Double-blind placebo controlled trials of psychotropic agents for alcoholism have rarely been reported and thus their efficacies have yet to be established. There are two factors that influence the outcome of drug trials: the pharmacological action of the drug and the adequacy of treatment (Sackett and Gent, 1979). One of the most frequently documented obstacles to adequate treatment is patient noncompliance with medication regime. Thus a drug may fail to work for some individuals because it is not capable of showing the desired pharmacological effects, or because the individual fails to comply with the medication regime and maintain a therapeutic blood level. A major goal of the proposed study is to assess the efficacy of two drug therapies for alcoholism (lithium carbonate and buspirone) with an adequate control of compliance behavior to insure a direct test of drug action. A second major goal will be the identification of clinical and sociodemographic variables which are predictive of favorable drug response in both active treatment conditions. These results will allow us to identify subgroups of patients more likely to respond to lithium carbonate or buspirone. In the proposed study we will examine the efficacy of lithium carbonate and buspirone for the treatment of alcoholism using a double-blind placebo controlled design. Alcoholic inpatients will be randomly assigned to one of three drug treatment groups (lithium, buspirone or placebo) and will receive medication for a six month period. Following the treatment phase, subjects will be monitored for an additional 12 months. Using duration of abstinence from alcohol as the primary outcome measure, lithium and buspirone assigned subjects will be compared to a placebo control group. A variety of baseline measures will be examined as possible predictors of drug responsiveness. These will include clinical and sociodemographic variables. Serum blood levels for all three treatment groups will be monitored on a regular schedule for the entire six months of therapy.
| Fawcett, J; Kravitz, H M; McGuire, M et al. (2000) Pharmacological treatments for alcoholism: revisiting lithium and considering buspirone. Alcohol Clin Exp Res 24:666-74 |
| Kravitz, H M; Fawcett, J; McGuire, M et al. (1999) Treatment attrition among alcohol-dependent men: is it related to novelty seeking personality traits? J Clin Psychopharmacol 19:51-6 |
