See the revised version of this protocol
This publication is provided for historical reference only and the information may be out of date.
Naltrexone and Alcoholism Treatment
Treatment Improvement Protocol (TIP) Series, No. 28
Center for Substance Abuse Treatment.
This TIP, Naltrexone and Alcoholism Treatment, presents current knowledge about the use of naltrexone, an opioid antagonist medication first synthesized in the 1960s and subsequently developed by the National Institute on Drug Abuse (NIDA). This medicine was initially developed to treat opiate addiction. Subsequently, research sponsored by the National Institute on Alcohol Abuse and Alcoholism, which research is still ongoing, found that naltrexone can help prevent relapse to alcohol use disorder when combined with traditional treatment modalities. Naltrexone, when combined with appropriate psychosocial interventions, relieves the craving for alcohol (and opiates) and decreases the relapse rate to heavy use. Naltrexone has been proven safe for most adults except pregnant or nursing women, the very obese (at doses higher than herein recommended for daily use), and probably those with acute hepatitis; women of child-bearing potential must be tested monthly for pregnancy.
This TIP describes the medication itself, its mode of action, possible common adverse effects, and interactions with other medications. A separate chapter on the clinical use of naltrexone presents guidelines for selecting patients who may benefit from naltrexone and for starting and maintaining these patients on naltrexone. Issues for program managers and administrators, including staff education and procedures for getting new drugs on health care system formularies, are presented in appendixes.
As naltrexone is used more widely, alcohol treatment programs will continue to be a source of important data about its use, and this TIP offers suggestions for research in several areas. Funding for the study of treatment and outcomes is available periodically from NIDA, National Institute on Alcohol Abuse and Alcoholism, SAMHSA, and other Federal agencies.
This publication is part of the Substance Abuse Prevention and Treatment Block Grant technical assistance program. This publication was written under contract number 270-95-0013 with The CDM Group, Inc. (CDM). Sandra Clunies, MS, ICADC, served as the CSAT government project officer. Rose M Urban, MSW, JD, CSAC, served as the CDM TIPs project director. Other CDM TIPs personnel included Mark A Meschter, senior editor/writer; Y-Lang Nguyen, editorial assistant; Raquel Ingraham, MS, assistant project manager; Mary Smolenski, EdD, CRNP, former project director; and MaryLou Leonard, former project manager. Special thanks go to consulting writers Suchitra Krishnan-Sarin, PhD, and Elyse Eisenberg, MD, for their contributions to this document.
The opinions expressed herein are the views of the Consensus Panel members and do not reflect the official position of CSAT, SAMHSA, or the U.S. Department of Health and Human Services (DHHS). No official support or endorsement of CSAT, SAMHSA, 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 substitutes for individualized patient care and treatment decisions. The clinician is responsible for following the medical literature as it evolves with respect to naltrexone and all medications.
To ensure fair and impartial communication during the Consensus Panel's deliberations and during the writing process, each panelist and each expert consultant signed a statement of disclosure of interest. The efficacy studies of naltrexone conducted in the United States have been funded by grants from the National Institute on Alcohol Abuse and Alcoholism; naltrexone and matching placebo were donated by DuPont Merck Pharmaceutical Company, the company that manufactures the drug. Several panelists participated in the multisite safety study of naltrexone that was sponsored by DuPont Merck. The following panelists and expert consultants, or entities with which they are now or have been affiliated, have received support or funding from DuPont Merck: Raymond Anton, MD; Lisa M D'Angelo, RN, MSN, ARNP; Hans C Geisse, MD; Robert S Geissinger; Sarz Maxwell, MD; Mary Elizabeth McCaul, PhD; Patrice Muchowski, ScD; Charles P O'Brien, MD, PhD; Stephanie O'Malley, PhD; David W Oslin, MD; Robert Swift, MD, PhD; and Joseph Volpicelli, MD, PhD.