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Therapeutics
Naltrexone for 3 or 12 months did not reduce drinking in alcohol dependence

https://doi.org/10.1136/ebm.7.4.125

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    (2001) N Engl J Med 345, 1734; Krystal JH, Cramer JA, Krol WF, et al, for the Veterans Affairs Naltrexone Cooperative Study 425 Group.. Naltrexone in the treatment of alcohol dependence.. Dec 13;. :. –9.
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 QUESTION: In patients with alcohol dependence and a recent history of drinking to intoxication, is treatment with naltrexone for 3 or 12 months in addition to standardised psychosocial treatment more effective than placebo for reducing alcohol consumption?

    Design

    Randomised {allocation concealed*}†, blinded (participants and health care providers),* controlled trial with 52 weeks of follow up.

    Setting

    15 Veterans Affairs medical centres in the US.

    Patients

    627 outpatients (mean age 49 y, 98% men) who had a diagnosis of alcohol dependence according to the Diagnostic and Statistical Manual of Mental Disorders, 4th ed, criteria; who had not drunk for ≥ 5 days; and who had a recent history of drinking to intoxication (≥ 6 drinks for men and ≥ 4 drinks for women at least twice during a 1 wk period in the 30 d before screening). Exclusion criteria included previous …

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    Footnotes

    • Sources of funding: Department of Veterans Affairs Office of Research and Development and Dupont Pharmaceuticals.

    • For correspondence: Dr J H Krystal, Veterans Affairs Connecticut Healthcare System, West Haven, Connecticut, USA.john.krystal{at}yale.edu.

    • Abstract and commentary also appear in Evidence-Based Mental Health.

    • ↵* See glossary.

    • ↵† Information provided by author.