New Treatments for Addiction: Behavioral, Ethical, Legal, and Social Questions

321 Pages·2004·6.72 MB·English

by  Committee on Immunotherapies and Sustained-Release Formulations for Treating Drug Addiction

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New Treatments for Addiction: Behavioral, Ethical,

Legal, and Social Questions

Henrick J. Harwood and Tracy G. Myers, Editors,

Committee on Immunotherapies and Sustained-Release
Formulations for Treating Drug Addiction, National
Research Council

ISBN: 0-309-52950-6, 320 pages, 6x9, (2004)

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New Treatments for Addiction: Behavioral, Ethical, Legal, and Social Questions
http://www.nap.edu/catalog/10876.html
Committee on Immunotherapies and
Sustained-Release Formulations for Treating Drug Addiction
Henrick J. Harwood and Tracy G. Myers, Editors
Board on Behavioral, Cognitive, and Sensory Sciences
Division of Behavioral and Social Sciences and Education
National Research Council
Board on Health Promotion and Disease Prevention
Board on Neuroscience and Behavioral Health
Institute of Medicine
Copyright © National Academy of Sciences. All rights reserved.
New Treatments for Addiction: Behavioral, Ethical, Legal, and Social Questions
http://www.nap.edu/catalog/10876.html
THE NATIONAL ACADEMIES PRESS • 500 Fifth Street, N.W. • Washington, DC 20001
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 Na-
tional Academy of Sciences, the National Academy of Engineering, and the Institute of Medi-
cine. The members of the committee responsible for the report were chosen for their special
competences and with regard for appropriate balance.
The study was supported by Contract No. N01-OD-4-2139 between the National Academy
of Sciences and the National Institute on Drug Abuse. Any opinions, findings, conclusions,
or recommendations expressed in this publication are those of the author(s) and do not
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Library of Congress Cataloging-in-Publication Data
New treatments for addiction : behavioral, ethical, legal, and social questions / Committee
on Immunotherapies and Sustained-Release Formulations for Treating Drug Addiction ;
Henrick J. Harwood and Tracy G. Myers, editors.
p. ; cm.
“Board on Behavioral, Cognitive, and Sensory Sciences, Division of Behavioral and Social
Sciences and Education, National Research Council [and] Board on Health Promotion and
Disease Prevnetion, Board on Neuroscience and Behavioral Health.”
Includes bibliographical references.
ISBN 0-309-09128-4 (pbk.) — ISBN 0-309-52950-6 (pdf)
1. Substance abuse—Treatment. 2. Substance abuse—Chemotherapy. 3. Immunotherapy.
[DNLM: 1. Substance-Related Disorders—therapy—United States. 2. Delayed-Action
Preparations—therapeutic use—United States. 3. Immunotherapy—ethics—United States.
4. Immunotherapy—legislation & jurisprudence—United States. 5. Substance-Related Dis-
orders—psychology—United States. WM 270 N5327 2004] I. Harwood, Henrick J. II. Myers,
Tracy G. III. National Academies (U.S.). Committee on Immunotherapies and Sustained-
Release Formulations for Treating Drug Addiction. IV. National Research Council (U.S.).
Board on Behavioral, Cognitive, and Sensory Sciences. V. Institute of Medicine (U.S.). Board
on Health Promotion and Disease Prevention. VI. Institute of Medicine (U.S.). Board on
Neuroscience and Behavioral Health.
RC564.N488 2004
616.86’061—dc22
2004008359
Additional copies of this report are available from the National Academies Press, 500Fifth
Street, N.W., Lockbox 285, Washington, DC 20055; [phone] or [phone] (in the
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Printed in the United States of America.
Copyright 2004 by the National Academy of Sciences. All rights reserved.
