Comparison of acamprosate and placebo in long-term treatment of alcohol dependence

Summary Background About 50% of alcoholic patients relapse within 3 months of treatment. Previous studies have suggested that acamprosate may help to prevent such relapse. The aim of our study was to assess the efficacy and safety of long-term acamprosate treatment in alcohol dependence. Methods In...

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Bibliographic Details
Published in:The Lancet (British edition) 1996-05, Vol.347 (9013), p.1438-1442
Main Authors: Whitworth, A.B, Oberbauer, H, Fleischhacker, W.W, Lesch, O.M, Walter, H, Nimmerrichter, A, Platz, T, Fischer, F, Potgieter, A
Format: Article
Language:English
Subjects:
Acamprosate
Adult
Alcoholism
Alcoholism - drug therapy
Alcoholism - epidemiology
Biological and medical sciences
Double-Blind Method
Drug therapy
Ethanol - poisoning
Female
Follow-Up Studies
Gabaergic and benzodiazepinic system
Humans
Male
Medical research
Medical sciences
Neuropharmacology
Neurotransmitters. Neurotransmission. Receptors
Pharmacology. Drug treatments
Recurrence
Substance abuse treatment
Taurine - administration & dosage
Taurine - adverse effects
Taurine - analogs & derivatives
Taurine - therapeutic use
Temperance
Time Factors
Treatment Outcome
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Summary:Summary Background About 50% of alcoholic patients relapse within 3 months of treatment. Previous studies have suggested that acamprosate may help to prevent such relapse. The aim of our study was to assess the efficacy and safety of long-term acamprosate treatment in alcohol dependence. Methods In this multicentre, double-blind, placebo-controlled study, we recruited 455 patients, aged 18-65 years, with chronic or episodic alcohol dependence. Patients were randomly allocated treatment with acamprosate (1998 mg daily for bodyweight >60 kg; 1332 mg daily for ≤60 kg) or placebo for 360 days. Patients were assessed on the day treatment started and on days 30, 90, 180, 270, and 360 by interview, self-report, questionnaire, and laboratory screening. Patients were classified as abstinent, relapsing, or non-attending. Time to first treatment failure (relapse or non-attendance) was the primary outcome measure. Findings Seven patients were excluded from the intention-to-treat analysis because they did not attend on the first treatment day and therefore received no medication. The acamprosate (n=224) and placebo (n=224) groups were well matched in terms of baseline demographic and alcohol-related variables. 94 acamprosate-treated and 85 placebo-treated patients completed the treatment phase: of those withdrawn, 104 (52 in each group) relapsed, 69 (33 vs 36, respectively) were lost to follow-up, 63 (31 vs 32) refused to continue treatment, 16 (15 vs 11) had concurrent illness, three (two vs one) died, ten (six vs four) had adverse side-effects, one (acamprosate treated) received the wrong medication, and three (placebo treated) were non-compliant. The proportion without treatment failure was higher in the acamprosate than in the placebo group throughout the treatment period (p
ISSN:0140-6736
1474-547X
DOI:10.1016/S0140-6736(96)91682-7