmed their success (e.g., Gleghorn 2002; Joseph and colleagues (2000) reported that Ho 1999). most community resistance involves concern about patient loitering, drug sales, and the Whether institution or community based, fixed diversion of methadone (see ìMedication site or mobile, OTPs should be situated, Diversion Control Plansî above). Adding designed, and operated in accordance with alternative care models and longer acting accreditation standards, Federal guidelines, pharmacotherapies to the services continuum and State and local licensing, approval, and can decrease loitering, illicit transactions, ille- operating requirements. The consensus panel gal parking, and other activities that increase recommends that MAT providers thoroughly community concerns. These options enable know and understand their communities and highly functioning patients who meet specific provide the levels of input and support criteria to receive ongoing medical care and requested by community leaders, representa- pharmacotherapy with fewer visits to the OTP. tives, and constituents to site a facility and In the view of the consensus panel, incorpora- develop services that are responsive to tion of primary medical care, day treatment, community needs. and short-stay residential models into

232 Chapter 14 Community Relations and funding for dedicated community relations staff Education Plan is unavailable, the OTP should develop an internal plan for community relations and Each OTP should develop a community rela- education. If the OTP is affiliated with a larger tions and education plan that extends from its institution, it should ensure full cooperation general mission statement. Staff and patients from the parent organizationís community should be part of a multifaceted, proactive effort relations department. to educate community entities affected by OTP operations, including the medical community, Initiating and maintaining neighbors, and agencies and individuals providing support services. Although program contacts with community activities differ in specificity and scope, a Personal contact with community leaders per- community relations plan should address the mits open dialog, information sharing, and dis- following: cussion of community developments, needs, and problems. Members of the consensus panel ï Learning about the community, its structures, agree that such communication fosters trust and directly affected constituents in the OTP. Moreover, personal contact with ï Delineating the community relations mission, community representatives goals, protocols, and staff roles ï Initiating and maintaining contact with com- ï Encourages leaders to use the OTP as a munity liaisons resource on addiction and related health issues ï Educating and serving the community ï Promotes MATís public health benefits ï Establishing effective media relations ï Highlights the value of the OTP for community ï Developing policies and procedures to members with addiction- and other health- address community concerns about the OTP related problems. ï Documenting community contacts and com- munity relations activities. Regular contact with key liaisons should include onsite and offsite meetings. Demysti- The forthcoming TIP Substance Abuse: fication of MAT Administrative Issues in Outpatient Treatment occurs when treat- (CSAT forthcoming c) provides additional ment is viewed first- OTP administra- information on developing a community hand. Community relations and education plan. members who visit tors should meet OTPs can observe Delineating the community operations and speak regularly with relations, mission, goals, with staff and consent- ing patients, assuming community protocols, and staff roles OTP operation is unimpaired and In the opinion of the consensus panel, commu- leadersÖ nity relations and education should be an patient confidentiality inherent function of OTP staff. OTPs with is maintained. sufficient resources might employ or retain a community relations professional to establish Educating and serving the links with local leaders, coordinate staff and community patient participation in community activities, determine who will represent the OTP at local Information about MAT and the OTP can be events and when, and arrange speaking and presented through various media. Brochures other community education activities. If and factsheets can be developed that cover the programís mission, its board membership, the

Administrative Considerations 233 types of services groups, and OTP alumni can be promoted as Highly visible offered, and data on potential speakers. Advocacy groups are patients. Occasional becoming increasingly instrumental in empow- community press releases can ering patients as active participants in public notify the public relations, community outreach, and program about specific support initiatives and in local, State, and services demon- services, activities, national community education efforts. accomplishments, strate an OTPís announcements, OTPs should take an aggressive, proactive improvements, or stance in community projects and events, commitment to events. Highlights of including some not directly tied to MAT. an OTPís annual Sponsoring conferences, forums, exhibits, community report can be shared and awareness events establishes an OTP as a with community leader, resource, and participant in the community. Staff members with community improvement and officials, liaisons, and the general development expertise can support other organizations in advocacy, promotional, and counter negative public. A program newsletter highlight- support efforts. OTPs can provide noninvasive ing health and medical-screening services (e.g., blood stereotypes. addiction issues pressure, pulse, and weight checks; nutritional and containing advice) to community members. Hospital-based OTP information OTPs and those licensed to provide primary and patient and staff articles can be distribut- medical services can furnish immunizations to ed. The Internet has enabled the public to view community residents. OTPs can donate surplus more information about opioid addiction and office items or other products to organizations MAT. Government and private organizations, or groups. Consenting patients and staff can professional journals, sponsoring or research organize projects such as community cleanups institutions, provider coalitions, advocacy and neighborhood patrols. Highly visible organizations, and individual OTPs and community services demonstrate an OTPís patients offer Web sites that discuss MAT commitment to community improvement and options, policies, services, and developments counter negative stereotypes. and frequently link to related Internet sites. OTPs also serve communities by providing Some examples are the following: addiction treatment for community residents ï American Association for the Treatment of and offering jobs for qualified residents. The Opioid Dependence, Inc. (AATOD; panel recommends that efforts be made to www.aatod.org) recruit and hire responsible, qualified personnel from the local community. ï National Institute on Drug Abuse (NIDA; www.nida.nih.gov) OTP administrators and staff can be active ï SAMHSA (www.samhsa.gov) as representatives, speakers, or planners at professional conferences and as members or ï SAMHSAís National Help Line leaders in professional and community coali- (www.ncadi.samhsa.gov) and Treatment tions, including advisory councils. Such affilia- Improvement Exchange tions augment community relations efforts ï White House Office of National Drug Control through increased professional education and Policy (www.whitehousedrugpolicy.gov). public awareness, providing an opportunity Some OTPs have developed speakersí bureaus to exchange information with and counter for local events. Interested, successful patients, MAT stigmatization among other treatment patient advisory committees, patient family professionals. These forums also may present

234 Chapter 14 community relations models that can be adapt- an outgrowth of providing service to the public. ed effectively by OTPs. Staff participation on The panel believes that providing quality treat- local planning or development bodies can ment and operating OTPs responsibly position contribute to community improvement, programs to interact openly and confidently particularly in social and health services. with the media.

OTPs are encouraged to participate in national The forthcoming TIP Substance Abuse: SAMHSA campaigns, for instance, by support- Administrative Issues in Outpatient Treatment ing National Alcohol and Drug Addiction (CSAT forthcoming c) provides additional Recovery Month or sponsoring events to details for establishing media relations. emphasize that addiction recovery is possible and facilitating MAT as compassionate and a Developing policies and sound investment. procedures to address and Establishing effective media resolve community concerns relations The best intentions to educate and serve the community are undermined if they are not Print, broadcast, and Internet media play crit- followed up to resolve problems and concerns ical roles in reporting and educating, as well as about OTPs. The panel recommends that influencing public opinion. Local and national detailed strategies and procedures be in place media differ widely in their portrayals of opioid to respond to sources of community anxiety addiction, MAT, and people addicted to opioids. and hostility. These differences reflect a combination of fac- tors including journalistic integrity, reporting It is essential for OTPs to take stepsópossibly style and philosophy, political leanings, regional including staff or security patrols of the com- influences, and business considerations. News munity, visits with local merchants or represen- accounts and other depictions of MAT often tatives, and establishment of a community hot seem limited, misinformed, and negative. lineóto curtail loitering, drug sales, and the diversion of methadone before they prompt Nevertheless, many noteworthy, responsible community complaints. These patrols should features have been produced, providing impor- emphasize observation, not intervention. Logs tant, accurate information to the public about summarizing observations should be main- the science and policy of opioid addiction and tained. Staff visibility reminds patients of the treatment (e.g., Barry 2002; Hammack 2002; negative effect of loitering and similar behavior Moyers and Moyers 1998). Although treatment and demonstrates to neighbors that OTPs providers sometimes are disciplined to resist actively are committed to community safety media exposure in order to protect patient and improving quality of life. confidentiality and avoid misrepresentation, the consensus panel believes that successful Patients observed loitering should be coun- media outreach enhances an OTPís image, seled, and their treatment plan should be improves understanding of a programís mission revised to address this behavior. OTPs with and methods, and generates supportive public loitering problems should investigate day treat- policies. Media outreach can demystify treat- ment programs to provide increased treatment ment, counteract stigma, and improve fairness intensity. Discharge should be considered for of coverage. patients observed in illegal transactions or medication diversion. Although discharge is OTPs operating in larger institutions can work counter to the mandates of voluntary treat- with institutional public affairs professionals. ment, patients who are unconcerned about an Administrators should respond to or address OTPís community acceptance might be better members of the local press when necessary, as

Administrative Considerations 235 served by a facility equipped to handle their received and the programís response). behaviors. Communications should be logged, and staff participation in community events should be Decisions to discharge patients for loitering summarized. Letters and communications should balance consequences for the individual substantiating community complaints and the patient and public health against the need to programís followup should be on file. Records ensure a stable OTP environment and maintain should be kept of staff participation in profes- community-based services open to all patients. sional and community conferences, articles The panel recommends that loitering policies published in professional journals, and that culminate in patient discharge should first contributions to local news organizations. provide for progressive discipline and interven- tion and incorporate patient rights to a fair Using this information, OTP administrators hearing and treatment (see discussion in regularly should evaluate community relations Appendix D). efforts. Such reviews can identify organizations excluded from previous efforts or problems Community representatives should have OTP requiring revision of program policies or contact information to report problems involv- practices. ing patients. However, OTPs should clarify that they cannot assume a police role; in emergency and criminal matters, the police OTPs and National should be contacted first, not the OTP. Effective liaison with local law enforcement Community Education personnel is critical to OTP relations with the Initiatives community. Although police officers are gener- ally supportive, OTPs should correct any mis- OTPs should be aware of and involved in the conceptions police personnel have about OTPs. national dialog and efforts to promote MAT, Patients should be differentiated from people improve and disseminate information about actively using illicit drugs or abusing prescrip- opioid addiction, and partner with other tion drugs, and law enforcement personnel national organizations and agencies in public should be informed about OTP operations, relations and community education efforts. with the understanding that police and OTPs In addition, OTPs should build on and con- share a purposeóaddressing substance abuse tribute to these national initiatives within in the community. Other community problems their communities. (e.g., drug sales, unsafe community conditions) Numerous resources are available to educate identified during staff tours can be reported to the public about MAT and assist OTPs with law enforcement authorities. Local officers public relations. National organizations such as should be encouraged to contact the OTP about AATOD and the American Society of Addiction problems involving patients. Confidentiality Medicine hold national and regional confer- remains paramount, so this relationship should ences that bring together treatment providers, be delineated carefully. policymakers, researchers, and advocates to share knowledge and discuss how to advance Documenting community national drug policy and expand effective treat- contacts and community ment models, including strategies to improve public relations and reduce stigma. Focused relations activities training sessions also provide critical informa- Programs should document their efforts to tion, for example, to encourage physicians not establish productive community contacts and associated with OTPs to enter into MAT or resolve community concerns. A database explain how to improve their current treatment should be developed and updated (e.g., the of patients who are opioid addicted. Other number and nature of community complaints sessions may focus on improving staff attitudes

236 Chapter 14 and the treatment system regarding implemen- opportunities of those stigmatized. Changing tation of accreditation (Parrino 2001). the ConversationóImproving Substance Abuse Treatment: The National Treatment Plan NIDA has invited professionals, practitioners, Initiative (CSAT 2000b) affirmed the value of policymakers, and the public to sessions mass media public health education campaigns, focused on merging research with everyday comprehensive community-based health clinical practices in community-based drug communications, media advocacy, and the treatment programs. For example, one application of commercial marketing conference, Blending Clinical Practice and technologies to programs to change social atti- ResearchóForging Partnerships To Enhance tudes. This publication proposed a unique Drug Addiction Treatment, held in April 2002 national approach to reducing stigma that (National Institute on Drug Abuse 2002), incorporates science-based marketing research, incorporated a special forum focused on the a social marketing plan, facilitation and sup- mediaís role in presenting addiction treatment port of grassroots efforts by the recovery and research issues in the context of science community, and promotion of the dignity of reporting. people in treatment.

Publications and other information resources, NIDAís Community Epidemiology Surveillance often available without charge or at low cost, Networksómultiagency work groups with a highlight stories about the life-changing effects public health orientationóstudy the growth of MAT (e.g., American Methadone Treatment and development of Association, Inc. 2000; CSAT 2000a). To edu- drug abuse and relat- cate drug court judges and practitioners, ed problems in com- AATOD has produced Drug Court Practitioner munities nationwide. OTPs should be... Fact Sheet (Parrino 2002). DEA and AATOD The primary objec- developed the first DEA-specific guidelines for tives are to describe involved inÖ OTPs, Narcotic Treatment Programs: Best drug abuse patterns Practice Guideline (Drug Enforcement in defined geographic efforts to promote Administration 2000), which is distributed areas, identify nationally to MAT providers and addresses the changes in these MAT, improve and safekeeping of and proper accountability for patterns, detect controlled opioid treatment medications. The emerging substances disseminate Center for Substance Abuse Treatmentís of abuse, and commu- (CSATís) Siting Drug and Alcohol Programs: nicate and dissemi- information about Legal Challenges to the ìNIMBYî Syndrome nate information so (Weber and Cowie 1995) provides assistance that appropriate opioid addiction, with problems related to siting treatment community agencies facilities including OTPs. and organizations can and partner with In 1999, SAMHSA convened expert panels and develop prevention and treatment hearings to examine critical issues affecting the other national National Treatment Plan Initiative to improve strategies. and extend alcohol and drug treatment to all As government and organizations and communities and people in need in the United provider-based orga- States (CSAT 2000b). This extensive exploration nizations mobilize agenciesÖ documented widespread stigma and bias and its national efforts, effect on public support and policy, such as patients in and delaying the acknowledgment of addiction as a providers of MAT, disease; inhibiting prevention, care, treatment, along with other interested citizens, have been and research efforts; and diminishing the life encouraged to unite and organize, educate

Administrative Considerations 237 health providers and their communities, and Beyond the general information below about actively engage in public relations initiatives program and staff evaluation in an OTP, read- and other advocacy efforts that advance knowl- ers who want to know more about the specific edge and change attitudes about MAT. CSATís questions to ask and the considerations that Recovery Community Support Program assists should be made during evaluation should refer advocacy organizations in promoting their to Demystifying Evaluation: A Manual for messages (www.samhsa.gov/search/search.html). Evaluating Your Substance Abuse Treatment ProgramóVolume 1 (CSAT 1997a). Evaluating Program and Staff Performance Background MAT is one of the most frequently studied addiction therapies, but evaluating program Why Program Evaluation and performance based on patient outcomes is Performance Improvement relatively new to OTPs. Previous regulations Are Important (21 CFR, Part 291), which gave regulatory oversight to FDA, stressed process evaluation Recent developments lend urgency to the based on compliance with recommended development of good program evaluation and treatment procedures. Process evaluation does performance improvement procedures in not ask whether a recommended process has OTPs. Federal regulations (42 CFR, Part 8 ß worked, only whether it has been followed. 12(c)) and guidelines (Guidelines for the Accreditation of Opioid Treatment Programs The Institute of Medicine (IOM) was among the [CSAT 1999b], Section III, Part C) require first organizations to recommend an outcome OTPs to establish performance improvement evaluation system for OTPs based on ìdirect programs based on ongoing assessment of and valid measures of reduction in opiate and patient outcomes. SAMHSA-approved accredit- non-opiate drug use and improvement in posi- ing bodies (listed above) require performance tive social functionî (Institute of Medicine improvement objectives in their guidelines. 1995, p. 228), which could be used by OTPs, Many Single State Agencies and managed care regulatory and funding agencies, and organizations also require programs to collect researchers. IOM looked to the Methadone and analyze outcome data. OTPs are pressed Treatment Quality Assurance System increasingly to (MTQAS)óa NIDA-funded effort lasting demonstrate their from 1989 to 1998óto develop a performance- effectiveness and based reporting and feedback system as the efficiency. Admini- foundation for a formal performance improve- OTPs are pressed strators and staff ment system in OTPs. MTQAS was never fully must implement pro- adopted because most OTPs lacked the increasingly to gram evaluation pro- ìfocused technical assistanceî (Ducharme cesses that help meet and Luckey 2000, p. 87) required to translate demonstrate their these demands. feedback into action. Eight States participated Program evaluation in the MTQAS study, but only Massachusetts effectiveness and contributes to and North Carolina are using elements of the improved treatment system at this writing. Many OTPs appear to be by enabling adminis- on their own in conducting program evalua- efficiency. trators to base tions that comply with accreditation and State changes in services mandates. on evidence of what works.

238 Chapter 14 Outcome and Process SAMHSAís accreditation guidelines list the Evaluation following treatment outcomes as examples of what might be measured by OTPs: Both performance outcome and process evaluations have value, but they answer ï ìreducing or eliminating the use of illicit different questions and require different opioids, other illicit-drugs, and the problem- approaches. Performance outcome evaluation atic use of prescription drugs focuses on results, for example, patient ï reducing or eliminating associated criminal progress. Process evaluation focuses on how activities results were achievedóthe active ingredients ï reducing behaviors contributing to the spread of treatment. The forthcoming TIP Substance of infectious diseases Abuse: Administrative Issues in Outpatient Treatment (CSAT forthcoming c) and ï improving quality of life by restoration of Demystifying Evaluation: A Manual for physical and mental health and functional Evaluating Your Substance Abuse Treatment status.î (CSAT 1999b, p. 7) ProgramóVolume 1 (CSAT 1997a) describe Outcome evaluation also can be focused nar- and contrast these two types of evaluations. rowly; it can assess the results of particular treatment approaches on patient behavior. For Outcome evaluation in OTPs example, an OTP might provide patients with bus tokens to defray transportation costs to Outcome evaluation in OTPs focuses on and from treatment (some cities fund this kind patients and their progress during or after par- of intervention). After a certain period, the ticipation in MAT. It should focus on progress OTP could evaluate whether providing bus markers (see chapter 7) and behavioral tokens improved program attendance. This improvements as guideposts and avoid terms simple evaluation would require only atten- such as ìsuccessî and ìfailure.î Even small dance data. The most reliable evaluation uses a improvements may be significant. For example, control group for comparison (e.g., a group of an outcome evaluation might measure drug use patients who must purchase their bus tokens), (as quantified by drug testing) in patients who but this is not always practical or ethical. have spent various times in treatment. Such a study can set a baseline and provide a bench- mark to evaluate the effects of changes in pro- Process evaluation gram practices, for example, prescribing indi- Process evaluation describes what is happening vidually appropriate dosages for patients. in the treatment program: what kind of treat- Researchers measure many variables to assess ment, who conducts the sessions, how many MAT treatment outcomes, including drug use, and how long the sessions are, and where the criminal activity, medical problems, vocational sessions occur. A process evaluation documents skills, employment, family relationships, and what actually happens during an intervention, social activities. The measures selected by an how a new program or initiative is put into OTP should agree with the target behaviors operation, who the players are and what steps specified in program goals and objectives. For they take, specific problems and barriers example, evaluation of a treatment initiative encountered, strategies used to overcome these designed to reduce substance use, decrease problems and barriers, and necessary modifi- criminal involvement, and increase job skills cations to the original plan. Process evaluation should be based on data in those areas. An also may describe what is happening within the OTP can measure other outcomes (such as ìblack boxî of the treatment program. Black patientsí use of emergency rooms for medical box, a commonly used term in this context (Ball care) to assess whether it has had other effects and Ross 1991, p. 5), refers to the unknown on patient behaviors or the community. quality of some treatment programsóthat is, the fact that patients go into a program as

Administrative Considerations 239 known entities and come out with certain Resources for Program measurable outcomes, but what actually occurs Evaluation and Performance in treatment is not readily apparent. Process evaluation permits others to replicate methods Improvement that achieve their goals by evaluating the factors CSAT has published a comprehensive, detailed responsible for those achievements. A process guide to program evaluation that provides a evaluation can lead to development of a manual modularized learning approach, including describing the theories and practices of an OTP exercises, for designing and conducting to guide others. Implementation analysis should evaluations. Demystifying Evaluation: A document a process fully. It is well suited to Manual for Evaluating Your Substance Abuse documenting an OTPís efforts in community Treatment ProgramóVolume 1 (CSAT 1997a) relations, which is required in the accreditation is available from SAMHSAís National process. Clearinghouse for Alcohol and Drug Abuse Information at 800-729-6686 or A process evaluation can serve as a manage- www.ncadi.samhsa.gov. ment tool for program development if it is used to assess the strengths and weaknesses of a pro- For OTPs that want to use cost accounting as gram and suggest ways to improve operations. a form of program evaluation, NIDA has A process evaluation helps administrators developed a manual based on a cost-procedure- understand how program resources, including process-outcome analysis model that has been both staff and time, are used and can lead to well researched and tested in substance abuse improved resource allocation. Process evalua- treatment programs. Measuring and Improving tion is useful for examining whether OTP pro- Costs, Cost-Effectiveness, and Cost-Benefit for cedures are congruent with its stated goals. For Substance Abuse Treatment ProgramsóA example, if a goal is to facilitate patientsí use of Manual is available at www.nida.nih.gov/ peer support groups, the OTP could measure IMPCOST/IMPCOSTIndex.html. how often meetings of such groups are held on site, how often counselors provide patients with The Institute of Behavioral Research at Texas lists of local meetings, or whether patients actu- Christian University has carried out a substan- ally receive interventions as intended. For tial body of research on treatment process and example, an OTP intending to individualize outcomes (Simpson, D.D., et al. 1997a, 2000). care and match services to patientsí needs may The instituteís findings and experience in decide to use the Addiction Severity Index adapting assessments to field settings have (ASI) as a guide to treatment planning because guided development of a set of core instruments research shows that the ASI indicates effective that are available at www.ibr.tcu.edu/pubs/ patientñservice matches (McLellan et al. 1997). datacoll/coresetforms.html. The Web site also A process evaluation might examine the degree contains useful program evaluation forms for to which treatment plans and service delivery gathering OTP data, including the organiza- were congruent with the needs identified by the tionís readiness to change and patient satisfac- ASI. If the program finds a lack of congruence, tion with treatment. it can make corrections through training and United Way of America has developed an supervision. The process evaluation also can Outcome Measurement Resource Network that measure the intensity and duration of services is available through national.unitedway.org/ received by patients. outcomes.

