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Cited by 271Substance Abuse Treatment and OutcomesAlcohol Consumption and Health EffectsOpioid Use Disorder Treatment

A double-blind, placebo-controlled study of oral nalmefene for alcohol dependence

Mason, Barbara J., Salvato, Fernando R., Williams, Lauren D., Ritvo, Eva C., Cutler, Robert B.·1999·Archives of General Psychiatry
DOI 10.1001/archpsyc.56.8.719
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Abstract

BACKGROUND: Nalmefene is a newer opioid antagonist that is structurally similar to naltrexone but with a number of potential pharmacological advantages for the treatment of alcohol dependence, including no dose-dependent association with toxic effects to the liver, greater oral bioavailability, longer duration of antagonist action, and more competitive binding with opioid receptor subtypes that are thought to reinforce drinking. METHODS: A double-blind, placebo-controlled trial was conducted to evaluate the safety and efficacy of 2 doses of oral nalmefene for alcohol dependence. The 105 outpatient volunteers were abstinent for a mean of 2 weeks prior to random assignment to the placebo or 20- or 80-mg/d dose nalmefene groups for 12 weeks. Cognitive behavioral therapy was provided weekly during treatment. Self-reported drinking or abstinence was confirmed by determinations of breath alcohol concentration and by collateral informant reports. RESULTS: Outcomes did not differ between the 20- and 80-mg dose nalmefene groups. Significantly fewer patients treated with nalmefene than patients given placebo relapsed to heavy drinking through 12 weeks of treatment (P<.02), with a significant treatment effect at the first weekly study visit (P<.02). The odds ratio of relapsing to heavy drinking was 2.4 times greater with placebo compared with nalmefene (95% confidence interval, 1.05-5.59). Patients treated with nalmefene also had fewer subsequent relapses (P<.03) than patients given placebo. CONCLUSIONS: Treatment with nalmefene was effective in preventing relapse to heavy drinking relative to placebo in alcohol-dependent outpatients and was accompanied by acceptable side effects.

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  • Altering euphoric and pleasurable effects of alcohol is hypothesized to underlie in part the efficacy of opioid receptor antagonists, including naltrexone and nalmefene.

    “The findings may have relevance to medication development, as altering euphoric and pleasurable effects of alcohol would be important targets for novel treatments and are hypothesized to underlie in part the efficacy of opioid receptor antagonists, including naltrexone and nalmefene(67–76).”

    From A Prospective 5-Year Re-examination of Alcohol Response in Heavy Drinkers Progressing in Alcohol Use Disorder (2016) · cites this paper as [70]

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Authors
Mason, B. J., Salvato, F. R., Williams, L. D., Ritvo, E. C., & Cutler, R. B.
Affiliations
University of Miami (US)
Venue
Archives of General Psychiatry
Publisher
American Medical Association (AMA)
Published
1999-08-01
Volume
56
Issue
8
Pages
719
ISSN
0003-990X (ISSN-L)
DOI
10.1001/archpsyc.56.8.719
OpenAlex
W2125230596
Cited by
271
References
38
Citations by year
2026: 1 · 2025: 2 · 2024: 4 · 2023: 2 · 2022: 8 · 2021: 3 · 2020: 5 · 2019: 8 · 2018: 7 · 2017: 11 · 2016: 13 · 2015: 23 · 2014: 18 · 2013: 13 · 2012: 11
FWCI
12.82
Type
journal article
Language
en
Open access
closed
Locations
  • Archives of General Psychiatry (publishedVersion)
  • PubMed (publishedVersion)
Funders
  • National Institutes of Health (5r01aa009560-03)
  • National Institute on Alcohol Abuse and Alcoholism (AA09560)
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
nalmefene, alcoholism, opioid antagonists, relapse prevention, heavy drinking, cognitive behavioral therapy, outpatient care, drug safety, dose comparison
MeSH terms
Administration, Oral, Alcohol Drinking, Ethanol, Alcoholism, Breath Tests, Dose-Response Relationship, Drug, Double-Blind Method, Drug Administration Schedule, Humans, Naltrexone, Narcotic Antagonists, Placebos, Temperance, Treatment Outcome, Secondary Prevention

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