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AHCPR Archived reports, Put Prevention Into Practice and Minnesota Health Technology Advisory Committee SAMHSA/CSAT Treatment Improvement Protocols

40. TIP 40. Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction

Laura McNicholas
Consensus Panel ChairM.D. Ph.D.


Title page

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

Substance Abuse and Mental Health Services Administration

Center for Substance Abuse Treatment

1 Choke Cherry Road

Rockville, MD 20857

This Treatment Improvement Protocol (TIP), Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction, provides consensus - and evidence -based treatment guidance for the use of buprenorphine, a new option for the treatment of opioid addiction. The goal of this TIP is to provide physicians with information they can use to make practical and informed decisions about the use of buprenorphine to treat opioid addiction. These guidelines address the pharmacology and physiology of opioids, opioid addiction, and treatment with buprenorphine; describe patient assessment and the choice of opioid addiction treatment options; provide detailed treatment protocols for opioid withdrawal and maintenance therapy with buprenorphine; and include information on the treatment of special populations, e.g., pregnant women, adolescents, and polysubstance users. This TIP represents another step by the Center for Substance Abuse Treatment (CSAT) toward its goal of bringing national leaders together to improve substance use disorder treatment in the United States.

DHHS Publication No. (SMA) 04 -3939

Printed 2004

Acknowledgments

Numerous people contributed to the development of this TIP (see pp. ix, xi, and appendix J). This publication was produced by the American Institutes for Research[reg] (AIR) under the Center for Substance Abuse Treatment (CSAT) contract, task order number 277 -00 -6401 under the Substance Abuse and Mental Health Services Administration (SAMHSA) contract, Number 277 -99 -6400, U.S. Department of Health and Human Services (DHHS). CAPT Susanne Caviness, Ph.D., SR SURG Angel A. González, M.D., and Raymond Hylton, Jr., R.N., M.S.N., served as the CSAT Government Project Officers. Anton C. Bizzell, M.D., and Alan Trachtenberg, M.D., M.P.H., served as the CSAT Medical Editors. Christina Currier served as the CSAT TIPs Task Leader. Elizabeth F. Howell, M.D., served as the Senior Medical Editor. Wayne Brandes, D.O., M.P.H., served as the AIR Medical Editor and Project Director. Janet Carrese served as the AIR Deputy Project Director. Other AIR personnel included Susan Bratten, Senior Editor; Susan Keller, M.P.H., M.S., B.S.N., Quality Assurance Editor; and Patricia Louthian, Document Production Specialist. In addition, Center for Health Policy Studies (CHPS) Consulting staff Roy Walker, M.B.A., Kimberly Stern, M.H.A., Elly Gilbert, M.S., R.N., C.H.E.S., and Ji Kim served as the original support team for the consensus and field review panels. Writers were Margaret Boone, Ph.D.; Nancy J. Brown; Mary A. Moon; Deborah J. Schuman; Josephine Thomas, M.F.A.; and Denise L. Wright, Ph.D.top link

Disclaimer

The opinions expressed herein are the views of the consensus panel members and do not necessarily reflect the official position of CSAT, SAMHSA, or DHHS. No official support of or endorsement by CSAT, SAMHSA or DHHS for these opinions or for particular instruments, software, or resources described in this document are intended or should be inferred. The guidelines in this document should not be considered substitutes for individualized client care and treatment decisions.top link

Public Domain Notice

All materials appearing in this volume except those taken directly from copyrighted sources are in the public domain and may be reproduced or copied without permission from SAMHSA/CSAT or the authors. Do not reproduce or distribute this publication for a fee without specific, written authorization from SAMHSA's Office of Communications.top link

Electronic Access and Copies of Publication

Copies may be obtained free of charge from SAMHSA's National Clearinghouse for Alcohol and Drug Information (NCADI), (800) 729 -6686 or (301) 468 -2600; TDD (for the hearing impaired), (800) 487 -4889; or electronically through the following site: http://www.kap.samhsa.gov/products/manuals/index.htm.top link

Recommended Citation

Center for Substance Abuse Treatment. Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction. Treatment Improvement Protocol (TIP) Series 40. DHHS Publication No. (SMA) 04 -3939. Rockville, MD: Substance Abuse and Mental Health Services Administration, 2004.top link

Originating Office

Division of Pharmacologic Therapies, Center for Substance Abuse Treatment, Substance Abuse and Mental Health Services Administration, 1 Choke Cherry Road, Rockville, MD 20857.

