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--> Federal Regulation of Methadone Treatment Richard A. Rettig and Adam Yarmolinsky, Editors Committee on Federal Regulation of Methadone Treatment Division of Biobehavioral Sciences and Mental Disorders INSTITUTE OF MEDICINE NATIONAL ACADEMY PRESS Washington, D.C. 1995
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--> NATIONAL ACADEMY PRESS 2101 Constitution Avenue, N.W. Washington, DC 20418 NOTICE: The project that is the subject of this report was approved by the governing board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competencies and with regard to appropriate balance. This report has been reviewed by a group other than the authors according to procedures approved by a report review committee consisting of members of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The Institute of Medicine was chartered in 1970 by the National Academy of Sciences to enlist distinguished members of the appropriate professions in the examination of policy matters pertaining to the health of the public. In this the Institute acts under both the Academy's 1863 congressional charter responsibility to be an advisor to the federal government and its own initiative in identifying issues of medical care, research, and education. Support for this project was provided by the U.S. Public Health Service pursuant to Contract No. 282-92-0079. Library of Congress Catalog Card No. 94-74890 International Standard Book No. 0-309-05240-8 Additional copies of the report are available from: National Academy Press 2101 Constitution Avenue, N.W. P.O. Box 285 Washington, DC 20055 Call 800-624-6242 or 202-334-3313 (in the Washington Metropolitan Area). B520 Copyright 1995 by the National Academy of Sciences. All rights reserved. Printed in the United States of America The serpent has been a symbol of long life, healing, and knowledge among almost all cultures and religions since the beginning of recorded history. The image adopted as a logotype by the Institute of Medicine is based on a relief carving from ancient Greece, now held at the Staatlichemuseen in Berlin. First Printing, January 1995 Second Printing, May 1995
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--> COMMITTEE ON THE FEDERAL REGULATION OF METHADONE TREATMENT ADAM YARMOLINSKY (Chairman), Regents Professor of Public Policy in the University of Maryland System, University of Maryland, Baltimore County, Baltimore, Maryland M. DOUGLAS ANGLIN, Director, Drug Abuse Research Center, UCLA Neuropsychiatric Institute, Los Angeles, California JOHN C. BALL, Senior Scientist, Center for Studies on Addiction, University of Pennsylvania, School of Medicine, Philadelphia, Pennsylvania JANICE F. KAUFFMAN, Director, Substance Abuse Treatment Services, North Charles, Inc., Harvard Medical School, Department of Psychiatry, The Cambridge Hospital, Somerville, Massachusetts MARY JEANNE KREEK, Professor and Head of Laboratory, Laboratory on the Biology of Addictive Diseases, The Rockefeller University, New York, New York A. THOMAS MCLELLAN, Research Professor of Psychiatry, Center for Studies on Addiction, University of Pennsylvania, School of Medicine, Philadelphia, Pennsylvania J. THOMAS PAYTE, Founder and Medical Director, Drug Dependence Associates, San Antonio, Texas MICHAEL L. PRENDERGAST, Drug Abuse Research Center, UCLA Neuropsychiatric Institute, Los Angeles, California PETER REUTER, School of Public Affairs, University of Maryland, College Park, Maryland LEE N. ROBINS, Professor of Social Science in Psychiatry, University Professor of Social Science, Department of Psychiatry, Washington University, School of Medicine, St. Louis, Missouri RICHARD J. RUSSO, Consultant, Substance Abuse Policy, West Trenton, New Jersey MARGUERITE T. SAUNDERS, Commissioner, Office of Alcoholism and Substance Abuse Services, State of New York, Albany, New York LEE SECHREST, Professor, Department of Psychology, University of Arizona, Tucson, Arizona EDWARD C. SENAY, Professor of Psychiatry, University of Chicago, Chicago, Illinois LISA MOJER-TORRES, Attorney, Jersey City, New Jersey WILLIAM W. VODRA, Senior partner, Arnold & Porter, Washington, D.C. JERRY V. WILSON, Senior Vice President, Crime Control Research Corporation, Washington, D.C.