The Change Book, a guidebook for organiza- tional change in OTPs, is produced and dis- tributed by the National ATTC, which can be reached at 877-652-2882 or www.nattc.org/resPubs/cbResources.html#cb.

240 Chapter 14 Appendix A: Bibliography

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244 Appendix A Cacciola, J.S.; Alterman, A.I.; Rutherford, Caplehorn, J.R., and Drummer, O.H. M.J.; and Snider, E.C. Treatment response Mortality associated with New South Wales of antisocial substance abusers. Journal of methadone programs in 1994: Lives lost and Nervous and Mental Disease 183(3):166ñ171, saved. Medical Journal of Australia 1995. 170(3):104ñ109, 1999. Calsyn, D.A.; Fleming, C.; Wells, E.A.; and Caplehorn, J.R.; Hartel, D.M.; and Irwig, L. Saxon, A.J. Personality disorder subtypes Measuring and comparing the attitudes and among opiate addicts in methadone mainte- beliefs of staff working in New York nance. Psychology of Addictive Behaviors methadone maintenance clinics. Substance 10(1):3ñ8, 1996. Use & Misuse 32:319ñ413, 1997. Calsyn, D.A.; Saxon, A.J.; and Barndt, C. Caplehorn, J.R.; Lumley, T.S.; and Irwig, L. Urine screening practices in methadone main- Staff attitudes and retention of patients in tenance clinics: A survey of how results are methadone maintenance programs. Drug and used. Journal of Nervous and Mental Alcohol Dependence 52(1):57ñ61, 1998. Disease 179:222ñ227, 1991. Caputo, F.; Addolorato, G.; Domenicali, M.; Calsyn, D.A.; Wells, E.A.; Fleming, C.; and Mosti, A.; Viaggi, M.; Trevisani, F.; Saxon, A.J. Changes in Millon Clinical Gasbarrini, G.; Bernardi, M.; Stefanini, Multiaxial Inventory scores among opiate G.F.; and Services for Addiction Treatment. addicts as a function of retention in Short-term methadone administration methadone maintenance treatment and reduces alcohol consumption in nonalcoholic recent drug use. American Journal of Drug heroin addicts. Alcohol and Alcoholism and Alcohol Abuse 26(2):297ñ309, 2000a. 37(2):164ñ168, 2002. Calsyn, D.A.; Wells, E.A.; Saxon, A.J.; Carroll, K.M.; Chang, G.; Behr, H.M.; Jackson, R.; Heiman, J.R.; and Matsumoto, Clinton, B.; and Kosten, T.R. Improving A.M. Sexual activity under the influence of treatment outcome in pregnant, methadone- drugs is common among methadone clients. maintained women: Results from a random- In: Harris, L.S., ed. Problems of Drug ized clinical trial. American Journal on Dependence: Proceedings of the 61st Annual Addictions 4(1):56ñ59, 1995. Scientific Meeting, the College on Problems Carroll, K.M.; Nich, C.; Ball, S.A.; McCance, of Drug Dependence, Inc. NIDA Research E.; Frankforter, T.L.; and Rounsaville, B.J. Monograph 180. NIH Publication No. One-year follow-up of disulfiram and psy- 00ñ4737. Rockville, MD: National Institute chotherapy for cocaine-alcohol users: on Drug Abuse, 2000b, p. 315. Sustained effects of treatment. Addiction Camacho, L.M.; Brown, B.S.; and Simpson, 95(9):1335ñ1349, 2000. D.D. Psychological dysfunction and Center for Substance Abuse Prevention. HIV/AIDS risk behavior. Journal of Acquired Cultural competence for social workers. In: Immune Deficiency Syndromes and Human Philleo, J., and Brisbane, F.L., eds. Cultural Retrovirology 11:198ñ202, 1996. Competence Series. DHHS Publication No. Caplan, Y.H., and Cone, E.J. Drug Testing (SMA) 95ñ3075. Rockville, MD: Substance Advisory Board. Rockville, MD: Substance Abuse and Mental Health Services Abuse and Mental Health Services Administration, 1995. Administration, 1997. Centers for Disease Control. Perspectives in Caplehorn, J.R., and Bell, J. Methadone disease prevention and health promotion dosage and retention of patients in mainte- update: Universal precautions for prevention nance treatment. Medical Journal of of transmission of human immunodeficiency Australia 154(3):195ñ199, 1991. Published virus, hepatitis B virus, and other blood- erratum in Medical Journal of Australia borne pathogens in health-care settings. 159(9):640, 1993.

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246 Appendix A Chaulk, C.P.; Moore-Rice, K.; Rizzo, R.; and and Back, D.J. Pharmacokinetic interactions Chaisson, R.E. Eleven years of community- of nevirapine and methadone and guidelines based directly observed therapy for tubercu- for use of nevirapine to treat injection drug losis. JAMA 274(12):945ñ951, 1995. users. Clinical Infectious Diseases Chawarski, M.C.; Schottenfeld, R.S.; 33(9):1595ñ1597, 2001a. OíConnor, P.G.; and Pakes, J. Plasma con- Clarke, S.M.; Mulcahy, F.M.; Tjia, J.; centrations of buprenorphine 24 to 72 hours Reynolds, H.E.; Gibbons, S.E.; Barry, M.G.; after dosing. Drug and Alcohol Dependence and Back, D.J. The pharmacokinetics of 55:157ñ163, 1999. methadone in HIV-positive patients receiving Childress, A.R.; Ehrman, R.; Rohsenow, D.J.; the non-nucleoside reverse transcriptase Robbins, S.J.; and OíBrien, C.P. Classically inhibitor efavirenz. British Journal of conditioned factors in drug dependence. In: Clinical Pharmacology 51(3):213ñ217, Lowinson, J.H.; Ruiz, P.; and Millman, 2001b. R.B., eds. Substance Abuse: A Clemmey, P.; Brooner, R.; Chutuape, M.A.; Comprehensive Textbook. Baltimore: Kidorf, M.; and Stitzer, M. Smoking habits Williams & Wilkins, 1992, pp. 56ñ69. and attitudes in a methadone maintenance Chutuape, M.A.; Silverman, K.; and Stitzer, treatment population. Drug and Alcohol M.L. Survey assessment of methadone treat- Dependence 44(2ñ3):123ñ132, 1997. ment services as reinforcers. American Coffin, P.O.; Galea, S.; Ahern, J.; Leon, A.C.; Journal of Drug and Alcohol Abuse Vlahov, D.; and Tardiff, K. Opiates, cocaine 24(1):1ñ16, 1998. and alcohol combinations in accidental drug Cicero, T.J.; Adams, E.H.; Geller, A.; Inciardi, overdose deaths in New York City, 1990ñ98. J.A.; Munoz, A.; Schnoll, S.H.; Senay, E.C.; Addiction 98(6):739ñ747, 2003. and Woody, G.E. A postmarketing surveil- Cohen, J.S. Preventing adverse drug interac- lance program to monitor UltramÆ (tramadol tions before they occur. Medscape hydrochloride) abuse in the United States. Pharmacotherapy 1(2), 1999. Drug and Alcohol Dependence 57:7ñ22, www.medscape.com [accessed May 3, 2004]. 1999. Compton, P., and Athanasos, P. Chronic pain, Cirimele, V.; Kintz, P.; Lohner, S.; and Ludes, substance abuse, and addiction. Nursing B. Enzyme immunoassay validation for the Clinics of North America 38(3):525ñ537, detection of buprenorphine in urine. Journal 2003. of Analytical Toxicology 27(2):103ñ105, 2003. Compton, P.; Charuvastra, V.C.; and Ling, W. Clark, H.W. Dear Colleague (Letter to opioid Pain intolerance in opioid-maintained former treatment professionals). Rockville, MD: opiate addicts: Effect of long-acting mainte- Substance Abuse and Mental Health Services nance agent. Drug and Alcohol Dependence Administration, July 18, 2003. 63:139ñ146, 2001. Clark, H.W.; Masson, C.L.; Delucchi, K.L.; Compton, P., and McCaffery, M. Treating Hall, S.M.; and Sees, K.L. Violent traumatic acute pain in addicted patients. In: events and drug abuse severity. Journal of McCaffery, M., and Pasero, C., eds. Pain: Substance Abuse Treatment 20(2):121ñ127, Clinical Manual, 2d ed. Carlsbad, CA: 2001. Mosby, Inc., 1999. Clarke, J.G.; Stein, M.D.; McGarry, K.A.; and Compton, P.A.; Ling, W.; Wesson, D.R.; Gogineni, A. Interest in smoking cessation Charuvastra, V.C.; and Wilkins, J. Urine among injection drug users. American toxicology as an outcome measure in drug Journal on Addictions 10(2):159ñ166, 2001. abuse clinical trials: Must every sample be Clarke, S.M.; Mulcahy, F.M.; Tjia, J.; analyzed? Journal of Addictive Diseases Reynolds, H.E.; Gibbons, S.E.; Barry, M.G.; 15(2):89ñ92, 1996.

Bibliography 247 Compton, W.M., III; Cottler, L.B.; Phelps, Cozza, K.L., and Armstrong, S.C. The D.L.; Ben Abdallah, A.; and Spitznagel, E.L. Cytochrome P450 System: Drug Interaction Psychiatric disorders among drug dependent Principles for Medical Practice. Washington, subjects: Are they primary or secondary? DC: American Psychiatric Publishing, Inc., American Journal on Addictions 2001. 9(2):126ñ134, 2000. Crane, E. Narcotic analgesics in brief. The Condelli, W.S. Strategies for increasing reten- DAWN Report, January 2003. Rockville, tion in methadone programs. Journal of MD: Office of Applied Studies, Substance Psychoactive Drugs 25(2):143ñ147, 1993. Abuse and Mental Health Services Condelli, W.S., and Dunteman, G.H. Exposure Administration, 2003. to methadone programs and heroin use. Crowley, T.J. Research on contingency man- American Journal of Drug and Alcohol Abuse agement of drug dependence: Clinical impli- 19(1):65ñ78, 1993. cations and future directions. In: Higgins, Cone, E.J. New developments in biological S.T., and Silverman, K., eds. Motivating measures of drug prevalence. In: Harrison, Behavior Change Among Illicit-Drug L.D., and Hughes, A., eds. The Validity of Abusers. Washington, DC: American Self-Reported Drug Use: Improving the Psychological Association, 1999. Accuracy of Survey Estimates. NIDA CSAT (Center for Substance Abuse Treatment). Research Monograph 167. DHHS Screening for Infectious Diseases Among Publication No. (NIH) 97ñ4147. Rockville, Substance Abusers. Treatment Improvement MD: National Institute on Drug Abuse, 1997, Protocol (TIP) Series 6. DHHS Publication p. 114. No. (SMA) 95ñ3060. Rockville, MD: Cone, E.J., and Preston, K.L. Toxicologic Substance Abuse and Mental Health Services aspects of heroin substitution treatment. Administration, 1993a, reprinted 1995. Therapeutic Drug Monitoring 24(2):193ñ198, CSAT (Center for Substance Abuse Treatment). 2002. State Methadone Treatment Guidelines. Conklin, C.A., and Tiffany, S.T. Applying Treatment Improvement Protocol (TIP) extinction research and theory to cue- Series 1. DHHS Publication No. (SMA) exposure addiction treatments. Addiction 93ñ1991. Rockville, MD: Substance Abuse 97:155ñ167, 2002. and Mental Health Services Administration, 1993b, reprinted 2000, 2002. Connaughton, J.F.; Reeser, D.; Schut, J.; and Finnegan, L.P. Perinatal addiction: Outcome CSAT (Center for Substance Abuse Treatment). and management. American Journal of Demystifying Evaluation: A Manual for Obstetrics and Gynecology 129(6):679ñ686, Evaluating Your Substance Abuse Treatment 1977. ProgramóVolume 1. DHHS Publication No. (SMA) 99ñ3341. Rockville, MD: Substance Courtwright, D.T. Dark Paradise: A History of Abuse and Mental Health Services Opiate Addiction. Cambridge, MA: Harvard Administration, 1997a, reprinted 1999. University Press, 1982, expanded edition 2001. CSAT (Center for Substance Abuse Treatment). Substance Abuse Treatment and Domestic Courtwright, D.T.; Joseph, H.; and Des Violence. Treatment Improvement Protocol Jarlais, D. Addicts Who Survived: An Oral (TIP) Series 25. DHHS Publication No. History of Narcotic Use in America, (SMA) 00ñ3406. Rockville, MD: Substance 1923ñ1965. Knoxville, TN: University of Abuse and Mental Health Services Tennessee Press, 1989. Administration, 1997b, reprinted 2000. Cowan, A. Buprenorphine: New pharmacologi- CSAT (Center for Substance Abuse Treatment). cal aspects. International Journal of Clinical Naltrexone and Alcoholism Treatment. Practice Supplement 113:3ñ8, 2003.

248 Appendix A Treatment Improvement Protocol (TIP) CSAT (Center for Substance Abuse Treatment). Series 28. DHHS Publication No. (SMA) Addiction Knows No Boundaries, Itís 98ñ3206. Rockville, MD: Substance Abuse Everybodyís Business: Methadone and Mental Health Services Administration, Community Education Kit. Rockville, MD: 1998a. Substance Abuse and Mental Health Services CSAT (Center for Substance Abuse Treatment). Administration, 2000a. Substance Abuse Among Older Adults. CSAT (Center for Substance Abuse Treatment). Treatment Improvement Protocol (TIP) Changing the ConversationóImproving Series 26. DHHS Publication No. (SMA) Substance Abuse Treatment: The National 01ñ3496. Rockville, MD: Substance Abuse Treatment Plan Initiative. DHHS and Mental Health Services Administration, Publication No. (SMA) 00ñ3479. Rockville, 1998b, reprinted 2001. MD: Substance Abuse and Mental Health CSAT (Center for Substance Abuse Treatment). Services Administration, 2000b. Substance Use Disorder Treatment for CSAT (Center for Substance Abuse Treatment). People With Physical and Cognitive Integrating Substance Abuse Treatment and Disabilities. Treatment Improvement Vocational Services. Treatment Improvement Protocol (TIP) Series 29. DHHS Publication Protocol (TIP) Series 38. DHHS Publication No. (SMA) 98ñ3249. Rockville, MD: No. (SMA) 00ñ3470. Rockville, MD: Substance Abuse and Mental Health Services Substance Abuse and Mental Health Services Administration, 1998c. Administration, 2000c. CSAT (Center for Substance Abuse Treatment). CSAT (Center for Substance Abuse Treatment). Enhancing Motivation for Change in Substance Abuse Treatment for Persons With Substance Abuse Treatment. Treatment Child Abuse and Neglect Issues. Treatment Improvement Protocol (TIP) Series 35. Improvement Protocol (TIP) Series 36. DHHS Publication No. (SMA) 00ñ3460. DHHS Publication No. (SMA) 00ñ3357. Rockville, MD: Substance Abuse and Mental Rockville, MD: Substance Abuse and Mental Health Services Administration, 1999a, Health Services Administration, 2000d. reprinted 2000. CSAT (Center for Substance Abuse Treatment). CSAT (Center for Substance Abuse Treatment). Substance Abuse Treatment for Persons With Guidelines for the Accreditation of Opioid HIV/AIDS. Treatment Improvement Protocol Treatment Programs. Rockville, MD: (TIP) Series 37. DHHS Publication No. Substance Abuse and Mental Health Services (SMA) 00ñ3410. Rockville, MD: Substance Administration, 1999b. Abuse and Mental Health Services CSAT (Center for Substance Abuse Treatment). Administration, 2000e. Treatment for Stimulant Use Disorders. CSAT (Center for Substance Abuse Treatment). Treatment Improvement Protocol (TIP) OxyContinÆ: Prescription drug abuse. CSAT Series 33. DHHS Publication No. (SMA) Treatment Advisory 1(1), 2001a. 99ñ3296. Rockville, MD: Substance Abuse CSAT (Center for Substance Abuse Treatment). and Mental Health Services Administration A Providerís Introduction to Substance Abuse 1999c. Treatment for Lesbian, Gay, Bisexual, and CSAT (Center for Substance Abuse Treatment). Transgender Individuals. DHHS Publication Treatment of Adolescents With Substance Use No. (SMA) 01ñ3498. Rockville, MD: Disorders. Treatment Improvement Protocol Substance Abuse and Mental Health Services (TIP) Series 32. DHHS Publication No. Administration, 2001b. (SMA) 99ñ3345. Rockville, MD: Substance CSAT (Center for Substance Abuse Treatment). Abuse and Mental Health Services Clinical Guidelines for the Use of Administration, 1999d, reprinted 2001. Buprenorphine in the Treatment of Opioid Addiction. Treatment Improvement Protocol

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Appendix B: Abbreviations and Acronyms

AA Alcoholics Anonymous AAS American Association of Suicidology AATOD American Association for the Treatment of Opioid Dependence (formerly American Methadone Treatment Association [AMTA]) ADA Americans with Disabilities Act of 1990 AD/HD attention deficit/hyperactivity disorder AMA American Medical Association APA American Psychiatric Association APD antisocial personality disorder ASAM American Society of Addiction Medicine ASI Addiction Severity Index ATTC Addiction Technology Transfer Center AZT zidovudine CA Cocaine Anonymous CALDATA California Drug and Alcohol Treatment Assessment CARF Commission on Accreditation of Rehabilitation Facilities CBT cognitive behavioral therapy CDC Centers for Disease Control and Prevention CFR Code of Federal Regulations CJS criminal justice system

