Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction
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Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction A Treatment Improvement Protocol TIP 40 U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES BP Substance Abuse and Mental Health Services Administration Buprenorphine Center for Substance Abuse Treatment Clinical Guide www.samhsa.gov BP Buprenorphine Clinical Guide Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction in the Treatment Clinical Guidelines for the Use of Buprenorphine TIP 40 Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction Laura McNicholas, M.D., Ph.D. Consensus Panel Chair A Treatment Improvement Protocol TIP 40 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 described in this document are intended or should be inferred. The guidelines in this Numerous people contributed to the document should not be considered development of this TIP (see pp. ix, xi, and substitutes for individualized client care and appendix J). This publication was produced treatment decisions. by the American Institutes for Research® (AIR) under the Center for Substance Abuse Treatment (CSAT) contract, task order Public Domain Notice number 277-00-6401 under the Substance All materials appearing in this volume except Abuse and Mental Health Services those taken directly from copyrighted sources Administration (SAMHSA) contract, Number are in the public domain and may be 277-99-6400, U.S. Department of Health and reproduced or copied without permission from Human Services (DHHS). CAPT Susanne SAMHSA/CSAT or the authors. Do not Caviness, Ph.D., SR SURG Angel A. reproduce or distribute this publication for a González, M.D., and Raymond Hylton, Jr., fee without specific, written authorization R.N., M.S.N., served as the CSAT from SAMHSA’s Office of Communications. Government Project Officers. Anton C. Bizzell, M.D., and Alan Trachtenberg, M.D., M.P.H., served as the CSAT Medical Editors. Electronic Access and Copies Christina Currier served as the CSAT TIPs of Publication Task Leader. Elizabeth F. Howell, M.D., served as the Senior Medical Editor. Wayne Copies may be obtained free of charge from SAMHSA’s National Clearinghouse for Alcohol Brandes, D.O., M.P.H., served as the AIR and Drug Information (NCADI), Medical Editor and Project Director. Janet (800) 729-6686 or (301) 468-2600; TDD (for Carrese served as the AIR Deputy Project the hearing impaired), (800) 487-4889; or Director. Other AIR personnel included Susan electronically through the following site: Bratten, Senior Editor; Susan Keller, M.P.H., http://www.kap.samhsa.gov/products/ M.S., B.S.N., Quality Assurance Editor; and manuals/index.htm. Patricia Louthian, Document Production Specialist. In addition, Center for Health Policy Studies (CHPS) Consulting staff Roy Recommended Citation Walker, M.B.A., Kimberly Stern, M.H.A., Center for Substance Abuse Treatment. Elly Gilbert, M.S., R.N., C.H.E.S., and Ji Clinical Guidelines for the Use of Kim served as the original support team for Buprenorphine in the Treatment of Opioid the consensus and field review panels. Writers Addiction. Treatment Improvement Protocol were Margaret Boone, Ph.D.; Nancy J. (TIP) Series 40. DHHS Publication No. (SMA) Brown; Mary A. Moon; Deborah J. Schuman; 04-3939. Rockville, MD: Substance Abuse and Josephine Thomas, M.F.A.; and Denise L. Mental Health Services Administration, 2004. Wright, Ph.D. Disclaimer Originating Office The opinions expressed herein are the views of Division of Pharmacologic Therapies, Center the consensus panel members and do not for Substance Abuse Treatment, Substance Abuse and Mental Health Services necessarily reflect the official position of Administration, 1 Choke Cherry Road, CSAT, SAMHSA, or DHHS. No official Rockville, MD 20857. support of or endorsement by CSAT, SAMHSA or DHHS for these opinions or for DHHS Publication No. (SMA) 04-3939 particular instruments, software, or resources Printed 2004 ii Contents What Is a TIP? .................................................................................................... vii Consensus Panel ................................................................................................... ix Buprenorphine Expert Panel .................................................................................. xi Foreword .......................................................................................................... xiii Executive Summary ............................................................................................. xv Chapter 1 Introduction ......................................................................................... 1 Practical Guidelines for Physicians ............................................................................ 1 Opioid Addiction Today in the United States ................................................................. 3 Current State of Opioid Addiction Treatment ................................................................ 4 Current Pharmacotherapy Treatment Options for Opioid Addiction .................................. 5 Buprenorphine: A New Treatment Option for Opioid Addiction ........................................ 6 Summary and Overview of the Guidelines .................................................................... 9 Chapter 2 Pharmacology ......................................................................................11 Overview ............................................................................................................ 11 General Opioid Pharmacology ................................................................................. 11 Pharmacology of Buprenorphine ............................................................................. 14 Buprenorphine Safety, Adverse Reactions, and Drug Interactions ................................... 18 Effectiveness of Buprenorphine Treatment ................................................................. 20 The Buprenorphine/Naloxone Combination ................................................................ 23 Diversion and Misuse of Either Buprenorphine Alone or the Buprenorphine/Naloxone Combination Product .......................................................... 23 Summary ............................................................................................................ 24 Chapter 3 Patient Assessment ................................................................................25 Overview ............................................................................................................ 25 Screening and Assessment of Opioid Use Disorders ...................................................... 25 Determining Appropriateness for Buprenorphine Treatment .......................................... 41 Chapter 4 Treatment Protocols .............................................................................49 Overview ............................................................................................................ 49 Maintenance Treatment With Buprenorphine ............................................................. 51 Opioid Detoxification With Buprenorphine ................................................................ 58 Patient Management ............................................................................................. 63 iii Chapter 5 Special Populations ...............................................................................67 Overview .......................................................................................................... 67 Patients With Medical Comorbidities ...................................................................... 67 Pregnant Women and Neonates ............................................................................. 68 Adolescents/Young Adults ..................................................................................... 71 Geriatric Patients ............................................................................................... 73 Patients With Significant Psychiatric Comorbidity ..................................................... 73 Polysubstance Abuse ........................................................................................... 74 Patients With Pain ............................................................................................. 74 Patients Recently Discharged From Controlled Environments ...................................... 77 Healthcare Professionals Who Are Addicted to Opioids ............................................... 78 Chapter 6 Policies and Procedures .........................................................................79 Overview .......................................................................................................... 79 The DATA 2000 Waiver ....................................................................................... 79 Preparing for Office-Based Opioid Treatment ........................................................... 81 Confidentiality and Privacy .................................................................................. 83 Buprenorphine Use in OTPs ................................................................................. 84 Appendix A Bibliography .................................................................................... 87 Appendix B Assessment and Screening Instruments .................................................101