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--> Study Staff RICHARD A. RETTIG, Study Director ELAINE LAWSON, Research Assistant THELMA L. COX, Project Assistant ROBERT COOK-DEEGAN, Director, Division of Biobehavioral Sciences and mental Disorders (until October 1994) CONSTANCE PECHURA, Director, Division of Biobehavioral Sciences and Mental Disorders (from October 1994)
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--> Acknowledgments This report results from the deliberations of the Institute of Medicine Committee on Federal Regulation of Methadone Treatment and its conclusions and recommendations reflect the judgments of the committee. Support for this study was provided by the U.S. Public Health Service (Contract No. 282-92-0079). The actual preparation of the report under the direction of the committee has been accomplished by the collective efforts of committee members, staff, and other contributors. The committee wishes to acknowledge its gratitude for these various contributions. Thanks for assistance in the preparation of this report, the provision of information, and the checking of facts are due to many people and organizations. The New York State Office of Alcoholism and Substance Abuse Services, headed by Marguerite Saunders, a member of the committee, deserves special thanks. In particular, the following individuals provided much assistance: Addi Corradi, Vincent Fenlon, William Lachanski, John Perez, Anthony Scro, and Frank Tardalo. The New York State Committee of Methadone Program Administrators prepared an analysis of federal regulations at the request of the Institute of Medicine. Thanks go especially to Martin Livenstein and Frank McGurk, and to their colleagues, for a document that was highly informative and very useful to the committee in the early stages of its work. Visits to methadone clinics were made in a number of cities. Clinic visits in New York City were facilitated by Sy Dempsky and Richard Marx at Mt. Sinai Hospital Narcotic and Rehabilitation Center, Elizabeth Khuri, the Adolescent Development Program, New York Hospital and Cornell Medical College. A tour of the Rockefeller University laboratories of Mary Jeanne Kreek was arranged by Janel Maki. At Beth Israel Hospital, we met with Robert Newman, Nina Peyser, Stuart Nichols, Marie Marciano, and Donald Des Jarlais, and were shown a treatment program by Lolita Silva. Massachusetts methadone program directors who met with the study director included Vincent Tobin, Edward Bloniari, Matthew Davis, Tim Schuettje, Harvey Kauffman, Norma Reppucci, Brian Foss, and Pat Rushton. Karst Besteman, director of the Substance Abuse Center, Institute for Behavior Resources, Inc., Washington, D.C., provided
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--> valuable historical information as well as a tour of two facilities. Jeffrey A. Hoffman, of Adapt, Inc., and Koba Associates, Inc., Washington, D.C., also arranged a facility tour and shared with the study the benefits of his research. In Baltimore, we visited Man Alive, courtesy of its long-time director, Richard Lane, who is now deceased. At the Sinai Hospital Drug Dependence Program in Baltimore, Franklin T. Evans hosted our visit. Robert W. Schuster, former Director of the National Institute on Drug Abuse (NIDA), under whom this study originated, provided counsel early in the study. The oversight committee of the Department of Health and Human Services for this study included Lorraine Fishback, Office of the Assistant Secretary of Health, Nicholas Reuter, Food and Drug Administration (FDA); Dorynne Czechowicz, Steve Molinari, and James Cooper of NIDA, and Robert Lubran, Center for Substance Abuse Treatment, Substance Abuse and Mental Health Services Administration (SAMHSA). At NIDA, we also received help from Bennett Fletcher, Charles Grudzinskas, and Frank Vocci. At SAMHSA, Sue Becker, Jerome Jaffe, Herman Diesenhaus, and Mady Chalk were helpful to the study. Additional help was provided by the following individuals at the FDA: Stuart Nightingale, Curtis Wright, Betty Jones, Ellsworth Dory, and Ross Laderman. A special note of thanks goes to David E. Joranson, associate director for Policy Studies, Pain Research Group, University of Wisconsin-Madison, for providing his own comments and stimulating communications from others to the committee regarding the effects of the methadone regulations on the management of pain. At the Drug Enforcement Administration, Thomas Gitchel, Ann Carter, Frank Sapienza, and Howard McLain were helpful at various times during the study. At the Office of National Drug Control Policy (ONDCP), John Gregorich and Sam Schildhaus were helpful, as was Lee Brown, director of ONDCP. Peter Edelman, counsel to the Secretary of Health and Human Services, met with the chairman and study director midway in the study and provided useful guidance on the departmental perspective on drug policy. Regarding the actual writing of the report, the first draft of chapter 1 was prepared by Richard Rettig and then reviewed extensively by the entire committee. Chapter 2 was written by Mary Jeanne Kreek. Sally Satel assisted on an early draft and Constance Pechura also provided helpful assistance. Chapter 3 was written by Lee Robins and Douglas Anglin. Robins conducted special analyses of the Epidemiologic Catchment Area study data for this chapter. Anglin received assistance in analyzing drug use forecasting data from Vincent Fenlon in the New York State Office of Alcoholism and Substance Abuse Services, Susan Nisenbaum in the California Department of Alcohol and Drug Programs, and Talbert Cottey, at the National Institute of Justice, and for data analysis from Jessie Hsieh and Mel Widawski, at the University of