279 CNS central nervous system HAV hepatitis A virus COPD chronic obstructive pulmonary HBV hepatitis B virus disease HCV hepatitis C virus CPS childrenís protective services HIPAA Health Insurance Portability CRA community reinforcement and Accountability Act of 1996 approach HIV human immunodeficiency virus CSA Controlled Substances Act ICD-10 International Statistical CSAT Center for Substance Abuse Classification of Diseases and Treatment Related Health Problems, 10th Edition CYP3A4 cytochrome P3A4 IND investigational new drug CYP450 cytochrome P450 IOM Institute of Medicine DASIS Drug and Alcohol Services Information System JCAHO Joint Commission on the Accreditation of Healthcare DATA Drug Abuse Treatment Act Organizations of 2000 LAAM levo-alpha acetyl methadol DAWN Drug Abuse Warning Network LGB lesbian, gay, and bisexual DCP diversion control plan MA Methadone Anonymous DEA U.S. Drug Enforcement Administration MAT medication-assisted treatment for opioid addiction DHHS U.S. Department of Health and Human Services MDI Bayley Mental Development Index DSM-IV-TR Diagnostic and Statistical Manual of Mental Disorders, MSW medically supervised Fourth Edition, Text Revision withdrawal ECA Epidemiological Catchment MTQAS Methadone Treatment Quality Area Assurance System ECG electrocardiogram NA Narcotics Anonymous EEG electroencephalogram NAPAN National Association for the Prevention of Addiction to EIA enzyme immunoassay Narcotics EMIT Enzyme Multiplied NAS neonatal abstinence syndrome Immunoassay Technique NASADAD National Association of FDA U.S. Food and Drug State Alcohol and Drug Administration Abuse Directors GC/MS gas chromatography/mass spectrometry

280 Appendix B NCADI SAMHSAís National SAMHSA Substance Abuse and Mental Clearinghouse for Alcohol and Health Services Administration Drug Abuse Information SAPT Substance Abuse Prevention NIDA National Institute on Drug and Treatment (name of block Abuse grant) NIH National Institutes of Health SMA State Methadone Authority

NIMBY not in my back yard SML serum methadone level NIMH National Institute of SSA Single State Agency Mental Health SSRI selective serotonin reuptake OBOT office-based opioid treatment inhibitor ONDCP Office of National Drug STD sexually transmitted disease Control Policy SVR sustained virologic response OTP opioid treatment program TB tuberculosis PCR polymerase chain reaction TC therapeutic community PEG polyethylene glycol THC tetra-hydrocannabinol PPD purified protein derivative TIP Treatment Improvement PTSD posttraumatic stress disorder Protocol QSOA Qualified Service Organization TLC thin layer chromatography Agreement TMA transcription mediated RIA radioimmunoassay amplification RNA ribonucleic acid VBRT voucher-based reinforcement therapy RTSH Recovery Training and Self-Help

Abbreviations and Acronyms 281

Appendix C: Glossary

-A- abstinence. Nonuse of alcohol or any illicit drugs, as well as nonabuse of medications normally obtained by prescription or over the counter. Abstinence in this TIP does not refer to nonuse of or with- drawal from maintenance medications (methadone, buprenorphine, LAAM, or naltrexone) when they are used in MAT. Compare medi- cally supervised withdrawal. accreditation. Process of periodic review of an OTP for conformance with accrediting-body standards. Accrediting bodies and their stan- dards are approved by SAMHSA. See 42 CFR, Part 8 ß 2, for other accreditation-related terms and definitions. acute phase. Initial and usually the most symptomatic intensive- treatment phase of MAT. addiction. Combination of the physical dependence on, behavioral manifestations of the use of, and subjective sense of need and craving for a psychoactive substance, leading to compulsive use of the substance either for its positive effects or to avoid negative effects associated with abstinence from that substance. Compare dependence. administrative discharge. Release or discharge of a patient from an OTP, often against the patientís wishes. See involuntary discharge. admission. Formal process of enrolling patients in an OTP, carried out by qualified personnel who determine that the patient meets acceptable medical criteria for treatment. Admission can include ori- entation to the program and an introduction to peer support, patient rights, services, rules, and treatment requirements related to MAT. agonist. See opioid agonist. analgesic. A compound that alleviates pain without causing loss of con- sciousness. Opioid analgesics are a class of compounds that bind to

283 specific receptors in the central nervous diazepam, chlordiazepoxide, clonazepam, system to block the perception of pain or alprazolam, lorazepam). affect the emotional response to pain. Such compounds include opium and its deriva- best-treatment practices. Methods deter- tives, as well as a number of synthetic com- mined, often by a consensus of experts, to pounds. Chronic administration or abuse be optimal for defined therapeutic situa- of opioid analgesics may lead to addiction. tions. Such guidelines usually are based on both an analysis of published research antagonist. See opioid antagonist. findings and the experience of experts. assessment. Process of identifying the pre- blood testing. Identifying evidence of opioid cise nature and extent of a patientís sub- and other psychoactive substance use and stance use disorder and other medical, measuring the levels of substances or medi- mental health, and social problems as a cations in the body by examining patient basis for treatment planning. Assessment blood specimens for the presence and con- usually begins during program admission centrations of identifiable drugs and their and continues throughout treatment. It metabolites. includes a personal substance abuse histo- ry, physical examination, laboratory evalu- buprenorphine. Partial opioid agonist ation, and determination of disease mor- approved by FDA for use in detoxification bidity. Severity of disease often is assessed or maintenance treatment of opioid addic- further in terms of physiologic dependence, tion and marketed under the trade names Æ Æ organ system damage, and psychosocial Subutex and Suboxone (the latter also morbidity. Assessment also may involve containing naloxone). determining patient motivation and readi- -C- ness for change. certification. Process by which SAMHSA assessment tools. Instruments (e.g., ques- determines that an OTP is qualified to pro- tionnaires) used to capture the range of vide opioid addiction treatment under the patient variables affecting treatment plan- Federal opioid treatment standards. ning, methods, and outcomes. Valid assess- ment tools contain quantifiable indicators civil commitment. Legal process that per- to measure patient progress and to track mits individuals to be confined against their patients through treatment. will in psychiatric or other treatment facili- ties, which usually is justified by determin- Axis I. DSM-IV-TR disorder classification ing that a patient is a threat to himself or comprising definitions and descriptions of herself or others. Although statutes permit- major disorders (i.e., psychotic, mood, and ting involuntary civil commitment may substance use disorders) that may require remain in some States, such laws rarely clinical attention. have been used to commit people who -B- abuse substances and are not under crimi- nal justice jurisdiction. benzodiazepines. Group of medications having a common molecular structure and Commission on Accreditation of similar pharmacological activity, including Rehabilitation Facilities (CARF). One antianxiety, sedative, hypnotic, amnestic, of several SAMHSA-approved accredita- anticonvulsant, and muscle-relaxing tion organizations charged with ensuring effects. Benzodiazepines are among the that OTPs meet the standards set forth in most widely prescribed medications (e.g., Federal regulations and SAMHSA guide- lines. Also known as CARF. . . The Rehabilitation Accreditation Commission.

284 Appendix C comprehensive maintenance maintain regular contact with their treatment. Continuous therapy with treatment program. medication in conjunction with a wide range of medical, psychiatric, and psy- co-occurring disorder. In this TIP, a men- chosocial services. Compare medical tal disorder, according to DSM-IV diagno- maintenance. sis, that is present in an individual who is admitted to an OTP. comprehensive treatment assessment. Evaluation made after formal admission to counseling. In MAT, a treatment service in an OTP, in which trained staff members which a trained counselor and a case man- determine the range and severity of a ager evaluate both a patientís external patientís problems and the patientís service circumstances and immediate treatment needs. These determinations are used to progress and offer appropriate advice and establish short- and long-term treatment assistance or referral to other experts and goals in the patientís treatment plan. services as needed. A major objective in MAT is to provide skills and support for a confidentiality regulations. Rules estab- substance-free lifestyle and encourage lished by Federal and State agencies to abstinence from alcohol and other limit disclosure of information about a psychoactive substances. Compare patientís substance use disorder and treat- psychotherapy. ment (described in 42 CFR, Part 2 ß 16). Programs must notify patients of their craving. Urgent, seemingly overpowering rights to confidentiality, provide a written desire to use a substance, which often is summary of these rights, and establish associated with tension, anxiety, or other written procedures regulating access to and dysphoric, depressive, or negative affective use of patient records. states.

consent to treatment. Form completed cross-tolerance. Condition in which repeat- with and signed by an applicant for MAT ed administration of a drug results in and by designated treatment program staff diminished effects not only for that drug members, which verifies that the applicant but also for one or more drugs from a simi- has been informed of and understands pro- lar class to which the individual has not gram procedures and his or her rights and been exposed recently. treatment goals, risks, and performance cultural competence. Capacity of a service expectations. provider or organization to understand and contingency contracting. Use of preestab- work effectively in accord with the beliefs lished, mutually agreed-on privileges (e.g., and practices of persons from a given take-home dosing) or consequences (e.g., ethnic/racial/religious/social group or sexu- loss of privileges) to motivate improvements al orientation. It includes the holding of in treatment outcomes. Many experts agree knowledge, skills, and attitudes that allow that negative contingencies in MAT (e.g., the treatment provider and program to reduction in medication) are neither effec- understand the full context of a patientís tive nor ethical and should be avoided. current and past socioenvironmental situation. continuing-care phase. Optional phase of MAT in which patients who have completed cultural diversity. Differences in back- medically supervised withdrawal from grounds and beliefs that may affect the way treatment medication and are leading groups of patients in OTPs and individuals socially productive lives continue to within these groups view the world and

Glossary 285 their place in it, their substance use, and treatment standards (42 CFR, Part 8 ß treatment. 12(c)(2)) require a diversion control plan in an OTP as part of its quality assurance -D- program. dependence. State of physical adaptation dosage determination. Process of identify- that is manifested by a drug class-specific ing the amount of medication that will mini- withdrawal syndrome that can be produced mize withdrawal symptoms and craving in by abrupt cessation, rapid dose reduction, patients in MAT and eliminate their opioid and/or decreasing blood level of a sub- abuse. Much evidence supports a linear stance and/or administration of an antago- relationship among the amount of medica- nist. Compare addiction. tion provided, the timeframe over which it detoxification. In this TIP, treatment for is allowed to act before another dose is addiction to an illicit substance in which administered (dose frequency), and treat- the substance is eliminated gradually from ment response. a patientís body while various types and dose tapering. See medically supervised levels of reinforcing treatment are provided withdrawal. to alleviate adverse physical or psychologi- cal reactions to the withdrawal process. drug interaction. Action of one drug on the This TIP avoids the term ìdetoxificationî effectiveness or toxicity of another drug. to designate the process of dose tapering from maintenance medication because that drug testing. Examination of an individual term incorrectly suggests that opioid treat- to determine the presence or absence of ment medications are toxic. Compare medi- illicit or nonprescribed drugs or alcohol or cally supervised withdrawal. to confirm maintenance levels of treatment medications, usually by a methodology that diagnosis. Classification of the nature and has been approved by the OTP medical severity of the substance use, medical, director based on informed medical judg- mental health, or other problems present in ment. OTPs also must conform to State a patient who is addicted to opioids. DSM- laws and regulations in this area. See blood IV-TR and ICD-10 classifications common- testing, oral-fluid drug testing, urine ly are used to classify substance use and testing. mental disorders. duration of action. Length of time that a discharge. Release from or discontinuation of treatment medication effectively prevents enrollment in treatment when maximum withdrawal symptoms or craving. Duration benefit has been achieved or when a patient of action can be affected by many factors, is deemed no longer suitable for treatment. including drug interactions, certain dis- See administrative discharge, involuntary eases and medical conditions, patient cross- discharge. tolerance, and the relative affinity of a medication for its targeted cell receptor. diversion. Sale or other unauthorized distri- bution of a controlled substance, usually -E- for a purpose other than the prescribed and legitimate treatment of a medical or eligibility. See treatment eligibility. mental disorder. elimination half-life. Time required after diversion control plan. Documented proce- administration of a substance (e.g., dures to reduce the possibility that con- methadone) for one-half the dose to leave trolled substances are used for other than the body. Elimination half-life affects the their legitimate use. Federal opioid duration of action of a substance or

286 Appendix C medication and can be influenced by intensity of treatment. Frequency and patient factors such as absorption rate, method of delivery for therapeutic services. variable metabolism and protein binding, In this TIP and in American Society of changes in urinary pH, concomitant Addiction Medicine Patient Placement medications, diet, physical condition, age, Criteria, intensity of treatment is one com- pregnancy, and even use of vitamins and ponent, along with treatment setting, that herbal products. determines the level of care for a patient. Levels of care are adjusted during MAT -H- based on patient needs and the treatment half-life. See elimination half-life. plan. See, for example, intensive inpatient treatment and intensive outpatient hepatitis C. Viral disease of the liver that is treatment. the leading cause of cirrhosis in the United States and a particular concern in MAT intensive inpatient treatment. Level of because of the high incidence of the disease care in which addiction professionals and and spread of the infection among people clinicians provide a regimen of around-the- who inject drugs. clock evaluation, care, and therapy in an inpatient setting. Involvement of physicians high-risk behavior. Activity that increases can range from monitoring multidisci- the likelihood that a recovering patient in plinary staff members to direct manage- substance abuse treatment will relapse to ment of cases, depending on the severity of substance use or contract a substance patientsí problems. use-related disorder, such as an infectious disease. intensive outpatient treatment. Level of care (possibly including partial hospitaliza- hospital-based treatment. Treatment of tion) in which addiction professionals and opioid addiction and related complications clinicians provide therapeutic services to that requires patient residency for some clients who live at home or in special resi- period in a hospital setting or outpatient dences. Treatment is delivered in two to treatment in a hospital-linked facility to five regularly scheduled sessions per week ensure that necessary services and levels of totaling 6 to 24 hours per week. Many care are available. treatment services and levels of care are compatible with intensive outpatient -I- treatment, but most programs include structured psychoeducation and group iatrogenic opioid addiction. Addiction counseling. resulting from medical use of an opioid (i.e., under physician supervision), usually interim maintenance treatment. Time- for pain management. limited pharmacotherapeutic regimen in conjunction with appropriate medical ser- induction. Initial treatment process of adjust- vices while a patient awaits transfer to an ing maintenance medication dosage levels OTP that provides comprehensive mainte- until a patient attains stabilization. nance treatment (42 CFR, Part 8 ß 2). induction stage. The period of opioid phar- intervention. The process of providing care macotherapy, usually during the acute to a patient or taking action to modify a phase of treatment, in which steady-state symptom, an effect, or a behavior. Also the blood levels of a medication are achieved. process of interacting after assessment with intake. Initial screening of applicants for a patient who is substance addicted to pre- admission to an OTP. sent a diagnosis and recommend and nego- tiate a treatment plan. Also frequently used

Glossary 287 as a synonym for treatment. Types of -M- intervention can include crisis interven- tion, brief intervention, and long-term maintenance dosage. Amount of medica- intervention. tion that is adequate to achieve desired therapeutic effects for 24 hours or more, involuntary discharge. Formal discontinu- with allowance for day-to-day fluctuations. ation of a patientís enrollment in an OTP without patient consent, usually for rea- maintenance medication. Medication sons related to program operations, safety, used for ongoing treatment of opioid or treatment complianceófor example, addiction. violence or threats of violence; buying and maintenance treatment. Dispensing of selling drugs; repeated loitering; flagrant an opioid addiction medication at stable noncompliance with program rules result- dosage levels for a period in excess of 21 ing in an observable, negative impact on days in the supervised treatment of an the program, staff, and other patients; individual for opioid addiction nonpayment of fees; and incarceration or (42 CFR, Part 8 ß 2). other confinement. See administrative discharge. medical maintenance. (1) Phase of MAT and type of treatment by an OTP, medica- -J- tion unit, or physician affiliated with an Joint Commission on Accreditation of OTP in which a person who has achieved a Healthcare Organizations (JCAHO). stable lifestyle and has remained abstinent One of several SAMHSA-approved accredi- from illicit drugs for at least 2 years (longer tation organizations charged with ensuring in some States) receives ongoing pharma- that OTPs meet the standards set forth in cotherapy with methadone, buprenor- Federal regulations and SAMHSA phine, or LAAM but no longer requires the guidelines. structure or frequency of psychosocial treatment services provided in an OTP, as -L- determined by the OTP medical director. (2) Medical maintenance also can be pro- LAAM. See levo-alpha acetyl methadol. vided by physicians using buprenorphine level of care. The setting or combination of or naltrexone (42 CFR, Part 8 ß settings in which the appropriate intensities 12(i)(3)(vi); 42 CFR, Part 8 ß 11(h)). and types of treatment services can be pro- medically supervised withdrawal. vided for individual patients. Dispensing of a maintenance medication in levo-alpha acetyl methadol (LAAM; gradually decreasing doses to alleviate trade name ORLAAM). An opioid ago- adverse physical or psychological effects nist medication derived from methadone incident to withdrawal from the continuous that is effective for up to 72 hours. Reports or sustained use of opioid drugs. The pur- in 2000 and 2001 of potential arrhythmo- pose of medically supervised withdrawal is genic cardiac effects of LAAM led to tight- to bring a patient maintained on mainte- ening of guidelines, including recommenda- nance medication to a medication-free state tions that LAAM no longer be used for within a target period. first-line therapy but only for treatment of medication-assisted treatment for patients who already have used it success- opioid addiction (MAT). Type of fully or do not show an acceptable response addiction treatment, usually provided in to other addiction treatments. At this writ- a certified, licensed OTP or a physicianís ing, LAAMís future availability for opioid office-based treatment setting, that provides pharmacotherapy is doubtful.

288 Appendix C maintenance pharmacotherapy using an combination with opioids are immediately opioid agonist, a partial agonist, or an life threatening. antagonist medication, which may be combined with other comprehensive mutual-help program. Program offering treatment services, including medical and the benefits of peer support to people who psychosocial services. are substance addicted, through attendance at group meetings and other activities. medication unit. Facility established as part Twelve-Step programs are one type of of, but geographically separate from, an mutual-help program. opioid treatment program, from which cer- tified private practitioners or community -N- pharmacists may dispense or administer naloxone. Short-acting opioid antagonist. opioid agonist medications for observed Because of its higher affinity than that of ingestion (42 CFR, Part 8 ß 11(i)(1)). opioids for mu opiate receptors, naloxone methadone. The most frequently used opioid displaces opioids from these receptors and agonist medication. Methadone is a synthet- can precipitate withdrawal, but it does not ic opioid that binds to mu opiate receptors activate the mu receptors, nor does it cause and produces a range of mu agonist effects the euphoria and other effects associated similar to those of short-acting opioids such with opioid drugs. Naloxone is not FDA as morphine and heroin. approved for long-term therapy for opioid addiction, except in the combination methadone maintenance treatment. buprenorphine-naloxone tablet. Some pro- Dispensing of methadone at stable dosage grams use naloxone to evaluate an individ- levels for more than 21 days in the super- ualís level of opioid dependence. See nalox- vised treatment of an individual for opioid one challenge test. addiction (42 CFR, Part 8 ß 2). naloxone challenge test. Test in which mobile treatment services. Substance use naloxone is administered to verify an appli- treatment provided directly to patients cantís current opioid dependence and eligi- from traveling units or vans, ranging from bility for admission to an OTP. Withdrawal comprehensive maintenance services (with symptoms evoked by naloxoneís antagonist medication and counseling in one or several interaction with opioids confirm an individ- mobile units) to more limited care, usually ualís current dependence. medication maintenance therapy, in con- junction with a fixed-site program offering naltrexone. Derivative of naloxone and the counseling and other psychosocial services. only opioid antagonist approved for use alone in long-term treatment of people with multiple substance abuse. Concurrent opioid addiction. Naltrexone is used pri- opioid and other substance useóa serious marily after medically supervised with- problem in OTPs. Other substances com- drawal from opioids to prevent drug monly used by people addicted to opioids relapse in selected, well-motivated patients. include alcohol, amphetamines, benzodi- azepines (particularly alprazolam and narcotic. See opioid (preferred usage). diazepam), other prescription sedatives, not-in-my-backyard (NIMBY) syn- cocaine, marijuana, and nicotine. Patterns drome. Informal name used to label of use range from periodic low doses to reg- opposition to the placement of OTPs in ular high doses that also can meet criteria communities. for addiction. Some drugsóin particular, high-dose barbituratesóused in

Glossary 289 -O- opioid agonist. Drug that has an affinity for and stimulates physiologic activity at cell office-based opioid treatment (OBOT). receptors in the central nervous system MAT provided in a physicianís office or normally stimulated by opioids. Methadone health care setting other than an OTP (42 and LAAM are opioid agonists. CFR, Part 8 ß 11(i)(1)). See medication unit. opioid antagonist. Drug that binds to cell receptors in the central nervous system opiate receptors. Areas on cell surfaces in that normally are bound by opioid psy- the central nervous system that are activat- choactive substances and that blocks the ed by opioid molecules to produce the activity of opioids at these receptors with- effects associated with opioid use, such as out producing the physiologic activity pro- euphoria and analgesia. Opiate receptors duced by opioid agonists. Naltrexone is an are activated or blocked by opioid agonist opioid antagonist. or antagonist medications, respectively, to mediate the effects of opioids on the body. opioid partial agonist. Drug that binds to, Mu and kappa opiate receptor groups prin- but incompletely activates, opiate receptors cipally are involved in this activity. in the central nervous system, producing effects similar to those of a full opioid ago- opioid. Natural derivative of opium or syn- nist but, at increasing doses, does not pro- thetic psychoactive substance that has duce as great an agonist effect as do effects similar to morphine or is capable of increased doses of a full agonist. conversion into a drug having such effects. Buprenorphine is a partial opioid agonist. One effect of opioid drugs is their addiction-forming or addiction-sustaining opioid treatment program (OTP). liability. SAMHSA-certified program, usually com- prising a facility, staff, administration, opioid addiction. Cluster of cognitive, patients, and services, that engages in behavioral, and physiological symptoms supervised assessment and treatment, using resulting from continuation of opioid use methadone, buprenorphine, LAAM, or nal- despite significant related problems. Opioid trexone, of individuals who are addicted to addiction is characterized by repeated self- opioids. An OTP can exist in a number of administration that usually results in settings, including, but not limited to, opioid tolerance, withdrawal symptoms, intensive outpatient, residential, and hospi- and compulsive drug taking. tal settings. Services may include medically opioid addiction treatment. Dispensing supervised withdrawal and/or maintenance of approved medication to prevent with- treatment, along with various levels of drawal and craving during the elimination medical, psychiatric, psychosocial, and of opioid use by a patient in MAT, with or other types of supportive care. without a comprehensive range of medical oral-fluid drug testing. Method of identify- and rehabilitation services or medication ing evidence of opioid and other psychoac- prescribed when necessary to alleviate the tive substance use and measuring the levels adverse medical, psychological, or physical of substances or medications in the body by effects. This term encompasses medically examining patient saliva for the presence supervised withdrawal, maintenance treat- and concentrations of identifiable drugs ment, comprehensive maintenance treat- and their metabolites. Oral-fluid testing ment, and, under restricted timeframes, must be approved for drug testing by the interim maintenance treatment (adapted OTP medical director for patient and pro- from 42 CFR, Part 8 ß 2). gram needs.

