Acamprosate in alcohol dependence: a randomized controlled efficacy study in a standard clinical setting.
OBJECTIVE
This study was undertaken to evaluate the efficacy and safety of acamprosate in the treatment of alcohol dependence.


METHODS
The investigation was a double-blind, placebo-controlled, 24-week study carried out at the University of São Paulo, Brazil. The sample comprised 75 patients, 18-60 years of age, with an International Classification of Diseases (ICD-10) diagnosis of alcohol dependence. After a 1-week detoxification period the patients were randomly divided into two groups: the first received acamprosate (1.998 mg/day) and the second received placebo. After the first 12 weeks, the patients continued follow-up for a similar length of time without medication. The main outcome measures were relapse rates, side effects and time to first relapse.


RESULTS
On an intention-to-treat basis, the Kaplan-Meier survival curve showed an advantage in relapse rates for acamprosate over placebo (log-rank test, p = .02), and acamprosate was well tolerated.


CONCLUSIONS
Acamprosate seems to be an effective treatment for alcohol dependence in a Brazilian population.
Interdisciplinary Group of Studies on Alcohol and Drugs, Instituto de Psiquiatria Hospital das Clínicas, FMUSP and Faculdade de Medicina do ABC, Rua Dr. Mello Alves, 110, CEP: 01417-010, São Paulo-S.P., Brazil. dbaltieri@uol.com.br
Danilo Antonio
DA
Baltieri
Arthur Guerra
AG
De Andrade
D000077443:Acamprosate; D000293:Adolescent; D000328:Adult; D000437:Alcoholism / Q000188:drug therapy* / Q000523:psychology; D000553:Ambulatory Care / Q000379:methods* / Q000523:psychology; D000704:Analysis of Variance; D016009:Chi-Square Distribution; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D018709:Statistics, Nonparametric; D016019:Survival Analysis; D013654:Taurine / Q000031:analogs & derivatives* / Q000627:therapeutic use*
D013654:Taurine; D000077443:Acamprosate