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--> California, Los Angeles Drug Abuse Research Center. Chapter 4 was written by Michael Prendergast, who was assisted by Dana Baldwin. Chapter 5 was written by Richard Rettig, who benefited from extensive documentation provided by Steve Molinari and James Cooper of NIDA, and from presentations to the committee by Peter Hutt, Jerome Jaffe, and Stewart Nightingale. Chapter 6 was written by Miriam Davis, consultant to the committee. She wishes to acknowledge the assistance of Daniel Melnick and Robert Lubran, SAMHSA; Elsworth Dory, FDA; Ralph Swindle, Veterans Affairs Medical Center, Palo Alto, Department of Veterans Affairs; Henrick Harwood and Douglas Fountain, Lewin-VHI, Inc.; Thomas D'Aunno, University of Michigan;, Helen Levine Batten, Brandeis University; William Butynski, National Association of State Alcohol and Drug Abuse Directors; Mark Parrino, American Methadone Treatment Association; Addie Corradi, New York State Office of Alcoholism and Substance Abuse Services; Joy Jarfors, California Department of Alcohol and Drug Programs; Phil Emenheiser, Florida Department of health and Rehabilitative Services; Richard Weisskopf, Illinois Department of Alcoholism and Substance Abuse; and Barbara Espey, Massachusetts Department of Public Health. Chapter 7 was written by Janice Kauffman, Thomas Payte, and Thomas McLellan. Chapter 8 was written by Richard Rettig. Thelma Cox, with patience, good humor, and grace, supported the project throughout its duration and prepared the many drafts and the camera-ready copy of this report with her usual competence. The readability of the report benefited immensely from the exemplary editorial work of Andrea Posner. Lastly, the chairman wishes to add that this report could not have been produced without the extraordinary efforts of Richard Rettig, who devoted more time, energy, and common sense to the effort than the committee and its chairman had any reason to expect or ask for. Neither could it have been produced without the active participation of committee members in the actual writing of the report—a practice that has characterized the Institute of Medicine from its beginnings—and in their willingness to resolve their differences in an amicable and reasonable fashion, making the task of the chairman that much less difficult. ADAM YARMOLINSKY, CHAIRMAN COMMITTEE ON THE FEDERAL REGULATION OF METHADONE TREATMENT
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--> Contents Executive Summary 1 1 Introduction 17 The Charge to the Committee 19 Objectives of Opiate Addiction Treatment 20 Effectiveness of Methadone Maintenance Treatment 21 Why Methadone Is Regulated Differently from Other Drugs 27 The Committee's View 30 Report Organization 31 Study Methods 33 A Note on Terminology 34 2 Pharmacology and Medical Aspects of Methadone Treatment 37 The Rationale for Pharmacotherapy 37 Pharmacokinetics of Methadone 42 Methadone Maintenance 43 Interactions of Methadone with Other Drugs 48 Impact of Methadone Maintenance on Infectious Diseases 50 3 Who are the Recipients of Treatment? 61 Heroin Use and Dependence 63 Characteristics of Untreated and Treated Heroin Addicts 71 Methadone Patient Characteristics 73 Summary 88 4 Methadone Diversion Control 92 Early Concern Over Diversion 92 The Narcotic Addict Treatment Act of 1974 96 More Recent Official Views on Diversion 97 The Data on Diversion 100 How Is Methadone Diverted? 110 Who Uses Diverted Methadone and Why? 112
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--> Consequences of Methadone Diversion 113 Summary 115 Appendix: Harris County, Texas 117 5 Federal Regulation of Methadone Treatment 120 The 1960s 121 The Nixon Administration 123 Defining the Regulatory Regime: 1970–1974 125 The Current Regulatory Regime 136 Levo-Alpha-Acetyl-Methadol 145 Summary 148 6 Methadone Treatment 151 The Provider Community 151 Financing of Methadone Treatment 161 State Substance Abuse Agencies 169 Summary 181 7 Treatment Standards and Optimal Treatment 185 Definition of Terms 186 Patient Evaluation and Admission Criteria 189 Maintenance Pharmacotherapy 192 Medically Supervised Withdrawal 205 Inpatient Treatment 207 Pain Management 210 Concluding Comments 213 8 Implementing Standards—And Beyond 217 Regulations and Their Enforcement 218 Clinical Practice Guidelines 222 Formal Quality Assurance Systems 225 What Can Be Done Now? 226 Federal Government Leadership 229 Summary 236
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Federal Regulation of Methadone Treatment
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