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Acamprosate in alcohol dependence: a randomized controlled efficacy study in a standard clinical setting
Danilo Antonio Baltieri1, Arthur Guerra De Andrade
1Interdisciplinary 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
Objective:
This study was undertaken to evaluate the efficacy and safety of acamprosate in the treatment of alcohol dependence.
Method:
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.