Amisulpride does not prevent relapse in primary alcohol dependence: results of a pilot randomized, placebo-controlled trial.

Background: Few medications have been proved to be effective in preventing relapse in alcoholism. The mesolimbic dopamine system is known to play an important role in alcohol dependence. Amisulpride, a substituted benzamide, seems to facilitate dopaminergic neurotransmission at low doses.

Methods: After short-term, inpatient detoxification, 71 patients participated in a randomized, double-blind, placebo-controlled study to evaluate the efficacy of amisulpride in relapse prevention. Patients received amisulpride 50 mg/day or placebo for 6 months.

Results: There were no differences between the two groups of treatment for time to first drink, length of time before dropout, number of drinking days, and number of heavy drinking days. However, significantly more patients who were treated with amisulpride than those who were treated with placebo were nonabstinent and had relapsed at each visit. Craving for alcohol was significantly higher in the amisulpride than in the placebo group. Transaminases, gamma-glutamyl-transferase, and mean erythrocyte corpuscular volume were regularly higher in the amisulpride group than in the placebo group.

Conclusions: The results indicate that treatment with amisulpride was not effective in preventing relapse to drinking in detoxified, alcohol-dependent patients. The significance of this finding is discussed, particularly in terms of the effects of neuroleptics on alcohol consumption.