290 Appendix C orientation. See patient orientation. be involved actively in their own treatment and have rights in its planning and imple- outcome-based evaluation. Measurement mentation (i.e., advocacy by patients). of program effectiveness based on patient Much of advocacy is about shifting the sys- response to treatment, such as measures of tem from the directive model to one in reduction in opioid and nonopioid drug use which the patient is an empowered, and improvement in social function. An involved participant in treatment decisions. outcome-based evaluation system requires This fits with the growing emphasis on indi- that the measures and instruments that are vidualized treatment. used reflect a consensus of the field, pro- vide incentives to programs to submit data, patient exception. Special permission and include ways to validate and aggregate requested from and decided by SAMHSA clinic-level data for national and regional for a substance abuse treatment program to evaluation purposes. Compare process- dispense or arrange for the offsite delivery based evaluation. of maintenance medication to a patient in an emergency or hardship situation when outpatient psychosocial program. In the patient does not meet regulatory this TIP, an approach to MAT that may requirements for such services. Patient involve the use of opioid addiction treat- exceptions are requested on SAMHSA form ment medication for medically supervised SMA-168. In most States, patient excep- withdrawal but not for ongoing mainte- tions are contingent on the approval of the nance pharmacotherapy. Counseling and appropriate State Methadone Authority. other psychosocial interventions are the primary features of outpatient psychosocial patient handbook. Document provided to a treatment programs. patient in an OTP that contains the infor- mation he or she should know to under- Æ OxyContin . Long-acting class II opioid drug stand MAT, program offerings, program usually obtained by prescription for treat- structure, and patient limits and privileges, ment of pain. OxyContin is one of several as well as rights and responsibilities of prescription opioids increasingly obtained patients and treatment providers. by illicit means and abused by people addicted to opioids. patient matching. See patientñtreatment matching. -P- patient motivation for change. Relative pain management. Treatment of acute or readiness to modify oneís lifestyle and the chronic pain by various treatment meth- sincerity and purposefulness of a patient in ods, often including administration of opi- an OTP toward achieving the goals of MAT. oid medications. patient orientation. Planned introduction patient. Any individual undergoing MAT in to the structure, services, offerings, and an opioid treatment program (42 CFR, methods used in an OTP and to patientsí Part 8 ß 2). and treatment providersí rights and patient advocacy. Term applied to two lev- responsibilities within the program. els of activity in addiction treatment: (1) a patient referral. Alternative to providing all social or political movement working for necessary treatment services and levels of changes in legislation, policy, and funding care at the program site by collaboratively to reflect patient concerns and protect their outsourcing some services to other settings rights (i.e., advocacy for patients) and (2) a and providers. When a patient must obtain philosophy of substance abuse treatment comprehensive services in multiple settings, practice maintaining that patients should

Glossary 291 treatment program staff members should psychotherapy. Treatment service provided arrange the referrals, monitor patient to patients in a comprehensive opioid treat- progress, and coordinate care. ment program, either directly or by refer- ral, in which a trained therapist evaluates patientñtreatment matching. Process of and treats patients for diagnosed psychi- individualizing therapeutic resources to atric problems. Compare counseling. patient needs and preferences, ideally by a participatory process involving both the -R- treatment provider and patient. Because many people addicted to opioids have mul- readmission. Reenrollment of a patient who tiple needs, effective patientñtreatment previously left an opioid treatment pro- matching in an OTP is a three-step process: gram. Readmission usually is preceded by a (1) assessing, (2) selecting the most suitable review of the patientís records to determine treatment modality and site, and (3) identi- whether and how the individualís treatment fying the most appropriate services. plan should be modified. pharmacology. Science that addresses the referral. See patient referral. origin, nature, chemistry, effects, and uses rehabilitative phase. Phase of MAT in of medications and drugs. which patients who are stabilized on opioid pharmacotherapy. Treatment of disease treatment medication continue to eliminate with prescribed medications. addictive substances from their lives while gaining control of other major life domains preliminary assessment. Basic assessment (e.g., medical problems, co-occurring dis- occurring before admission to a treatment orders, vocational and educational needs, program, in which an individualís eligibility family circumstances, legal issues). for entry and level of any psychosocial crisis are determined. relapse. Breakdown or setback in a personís attempt to change or modify a particular prevalence. Number of cases of a disease in a behavior; an unfolding process in which the population, either at a point in time (point resumption of compulsive substance use is prevalence) or over a period (period the last event in a series of maladaptive prevalence). Prevalence rate is the fraction responses to internal or external stressors of people in a population who have a or stimuli. disease or condition at one time (the numerator of the rate is the number of remission. State in which a mental or physi- existing cases of the condition at a specified cal disorder has been overcome or a disease time and the denominator is the total process halted. population). residential treatment. Therapy received process-based evaluation. Evaluation of within the context of a cooperative living program effectiveness based on compliance arrangement. Residential treatment pro- with procedural standards. Compare grams vary in duration and intensity of outcome-based evaluation. services and general philosophy. psychiatric comorbidity. See co-occurring retention in treatment. Period during disorder. which a patient is able and willing to remain in therapy, which is influenced by a . A substance that affects combination of patient and program char- the mind, thoughts, feelings, and sometimes acteristics. Retention in treatment should behaviors. be considered the product of a continuing

292 Appendix C therapeutic relationship between recover- are opioid addicted, including all levels of ing patients and their treatment providers. care and phases of treatment. Compare hospital-based treatment. -S- State Authority. Agency (sometimes saliva testing. See oral-fluid drug testing. referred to as a ìSingle State Agencyî) des- screening. Process of determining whether a ignated by the governor or another official prospective patient has a substance use dis- assigned by the governor to exercise the order before admission to treatment. responsibility and authority within a State Screening usually involves use of one or or territory for governing the treatment of more standardized techniques, most of addiction to opioid drugs (adapted from 42 which include a questionnaire or a struc- CFR, Part 8 ß 2). tured interview. Screening also may include stigma. Negative association attached to an observation of known presenting com- activity or condition; a cause of shame or plaints and symptoms that are indicators of . Stigma commonly is associ- substance use disorders. ated with opioid addiction and MAT.

sedative. Medication with central nervous stimulant. Agent, drug, or medication that system sedating and tranquilizing proper- produces stimulation. In this TIP, stimu- ties. An example is any of the benzodi- lant usually refers to drugs that stimulate azepines. Most sedatives also promote the central nervous system (e.g., sleep. Overdoses of sedatives can lead to amphetamines, cocaine). dangerous respiratory depression (slowed breathing). substance addiction. See opioid addiction.

self-help program. See mutual-help substance dependence. See dependence. program. substance use disorder (frequently self-medication. Medically unsanctioned use referred to as substance abuse or of drugs by a person to relieve any of a dependence). Maladaptive pattern of variety of problems (e.g., pain, drug or alcohol use manifested by recur- depression). rent, significant adverse consequences related to the repeated use of these drugs serum half-life. Time required for the or alcohol. The substance-related problem amount of a compound (e.g., an opioid) in must have persisted and occurred repeat- blood serum to be halved through edly during a 12-month period. It can metabolism or excretion. occur sporadically and mainly be associat- side effect. Consequence (especially an ed with social or interpersonal problems, adverse result) other than that for which a or it can occur regularly and be associated drug is usedóespecially the result pro- with medical and mental problems, often duced on a tissue or organ system other including tolerance and withdrawal. than that being targeted. supportive-care phase. Phase of MAT in stabilization (stability). Process of provid- which patients maintain abstinence from ing immediate assistance (as with an opioid substances and continue on maintenance agonist) to eliminate withdrawal symptoms medication while receiving other types of and drug craving. intervention as needed to resume primary responsibility for other aspects of their stand-alone clinic. Facility that generally lives. offers a comprehensive range of medication and psychosocial services for patients who

Glossary 293 -T- treatment barrier. Anything that hinders treatment. Examples include financial take-home medication. Opioid addiction problems, language difficulties, ethnic and treatment medication dispensed to patients social attitudes, logistics (caring for chil- for unsupervised self-administration. dren, transportation), and unhelpful tapering phase. Phase of MAT in which patient behaviors (tardiness, missed patients receiving medication maintenance appointments). attempt gradually to eliminate their treat- treatment efficacy. Ability of an interven- ment medication (e.g., methadone) while tion or medication in expert hands and remaining abstinent from illicit substances. under ideal circumstances to produce the therapeutic alliance. Joining of patients desired therapeutic effect. and their treatment providers in an effec- treatment eligibility. Relative qualification tive collaboration to assess and treat of a prospective patient for admission to an patientsí substance use disorders. OTP according to Federal, State, or third- therapeutic community (TC). Consciously party payer requirements. In general, designed social environment or residential Federal guidelines are minimum require- treatment setting in which social and group ments and restrict admission to individuals processes are harnessed with treatment who have been demonstrably dependent on intent. A TC promotes abstinence from opioids for 1 year; however, certain high- substance use and seeks to decrease antiso- risk populations including pregnant women cial behavior and effect a global change in are admitted more quickly. lifestyle, including attitudes and values. A treatment intensity. Frequency and meth- TC views substance abuse as a disorder of ods for delivery of therapeutic services. the whole person, reflecting problems in OTPs aim to establish levels of treatment conduct, attitudes, moods, values, and intensity that match patientsí needs. emotional management. Treatment focuses on drug abstinence, coupled with social and treatment outcomes. Observable results of psychological change requiring a multidi- therapy, including decreased use of illicit mensional effort along with intensive mutu- psychoactive substances, improved physical al help and support. and emotional health, decreased antisocial activities, and improved social functioning; therapeutic dosage. Combination of considered the best indicator of treatment amount of medication and frequency and program effectiveness. timing of administration that is determined by laboratory analysis, professional obser- treatment plan. Documented therapeutic vation, or patient self-report to be benefi- approach for each patient that outlines cial to control and ameliorate symptoms of attainable short-term goals mutually withdrawal from addiction and drug- acceptable to the patient and the OTP and seeking behavior. Therapeutic dosage levels that specifies the services to be provided should be determined by what each patient and their frequency and schedule (adapted needs to remain stable. from 42 CFR, Part 8 ß 2). tolerance. Condition of needing increased treatment retention. See retention in amounts of an opioid to achieve intoxica- treatment. tion or a desired effect; condition in which continued use of the same amount of a sub- 12-Step program. Self-help program requir- stance has a markedly diminished effect. ing mastery of a set of steps to achieve and maintain abstinence, based on the program

294 Appendix C of Alcoholics Anonymous. Many addiction among the patient, program physician, and treatment programs use a 12-Step structure treatment providers. or philosophy as a construct for treatment design. -W- -U- withdrawal. Reduction and elimination of substance use. See medically supervised urine drug testing. Most common laborato- withdrawal, withdrawal syndrome. ry assessment technique in addiction treat- ment, which involves analysis of urine sam- withdrawal syndrome (or withdrawal). ples from patients for the presence or Predictable constellation of signs and absence of specific drugs. Originally used symptoms after abrupt discontinuation of as a measure of program effectiveness, or rapid decrease in use of a substance that urine testing now is used to make program- has been used consistently for a period. matic decisions, monitor psychoactive sub- Signs and symptoms of withdrawal are usu- stance use, adjust medication dosage, and ally opposite to the direct pharmacological decide whether a patient is responsible effects of a psychoactive substance. enough to receive take-home medication. Methods of urine testing vary widely. -V-

voluntary discharge. Departure from an OTP that is initiated by the patient. Tapering from medication is negotiated

Glossary 295

Appendix D: Ethical Considerations in MAT

Medication-assisted treatment for opioid addiction (MAT) is firmly rooted in medical treatment models. Treatment decisions by MAT providers should be based on four accepted principles of medical ethics, which can be listed briefly as beneficence, autonomy, nonmalfeasance, and justice (Beauchamp and Childress 2001).

Fundamental Ethical Principles

Beneficence (Benefit) According to Beauchamp and Childress (2001), the medical principle of beneficence emphasizes that treatment providers should act for the benefit of patients by providing competent, timely care within the bounds of accepted treatment practice. The principle of beneficence is satisfied when treatment providers make proper diagnoses and offer evidence-based treatments, that is, treatments drawn from research that provides statistical data about outcomes or from consensus-based stan- dards of care. Beneficence is compromised when diagnoses are question- able or when outcome data do not validate a diagnosis or treatment. When MAT is carried out according to best-practice standards, the principle of beneficence is satisfied (Bell and Zador 2000).

Autonomy Autonomy, like beneficence, springs from the ideal of promoting patientsí best interests. However, whereas beneficence emphasizes the application of provider knowledge and skills to improve patient health, autonomy emphasizes respect for patientsí rights to decide what treat- ment is in their best interests (Beauchamp and Childress 2001).

Standard medical practice places great value on patient autonomy. Usually, patientsí and physiciansí goals for treatment are identical, but, when they differ, physicians generally accord patients the right to make

297 their own choices and accept the fact that Justice patientsí values may differ from physiciansí The principle of justice emphasizes that treat- values. For example, a physician might focus ment providers should act with fairness on extending a patientís life, whereas the (Beauchamp and Childress 2001). Sometimes patient might be more concerned with the this principle is expressed as the duty of quality of that life. providers to treat patients in similar circum- Exceptions to the principle of autonomy in stances equally and to use resources equitably. standard medical practice are limited to cir- When treatment resources are limited, it may cumstances in which patientsí decisions might be unclear how to apply this principle in MAT. endanger themselves or others or in which The principle of justice also applies when treat- patients may lack the capacity (because of ment providers consider the involuntary dis- physical or mental impairment) to make ratio- charge of patients. nal choices. Normally, standard medical prac- Besides emphasizing that clinicians should act tice does not permit an exception when patients fairly toward patients, the principle of justice make the ìwrongî choice and the physician imposes a responsibility to advocate politically ìknows better.î The physician may educate or and socially for resources (including adequate perhaps attempt to persuade a patient but may funding and better treatment by other medical not make decisions for the patient. providers) to meet the needs of patients in MAT.

NonmalfeasanceóìFirst, Do No Harm î Ethics in Practice The principle of nonmalfeasance emphasizes Conflict Between Beneficence that health care providers should not harm or injure patients (Beauchamp and Childress and Autonomy 2001). Opioid treatment programs (OTPs) are A conflict arises between the principles of on strong footing in terms of this principle. beneficence and autonomy when a treatment Before entering MAT, patients have been provider and a patient disagree about what is ingesting illicit opioids (and often other sub- in the patientís best interest and how treatment stances) and exposing themselves to serious should progress. Exhibit D-1 describes such a health risks. Patients entering MAT are also at clash in which a provider believes that stopping risk of arrest and imprisonment for illegal all illicit drug use is feasible and in the patientís activities to support their addictions. best interest but the patient disagrees or cannot comply. One or both of the following questions Once enrolled in OTPs, patients begin ingesting express the source of controversy: medications that have been manufactured in a regulated setting. The risks associated with ï What is the proper balance between respect injecting or otherwise ingesting substances of for a patientís autonomy and a providerís abuse produced under unknown conditions are responsibility for that patientís health? gradually eliminated. Patients come under the ï Should the patient or the clinician decide care of professionals who monitor adverse drug what is in a patientís best interests? reactions and attend to other health care needs. However, MAT carries risks of its own, includ- Patients in MAT who stop their opioid abuse ing an increased risk of death in the induction but not their abuse of other substances (i.e., phase of pharmacotherapy if medication dosage ìnoncompliantî or ìnonrespondingî patients) is not adjusted carefully (see chapter 5). are a major research focus. The literature is replete with studies of strategies, such as con- tingency contracting (see chapter 8), that use patientsí dependence on their treatment

298 Appendix D Exhibit D-1

Case Example

R.S., a 35-year-old man who has been in MAT for 18 months, is in his second MAT episode. The first ended when he was arrested and imprisoned for armed robbery. R.S. has not missed medication appointments but is less attentive to counseling sessions. He regularly uses alcohol and marijuana and occasionally cocaine. R.S. is unwilling to stop using alcohol and drugs. His position is that he has stopped his use of illicit opioids entirely, which was his goal entering treat- ment. His other drug use is his choice, and the clinic should ìget off his back.î

medication to compel their compliance with upper hand. Patients who refuse to comply treatment-related mandates. These strategies with provider views of what is in their best ìare based on the assumption that patients interests risk administrative discharge or other have the necessary skills to produce drug-free sanctions. Until recently, only an OTP could urine samples but often lack sufficient motiva- provide patients with medication, ensuring the tionî (Iguchi et al. 1996, p. 315). Examples of OTPís hold over patients. Often no other facili- mandates enforced by contingency contracting ty exists from which to obtain MAT. include adoption of and adherence to a drug- free lifestyle (Iguchi et al. 1997), attendance at Why do treatment providers in OTPs lean additional therapy-related sessions (with or toward the principle of beneficence and away without a significant other) (Iguchi et al. 1996; from the principle of autonomy in their Kidorf et al. 1997), and performance of approach to patients? The following factors employment-related tasks (Kidorf et al. 1998). may apply: Training in substance abuse treatment provides ï A longstanding, complex regulatory system treatment providers with an awareness and that favors a rule-governed perspective in understanding of patientsí tendencies toward OTPs denial, minimization, and rationalization of their substance use. A working familiarity with ï Belief that patients in denial cannot act in such studies provides treatment providers with their best interests a reasonable basis to choose beneficence over ï Disagreement about goals between patients autonomy when they conclude that they know and treatment providers better than patients what is in patientsí best ï Attention to community concerns interest. ï Effects of noncompliant patients on staff, The conflict between beneficence and autonomy patients in compliance, and new patients is not unique to MAT, but it is especially acute ï Discomfort with the disease model (see below) in MAT because of the fundamental power ï View of patients in MAT as failures imbalance between treatment providers and patients. Patients in OTPs depend on their ï Limited research examining the precept medication and may fear the effects of with- that complete abstinence is in patientsí best drawal from it. That dependence gives interests. providers (and the principle of beneficence) the