DHHS Publication No. (SMA) 04 -3939

Printed 2004top link

What Is a TIP?

Treatment Improvement Protocols (TIPs) are best -practice guidelines for the treatment of substance use disorders, provided as a service of the Substance Abuse and Mental Health Services Administration's (SAMHSA's) Center for Substance Abuse Treatment (CSAT). CSAT's Office of Evaluation, Scientific Analysis and Synthesis draws on the experience and knowledge of clinical, research, and administrative experts to produce the TIPs, which are distributed to a growing number of facilities and individuals across the country. As alcoholism and other substance use disorders are increasingly recognized as major problems, the audience for the TIPs is expanding beyond public and private substance use disorder treatment facilities.

After selecting a topic, CSAT invites staff from pertinent Federal agencies and national organizations to a resource panel that recommends specific areas of focus as well as resources that should be considered in developing the content of the TIP. Then recommendations are communicated to a consensus panel composed of experts who have been nominated by their peers. This panel participates in a series of discussions; the information and recommendations on which they reach consensus become the foundation of the TIP. The members of each consensus panel represent substance use disorder treatment programs, hospitals, community health centers, counseling programs, criminal justice and child welfare agencies, and private practitioners. A panel chair (or cochairs) ensures that the guidelines mirror the results of the group's collaboration.

A large and diverse group of experts reviews the draft document closely. The Buprenorphine Expert Panel, a distinguished group of substance abuse experts and professionals in such related fields as primary care, mental health, and social services, worked with the Consensus Panel Chair and the CSAT Division of Pharmacologic Therapies to generate new and updated changes to the subject matter for this TIP based on the field's current needs for information and guidance. Once the changes recommended by the field reviewers have been incorporated, the TIP is prepared for publication in print and online.

The TIPs can be accessed via the Internet at http://www.kap.samhsa.gov/products/manuals/index.htm. The use of electronic media also means that the TIPs can be updated more easily so that they can continue to provide the field with state -of -the -art information. Although each TIP includes an evidence base for the practices its panel recommends, CSAT recognizes that the field of substance use disorder treatment is evolving continuously and that research frequently lags behind the innovations pioneered by those in the field. A major goal of each TIP is to convey "front line" information quickly but responsibly. For this reason, recommendations in the TIP are attributed either to panelists' clinical experience or to the appropriate literature. If there is research to support a particular approach, citations are provided.

This TIP, Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction, provides consensus - and evidence -based guidance on the use of buprenorphine, a new option for the treatment of opioid addiction. The goal of this TIP is to provide information that physicians can use to make practical and informed decisions about the use of buprenorphine to treat opioid addiction. The Guidelines address a number of topic areas related to this goal, including the physiology and pharmacology of opioids, opioid addiction, and treatment with buprenorphine; the screening and assessment of opioid addiction problems; detailed protocols for opioid addiction treatment with buprenorphine; management of special populations; and policies and procedures related to office -based opioid addiction treatment under the paradigm established by the Drug Addiction Treatment Act of 2000. This TIP represents another step by CSAT toward its goal of bringing national leaders together to improve substance use disorder treatment in the United States.

Other TIPs may be ordered by contacting the National Clearinghouse for Alcohol and Drug Information (NCADI), (800) 729 -6686 or (301) 468 -2600; TDD (for the hearing impaired), (800) 487 -4889. See http://www.kap.samhsa.gov/products/manuals/index.htm.top link

Consensus Panel

Chair


Laura McNicholas, M.D., Ph.D.
Clinical Assistant Professor
Department of Psychiatry
University of Pennsylvania Treatment Research Center
Philadelphia, Pennsylvania
Panelists


Tony Aguilar, L.M.F.T.
Legislative Consultant
California Department of Social Services
Sacramento, California

Daniel Alford, M.D., M.P.H.
Association for Medical Education and Research in Substance Abuse (AMERSA)
Assistant Professor of Medicine
Boston University School of Medicine
Clinical Addiction Research and Education Unit
Boston, Massachusetts

Catherine T. Baca, M.D.
Clinical Supervisor
Center on Alcoholism, Substance Abuse, and Addictions
Albuquerque, New Mexico

Thomas J. Croce, Jr., R.Ph. (replacing Jann B. Skelton)
Senior Manager
Strategic Alliances
American Pharmaceutical Association
Philadelphia, Pennsylvania

