Efficacy of acamprosate for the treatment of alcohol dependence long after recovery from withdrawal syndrome: a randomized, double-blind, placebo-controlled study conducted in Japan (Sunrise Study).

OBJECTIVE: 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.

METHOD: 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.

RESULTS: 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%).

CONCLUSIONS: 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.

TRIAL REGISTRATION: JapicCTI identifier: 090694.