Ethical Considerations in MAT 299 Clinicians Who Are Uneasy should be supported as they reduce their sub- With the Disease Model stance use. MAT providers generally embrace the concept Research suggests that many patients are aware of addiction as a chronic relapsing disease; that they may relinquish their autonomy when however, unlike medical professionals treating they enter MAT. A study about the attitudes other chronic illnesses, some providers appear of patients receiving methadone found that uncomfortable with the idea of alleviation of many see OTPs as institutions that control symptoms without cure (Hunt and Rosenbaum and punish more than they helpóOTPs are 1998, p. 202). These providers might draw on agents of conventional society (Hunt and lessons from physicians caring for patients with Rosenbaum 1998). other chronic diseases. How do they deal with In the opinion of Bell (2000, p. 1741), ìPatients noncompliant patients who fail to alter their need protection because many are reluctant to diets or lifestyles, for example? Based on the complain because they have a sense of power- disease model underlying comprehensive main- lessness and do not want to jeopardize their tenance treatment, total abstinence may be treatment.î Providers at OTPs should be unrealistic in the short run for some patients. aware of any bias toward the principle of When OTPs refuse to recognize that immediate beneficence and away from the principle of abstinence is unrealistic and punish patients for autonomy. Rather than assuming that the tilt the continuing but reduced presence of symp- toward beneficence is always correct, treatment toms, they are not defining addiction as a dis- providers and administrators should ask them- ease. The long-term goal is always reducing or selves in each case whether they are striking eliminating the use of illicit opioids and other a proper balance between these two fundamen- illicit drugs and the problematic use of pre- tal principles. scription drugs; but, in the short run, patients

Some Patientsí Perspectives

ì[C]lients often felt that the relationship between themselves and their coun- selors was less focused on therapy than power; less about psychological growth, getting help and a sense of well-being than about social control, conforming to rules and regulations, and punishment.î (Hunt and Rosenbaum 1998, p. 209)

ì[Study participants] were also aware and fearful that having once adopted the culture of the clinic they would become dependent on it, and more significantly on the goodwill of individual counselors. This dependence was particularly troubling to them because of the increasing insecurity of subsidized slots. Many users expressed concern about once having entered the system and accepting its lifestyle with little or no warning they would be ejected from it. . . . [M]any study participants felt, precisely because of the asymmetrical relationship between the client and the clinic, the staff used this as a way of exacting compli- ance.î (Hunt and Rosenbaum 1998, pp. 200ñ201)

300 Appendix D Other Conflicts Among the Failure to pay Four Principles of Medical Involuntary discharge for failure to pay treat- Ethics ment fees presents a more difficult ethical issue involving the limited financial resources of Involuntary discharge many patients and the uneven public funding of MAT. Patients discharged for inability to pay An OTPís decision to discharge a patient or because their OTPs have lost funding might against his or her wishes calls into question all have been doing well, and terminating treat- four ethical principles. Involuntary discharge ment, in most cases, will halt their recovery or appears to breach practitionersí duties to put precipitate relapse (Knight et al. 1996a). patient health first, do no harm, and respect Although involuntary discharge for failure to patientsí wishes, as well as to avoid harm to the pay fees appears to violate the principles of community from reintroducing the effects of autonomy, beneficence, and nonmalfeasance, untreated opioid use (especially criminal the unfortunate reality is that OTPs must oper- behavior and potential disease transmission). ate within fiscal constraints. If OTPs continue Yet an OTP often must balance the interests of to deliver uncompensated care, they may face individuals facing discharge with those of other financial ruinóa consequence that would jeop- patients, staff, future patients, and the larger ardize treatment for all patients (including community and society. those who continue to pay). Nonetheless, OTPs considering patient discharge for nonpayment Threats to safety should address the principle of nonmalfea- When a patient commits or threatens an act of sance, at least in part, by mitigating harm to violence against another patient (on OTP patients, for example, by working out payment premises) or against staff (on or off OTP schedules, assisting with access to insurance or premises), comes to treatment armed with a other funding sources, or facilitating transfer to weapon, or deals drugs at or near an OTP, that lower cost facilities. In 2003, the American patient poses a threat to the safety of the pro- Association for the Treatment of Opioid gram, its staff, and its patients. Involuntary Dependence (AATOD) released new recommen- discharge of such a patient, although not in his dations addressing involuntary withdrawal or her best interests, takes into account the from treatment for nonpayment of fees OTPís ethical responsibility to the rest of its (www.dmhas.state.ct.us/opioid/ patients (current and future), its staff, and oth- withdrawal.htm). ers. The consensus panel believes that patient behavior threatening the safety of patients and Failure to respond staff or the status of the program in the com- Another difficult ethical issue occurs when an munity is grounds for patient discharge. OTP OTP proposes to discharge a patient involun- administrators may need to make difficult judg- tarily for failure to respond to treatment. No ments about what constitutes threatening matter which principle the OTP follows, it will behavior (especially in light of deficits in inter- fail to uphold anotheróperhaps even the very personal skills and possible untreated co- principle it is seeking to uphold. An OTP has at occurring disorders) and evidence of drug deal- least two choices, and all four ethical principles ing. But an OTPís responsibility to provide are implicated. good treatment for its other patientsóindeed, its responsibility to remain a viable resource in ï To discharge. When an OTP discharges a the communityórequires that these limits be noncompliant patient, it risks violating the set and enforced. principle of beneficence because discharge might lead to a poorer health outcome for

Ethical Considerations in MAT 301 that patient and perhaps repercussions for require that all four ethical principles be the community. Indeed, because research has weighed. Patients are usually interested in shown that discharge from MAT leads to poor increasing their autonomy and ability to carry outcomes, by pursuing the principle of benef- out normal daily activities by reducing visits to icence to its logical conclusion of involuntary their OTP for medication, but the medical discharge, the OTP may be putting a director must consider what is safest for patientís health at greater risk. The OTP patients. Take-home medication privileges may be violating the principle of nonmal- might benefit a patient by reducing his or her feasance as well, especially if it is unaware exposure to an OTPís less stable patients and of the possible consequences of involuntary making it easier for the patient to lead a normal discharge. life, by providing an incentive to further Involuntary discharge of noncompliant enhance recovery, and by expressing a pro- patients often occurs when OTPs have wait- gramís confidence in the patientís progress. ing lists. When limited slots existóbecause of However, increased take-home privileges may the limits of public sector funding or regula- pose a risk to a patient of overmedication and tory caps on slotsóand applicants are wait- lethal use and to people in the community of ing for treatment, pressure mounts to dis- drug diversion or accidental life-threatening charge patients who are not fully compliant ingestion by intolerant individuals (e.g., chil- with treatment regimens. Concerns about the dren). Federal regulations governing OTPs fairness of continuing to treat a patient who is require that a medical director deciding unwilling or unable to take full advantage of whether to allow or increase patient take-home treatment appeal to the principle of justice. privileges consult the principle of nonmalfea- sance by considering the risk of harm to ï Not to discharge. Arguably, when treatment patients or others (42 Code of Federal providers do not discharge noncompliant Regulations, Part 8 ß 12(i)(2)). patients but continue treating them, they risk violating the principle of beneficence because The longstanding concern with methadone they are not providing care they believe will diversion also is rooted in the principle of promote patient health. By ignoring the effect justice. OTPs are under considerable public noncompliant patients have on the therapeu- scrutiny. If an OTP gives take-home privileges tic milieu for other patients, providers are to irresponsible patients and those patients, violating the principle of beneficence for those their family members, or others in the commu- other patients. Treatment providers who con- nity are harmed, the OTPís operations may be tinue to treat noncompliant patients also vio- restricted or the OTP might be shut down. late the principle of justice by denying treat- When an OTP closes its doors, its responsible ment to potential patients on the waiting list. patientsóand the staff and ultimately the OTPs should decide how to respond to communityósuffer. Therefore, it is important treatment noncompliance based on factors to consider a patientís behavior carefullyónot and principles discussed above and patientsí just the time in treatmentóbefore allowing specific circumstances. No single decision is take-home medication. correct in all cases. The OTP has an ethical responsibility to consider these principles A word about due process and the effect of discharge on patients and The decision to discharge a patient involuntari- the program. ly or adjust take-home privileges might require Take-home privileges that a treatment provider or administrator resolve factual disputes or differences in inter- The decisions a medical director makes about pretation between a staff member and a patient take-home privileges, although not as stark as or between two patients. It is important that an those related to involuntary termination, also OTP provide a forum so that patients can

302 Appendix D receive a fair hearing on their versions of dis- principles in mind, familiarizing themselves puted events, including a review of the evidence with the ethical standards of their profession, and proposed sanctions. Some States require and discussing potential conflicts with patients additional due-process procedures. and other staff members. The goal always is reducing or eliminating the use of illicit opioids and other illicit drugs and the problematic use Ethics: Conclusion of prescription drugs. Exhibit D-2 presents the OTP staff members can avoid or minimize canon of ethics adopted by AATOD. Exhibit D- some ethical dilemmas by remaining aware of 3 provides Internet links to the ethical guide- sources of potential conflict, keeping ethical lines of other treatment-centered organizations.

Exhibit D-2

AATOD Canon of Ethics

ï Ensure that patients are treated with compassion, respect, and dignity regardless of race, creed, age, sex, handicaps, or sexual orientation. ï Retain competent and responsible personnel who adhere to a strict code of ethics, including but not limited to prohibiting of fraternization with patients, exploitation of patients, and criminal behavior. ï Subscribe to the treatment principles published in TIP 43, Medication- Assisted Treatment for Opioid Addiction in Opioid Treatment Programs, which serves as a resource in making therapeutic decisions. ï Provide patients with accurate and complete information regarding methadone treatment, the nature of available services, and the availability of alternative treatment modalities before admission and throughout the treat- ment process. ï Ensure that discharge from treatment is conducted in accordance with sound and medically acceptable practice. The patient is assured of due process if the discharge is administrative in nature. ï Provide a safe and clean environment for patients and staff that is conducive to the therapeutic process. ï Remain in compliance with the required Federal, State, and local operating standards. ï Take all necessary and appropriate measures to maintain individual patient records and information in a confidential and professional manner. ï Strive to maintain good relations with the surrounding community, and pur- sue every reasonable action to encourage responsible patient behavior and community safety.

Ethical Considerations in MAT 303 Exhibit D-3

Ethical Codes of Selected Treatment-Oriented Organizations and Their Web Sites

American Medical Association’s Code of Ethics www.ama-assn.org/ama/pub/category/8600.html American Nurses Association’s Code of Ethics nursingworld.org/ethics/chcode.htm American Psychological Association’s Code of Ethics www.apa.org/ethics Mental Health Counselors’ Code of Ethics www.counseling.org National Association of Alcohol and Drug Abuse Counselors’ Code of Ethics www.naadac.org National Association of Social Workers’ Code of Ethics www.socialworkers.org/pubs/code/code.asp Public Policy of the American Society of Addiction Medicine, Principles of Medical Ethics www.asam.org/ppol/Principles%20of%20Medical%20Ethics.htm

304 Appendix D Appendix E: Resource Panel

Nancy Bateman, LCSW-C, CAC Fred C. Cristofuri, M.D. Senior Staff Associate Medical Director Behavioral Health Care We Care Methadone Clinic National Association of Social Workers Laurel, Maryland Washington, D.C. James Dorsey, M.D. Shirley Beckett Medical Director Certification Administrator Adult Addiction Services National Association of Alcoholism & Anne Arundel County Department Drug Abuse Counselors of Health Alexandria, Virginia Annapolis, Maryland

Brent Bowman Joel A. Egertson Clinical Director Drug Policy Advisor Metwork Health Services, Inc. U.S. Department of Health and Human Eldersburg, Maryland Services Washington, D.C. Kurt Brandt, M.D. Medical Supervisor Irene Gainer Alexandria Substance Abuse Services Executive Director Alexandria, Virginia National TASC Washington, D.C. Carol Butler Program Director Janis Gold R.E.A.C.H. Mobile Health Services Director Baltimore, Maryland Outpatient Services Alexandria Mental Health, Mental James F. Callahan, D.P.A. Retardation, and Substance Abuse Executive Vice President Services American Society of Addiction Medicine Alexandria, Virginia Chevy Chase, Maryland Janice Ford Griffin Cynthia Cohen, R.N., CS-P Deputy Director Clinical Coordinator Join Together Addiction & Mental Health Center Boston University SPH Montgomery General Hospital Boston, Massachusetts Olney, Maryland

305 Michael G. Hayes, M.D. James J. Manlandro, D.O., FAOAA Center for Addiction Medicine American Osteopathic Academy for Baltimore, Maryland Addiction Medicine Somerspoint, New Jersey Vladimire Herard Editor David Monosson Substance Abuse Funding News N.A.M.A. Washington Chapter Silver Spring, Maryland N.A.M.A./W.A.M.A. Washington, D.C. James G. Hill Director Dennis Scurry, Jr., M.D. Office of Substance Abuse Chief Medical Officer American Psychological Association D.C. Department of Health Washington, D.C. Addiction Prevention and Recovery Administration Hendree Jones, Ph.D. Washington, D.C. Assistant Professor of Psychiatry/ Director of Cornerstone/Research Suzan Swanton, LCSW-C Director of Center for Clinical Director Addiction & Pregnancy Analyze Research, Inc. Johns Hopkins University Baltimore, Maryland Baltimore, Maryland Susan Tatum Jennifer Kasten Therapist Supervisor Policy Analyst MHMRSA/SAóCity of Alexandria Research Triangle Institute Alexandria, Virginia Research Triangle Park, North Carolina Annie Umbricht, M.D. Chris Kelly, M.P.H., M.P.A. Medical Director Advocates for Recovery Through Medicine SHARP Washington, D.C. Baltimore, Maryland

Joseph G. Liberto, M.D. Diane Wood, LPN Clinical Manager LPN/Nursing Supervisor Substance Abuse Treatment Program Metwork Health Services, Inc. VA Maryland Health Care System Eldersburg, Maryland American Academy of Addiction Psychiatry Baltimore, Maryland

306 Appendix E Appendix F: Field Reviewers

Cynthia E. Aiken Doug Baker, M.S., CCAS Executive Director/Clinical Consultant North Carolina State Opioid Treatment Narcotic Drug Treatment Center, Inc. Authority Anchorage, Alaska North Carolina Division of Mental Health, Developmental Disabilities, and Janet Aiyeku, M.P.A., CASAC Substance Abuse Services Associate Director Raleigh, North Carolina Kings County Hospital Center Brooklyn, New York Cynthia Banfield-Weir, LICSW, BCD Clinical Director Norma E. Alexander, CMA Community Substance Abuse Center Board of Directors Chicopee, Massachusetts Dora Weiner Foundation Staten Island, New York Mac R. Bell SAN-Administrator Marsha Althoff Kentucky Division of Substance Abuse Nursing Supervisor Services Operation PAR Frankfort, Kentucky Clearwater, Florida Bert Bennett, Ph.D. John J. Appeldorn, CAC, LPC, NCC, MAC Best Practice Team Director of Social Services North Carolina Division of Mental Health, Tadiso, Inc. Developmental Disabilities, and Pittsburgh, Pennsylvania Substance Abuse Services Raleigh, North Carolina G. Dean Austin, M.A. Bureau Chief Richard Bilangi, M.S. Bureau of Substance Abuse Services and Executive Director Licensure Connecticut Counseling Centers, Inc. Iowa Department of Public Health Middlebury, Connecticut Des Moines, Iowa Dona C. Blair, R.N., CHCQM Administrator The Life Center of Galax Galax, Virginia

307 Gary Blanchard, M.A., CAC-AD Matthew Cassidy Director Director of Administration Center for Positive Path Recovery Mount Sinai Medical Centerís Narcotics Crownsville, Maryland Rehabilitation Center New York, New York Cynthia H. Bolger, R.Ph., FASCP Pharmacist Consultant Patricia A. Champ, LMHC, LADC Richmond, Virginia Clinical Director Habit Management Incorporated Jean J.E. Bonhomme, M.D., M.P.H. South Yarmouth, Massachusetts Medical Director Alliance Recovery Center Steven J. Chen, Ph.D. Decatur, Georgia Assistant Director Division of Substance Abuse and Susan Mayo Bosarge Mental Health State Methadone Authority Department of Human Services Behavioral Health Services Division Salt Lake City, Utah New Mexico Department of Health Santa Fe, New Mexico George K. Clarke Director Daniel Brown Southeastern CT Advocates for Recovery President Through Medicine Brown Consulting, Ltd. New London, Connecticut Toledo, Ohio Peter Coleman, M.S., CASAC Marylee Burns, M.Ed., M.A., CRC Senior Director, Substance Abuse Assistant Director NYC Health and Hospitals Corporation Office of Behavioral Health New York, New York NYC Health and Hospitals Corporation New York, New York Carol Colleran, CAP, ICADC National Director Denise Calcagnino, CSW, CASAC, ADS Older Adult Services Program Supervisor Hazelden Foundation Methadone Maintenance Treatment West Palm Beach, Florida Program Crouse Hospital, Inc. James P. Connolly, CMA Syracuse, New York Regional Director PA-NAMA Donald Calsyn, Ph.D. Newtown, Pennsylvania Psychologist/Director of Outpatient Services Addiction Treatment Center Glen J. Cooper, M.A. Veterans Affairs Puget Sound Health Care President System Pennsylvania Association of Methadone Seattle, Washington Providers Allentown, Pennsylvania James C. Carleton, M.S. Director of Opioid Treatment Services CODAC Behavioral Health Cranston, Rhode Island

308 Appendix F Nancy L. Culver, R.N., CD Mairead Desmond, M.A. Head Nurse/Unit Manager Program Director Methadone Program New Directions Treatment Services Kent County Counseling Services West Reading, Pennsylvania Dover, Delaware Kay M. Doughty Eugenia Curet, M.S.W. Director Administrative Director Family Centered Substance Abuse Services Adult Services Clinic Drug Abuse Comprehensive Coordinating Cornell Medical College Office, Inc. Department of Public Health Tampa, Florida New York, New York Sharon R. Dow, M.S. Julie DíAscenzo Project Director Community Education Coordinator Joint Commission on Accreditation of PA-NAMA Healthcare Organizations Philadelphia, Pennsylvania Washington, D.C.

