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LAAM in the Treatment of Opiate Addiction: Treatment Improvement Protocol (TIP) Series 22

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LAAM in the Treatment of Opiate Addiction: Treatment Improvement Protocol (TIP) Series 22 TIP 22: LAAM in the Treatment of Opiate Addiction: Treatment Improvement Protocol (TIP) Series 22 A43664 Ira J. Marion, M.A. Consensus Panel Chair U.S. Department of Health and Human Services Public Health Service Substance Abuse and Mental Health Services Administration Center for Substance Abuse Treatment Rockwall II, 5600 Fishers Lane Rockville, MD 20857 DHHS Publication No. (SMA) 95-3052 Printed 1995. Disclaimer This publication is part of the Substance Abuse Prevention and Treatment Block Grant technical assistance program. All material appearing in this volume except quoted passages from copyrighted sources is in the public domain and may be reproduced or copied without permission from the Center for Substance Abuse Treatment (CSAT) or the authors. Citation of the source is appreciated. This publication was written under contract number ADM 270-91-0007 from the Center for Substance Abuse Treatment of the Substance Abuse and Mental Health Services Administration (SAMHSA). Sandra Clunies, M.S., served as the CSAT Government project officer. Robert A. Lubran, M.S., M.P.A., was the Government content advisor. Carolyn Davis, Constance Gartner, Linda Harteker, Lise Markl, Barbara Shapiro, and Deborah Shuman served as writers. The opinions expressed herein are the views of the consensus panel members and do not reflect the official position of CSAT or any other part of the U. S. Department of Health and Human Services (DHHS). No official support or endorsement of CSAT or DHHS for these opinions or for particular instruments or software that may be described in this document is intended or should be inferred. The guidelines proffered in this document should not be considered as substitutes for individualized patient care and treatment decisions. What Is a TIP? CSAT Treatment Improvement Protocols (TIPs) are prepared by the Quality Assurance and Evaluation Branch to facilitate the transfer of state-of-the-art protocols and guidelines for the treatment of alcohol and other drug (AOD) abuse from acknowledged clinical, research, and administrative experts to the Nation's AOD abuse treatment resources. The dissemination of a TIP is the last step in a process that begins with the recommendation of an AOD abuse problem area for consideration by a panel of experts. These include clinicians, researchers, and program managers, as well as professionals in such related fields as social services or criminal justice. Once a topic has been selected, CSAT creates a Federal resource panel, with members from pertinent Federal agencies and national organizations, to review the state of the art in treatment and program management in the area selected. Recommendations from this Federal panel are then communicated to the members of a second group, which consists of non-Federal experts who are intimately familiar with the topic. This group, known as a non-Federal consensus panel, meets in Washington for 5 days, makes recommendations, defines protocols, and arrives at agreement on protocols. Its members represent AOD abuse treatment programs, hospitals, community health centers, counseling programs, criminal justice and child welfare agencies, and private practitioners. A Chair (or Co-Chairs) for the panel is charged with responsibility of ensuring that the resulting protocol reflects true group consensus. The next step is a review of the proposed guidelines and protocol by a third group whose members serve as expert field reviewers. Once their recommendations and responses have been reviewed, the Chair approves the document for publication. The result is a TIP reflecting the actual state of the art of AOD abuse treatment in public and private programs recognized for their provision of high quality and innovative treatment. This TIP, titled LAAM in the Treatment of Opiate Addiction, presents current knowledge about the use of levo-alpha-acetyl-methadol (LAAM), an opioid agonist medication approved for use in 1993. LAAM suppresses opiate withdrawal symptoms for more than 72 hours, and it can be administered no more frequently than every other day. Thus, daily visits to the program clinic are not required for LAAM-maintained patients, as are visits for patients on methadone. In addition to the difference in dosing schedule, no take-home doses of LAAM are permitted under Federal regulations, and women of child-bearing potential must be tested monthly for pregnancy. The introduction of LAAM into the current treatment system will require programs to educate staff and patients about the use of LAAM. This TIP describes the medication itself, its