Cited by 618Substance Abuse Treatment and OutcomesAlcohol Consumption and Health EffectsOpioid Use Disorder Treatment

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Naltrexone in the Treatment of Alcohol Dependence

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Krystal, John H., Cramer, Joyce A., Krol, William F., Kirk, Gail F., Rosenheck, Robert A.·2001·New England Journal of Medicine

DOI 10.1056/nejmoa011127

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Abstract

BACKGROUND: Although naltrexone, an opiate-receptor antagonist, has been approved by the Food and Drug Administration for the treatment of alcohol dependence, its efficacy is uncertain. METHODS: We conducted a multicenter, double-blind, placebo-controlled evaluation of naltrexone as an adjunct to standardized psychosocial treatment. We randomly assigned 627 veterans (almost all men) with chronic, severe alcohol dependence to 12 months of naltrexone (50 mg once daily), 3 months of naltrexone followed by 9 months of placebo, or 12 months of placebo. All patients were offered individual counseling and programs to improve their compliance with study medication and were encouraged to attend Alcoholics Anonymous meetings. RESULTS: There were 209 patients in each group; all had been sober for at least five days before randomization. At 13 weeks, we found no significant difference in the number of days to relapse between patients in the two naltrexone groups (mean, 72.3 days) and the placebo group (mean, 62.4 days; 95 percent confidence interval for the difference between groups, -3.0 to 22.8). At 52 weeks, there were no significant differences among the three groups in the percentage of days on which drinking occurred and the number of drinks per drinking day. CONCLUSIONS: Our findings do not support the use of naltrexone for the treatment of men with chronic, severe alcohol dependence.

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Authors: Krystal, J. H., Cramer, J. A., Krol, W. F., Kirk, G. F., & Rosenheck, R. A.
Affiliations: Yale University (US)
ORCID: Cramer, Joyce A.
Rosenheck, Robert A.
Venue: New England Journal of Medicine
Publisher: Massachusetts Medical Society
Published: 2001-12-13
Volume: 345
Issue: 24
Pages: 1734-1739
ISSN: 0028-4793 (ISSN-L)
1533-4406
DOI: 10.1056/nejmoa011127
OpenAlex: W2108258874
Cited by: 618
References: 32
Citations by year: 2026: 4 · 2025: 5 · 2024: 10 · 2023: 6 · 2022: 7 · 2021: 8 · 2020: 71 · 2019: 9 · 2018: 18 · 2017: 17 · 2016: 19 · 2015: 21 · 2014: 23 · 2013: 23 · 2012: 25
FWCI: 29.39
Type: journal article
Language: en
Open access: bronze
doi.org
Locations: New England Journal of Medicine (publishedVersion)
PubMed (publishedVersion)
Funders: U.S. Department of Veterans Affairs
Topics: Health Sciences › Medicine › Epidemiology › Substance Abuse Treatment and Outcomes
Health Sciences › Medicine › Pathology and Forensic Medicine › Alcohol Consumption and Health Effects
Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Opioid Use Disorder Treatment
Keywords: naltrexone, alcoholism, opioid antagonists, relapse prevention, veterans, adjunct pharmacotherapy, psychosocial interventions, Alcoholics Anonymous
MeSH terms: Alcoholics Anonymous, Alcoholism, Combined Modality Therapy, Counseling, Double-Blind Method, Female, Humans, Male, Middle Aged, Naltrexone, Narcotic Antagonists, Patient Compliance, Recurrence, Multivariate Analysis, Treatment Failure

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