Joy Davidoff, M.P.A. Marilyn Dubin, R.N. Coordinator of Addiction Medicine Nurse Coordinator New York State Office of Alcoholism and Sinai Hospital Addictions Recovery Substance Abuse Services Program Albany, New York Baltimore, Maryland

Carol Davidson, M.S.W. Eric Ennis, LCSW, CAC III Treatment Director Instructor of Psychiatry/Director of Evergreen Treatment Services Outpatient Services Seattle, Washington Addiction Research and Treatment Services University of Colorado School of Medicine M. Brooke Dawson, M.S.W., LCSW Denver, Colorado Program Specialist II Division of Alcohol and Drug Abuse Beth Epstein Missouri Department of Mental Health Practice Improvement Director Jefferson City, Missouri TASC, Inc. Chicago, Illinois Melissa DeFilippi, M.S.W., LICSW Quality Management Manager Michael Fingerhood, M.D. Health and Addictions Research, Inc. Associate Professor of Medicine Boston, Massachusetts Johns Hopkins Bayview Medical Center Baltimore, Maryland Peter A. DeMaria, Jr., M.D., FASAM Coordinator of Psychiatric Services Loretta P. Finnegan, M.D. Tuttleman Counseling Services Medical Advisor Philadelphia, Pennsylvania Office of Research on Womenís Health National Institutes of Health John de Miranda, Ed.M. Bethesda, Maryland Executive Director National Association on Alcohol, Drugs and Disability San Mateo, California

Field Reviewers 309 Michael T. Flaherty, Ph.D. Alice Gleghorn, Ph.D. Executive Director Project Director Institute for Research, Education and Community Substance Abuse Services Training in Addictions San Francisco Department of Public Health Northeast Addiction Technology Transfer San Francisco, California Center Pittsburgh, Pennsylvania Janis Gold, LPC, LMFT Director Beth E. Francisco Outpatient Services Vice President/Director Alexandria Mental Health, Mental Advocates for Recovery Through Medicine Retardation, and Substance Abuse Burton, Michigan Services Alexandria, Virginia Michael C. Freeman, M.S., LADC, CCS Program Director Marc N. Gourevitch, M.D., M.P.H. Connecticut Counseling Centers, Inc. Director of Addiction Medicine Waterbury, Connecticut Associate Professor Albert Einstein College of Medicine Michael Galer, D.B.A., M.B.A., M.F.A. Montefiore Medical Center Chairman of the Graduate School of Bronx, New York Business University of PhoenixóGreater Boston Douglas Gourlay, M.D., FRCP, FASAM Campus Medical Consultant Braintree, Massachusetts Centre for Addiction and Mental Health Toronto, Ontario, Canada Devang H. Gandhi, M.D. Assistant Professor of Psychiatry Diane M. Grieder, M.Ed. University of Maryland School of Medicine Owner/Consultant Baltimore, Maryland AliPar, Inc. Suffolk, Virginia Lynn Gerard Quality Improvement Coordinator Therese E. Gruble, M.A., NCC Addiction Research and Treatment Therapist/Project Manager San Francisco, California Middle Tennessee Treatment Center Nashville, Tennessee Karen K. Gilmore-Thomas, LPN ADA Liaison/LPN Clinic Administrator Hildi Hagedorn, Ph.D., LP Substance Abuse Treatment Clinic Staff Psychologist University of Arkansas for Medical Sciences Minneapolis VA Medical Center Little Rock, Arkansas Minneapolis, Minnesota

Paolo Giudici, LPCC, LADAC Dana Harlow, LISW, CCDCIII-E Clinical Director Manager Ayudantes, Inc. Quality Management Unit Santa Fe, New Mexico Ohio Department of Alcohol and Drug Addiction Services Columbus, Ohio

310 Appendix F John Haywood, Jr., CSAC, ADS Patti Juliana, ACSN Program Manager Associate Executive Director Hampton-Newport News Community Division of Substance Abuse Services Board Albert Einstein College of Medicine Hampton, Virginia Bronx, New York

Laurel Heiser, M.S.W., CSAC David Kalman, Ph.D. Assistant Program Director Assistant Professor Sellati & Co., Inc./Cardinal Group, Inc. Department of Psychiatry Richmond, Virginia Boston University Bedford, Massachusetts Michael Pierre Henson, LAC PIDARC Linda Kaplan, M.A. Washington, D.C. Executive Director Danya Institute/Central East ATTC James Herrera, M.A., NCC, LPCC Silver Spring, Maryland Clinical Counselor University of New Mexico Hospital Jennifer Kasten Albuquerque, New Mexico Policy Analyst Research Triangle Institute Robert Holden Research Triangle Park, North Carolina Director PIDARC Chris Kelly, M.P.H., M.P.A. Washington, D.C. Advocates for Recovery Through Medicine Washington, D.C. Beatrice Huey Director Van L. King, M.D. Program Compliance and Outcome Associate Professor Monitoring Johns Hopkins University School of Arkansas Department of Health, Alcohol Medicine and Drug Abuse Prevention Baltimore, Maryland Little Rock, Arkansas Suzanne A. Kinkle, R.N., CARN Kimberly Johnson Risk Reduction Coordinator Director Southern New Jersey Perinatal Cooperative Maine Office of Substance Abuse Registered Nurse Augusta, Maine Kennedy Health System Pennsauken, New Jersey Nora R. Johnson, M.A., CAP Program Coordinator Steven Kipnis, M.D., FACP, FASAM DACCO Methadone Maintenance Medical Director Treatment Program New York State Office of Alcoholism and Tampa, Florida Substance Abuse Services Orangeburg, New York Herman Joseph, Ph.D. Social Science Research in the Addictions Social Research in OASAS New York, New York

Field Reviewers 311 Daniel Kivlahan, Ph.D. Thomas Magaraci, M.Ed., M.B.A. Director CEO Center of Excellence in Substance Abuse Habit Management Treatment and Education Boston, Massachusetts VA Puget Sound Health Care System Seattle, Washington Terri Martinez Director/Consultant Marc H. Kleinman, Ph.D. Addiction Treatment Watchdog Regional Administrator Platte City, Missouri Methadone Services Operation PAR/PAR Clinical Services Megan Marx, M.P.A. Port Richey, Florida Administrator State Controlled Substance Thomas Kosten, M.D. Alcohol and Drug Abuse Division Professor of Psychiatry Colorado Department of Human Services Yale University School of Medicine Denver, Colorado New Haven, Connecticut Arlene F. Mayotte, R.N., M.S. Robert C. Lambert, M.A. Nurse Manager Program Director Habit Management Connecticut Counseling Centers, Inc. Fitchburg, Massachusetts Norwalk, Connecticut Elinore F. McCance-Katz, M.D., Ph.D. John Langrod, Ph.D., CASAC, CSW-R Professor of Psychiatry Director of Admissions/Evaluation Chair of the Division of Addiction Division of Substance Abuse Psychiatry Albert Einstein College of Medicine Medical College of Virginia Bronx, New York Virginia Commonwealth University Richmond, Virginia Shirley Linzy, R.N., M.S. Program Director Brian A. McCarroll, M.S., D.O. Dr. Miriam & Sheldon G. Adelson Clinic Medical Director for Drug Abuse Treatment Biomed Behavioral Healthcare, Inc. and Research Clinton Township, Michigan Las Vegas, Nevada Sarah S. McHugh Sheera Lipshitz, M.H.S., CADC Vice President, Performance Improvement Director Family Guidance Centers, Inc. Community Support Programs Chicago, Illinois Brandywine Counseling Wilmington, Delaware Paul McLaughlin, M.A. Executive Director Howard S. Lotsof, CMA Hartford Dispensary President Hartford, Connecticut Dora Weiner Foundation Staten Island, New York Don McNamee, M.A., LPC, LAODC Clinical Supervisor Montgomery County Medication Assisted Treatment Program Rockville, Maryland

312 Appendix F Ray Miller, M.A., LCADC Luc R. Pelletier, R.N., M.S.N., BC, CPHQ Chief, Treatment Services Project Director Maryland Alcohol and Drug Abuse Danya International, Inc. Administration Silver Spring, Maryland Catonsville, Maryland Cheryl Petty, R.N., M.S.N., NP Carolyn J. Miranda, CMA Coordinator, OSC President RLR Veterans Affairs Medical Center NAMA SOCAL Indianapolis, Indiana Fountain Valley, California Mary Planthaber, LPN Richard Moldenhauer, M.S., LADC, ICADC Nursing Manager State Methadone Authority Operation PAR Chemical Health Division Pasco, Pinellas, Manatee, and Lee Counties State of Minnesota Clearwater, Florida St. Paul, Minnesota Deborah Podus, Ph.D. Nancy A. Murray, M.A., CAGS, LDCP Assistant Research Sociologist Vice President of Operations UCLA Integrated Substance Abuse Discovery House Programs Providence, Rhode Island Los Angeles, California

Maureen E. Neville Deborah J. Powers Certified Methadone (Patient) Advocate State Methadone Authority NAMA Department of Health and Family Services Haverhill, Massachusetts Madison, Wisconsin

James Nolan, CAS, CPP Michelle R. Rawls, RCAC Administrator, Addiction Medicine Substance Abuse Counselor Prison Health Services, Inc. PIDARC Rikers Island Washington, D.C. East Elmhurst, New York Philip F. Richmond, M.S., LADC Jeanne L. Obert, M.F.T., M.S.M. Associate Director Executive Director Hartford Dispensary Matrix Institute on Addictions Hartford, Connecticut Playa Vista, California Kimber P. Richter, Ph.D., M.P.H. Beth OíNeal, LPC, LMFT Assistant Professor Clinical Supervisor University of Kansas Medical Center Austin Travis County Mental Health- Kansas City, Kansas Mental Retardation Austin, Texas Deborah S. Rienhimer, M.S., LCADC Treatment Systems Administrator Carmen Pearman-Arlt, CADAC II Maryland Alcohol and Drug Abuse Director Administration Chemical Dependency and Addictions Catonsville, Maryland Porter Starke Services Valparaiso, Indiana

Field Reviewers 313 Michael Rizzi Diane Sevening, Ed.D. President/CEO Assistant Professor CODAC Behavioral Healthcare Alcohol and Drug Abuse Studies Cranston, Rhode Island Department University of South Dakota Elias Robles, Ph.D. Vermillion, South Dakota Research Assistant Professor University of Arkansas for Medical Sciences Stephen Shearer, CPHQ, CCM, CADC, CEAP Little Rock, Arkansas Healthcare Consultant Stephen Shearer, Inc. Aaron Rolnick Redwood City, California Executive Vice President Detroit Organizational Needs in Treatment Karl G. Sieg, M.D. Detroit, Michigan Medical Director of Addiction Psychiatry Hampton Roads Clinic Andrew J. Saxon, M.D. Hampton, Virginia Professor Department of Psychiatry and Behavioral Susan Simon Sciences CEO/President University of Washington/VA Puget Sound Hepatitis C Association Healthcare System Scotch Plains, New Jersey Seattle, Washington Genie Skypek, Ph.D. Brent Scobie, LCSW President Clinical Supervisor The Skypek Group, Inc. The Acadia Hospital Tampa, Florida Bangor, Maine Lisa M. Soderlund Anthony Scro ACI/OTP Program Supervisor Technical Assistance Unit Manager/Board CODAC Behavioral Healthcare Member Cranston, Rhode Island New York State OASAS/National Alliance of Methadone Advocates Jim Soward, CPC, CSAC New York, New York Alcohol and Substance Abuse Program Manager Audrey Sellers, M.D. Pascua Yaqui Tribe of Arizona Medical Director Tucson, Arizona Bay Area Addiction Research and Treatment Shannon Staggers, BRPS San Francisco, California Senior Substance Abuse Counselor Hartford Dispensary Edward C. Senay, M.D. Hartford, Connecticut Professor Emeritus, Psychiatry University of Chicago Deborah Stephenson, M.D. Naperville, Illinois Central Valley Clinic San Jose, California

314 Appendix F Eric C. Strain, M.D. Ernest J. Vasti, M.D. Professor Medical Director Department of Psychiatry and Behavioral San Joaquin County Sciences Office of Substance Abuse Johns Hopkins University School of Stockton, California Medicine Baltimore, Maryland Winifred Verse-Barry, Ph.D., R.N. CTP Nursing Coordinator William B. Swafford, M.D. Dayton Veterans Affairs Medical Center Medical Director Dayton, Ohio Addiction Research and Treatment Services Division of Substance Dependence Gary Wenner University of Colorado Health Sciences Vice President of Methadone and Center Laboratory Services Denver, Colorado Operation PAR Clearwater, Florida James Szabo, LICSW Manager Carol Wertheimer, Psy.D. Family Outpatient Services Director of Clinical Services Gateway Healthcare Habit Management Pawtucket, Rhode Island Boston, Massachusetts

Charlotte L. Thomas, M.S.W., CACIII Melvin H. Wilson Retired Addiction Treatment Provider HIDTA Coordinator Colorado Springs, Colorado WB/HIDTA-Maryland Division of Parole and Probation Elaine Tophia Baltimore, Maryland Executive Director National Opioid Treatment Clinicians Diane Wood, LPN Association LPN/Nurse Supervisor Decatur, Georgia Metwork Health Services Eldersburg, Maryland Sari Trachtenberg, M.A., CCS, LPC Program Coordinator Johanna Esmus York, M.P.H., CAP Narcotic Addict Rehabilitation Program Program Director, NATC-B Thomas Jefferson University Operation PAR Philadelphia, Pennsylvania Bradenton, Florida

Field Reviewers 315

Index

Notes: Because the entire volume is about medication-assisted treatment for opioid addiction, the use of these terms as entry points has been minimized in this index. Commonly known acronyms are listed as main headings. Page references for information contained in exhibits appear in italics.

12-Step programs. See mutual-help programs review and appeals processes, 141 42 CFR, Part 8, 3, 22, 46, 103, 121, 134, 154 admission process, 46 denial of, 47 A adolescents, 92ñ93 About Methadone (patient handbook), 132 parental consent to treatment, 48, 50 abstinence, 187 Advisory Commission on Narcotic and Drug definition, 2 Abuse, 1963, 16 violation effect, 138 advocacy, patient, 142 accreditation, and movement from compliance Advocates for Recovery Through Medicine, 84, orientation, 22 142 acupuncture, 136 aging patients, 95 acute phase of treatment, 102ñ103, 104ñ105 alcohol and co-occurring disorders, 106 effects of, 182 goals of, 103ñ105 and overdose risk, 188 and hospitalization, 178 treatment for dependence, 183 and legal problems, 106ñ107 and use of stimulants, 184 and medical and dental problems, 106 American Association for the Treatment of and therapeutic relationships, 107 Opioid Dependence, 18, 171 and transition to rehabilitative phase, 108 Canon of Ethics, 303 addiction American Society of Addiction Medicine, definition, 2 patient placement criteria, 87 disease versus moral view of, 12 Americans with Disabilities Act, 112, 173 iatrogenic, 12 antisocial personality disorder, 191, 198ñ199 and pain management, 7, 12 anxiety disorders, medications for, 207 perinatal, 219ñ220 appropriate language, 9 as a social issue, 14 arrythmia, cardiac, 35, 41 Addiction Severity Index, 43, 139, 194, 240 ASI. See Addiction Severity Index Addiction Technology Transfer Center assessment Network, 7 Brazelton Neonatal Behavioral Assessment administrative discharge, 138ñ139, 186 Scale, 220 alternatives to, 140 of children, 134 for continued substance abuse, 139 comprehensive, 53 guidelines for, 140 cultural, 54ñ55 for incarceration, 140 of financial status, 60 for nonpayment, 139ñ140 induction, 53 prevention of, 140 of insurance status, 58 and principles of medical ethics, 301 medical, 49, 65 procedures for, 141 and patient-treatment matching, 88

317 of peer relations and support, 58 overdose, 30, 42 psychosocial, 55 pharmacology and pharmacotherapy of, 30 of recreation activities, 60 and physician waivers, 26, 27 of spirituality, 59 and pregnancy, 220 of substance use, 54 safety of, 42 ATTC. See Addiction Technology Transfer side effects of, 36 Center Network and youth, 93 attention deficit/hyperactivity disorder, 199 medications for, 207ñ208 C autonomy California Drug and Alcohol Treatment and conflict with beneficence, 298 Assessment, 19ñ20 principle of medical ethics, 297 cardiac arrhythmia, 35 cardiovascular effects, 35 B case management, 124, 127 barriers to treatment, 44, 222 case studies basic-care services, 107, 121 conflict between beneficence and autonomy, behavioral problems, remedial approaches to, 299 140 patient-treatment planning in MAT, 97ñ99 beneficence Changing the Conversation: Improving and conflict with autonomy, 298 Substance Abuse Treatment: The National principle of medical ethics, 297 Treatment Plan Initiative, 237 benzodiazepines childrenís issues and ìboostingî, 183 assessment, 134 effects of, 183ñ184 child abuse, 56 bidirectional model of co-occurring disorders, childcare, onsite, 94 192 childrenís protective services, 94, 134 bipolar disorder, medications for, 206ñ207 Chinese immigrants, and opium smoking, 12 Blending Clinical Practice and Research: chromatographic analyses, 151 Forging Partnerships To Enhance Drug civil commitment, 15ñ16 Addiction Treatment (2002 conference), 237 definition, 15 blind withdrawal, 141 Civil War veterans, and opioid addiction, 12 blood drug testing, 147 CLIA. See Clinical Laboratory Improvement botulism, wound, 164 Amendments breast-feeding, 218 Clinical Laboratory Improvement during buprenorphine treatment, 222 Amendments, 154, 155 and methadone, 218 cocaine buprenorphine, 4, 5, 8 and concurrent alcohol use, 184 and compliance testing, 144 effects of, 184 DEA classification of, 22 cognitive behavioral therapies, 127ñ128 development of, 19 community reinforcement approach, 128 dosage forms, 32 contingency management, 128ñ129 dose levels, 71 motivational enhancement, 130 efficacy of, 33 node-link mapping, 128 FDA approval for use, 25 cognitive impairment, screening for, 193 and induction stage of pharmacotherapy, 68 common pathway model of co-occurring metabolization of, 30 disorders, 192 and mu receptors, 30 Community Epidemiology Surveillance and naloxone combination, 26, 30ñ36, 69, Network (NIDA), 237 221

318 Index community issues group, 126 community relations and education plan, individual, 125ñ126 232ñ233 resistance to, 132 documenting community activities, 236 resources for, 127 and media relations, 235 criminal history, 58 national community education initiatives, 236 criminal justice overcoming negative reactions, 232, 235 populations, 8 community reinforcement approach, 128 treatment settings, 90ñ91 complementary medicine, 136 cross-tolerance, 28ñ29, 70ñ71 comprehensive treatment assessment, 53 cultural assessment, 54ñ55 comprehensive treatment services, 8 cultural sensitivity, 226 concurrent medical disorder, 82, 111, 122, 178 and language use, 227 confidentiality, 47ñ48, 60, 91, 149 custody, 134 consent to treatment, written, 48, 61, 107 cytochrome P3A4 enzyme system, 28, 36, 41, contingency management, 128ñ129 184, 208 and pregnancy, 223 inducers and inhibitors of, 40 strategy for, 129 continuing-care phase of treatment, 119 D Controlled Substances Act of 1970, 21 DATA. See Drug Addiction Treatment Act of co-occurring disorders 2000 classification of diagnoses, 194, 196 deemed status, 22 definition, 2, 189 definitions diagnostic instruments, 195, 209 abstinence, 2 differential diagnosis, 106, 196 addiction, 2 DSM-IV-TR criteria, 194 civil commitment, 15 etiology of, 191ñ192 co-occurring disorders, 2, 189 and gender differences, 190ñ191 dependence, 2 history of, 55 level of care, 87 and HIV risk, 201 medication-assisted treatment for opioid and homicidality, 202 addiction, 2 identification of, 190 opioid agonist, 28 models of care, 192 opioid treatment programs, 2 mutual-help programs for, 203 QT interval, 35 and pharmacotherapy, 204 steady state, 66 prevalence of, 190 tolerance, 12 prognosis for, 197 Demystifying Evaluation: A Manual for psychiatric diagnosis, 194 Evaluating Your Substance Abuse Treatment and psychoeducation, 204 Program, 238, 239 screening for, 192 dental problems, 106 substance-induced versus non-substance- and acute pain, 175 induced, 194, 197 dependence, definition, 2 and symptom severity, 198 dependence duration rule, SAMHSA, 49 treatment issues, 199ñ200 depression, medications for, 206ñ207 and treatment motivation, 191 detoxification and treatment outcomes, 197ñ198 in acute phase of treatment, 103 and treatment planning, 200 inpatient, 188 cost benefits of treatment, 19ñ20 and medically supervised withdrawal, 79ñ80 counseling types of, 80 and case management, 124ñ125