mode of action, possible side effects, and interactions with other medications. A separate chapter on clinical use of LAAM presents guidelines for selecting patients who may benefit from LAAM and starting and maintaining them on the medication. A chapter on treatment planning addresses issues that may arise for counselors and patients, such as structuring free time and creating incentives for treatment progress. Issues for program managers and administrators, including staff education and costs of LAAM, are discussed in another chapter. A chapter on regulatory and ethical issues is included. As LAAM is introduced, programs will be a source of important data about its use, and the TIP presents suggestions for research in several areas. This TIP represents another step by CSAT toward its goal of bringing national leadership to bear in the effort to improve AOD abuse treatment. Other TIPS may by ordered by contacting the National Clearinghouse for Alcohol and Drug Information (NCADI), (800) 729-6686 or (301) 468-2600; TDD (for hearing impaired), (800) 487-4889. Contents Consensus Panel Foreword Chapter 1 - Introduction Chapter 2 - Clinical Profile of LAAM Chapter 3 - Clinical Application of LAAM Therapy Chapter 4 - Treatment Planning Chapter 5 - Management and Administrative Issues Chapter 6 - Regulatory and Ethical Issues Appendix A - Bibliography Appendix B - Training Resources Appendix C - Federal Resource Panel Appendix D - Field Reviewers TIP 22: Consensus Panel Chair Ira J. Marion, M.A. Associate Executive Director, Division of Substance Abuse Albert Einstein College of Medicine of Yeshiva University Bronx, New York Facilitators Sharon R. Dow M.S. Chief, Program Planning and Policy Development Maryland Alcohol and Drug Abuse Administration Baltimore, Maryland J. Thomas Payte, M.D. Medical Director Drug Dependence Associates San Antonio, Texas Richard A. Rawson, Ph.D. Executive Director Matrix Center Beverly Hills, California Workgroup Members Hope Bolger, R.Ph. Methadone Services Consultant Department of Mental Health, Mental Retardation and Substance Abuse Services Office of Substance Abuse Services Richmond, Virginia Richard Christensen, P.A., C.A.S. Director of Medical Services Valle del Sol Phoenix, Arizona Eugenia Curet, M.S.W. Administrator, Adult Methadone Clinic The New York Hospital New York, New York Robert S. Geissinger, C.C.D.C. III Certification Specialist, Certification Section Division of Alcohol and Substance Abuse Department of Social and Health Services Lacey, Washington Michael G. Hayes, M.D. Medical Director Man Alive Research, Inc. Baltimore, Maryland Nancy Jane Heilman, M.S. Program Manager, Division of Substance Abuse New Mexico Department of Health Santa Fe, New Mexico Roland C. Lamb Director, Methadone Clinic Parkside Human Services and Associates Philadelphia, Pennsylvania Beny J. Primm, M.D. Executive Director Addiction Research and Treatment Corporation Brooklyn, New York Richard B. Resnick, M.D. Clinical Associate Professor, Department of Psychiatry New York University School of Medicine New York, New York Marianne L. Scheck, R.N., B.S., C.A.D.C. Mental Health Specialist I Family Support Team, Children's Services Division Marion County Drug Treatment Program Salem, Oregon Harold C. Urschel III, M.D., M.B.A. President and CEO The Urschel Enterprise Group Dallas, Texas Janicemarie K. Vinicky, Ph.D. Chairperson, Department of Bioethics Washington Hospital Center Washington, D.C. Foreword The Treatment Improvement Protocol (TIP) series fulfills CSAT's mission to improve alcohol and other drug (AOD) abuse and dependency treatment by providing best practices guidance to clinicians, program administrators, and payers. This guidance, in the form of a protocol, results from a 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 patient advocates employs a consensus process to produce the product. This panel's work is reviewed and critiqued by field reviewers as it evolves. The talent, dedication, and hard work that TIPs panelists and reviewers bring to this highly participatory process have bridged the gap between the promise of research and the needs of practicing clinicians and administrators. We are grateful to all who have joined with us to contribute to advance our substance abuse treatment field. Nelba Chavez, Ph.D. Administrator Substance Abuse and Mental Health Services Administration David J. Mactas Director Center for Substance Abuse Treatment TIP 22: Chapter 1 - Introduction LAAM (levo-alpha-acetyl-methadol) is a synthetic opioid agonist medication for use in the treatment of opiate addiction. It was approved by the Food and Drug Administration (FDA) in July 1993 and became commercially available in August 1993. Like methadone, LAAM creates a pharmacologic cross-tolerance to other opioids and therefore
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