Suggested citation: National Research Council and Institute of Medicine. (2004). New Treat-
ments for Addiction: Behavioral, Ethical, Legal, and Social Questions. Committee on Immuno-
therapies and Sustained-Release Formulations for Treating Drug Addiction. Henrick J.
Harwood and Tracy G. Myers, Eds. Board on Behavioral, Cognitive, and Sensory Sciences,
Division of Behavioral and Social Sciences and Education, National Research Council; and
Board on Health Promotion and Disease Prevention, Board on Neuroscience and Behavioral
Health, Institute of Medicine. Washington, DC: The National Academies Press.
Copyright © National Academy of Sciences. All rights reserved.
New Treatments for Addiction: Behavioral, Ethical, Legal, and Social Questions
http://www.nap.edu/catalog/10876.html
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Copyright © National Academy of Sciences. All rights reserved.
New Treatments for Addiction: Behavioral, Ethical, Legal, and Social Questions
http://www.nap.edu/catalog/10876.html
Copyright © National Academy of Sciences. All rights reserved.
New Treatments for Addiction: Behavioral, Ethical, Legal, and Social Questions
http://www.nap.edu/catalog/10876.html
COMMITTEE ON IMMUNOTHERAPIES AND
SUSTAINED-RELEASE FORMULATIONS FOR
TREATING DRUG ADDICTION
HENRICK J. HARWOOD (Chair), The Lewin Group, Fairfax, VA
ALEXANDER M. CAPRON, Pacific Center for Health Policy and Ethics,
University of Southern California
JONATHAN P. CAULKINS, Heinz School of Public Policy and
Management, Carnegie Mellon University
JAMES W. CORNISH, Philadelphia Department of Veterans Affairs
Medical Center and University of Pennsylvania Department of
Psychiatry
LEWIS E. GALLANT, National Association of State Alcohol and Drug
Abuse Directors, Inc., Washington, DC
SHIRLEY Y. HILL, University of Pittsburgh School of Medicine
MARTIN Y. IGUCHI, Drug Policy Research Center, RAND Corporation,
Santa Monica, CA
THOMAS R. KOSTEN, Yale University Medical School
JOSEPH O. MERRILL, Harborview Medical Center and University of
Washington
S. MICHAEL OWENS, University of Arkansas for Medical Sciences
CHARLES R. SCHUSTER, Department of Psychiatry and Behavioral
Neurosciences, Wayne State University, Detroit, MI
ZILI SLOBODA, Institute for Health and Social Policy, University of
Akron
KATHRYN E. STEIN, Macrogenics, Inc., Rockville, MD
ELLEN M. WEBER, University of Maryland School of Law
TRACY G. MYERS, Study Director
WENDY E. KEENAN, Senior Project Assistant
v
Copyright © National Academy of Sciences. All rights reserved.
New Treatments for Addiction: Behavioral, Ethical, Legal, and Social Questions
http://www.nap.edu/catalog/10876.html
BOARD ON BEHAVIORAL, COGNITIVE,
AND SENSORY SCIENCES
ANNE C. PETERSEN (Chair), W.K. Kellogg Foundation, Battle Creek,
MI
LINDA MARIE BURTON, Center for Human Development and Family
Research, Pennsylvania State University
STEPHEN J. CECI, Department of Human Development, Cornell
University
EUGENE K. EMORY, Department of Psychology, Emory University
ROCHEL GELMAN, Center for Cognitive Science, Rutgers University
ANTHONY W. JACKSON, Asia Society, Los Angeles
PETER LENNIE, Center for Neural Science, New York University
MARCIA C. LINN, Graduate School of Education, University of
California, Berkeley
ELISSA L. NEWPORT, Department of Brain and Cognitive Sciences,
University of Rochester
MICHAEL L. RUTTER, Institute of Psychiatry, University of London
ARNOLD SAMEROFF, Center for Human Growth and Development,
University of Michigan
JAMES W. STIGLER, Department of Psychology, University of
California, Los Angeles
WILLIAM A. YOST, Office of Research and the Graduate School, Loyola
University, Chicago
CHRISTINE R. HARTEL, Board Director
vi
Copyright © National Academy of Sciences. All rights reserved.
New Treatments for Addiction: Behavioral, Ethical, Legal, and Social Questions
