Efficacy of Acamprosate for the Treatment of Alcohol Dependence Long After Recovery From Withdrawal Syndrome

To undertake a double-blind, randomized, placebo-controlled trial to examine the efficacy of acamprosate in maintaining complete abstinence in Japanese patients with alcohol dependence.We enrolled 327 patients with ICD-10-defined alcohol dependence and randomly assigned them to treatment with either acamprosate (1,998 mg/d orally) or placebo for 24 weeks. The primary endpoint was complete abstinence after 24 weeks of administration. The study was performed at 34 medical institutions between 2009 and 2011.The acamprosate group demonstrated significantly superior efficacy versus the placebo group on the primary endpoint: the proportion maintaining complete abstinence in the acamprosate group was 47.2% (77/163 subjects), compared with 36.0% (59/164 subjects) in the placebo group (P = .039). The difference in complete abstinence rates between the 2 groups was 11.3% (95% CI, 0.6%-21.9%).Acamprosate is superior to placebo in maintaining abstinence in Japanese patients with alcohol dependence. These findings concur with 11 randomized, blinded, placebo-controlled clinical trials conducted in Europe. This study was designed to reflect clinical practice in Japan and is therefore a meaningful addition to the available evidence in this field.JapicCTI identifier: 090694.