A double-blind, placebo-controlled study of olanzapine in the treatment of alcohol-dependence disorder.

: Background: A 12-week, double-blind, randomized, parallel-group clinical trial, comparing olanzapine and placebo treatment together with cognitive-behavioral psychotherapy, was carried out to determine the efficacy, safety, and tolerability of olanzapine in the treatment of alcoholism. Methods: A total of 60 alcohol-dependent patients were assigned to 12 weeks’ treatment with either olanzapine or placebo. The primary variable relapse to heavy drinking rate was evaluated by means of intention-to-treat analyses. Alcohol consumption, craving, adverse events, and changes in the biochemical markers of heavy drinking and possible toxicity were also evaluated. Results: We did not find significant differences in the survival analysis between placebo and olanzapine-treated patients (Kaplan-Meier log rank = 0.46, df= 1, p= 0.50). Eleven (37.9%) patients treated with olanzapine relapsed compared with 9 (29%) of those receiving placebo (χ2= 0.53, df= 1, p= 0.5). Although some adverse events (weight gain, increased appetite, drowsiness, constipation, and dry mouth) were found more frequently in the olanzapine group, differences did not reach statistical significance in comparison with the placebo group. Conclusions: Olanzapine was well tolerated, as the rate of adverse events was low, and it was safe, because it did not interfere with the normalization of biochemical markers of heavy drinking or alter liver function markers. Alcohol-dependent patients showed good adherence and compliance with the treatment protocol, but we found no differences in relapse rate or other drinking variables when comparing olanzapine with placebo-treated patients.