A double-blind, placebo-controlled trial of lithium carbonate therapy for alcoholism.

The efficacy of lithium carbonate as a treatment for alcoholism was examined in a double-blind, placebo-controlled study of 104 men and women meeting DSM-III criteria for alcohol dependence. Subjects entered the study during inpatient treatment and were subsequently followed up for 12 months. Survival analysis disclosed essentially three categories of treatment response: one for noncompliant subjects (0% to 7% abstinent), one for compliant subjects not attaining therapeutic serum lithium levels (31% to 44% abstinent), and one for compliant subjects with therapeutic serum levels (67% abstinent). Two findings led us to believe that therapeutic serum levels of lithium were associated with better outcome over and above a behavioral compliance effect. First, in a dose-response analysis, serum lithium levels and abstinence rates were not linearly associated. Second, all subjects who started lithium carbonate therapy as inpatients were significantly less likely to relapse to drinking during the first month than were placebo-compliant subjects. There was no evidence that depressed alcoholics showed a better treatment response than nondepressed alcoholics or that lithium had any significant impact on the mood or social adjustment of alcoholics. Although the sample size and the difficulties of ascertaining placebo compliance caution against drawing firm conclusions, the data add further support to the hypothesis that lithium has an effect on drinking behavior not related to the treatment of affective symptoms.