A double-blind, placebo-controlled pilot study of carbamazepine for the treatment of alcohol dependence.

Carbamazepine, chemically related to the tricyclic antidepressants, has multiple clinical actions. It is a potent anticonvulsant, mild sedative, and mood stabilizer. It is nonaddictive and has little toxicity when clinical and laboratory monitoring is performed. It has proven efficacy in the treatment of acute alcohol withdrawal. Kindling and protracted withdrawal are the theoretical rationale for the mechanism of its action in the treatment of alcohol dependence. This 12-month double-blind placebo-controlled pilot study of 29 subjects evaluated the efficacy of carbamazepine for the treatment of alcohol dependence. Subjects were randomly assigned to either placebo or carbamazepine. A baseline assessment and bimonthly follow-up for 12 months assessed demographic variables, mood and functioning, treatment compliance, drinking behaviors, biological markers of drinking, and medication toxicity. Despite the small sample size, compliance difficulties after 4 months and a sizable drop-out rate, there were treatment effects favoring carbamazepine. Univariate analyses showed a decrease in drinks per drinking day and maximum number of heavy drinking days in a row at 2 and 4 months of follow-up. Survival analysis revealed a significant delay in time to first episode of heavy drinking, and close to a trend level of significance for time to first drink. There were significant time, but not time by treatment group, effects on multiple measures of mood. These pilot results are encouraging and support carbamazepine as a possible pharmacologic tool in the treatment of alcohol dependence.

RCT Entities:   Population Interventions Outcomes