A randomized, double-blind, placebo-controlled clinical trial of acamprosate in alcohol-dependent individuals with bipolar disorder: a preliminary report.

BACKGROUND

Alcohol use disorders commonly co-occur with bipolar disorder and are associated with a more severe course of bipolar illness, yet treatment research in this important clinical population is scarce. The current study assessed the effects of acamprosate on alcohol use and mood symptoms in subjects with co-occurring bipolar disorder and active alcohol dependence.

METHODS

Thirty-three adults meeting criteria for bipolar I or bipolar II disorder and current alcohol dependence were randomized to receive add-on acamprosate (1998 mg/day) or placebo while concurrently maintained on mood stabilizing medications. Participants were assessed weekly for frequency and quantity of alcohol consumption and general clinical severity for eight weeks. Depressive symptoms, manic symptoms, and alcohol craving were assessed biweekly. Biomarkers of alcohol use were assessed at study baseline and endpoint.

RESULTS

Of the 33 subjects randomized, 23 (69.7%) completed all active phase visits. Over the trial as a whole, no statistically significant treatment differences were detected in drinking outcomes. Post-hoc analysis revealed lower Clinical Global Impression scores of substance use severity in acamprosate-treated participants in weeks 7-8 of the trial. No significant differences in depressive symptoms, manic symptoms, or adverse events were observed between groups.

CONCLUSIONS

Acamprosate was well-tolerated, with no worsening of depressive or manic symptoms, and appeared to confer some clinical benefit in study completers in the last two weeks of the trial. Larger studies of longer duration are required to fully explore the utility of acamprosate in this population.