http://www.nap.edu/catalog/10876.html
BOARD ON HEALTH PROMOTION AND DISEASE PREVENTION
JAMES W. CURRAN (Chair), School of Public Health, Emory University
RONALD BAYER, School of Public Health, Columbia University
WILLIAM V. CORR, National Center for Tobacco-Free Kids,
Washington, DC
HELEN B. DARLING, National Business Group on Health,
Washington, DC
STEPHEN B. FAWCETT, Department of Human Development and
Family Life, University of Kansas
JONATHAN E. FIELDING, Department of Health Services, Los Angeles
County, CA
LAWRENCE O. GOSTIN, Georgetown University Law Center
ELLEN R. GRITZ, M.D. Anderson Cancer Center, University of Texas,
Houston
GEORGE J. ISHAM, HealthPartners, Inc., Minneapolis, MN
MARK SCOTT KAMLET, School of Public Policy and Management,
Carnegie Mellon University
JOYCE SEIKO KOBAYASHI, Denver Health Medical Center
ROXANNE PARROTT, College of Arts and Sciences, Pennsylvania State
University
THOMAS A. PEARSON, School of Medicine and Dentistry, University
of Rochester
IRVING ROOTMAN, Human and Social Development, University of
Victoria
DAVID J. TOLLERUD, School of Public Health, University of Louisville
KATHLEEN E. TOOMEY, Georgia State Health Department
WILLIAM A. VEGA, Behavioral and Research Training Institute, Robert
Wood Johnson Medical School
PATRICIA WAHL, School of Public Health and Community Medicine,
University of Washington
LAUREN A. ZEISE, Office of Environmental Health Hazard
Assessment, California Environmental Protection Agency, Oakland
ROSE MARIE MARTINEZ, Board Director
vii
Copyright © National Academy of Sciences. All rights reserved.
New Treatments for Addiction: Behavioral, Ethical, Legal, and Social Questions
http://www.nap.edu/catalog/10876.html
BOARD ON NEUROSCIENCE AND BEHAVIORAL HEALTH
KENNETH B. WELLS (Chair), School of Medicine, University of
California, Los Angeles
SID GILMAN, Department of Neurology, University of Michigan
NANCY E. ADLER, Department of Psychiatry and Pediatrics,
University of California, San Francisco
PAUL S. APPELBAUM, University of Massachusetts Medical School
WILLIAM E. BUNNEY, JR., Department of Psychiatry and Human
Behavior, University of California, Irvine
HOWARD L. FIELDS, Department of Neurology, University of
California, San Francisco
RICHARD G. FRANK, Harvard Medical School
ALAN I. LESHNER, American Association for the Advancement of
Science, Washington, DC
KAREN MATTHEWS, University of Pittsburgh School of Medicine
BRUCE S. MCEWEN, Harold and Margaret Milliken Hatch Laboratory
of Neuroendocrinology, The Rockefeller University
KATHLEEN R. MERIKANGAS, Division of Intramural Research
Programs, National Institute of Mental Health
EMMANUEL MIGNOT, Center for Narcolepsy, Stanford University
DAVID REISS, George Washington University Medical Center
RHONDA J. ROBINSON-BEALE, CIGNA Corporation, Eden Prairie, MN
MICHAEL L. RUTTER, Institute of Psychiatry, University of London
MARLEEN WONG, Los Angeles Unified School District
CHARLES ZORUMSKI, Department of Psychiatry, Washington
University
ANDREW M. POPE, Acting Board Director
viii
Copyright © National Academy of Sciences. All rights reserved.
New Treatments for Addiction: Behavioral, Ethical, Legal, and Social Questions
http://www.nap.edu/catalog/10876.html
Contents
PREFACE xi
EXECUTIVE SUMMARY 1
1 INTRODUCTION AND BACKGROUND 7
Committee Charge and Report, 8
Medical Basis of Immunotherapy, 9
2 CLINICAL TRIALS 16
FDA Process, 16
Phase IV Considerations, 17
3 TREATMENT, FINANCING, AND COSTS 23
Specialty Addiction Treatment Settings, 24
Primary Care Settings, 26
Previous Pharmacotherapies Lessons Learned, 29
Cost and Economic Issues, 33
4 BEHAVIORAL RESPONSES AND CONSENT 37
Unintended Behavioral Consequences, 37
Consent and Vulnerable Populations, 44
REFERENCES 54
ix
Copyright © National Academy of Sciences. All rights reserved.