Acamprosate in alcohol dependence: a randomized controlled efficacy study in a standard clinical setting.

Author(s): Baltieri DA, De Andrade AG

Affiliation(s): Interdisciplinary Group of Studies on Alcohol and Drugs, Instituto de Psiquiatria Hospital das Clinicas, FMUSP and Faculdade de Medicina do ABC, Rua Dr. Mello Alves, 110, CEP: 01417-010, Sao Paulo-S.P., Brazil. dbaltieri@uol.com.br

Publication date & source: 2004-01, J Stud Alcohol., 65(1):136-9.

Publication type: Clinical Trial; Randomized Controlled Trial

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.