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. Method: The investigation was a double-blind, placebo-controlled, 24-week study carried out at the University of Sao 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.