Index 319 diagnosis drug testing, 52ñ53 of HIV infection, 52 accuracy of, 158 of substance use, DSM-IV-TR classifications, benefits and limitations of, 144 195 blood, 147 differential diagnosis of co-occurring disorders, components and methods, 148 195 and false-positive results, 144ñ145 disabilities frequency of, 111, 154, 188 patients with, 92, 173 hair, 148 physical, 92 immunoassays in, 150 and take-home medications, 84 interpretation of, 155ñ156 discharging patients, 235ñ236 laboratory selection, 154 disease model of co-occurring disorders, 192 minimum concentrations of substances of and clinicians uneasy with the concept, 300 abuse, 145 diversion control, 9, 83, 115, 159, 230, 302 and multiple substance use, 188 Dole, Dr. Vincent P., 17, 18 onsite test analysis, 155, 156 domestic violence, 56, 57, 135 oral-fluid, 147 dosage determination, 70 patient falsification of, 157 dosage forms and patient self-reports, 146 of buprenorphine, 32 reliability, 158 of LAAM, 32 results, 143, 156, 159 of methadone, 31 specimen collection, 148 of naltrexone, 32 for substance abuse, 144 dosage reduction, 78 sweat, 147ñ148 blind, 79 for treatment compliance, 144 and incarceration, 81 of urine, 146 involuntary, 80 validity, 158 dosing and written procedures, 151 contigency, 77 due process, and principles of medical ethics, determination of, 70 302ñ303 dose levels, 6, 71, 75 duration of action home dosing, 173 buprenorphine, 30, 174 missed doses, 85 LAAM, 28, 67 optimal, 67ñ68 methadone, 216 and overmedicating and undermedicating, 70, 76 E split, 67, 76, 217 early intervention, 173 studies of, 72ñ75 education and vomiting, 76ñ77 formal, 112 Drug Abuse Warning Network, 83, 181 patient, 41, 44, 106, 132 Drug Addict as a Patient, The, 17 Effective Treatment of Opiate Addiction (1997 Drug Addiction Treatment Act of 2000, 6, 21, conference), 22 26, 27, 68 efficacy drug combinations of buprenorphine, 33 common, 181ñ182 of LAAM, 33 reasons for use, 182 of methadone, 32 drug interactions, 36 of naltrexone, 33 for depression and bipolar disorder, 206 EIA. See immunoassay with methadone, 37ñ39 elderly, 95 preventing harmful, 40ñ42

320 Index eligibility for treatment, 115 hepatitis, A and B, 167, 213 and Federal regulations, 49, 89 testing, 51, 167 emergency room admissions, 181 hepatitis C infection, 7 emergency situations, 82, 84, 202 and alcohol use, 183 endocarditis, 163 counseling for, 126, 131 Enzyme Multiplied Immunoassay Technique, determination of disease activity, 168 150 evaluation, 169 ethics, 298, 304 and liver disease, 168 etiology, of co-occurring disorders, 191ñ192 liver transplant, 171 European immigrants, 13 and pregnancy, 213ñ214 evaluation sustained virologic response, 170 outcome, 238ñ239 testing for, 51, 168 process, 239 treatment of, 168, 169 program, 238 heroin resources for, 240 blockade of effects, 70 staff, 238 and cross-tolerance, 72 evidence-based practices, 7 immune system effects, 35 extended-care services, 122 introduction, 12 extinction therapy, 138 prevalence, 7, 12ñ16, 180ñ181 route of administration, 122 F and suicide, 202 false-positive drug tests, 144ñ145, 158 use and cost to criminal justice system, 1 family background, 56ñ57 use, and methadone maintenance, 73 family involvement, benefits of, 133 HIPAA. See Health Insurance Portability and Federal Regulation of Methadone Treatment, Accountability Act Institute of Medicine study, 20 history financial issues, patient, 123ñ124, 139 of co-occurring disorders, 55 and principles of medical ethics, 301 criminal, 58 forms of dosage. See dosage forms drug and medication, 40 funding issues, 7ñ8 employment, 59 medical, 50 G military, 59 of nonopioid substance use, 50 gateway drugs, 1, 14 of opioid addiction, 11 Gearing, Dr. Frances Rowe, 18 physical or sexual abuse, 57ñ58 gender differences and co-occurring disorders, psychosocial, 53 190ñ191 sexual, 60 Goodman and Gilmanís Pharmacological Basis sociodemographic, 55 of Therapeutics, 28 substance abuse, 47 group counseling, 126 HIV/AIDS Guidelines for the Accreditation of Opioid and co-occurring disorders, 201 Treatment Programs, 238 counseling for, 131ñ132 interactions of medications and methadone, H 172 hair drug testing, 148 neurologic complications of, 172 Harrison Narcotic Act of 1914, 14 and pregnancy, 214ñ215 HCV. See hepatitis C infection prevention of, 172 Health Insurance Portability and rapid tests for, 52, 172 Accountability Act, 3, 154 referral for treatment, 172ñ173

Index 321 testing for, 171 initial screening, 43 HIV testing, 52 and admission, 46 Western blot analysis, 171ñ172 goals of, 44 homelessness, 58 inner-city populations, 13ñ14 homicidality, 44ñ46 insurance status, 58ñ59 hospitalization, 84ñ85, 178 intake. See screening process housing status, 58 integrated services, versus referral services, and referrals, 92 162 hydrocodone, 83 integrative approaches to MAT, peer support, hypodermic drug administration, 12 135 interim maintenance treatment, 46ñ47 I International Center for Advancement of iatrogenic addiction, 12 Addiction Treatment, 142 immigrants, 12, 13 involuntary discharge, 138ñ139, 186 immune system effects, 35 alternatives to, 140 immunoassay, 149, 150, 168, 171 for continued substance abuse, 139 impulse control disorders, 48 guidelines for, 140 incarceration for incarceration, 140 and dosage reduction, 81 for nonpayment, 139ñ140 failure of, 16 prevention of, 140 and involuntary withdrawal, 81 and principles of medical ethics, 301 treatment discharge for, 140 procedures for, 141 individual counseling, 125ñ126 review and appeals processes, 141 induction stage of MAT, 68ñ69 isoniazid treatment of tuberculosis, 166 assessment during, 53 induction stage of pharmacotherapy, 65 J with buprenorphine, 68 Jaffe, Dr. Jerome, 18 and dosing, 65ñ66, 67 justice, principle of medical ethics, 298 with methadone and LAAM, 67ñ68 with naltrexone, 70 K and pregnancy, 216 Kreek, Dr. Mary Jeanne, 17 and steady state, 66ñ67 infections, acute, life-threatening, 163 L endocarditis, 163 necrotizing fasciitis, 163ñ164 LAAM, 5 soft-tissue, 163 cessation of production, 25 tuberculosis, 164, 165 clinical guidelines for, 18ñ19 wound botulism, 164 and compliance testing, 144 infectious diseases, 164 development of, 18ñ19 chlamydia and gonococcus, 167 dosage forms, 32 hepatitis, 167 dose levels, 72 syphilis, 166 efficacy of, 33 tuberculosis, 164 equivalency dosing tables for methadone, 72 Venereal Disease Reference Laboratory test, overdose, 67 166 pharmacology and pharmacotherapy of, information collection, 47 28ñ29 informed consent. See written consent to safety of, 42 treatment side effects, 35 initial dosing, 69 withdrawal and termination from, 79

322 Index laboratory medical problems selection, 154 acute, life-threatening infections, 163 testing, 51 disability, 173 legal problems, 58, 106ñ107 followup for, 163 leisure activities, 60 HIV/AIDS, 171 lesbian, gay, and bisexual patients, 94 and hospitalization of patients in MAT, 178 level of care, 87 and pregnancy, 212, 213 levo-alpha acetyl methadol. See LAAM medication LGB. See lesbian, gay, and bisexual patients diversion of, 159 liver over-the-counter, 48 effects on, 35ñ36 for patients with co-occurring disorders, 205 toxicity, 166 prescription, 48 liver disease take-home, 81ñ82 and hepatitis C, 168 medication-assisted treatment for opioid and liver transplant, 171 addiction. See MAT medication dosages, individualized, 123 M medication unit, 2, 115 maintenance medication, 4 methadone, 4, 8 maintenance stage of pharmacotherapy, 77 access to by people in the criminal justice and dose reduction, 78ñ81 system, 5 origins of, 17 cardiovascular effects, 35 and relapse prevention, 78 development of, 17ñ18 maintenance treatment, 5 dosage forms, 31ñ32 major depression, medications for, 206ñ207 dosage reduction, 78ñ79 Manhattan County Jail for Men, 16 dose levels, 6, 71, 74ñ75 marijuana, effects of, 185 and dose tapering, 79 MAT drug interactions with, 37ñ39, 206 and conflict with mutual-help programs, 135 efficacy of, 32ñ33 definition, 2 equivalency dosing tables for LAAM, 72 eligibility for, 49 and HIV medications, 172 information resources for, 237 metabolization of, 29 involuntary discharge from, 138ñ139 optimal levels, 68 orientation to, 47ñ48 overdose, 67, 202 phases of. See phases of treatment pharmacology and pharmacotherapy of, rationale for phased-treatment approach, 28ñ29 101 and pregnancy, 219 reduction in unnecessary regulation of, 20 regulation, 22 media safety of, 42 relations, 235 side effects, 35 reports about MAT, 9 States not available in, 5 Medicaid, 7ñ8 and use of stimulants, 184 medical assessment, 49, 65 methadone maintenance treatment, 63 medical ethics, principles of, 297 efficacy of, 17 medically supervised withdrawal treatment, 6, origins of, 17 78, 141, 217ñ218 and pain management, 174ñ175 medical maintenance phase of treatment, 5, 116 and pregnancy, 215ñ216 eligibility for, 114ñ115 as public health program, 18 and OBOT, 115ñ116 split dosing in pregnancy, 217 and random drug testing, 115 methadone regulation, history of, 22ñ23

Index 323 missed doses, 85 Narcan challenge. See naloxone challenge test mobile treatment units, 90 Narcotic Addict Treatment Act of 1974, 21, 25 models of care, 202 narcotics farms, 15 money management, 60 Narcotics Register, New York City, 16 monotherapy tablets, 69 Narcotic Treatment Programs: Best Practice morphine, 12ñ17 Guideline, 237 duration of action, 217 National Institutes of Health consensus panel and neonatal abstinence syndrome, 219 recommendations, 4, 20 and pain management, 174ñ175 necrotizing fasciitis, 163ñ164 motivational enhancement, 130 Neonatal Abstinence Score, 219 motivational interviewing, 53 neonatal abstinence syndrome, 216, 218ñ219 Motivational Interviewing: Preparing People and buprenorphine, 220ñ221 for Change, 130 and methadone, 219 motivation for seeking treatment, 54, 96, 107, nicotine, effects of, 185 191 and pregnancy, 212 multidisciplinary treatment team, 100 node-link mapping, 128 multiple substance use, 48, 106, 111 nonmalfeasance, principle of medical ethics, and co-occurring disorders, 181 298 and dosage adjustments, 187 nutrition, and pregnancy, 223ñ224 and increased drug testing, 188 Nyswander, Dr. Marie E., 17 management of, 186 and morbidity and mortality, 181 O and pregnancy, 217 OBOT. See office-based opioid treatment prevalence of, 180, 181 observed dosing, 65ñ66 and psychosocial treatment services, 187ñ188 office-based opioid treatment, 6, 63, 85, 90 mu opiate receptors, 28, 29 with methadone, 115 and buprenorphine, 30 opioid addiction and methadone, 29 diagnosing in pregnant patients, 212 and naltrexone, 30 history of, 11ñ12 mutual-help programs as a medical disorder, 3ñ5 and conflict with MAT, 135 opioid agonist, 64 and patientñtreatment matching, 88 definition, 28 for people with co-occurring disorders, 203 side effects of, 34 Web sites for, 136, 203 opioid analgesic abuse, 14 opioid antagonist, 5, 19 N and diagnosing addiction in pregnant naloxone-buprenorphine combination. See women, 212 buprenorphine, SuboxoneÆ side effects of, 34 naloxone challenge test, 50, 70 opioid overdose, 50 naltrexone, 5 opioid pharmacotherapy development of, 19 contraindications to, 64ñ65 dosage forms, 32 stages of, 65 dose levels, 72 opioid treatment programs efficacy of, 33 administrative considerations, 225 induction stage of pharmacotherapy, 70 attendance requirements, 124 and overdose, 42 and co-occurring medical and mental pharmacology and pharmacotherapy of, 30ñ31 disorders, 91 safety of, 42 definition, 2 side effects of, 35 and duty to warn, 202

324 Index early OTPs, 14ñ15 pain, 95 evaluation, 238 patient placement criteria, 87 Federal regulation of, 6 retention, steps to improving, 123ñ124 managing to meet service needs, 122 social problems, 92 offsite treatment options for, 122 special needs, 91 outpatient, 89 patientñtreatment matching, steps in, 88ñ91, 97 readmission to, 120 patterns of opioid abuse, 48 who should not be admitted, 64, 199 pharmacotherapeutic medications, 26 opioid use buprenorphine, 30 abuse patterns, 7, 48 and co-occurring disorders, 204 additional doses for acute pain, 177 LAAM, 28 methods of, 48 methadone, 28 opium smoking, among Chinese immigrants, 12 naltrexone, 30 optimal dosing, 67ñ68, 71 pharmacotherapy oral-fluid drug testing, 147 maintenance, 77ñ78 orientation to MAT, 47ñ48 methadone, 28 OTP. See opioid treatment programs stages of, 65 outcome predictors, 3 phases of treatment, 101 overdose in pregnancy, 217 acute, 102ñ108 overdose risk, 65, 202 continuing-care, 119 oxycodone, 17, 83, 122, 151, 175 medical maintenance, 114ñ116 OxyContinÆ, 151, 217 rehabilitative, 108ñ113 supportive-care, 113ñ114 P tapering and readjustment, 116ñ119 pain management, 95, 112 transition between, 108, 119 for acute pain, 175 physical examination, 50ñ51 and addiction, 7 physicianís waiver. See waiver, physicanís, to for chronic pain, 176ñ177 dispense buprenorphine and methadone dosing, 177 polysubstance abuse. See multiple substance nonpharmacologic, 177 use and relapse, 174 population shifts, 13 parenting groups, 134 postpartum treatment of women in MAT, 218 parenting issues, 94 posttraumatic stress disorder, 56, 93, 199 custody, 134 pregnancy, 93 partial response to maintenance medication, 4 barriers to treatment, 222 Partners for Recovery (national educational breast-feeding, 218 campaign), 9 buprenorphine, 211 patient exception, 49, 82, 104, 116 comprehensive treatment services, 222 patient handbook, 47 diagnosing opioid addiction, 212, 214 patient issues medical problems, 212, 213 advocacy, 142 methadone maintenance, 211 aging, 95 neonatal abstinence syndrome, 216 disabilities, 92 nutrition, 212, 223ñ224 education, 41, 44, 132 obstetrical complications, 212, 215 failure to respond to MAT, 301 and opioid antagonists, 212 family, 92 overdose, 217 followup, 138 postpartum treatment, 218 housing, 92 testing, 51, 53 motivation, 54 withdrawal from methadone, 217ñ218

Index 325 prescription opioids to social services, 138 and blockade of effects, 70 referral services, versus integrated services, prevalence, 83 162 Principles of Addiction Treatment: A Research- regulations Based Guide, 8 history of, 21ñ23 principles of effective drug addiction treat- reduction of unnecessary, 20 ment, 8 rehabilitative phase of treatment, 109ñ110 principles of medical ethics, conflicts among the and continued alcohol and prescription drug principles, 301 abuse, 111 program and co-occurring disorders, 113 administration, 225 and income-related issues, 112 evaluation, 238 and legal problems, 112ñ113 goals, 123 and social supports, 112 management, 10 relapse proprietary programs, 5 after tapering, 117 psychiatric instruments, 209 risk, 4 psychoeducation, 132 warning signs of, 138 for people with co-occurring disorders, 204 relapse prevention, 33, 64, 78, 136 strategies for, 133 and abstinence violation effect, 138 psychosocial assessment, 55 building relapse prevention skills, 137 psychosocial history, 53 and extinction therapy, 138 psychosocial treatment services Relapse Prevention Workbook, 137 and multiple substance use, 187 strategies for multiple substance use, and patient-treatment matching, 88 137ñ138 psychotherapy remedial approaches to behavioral problems, group, 130ñ131 140 and staff qualifications, 130 Report to Congress on the Prevention and strategies for, 131 Treatment of Co-Occurring Substance Abuse PTSD. See posttraumatic stress disorder Disorders and Mental Disorders, 189 public relations, 9ñ10, 237 residential treatment programs, 89ñ90 Pure Food and Drug Act of 1906, 14 resources for counseling, 127 Q for evaluation, 240 QT interval, 64 for MAT, 237 definition, 35 restrictions on treatment, State mandated, 5 retaining patients, 122ñ124 R retention, patient, 123 RIA. See immunoassay Rapid HIV Testing Initiative, SAMHSA, 52 Rikers Island, New York City, 91 recovery resources, patient, 49 Riverside Hospital for adolescents with Recovery Training and Self-Help, 136 addiction disorders, 15 Recovery Training and Self-Help: Relapse Roxane Laboratories, Inc., 18, 35 Prevention and Aftercare for Drug Addicts, 132 S referral, 46, 88, 111, 122, 141, 162, 187 for co-occurring disorders, 194, 202 safety, 42, 65, 193 for HIV treatment, 172 of patients and employees, 139 and lesbian, gay, and bisexual patients, 94 and principles of medical ethics, 301 for pregnant women, 93 staff, 149 and sexual or physical abuse, 93 saliva drug testing. See oral-fluid drug testing

326 Index sanatoriums for opioid addiction, 12 staff evaluation, 238 schedule II controlled substance, 18, 20 staff needs, 122 scheduling, 49 staff retention, 227ñ228 schizophrenia, medications for, 208 training, 144, 208, 228 screening process transference and countertransference, 226 admission process, 46 stages of change, 96 for cognitive impairment, 193 Statesí authority to regulate OTPs, 23 for co-occurring disorders, 192 steady state, 66, 68 and emergency situations, 44 versus stabilization, 70 initial screening, 43 stigma, 4, 6, 8ñ10, 13, 92, 231 instruments, 196 stimulants. See cocaine for suicidality, 203 Strategies for Developing Treatment Programs tools for, 194 for People With Co-Occurring Substance sedatives, nonbenzodiazepine, effects of, 184 Abuse and Mental Disorders, 189 selective serotonin reuptake inhibitors. See SuboxoneÆ, 6, 32 SSRIs Substance Abuse and Mental Health Services self-help programs. See mutual-help programs Administration, and MAT approval and self-medication model of co-occurring monitoring, 22ñ23 disorders, 192 substance use, testing for, 144 serious medical disorders, 91 SubutexÆ, 6, 32 serum methadone level, 28ñ29, 73ñ75, 76 suicidality, 44 and SSRIs, 37 and co-occurring disorders, 200, 202 sexual abuse, 57, 93, 131 risk factors, 45, 202 sexually transmitted diseases, 52 supportive-care phase of treatment, 114 chlamydia and gonococcus, 167 and treatment compliance, 114 syphilis, 166 support systems, patient, 58 and youth, 93 sweat drug testing, 147ñ148 sexual orientation, 60, 126, 226 syphilis testing, 166 side effects, 33ñ36 Siting Drug and Alcohol Programs: Legal T Challenges to the ìNIMBYî Syndrome, 237 take-home medications, 81, 129 SML. See serum methadone level for acute pain, 176 social services and callbacks, 230 case management, 127 and concurrent medical disorders, 82 referral to, 138 and contingency contracting, 77 social supports, 112 decisions about, 159 Special Action Office for Drug Abuse and disability or illness, 84, 92, 173 Prevention, 18 and emergency situations, 82 specimen collection, 148, 151ñ152 Federal criteria for, 81, 90, 230 spirituality, 59ñ60 medical exceptions for, 82 split dosing, 67, 76 in medical maintenance phase of treatment, SSRIs, 37, 170 115 stabilization monitoring patients, 83ñ84 and pregnancy, 216 and positive drug tests, 82ñ83 versus steady state, 70 and principles of medical ethics, 302 staffing issues tapering, 123 cultural sensitivity, 226 involuntary, 80ñ81 and inclusion of recovering patients, 227 medically supervised, 141 knowledge and attitudes, 9, 124, 227 voluntary, 78 qualifications, 130, 225