George De Leon, Ph.D.
Director
Center for Therapeutic Community Research of The National Development and Research Institutes
New York, New York

Elizabeth F. Howell, M.D.
Senior Medical Editor
Atlanta, Georgia

Martin Iguchi, Ph.D.
Senior Behavioral Scientist
Director
Drug Policy Research Center
Rand Corporation
Santa Monica, California

Herbert D. Kleber, M.D.
Professor of Psychiatry
Director
The Division on Substance Abuse
Columbia University
New York, New York

Ervin Lewis, M.D.
Area Chief Medical Officer
Albuquerque Area Indian Health Service
Albuquerque, New Mexico

James J. Manlandro, D.O.
Medical Director
Family Addiction Treatment Services
Rio Grande, New Jersey

Andrew J. Saxon, M.D.
Professor
Department of Psychiatry and Behavioral Sciences
University of Washington
Center of Excellence in Substance Abuse Treatment and Education
VA Puget Sound Health Care System
Seattle, Washington

Charles R. Schuster, Ph.D.
Professor
Department of Psychiatry and Behavioral Neuroscience
Wayne State University School of Medicine
Detroit, Michigan

Audrey Sellers, M.D.
Medical Director
Bay Area Addiction Research and Treatment, Inc.
San Francisco, California

Jann B. Skelton, R.Ph., M.B.A.
Vice President
U.S. Wellness, Inc.
Gaithersburg, Maryland

David E. Smith, M.D.
President and Founder
Haight Ashbury Free Clinic
San Francisco, California

Eric C. Strain, M.D.
Professor
Johns Hopkins University School of Medicine
Baltimore, Maryland

Joycelyn Woods, M.A.
President
National Alliance of Methadone Advocates
New York, New York
Buprenorphine Expert Panel

Chair


Eric C. Strain, M.D.
Professor
Johns Hopkins University School of Medicine
Baltimore, Maryland

Leslie Amass, Ph.D.
Principal Investigator
Friends Research Institute, Inc.
Los Angeles, California

David Fiellin, M.D.
Associate Professor of Medicine
Yale University School of Medicine
Primary Care Center
Yale -New Haven Hospital
New Haven, Connecticut

R. E. Johnson, Pharm.D.
Professor
Department of Psychiatry and Behavioral Sciences
Behavioral Pharmacology Research Unit
Johns Hopkins University School of Medicine
Baltimore, Maryland

Thomas R. Kosten, M.D.
Professor of Psychiatry
Yale University School of Medicine
Deputy Chief of Psychiatry Research
VA Connecticut Healthcare System
West Haven, Connecticut

James J. Manlandro, D.O.
Medical Director
Family Addiction Treatment Services
Rio Grande, New Jersey

Elinore F. McCance -Katz, M.D., Ph.D.
Professor of Psychiatry and Chair
Addiction Psychiatry
Medical College of Virginia
Virginia Commonwealth University
Richmond, Virginia

Joe Merrill, M.D., M.P.H.
Research Scientist
Division of General Medicine
Harborview Medical Center
Seattle, Washington

Geoff Mumford, Ph.D.
American Psychological Association
Washington, District of Columbia

Richard T. Suchinsky, M.D.
Associate Director for Addictive Disorders and Psychiatric Rehabilitation
U.S. Department of Veterans Affairs
Veterans Health Administration
Washington, District of Columbia
Foreword

Our Nation has made great strides in recent years in achieving recovery for persons with substance use disorders. We know much more about how to deliver recovery -oriented substance abuse treatment, improve service quality, achieve desired improvements in quality -of -life outcomes, and implement needed care systems in each community in the United States. Our vision is of a life in the community for everyone.

The Treatment Improvement Protocol (TIP) series promotes resilience and facilitates recovery from substance use disorders. The TIPs add to our knowledge base and provide best practice guidance to clinicians, program administrators, and payors. They are the result of careful consideration of all relevant clinical and health services research findings, demonstration experience, and implementation requirements. For each TIP topic, an expert panel of non -Federal clinical researchers, clinicians, program administrators, and patient advocates debates and discusses best practices until its members reach a consensus.

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 advances in the substance use disorder treatment field.

We hope you will find many uses for the information contained in this volume and that you will join in our goal of helping all Americans with substance use disorders realize healthy, contributing lives in their communities nationwide.

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 Administrationtop link


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