Index 327 tapering and readjustment phase of treatment, 94, 217, 222 118 Substance Abuse Treatment and Domestic versus detoxification, 116 Violence (TIP 25), 56, 135, 193 and patient stage of change, 117 Substance Abuse Treatment and Family reasons for, 117 Therapy (TIP 39), 134 and relapse, 117 Substance Abuse Treatment for Adults in the and reversion to MAT, 119 Criminal Justice System (TIP 44), 91, 107 testing Substance Abuse Treatment for People With hepatitis, 51, 213 Physical and Cognitive Disabilities (TIP HIV, 52 29), 173 laboratory, 51 Substance Abuse Treatment for Persons medical, 163 With Child Abuse and Neglect Issues (TIP onsite test analysis, 155ñ156 36), 56, 93, 131, 193, 226 for pregnant women, 214 Substance Abuse Treatment for Persons STD, 52 With Co-Occurring Disorders (TIP 42), 2, tuberculosis, 51 189, 190, 194, 196, 200, 206 therapeutic relationships, 107 Substance Abuse Treatment for Persons TIPs cited With HIV/AIDS (TIP 37), 131, 163, 171, Assessment and Treatment of Cocaine- 201, 205 Abusing Methadone-Maintained Patients Substance Abuse Treatment: Group Therapy (TIP 10), 1 (TIP 41), 126 Clinical Guidelines for the Use of Substance Use Disorder Treatment for Buprenorphine in the Treatment of Opioid People With Physical and Cognitive Addiction (TIP 40), 19, 25, 63, 70, 221 Disabilities (TIP 29), 173, 193 Detoxification and Substance Abuse Treatment for Stimulant Use Disorders (TIP Treatment (forthcoming), 186 33), 184, 194 Enhancing Motivation for Change in Treatment of Adolescents With Substance Substance Abuse Treatment (TIP 35), 54, Use Disorders (TIP 32), 93 96, 130 tobacco. See nicotine, effects of Improving Cultural Competence in tolerance to opioids, 12, 71 Substance Abuse Treatment (forthcoming), Tombs, the. See Manhattan County Jail for 55, 226 Men Integrating Substance Abuse Treatment and torsade de pointes, 35 Vocational Services (TIP 38), 112 transference and countertransference, 226 LAAM in the Treatment of Opiate Addiction trauma, 193 (TIP 22), 1 treatment Matching Treatment to Patient Needs in cost benefits of, 19ñ20 Opioid Substitution Therapy (TIP 20), 1 duration, 102 Screening for Infectious Diseases Among interruptions, 84 Substance Abusers (TIP 6), 167 offsite, 122 State Methadone Treatment Guidelines (TIP options, 5ñ6 1), 1, 143, 231 treatment compliance, testing for, 144 Substance Abuse: Administrative Issues in treatment history, 47 Outpatient Treatment (forthcoming), 228, treatment outcomes for people with co-occur- 233, 235, 239 ring disorders, 197ñ198 Substance Abuse and Trauma (forthcoming), treatment, phases of. See phases of treatment 193 treatment planning, 95ñ96 Substance Abuse Treatment: Addressing the case study, 97ñ99 Specific Needs of Women (forthcoming), 53, and co-occurring disorders, 200

328 Index elements of, 96ñ97 Addiction Technology Transfer Center and multidisciplinary team approach, 100 Network, 7, 229 and role of counselor and patient, 96 Advocates for Recovery Through Medicine, treatment program types 84 and criminal justice settings, 90ñ91 American Association for the Treatment of mobile treatment units, 90 Opioid Dependence, 140, 234 office-based opioid treatment, 90 Centers for Disease Control and Prevention, outpatient OTPs, 89 164 residential treatment programs, 89ñ90 The Change Book (ATTC), 240 tuberculosis Comorbidity and Addictions Center, 209 classification of, 165 DATA, 26 and isoniazid treatment, 166 Double Trouble in Recovery, 203 prevention of, 166 Dual Diagnosis Recovery Network, 203 treatment of, 166 Dual Recovery Anonymous, 203 tuberculosis testing, 51 ethical codes, 304 Bacillus Calmette-Guerin vaccination, 165 Exception Request and Record of Mantoux test, 164 Justification form, 82 purified protein derivative, 164 Federal Women, Infants, and Children types and frequency of, 164ñ165 program, 224 food stamps, 224 U International Center for Advancement of urine drug testing, 146 Addiction Treatment, 142 chromatographic analyses, 151 medication interactions with methadone, 42 cutoff concentrations, 145 Mini International Neuropsychiatric direct observation, 149 Interview, 209 Enzyme Multiplied Immunoassay Technique, Mini-Mental State Examination, 194 150 mutual-help programs, 136 and patient privacy, 149 National Alliance of Methadone Advocates, sample guidelines for monitoring, 151ñ153 135, 142 U.S. Public Health Service Narcotics Hospital, National Association of Social Workers, 226 15 National Center for Nutrition and Dietetics, 224 V National Clearinghouse for Alcohol and Drug Abuse Information, 240 vaccination National Institute on Alcohol Abuse and Bacillus Calmette-Guerin, 165 Alcoholism, 209 against hepatitis B infection, 167 National Institute on Drug Abuse, 234 Vietnam, 13 National Womenís Health Information violence, 44ñ46, 139, 202, 301 Center, 224 domestic, 56, 57 NIDA cost analysis manual, 240 Violence Against Women Act, 56 Outcome Measurement Resource Network, vomiting, 76ñ77 240 voucher-based reinforcement therapy, 223 pharmacokinetics of methadone and HIV medications, 146 W Rapid HIV Testing Initiative, SAMHSA, 52 waiting lists for treatment, 46 recommendations on involuntary withdrawal waiver, physicianís, to dispense buprenor- from treatment, 301 phine, 26, 27 Recovery Community Support Program Web sites cited, 227 (CSAT), 237ñ238

Index 329 Substance Abuse and Mental Health Services fetal, 211 Administration, 226, 234 and incarceration, 81 Texas Christian University core instruments, medically supervised, 5, 78ñ79, 141, 240 217ñ218 translation services, 227 and pregnancy, 217ñ218 University of Adelaide Library Guide, 209 severity of, 12 U.S. Department of Agriculture survey triggered, 77 forms, 224 womenís issues, 53, 93 Violence Against Women Act, 56 written consent to treatment, 48, 61, 143 White House Office of National Drug Control Policy, 234 Y Western blot analysis, 171ñ172 youth, 92ñ93 withdrawal, 64, 188 after detoxification, 79ñ80 blind, 141

330 Index CSAT TIPs and Publications Based on TIPs What Is a TIP? Treatment Improvement Protocols (TIPs) are the products of a systematic and innovative process that brings together clinicians, researchers, program managers, policymakers, and other Federal and non-Federal experts to reach consensus on state-of-the-art treatment practices. TIPs are developed under CSAT’s Knowledge Application Program to improve the treatment capabilities of the Nation’s alcohol and drug abuse treatment service system. What Is a Quick Guide? A Quick Guide clearly and concisely presents the primary information from a TIP in a pocket-sized booklet. Each Quick Guide is divided into sections to help readers quickly locate relevant material. Some contain glossaries of terms or lists of resources. Page numbers from the original TIP are referenced so providers can refer back to the source document for more information. What Are KAP Keys? Also based on TIPs, KAP Keys are handy, durable tools. Keys may include assessment or screening instruments, checklists, and summaries of treatment phases. Printed on coated paper, each KAP Keys set is fastened together with a key ring and can be kept within a treatment provider’s reach and consulted frequently. The Keys allow you—the busy clinician or program administrator— to locate information easily and to use this information to enhance treatment services. TIP 1 State Methadone Treatment Guidelines—Replaced by TIP 43 TIP 14 Developing State Outcomes Monitoring Systems for Alcohol and Other Drug Abuse Treatment—BKD162 TIP 2* Pregnant, Substance-Using Women—BKD107 TIP 15 Treatment for HIV-Infected Alcohol and Other Quick Guide for Clinicians QGCT02 Drug Abusers—Replaced by TIP 37 KAP Keys for Clinicians KAPT02 TIP 16 Alcohol and Other Drug Screening of Hospitalized TIP 3 Screening and Assessment of Alcohol- and Other Trauma Patients—BKD164 Drug-Abusing Adolescents—Replaced by TIP 31 Quick Guide for Clinicians QGCT16 TIP 4 Guidelines for the Treatment of Alcohol- and Other KAP Keys for Clinicians KAPT16 Drug-Abusing Adolescents—Replaced by TIP 32 TIP 17 Planning for Alcohol and Other Drug Abuse TIP 5 Improving Treatment for Drug-Exposed Infants— Treatment for Adults in the Criminal Justice BKD110 System—Replaced by TIP 44 TIP 6 Screening for Infectious Diseases Among Substance TIP 18 The Tuberculosis Epidemic: Legal and Ethical Abusers—BKD131 Issues for Alcohol and Other Drug Abuse Treatment Quick Guide for Clinicians QGCT06 Providers—BKD173 KAP Keys for Clinicians KAPT06 Quick Guide for Clinicians QGCT18 TIP 7 Screening and Assessment for Alcohol and Other KAP Keys for Clinicians KAPT18 Drug Abuse Among Adults in the Criminal Justice TIP 19* Detoxification From Alcohol and Other Drugs— System—Replaced by TIP 44 BKD172 TIP 8* Intensive Outpatient Treatment for Alcohol and Quick Guide for Clinicians QGCT19 Other Drug Abuse BKD139 — KAP Keys for Clinicians KAPT19 TIP 9 Assessment and Treatment of Patients With TIP 20 Matching Treatment to Patient Needs in Opioid Coexisting Mental Illness and Alcohol and Other Substitution Therapy—Replaced by TIP 43 Drug Abuse—Replaced by TIP 42 TIP 21 Combining Alcohol and Other Drug Abuse TIP 10 Assessment and Treatment of Cocaine-Abusing Treatment With Diversion for Juveniles in the Methadone-Maintained Patients—Replaced by TIP 43 Justice System—BKD169 TIP 11 Simple Screening Instruments for Outreach for Quick Guide for Clinicians and Administrators Alcohol and Other Drug Abuse and Infectious QGCA21 Diseases— BKD143 TIP 22 LAAM in the Treatment of Opiate Addiction— Quick Guide for Clinicians QGCT11 Replaced by TIP 43 KAP Keys for Clinicians KAPT11 TIP 23 Treatment Drug Courts: Integrating Substance TIP 12 Combining Substance Abuse Treatment With Abuse Treatment With Legal Case Processing— Intermediate Sanctions for Adults in the Criminal BKD205 Justice System Replaced by TIP 44 — Quick Guide for Administrators QGAT23 TIP 13 Role and Current Status of Patient Placement TIP 24 A Guide to Substance Abuse Services for Primary Criteria in the Treatment of Substance Use Care Clinicians—BKD234 Disorders—BKD161 Concise Desk Reference Guide BKD123 Quick Guide for Clinicians QGCT13 Quick Guide for Clinicians QGCT24 Quick Guide for Administrators QGAT13 KAP Keys for Clinicians KAPT24 KAP Keys for Clinicians KAPT13 *Under revision 331 TIP 25 Substance Abuse Treatment and Domestic TIP 34 Brief Interventions and Brief Therapies for Violence—BKD239 Substance Linking Substance Abuse Treatment and Domestic Abuse—BKD341 Violence Services: A Guide for Treatment Quick Guide for Clinicians QGCT34 Providers MS668 KAP Keys for Clinicians KAPT34 Linking Substance Abuse Treatment and Domestic TIP 35 Enhancing Motivation for Change in Substance Violence Services: A Guide for Administrators Abuse Treatment BKD342 MS667 — Quick Guide for Clinicians QGCT35 Quick Guide for Clinicians QGCT25 KAP Keys for Clinicians KAPT35 KAP Keys for Clinicians KAPT25 TIP 36 Substance Abuse Treatment for Persons With Child TIP 26 Substance Abuse Among Older Adults—BKD250 Abuse and Neglect Issues—BKD343 Substance Abuse Among Older Adults: A Guide for Quick Guide for Clinicians QGCT36 Treatment Providers MS669 KAP Keys for Clinicians KAPT36 Substance Abuse Among Older Adults: A Guide for Social Service Providers MS670 Helping Yourself Heal: A Recovering Woman’s Guide to Coping With Childhood Abuse Issues Substance Abuse Among Older Adults: Physician’s — PHD981 Guide MS671 Also available in Spanish: PHD981S Quick Guide for Clinicians QGCT26 Helping Yourself Heal: A Recovering Man’s Guide KAP Keys for Clinicians KAPT26 to Coping With the Effects of Childhood Abuse— TIP 27 Comprehensive Case Management for Substance PHD1059 Abuse Treatment—BKD251 Also available in Spanish: PHD1059S Case Management for Substance Abuse Treatment: TIP 37 Substance Abuse Treatment for Persons With A Guide for Treatment Providers MS673 HIV/AIDS—BKD359 Case Management for Substance Abuse Treatment: Fact Sheet MS676 A Guide for Administrators MS672 Quick Guide for Clinicians MS678 Quick Guide for Clinicians QGCT27 KAP Keys for Clinicians KAPT37 Quick Guide for Administrators QGAT27 TIP 38 Integrating Substance Abuse Treatment and TIP 28 Naltrexone and Alcoholism Treatment—BKD268 Vocational Services—BKD381 Naltrexone and Alcoholism Treatment: Physician’s Quick Guide for Clinicians QGCT38 Guide MS674 Quick Guide for Administrators QGAT38 Quick Guide for Clinicians QGCT28 KAP Keys for Clinicians KAPT38 KAP Keys for Clinicians KAPT28 TIP 39 Substance Abuse Treatment and Family Therapy— TIP 29 Substance Use Disorder Treatment for People With BKD504 Physical and Cognitive Disabilities—BKD288 Quick Guide for Clinicians QGCT39 Quick Guide for Clinicians QGCT29 Quick Guide for Administrators QGAT39 Quick Guide for Administrators QGAT29 TIP 40 Clinical Guidelines for the Use of Buprenorphine in KAP Keys for Clinicians KAPT29 the Treatment of Opioid Addiction—BKD500 TIP 30 Continuity of Offender Treatment for Substance TIP 41 Substance Abuse Treatment: Group Therapy— Use Disorders From Institution to Community— BKD507 BKD304 Quick Guide for Clinicians QGCT41 Quick Guide for Clinicians QGCT30 TIP 42 Substance Abuse Treatment for Persons With Co- KAP Keys for Clinicians KAPT30 Occurring Disorders—BKD515 TIP 31 Screening and Assessing Adolescents for Substance Quick Guide for Clinicians QGCT42 Use Disorders—BKD306 Quick Guide for Administrators QGAT42 See companion products for TIP 32. KAP Keys for Clinicians KAPT42 TIP 32 Treatment of Adolescents With Substance Use Disorders—BKD307 TIP 43 Medication-Assisted Treatment for Opioid Addiction in Opioid Treatment Programs—BKD524 Quick Guide for Clinicians QGC312 KAP Keys for Clinicians KAP312 TIP 44 Substance Abuse Treatment for Adults in the Criminal Justice System—BKD526 TIP 33 Treatment for Stimulant Use Disorders—BKD289 Quick Guide for Clinicians QGCT33 KAP Keys for Clinicians KAPT33

*Under revision 332 Treatment Improvement Protocols (TIPs) from the Substance Abuse and Mental Health Services Administrationís (SAMHSAís) Center for Substance Abuse Treatment (CSAT)

Place the quantity (up to 5) next to the publications you would like to receive and print your mailing address below.

___TIP 2* BKD107 ___TIP 26 BKD250 ___TIP 36 BKD343 ___QG+ for Clinicians QGCT02 ___Guide for Treatment Providers MS669 ___QG for Clinicians QGCT36 ___KK+ for Clinicians KAPT02 ___Guide for Social Service Providers ___KK for Clinicians KAPT36 MS670 ___Brochure for Women (English) ___TIP 5 BKD110 ___Physician’s Guide MS671 PHD981 ___QG for Clinicians QGCT26 ___Brochure for Women (Spanish) ___TIP 6 BKD131 ___KK for Clinicians KAPT26 PHD981S ___QG for Clinicians QGCT06 ___Brochure for Men PHD1059 ___KK for Clinicians KAPT06 ___TIP 27 BKD251 ___Brochure for Men (Spanish) ___Guide for Treatment Providers MS673 PHD1059 ___TIP 8* BKD139 ___Guide for Administrators MS672 ___QG for Clinicians QGCT27 ___TIP 37 BKD359 ___TIP 11 BKD143 ___QG for Administrators QGAT27 ___Fact Sheet MS676 ___QG for Clinicians QGCT11 ___QG for Clinicians MS678 ___KK for Clinicians KAPT11 ___TIP 28 BKD268 ___KK for Clinicians KAPT37 ___Physician’s Guide MS674 ___TIP 13 BKD161 ___QG for Clinicians QGCT28 ___TIP 38 BKD381 ___QG for Clinicians QGCT13 ___KK for Clinicians KAPT28 ___QG for Clinicians QGCT38 ___QG for Administrators QGAT13 ___QG for Administrators QGAT38 ___KK for Clinicians KAPT13 ___TIP 29 BKD288 ___KK for Clinicians KAPT38 ___QG for Clinicians QGCT29 ___TIP 14 BKD162 ___QG for Administrators QGAT29 ___TIP 39 BKD504 ___KK for Clinicians KAPT29 ___QG for Clinicians QGCT39 ___TIP 16 BKD164 ___QG for Administrators QGAT39 ___QG for Clinicians QGCT16 ___TIP 30 BKD304 ___KK for Clinicians KAPT16 ___QG for Clinicians QGCT30 ___TIP 40 BKD500 ___KK for Clinicians KAPT30 ___TIP 18 BKD173 ___TIP 41 BKD507 ___QG for Clinicians QGCT18 ___TIP 31 BKD306 ___QG for Clinicians QGCT41 ___KK for Clinicians KAPT18 (see products under TIP 32) ___TIP 42 BKD515 ___TIP 19* BKD172 ___TIP 32 BKD307 ___QG for Clinicians QGCT42 ___QG for Clinicians QGCT19 ___QG for Clinicians QGC312 ___QG for Administrators QGAT42 ___KK for Clinicians KAPT19 ___KK for Clinicians KAP312 ___KK for Clinicians KAPT42

___TIP 21 BKD169 ___TIP 33 BKD289 ___TIP 43 BKD524 ___QG for Clinicians & Administrators ___QG for Clinicians QGCT33 QGCA21 ___KK for Clinicians KAPT33 ___TIP 44 BKD526

___TIP 23 BKD205 ___TIP 34 BKD341 ___QG for Administrators QGAT23 ___QG for Clinicians QGCT34 *Under revision ___KK for Clinicians KAPT34 +QG = Quick Guide; KK = KAP Keys ___TIP 24 BKD234 ___Desk Reference BKD123 ___TIP 35 BKD342 ___QG for Clinicians QGCT24 ___QG for Clinicians QGCT35 ___KK for Clinicians KAPT24 ___KK for Clinicians KAPT35

___TIP 25 BKD239 ___Guide for Treatment Providers MS668 ___Guide for Administrators MS667 ___QG for Clinicians QGCT25 ___KK for Clinicians KAPT25

Name: Address: City, State, Zip: Phone and e-mail: You can either mail this form or fax it to (301) 468-6433. Publications also can be ordered by calling SAMHSA’s NCADI at (800) 729-6686 or (301) 468-2600; TDD (for hearing impaired), (800) 487-4889. TIPs can also be accessed online at www.kap.samhsa.gov. FOLD

STAMP

SAMHSA’s National Clearinghouse for Alcohol and Drug Information P.O. Box 2345 Rockville, MD 20847-2345

FOLD Medication-Assisted Treatment for Opioid Addiction in Opioid Treatment Programs

This TIP, Medication-Assisted Treatment for Opioid Addiction in Opioid Treatment Programs, incorporates the many changes in medication- assisted treatment for opioid addiction (MAT) that have occurred over the most active decade of change since the inception of this treatment modality approximately 40 years ago. The TIP describes the nature and dimensions of opioid use disorders and their treatment in the United States, including basic principles of MAT and historical and regulatory developments. It presents consensus panel recommendations and evidence-based best practices for treatment of opioid addiction in opioid treatment programs (OTPs). It also examines related medical, psychiatric, sociological, and substance use disorders and their treatment as part of a comprehensive maintenance treatment program. The TIP includes a discussion of the ethical considerations that arise in most OTPs, and it provides a useful summary of areas for emphasis in successfully administering MAT in OTPs.

Collateral Products Based on TIP 43 Quick Guide for Clinicians KAP Keys for Clinicians

DHHS Publication No. (SMA) 05-4048 Printed 2005

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Center for Substance Abuse Treatment