A randomized, double-blind, placebo-controlled clinical trial of acamprosate in alcohol-dependent individuals with bipolar disorder: a preliminary report
Article first published online: 13 FEB 2012
© 2012 John Wiley and Sons A/S
Volume 14, Issue 1, pages 54–63, February 2012
How to Cite
Tolliver, B. K., DeSantis, S. M., Brown, D. G., Prisciandaro, J. J. and Brady, K. T. (2012), A randomized, double-blind, placebo-controlled clinical trial of acamprosate in alcohol-dependent individuals with bipolar disorder: a preliminary report. Bipolar Disorders, 14: 54–63. doi: 10.1111/j.1399-5618.2011.00973.x
- Issue published online: 13 FEB 2012
- Article first published online: 13 FEB 2012
- Received 10 November 2010, revised and accepted for publication 26 September 2011
- bipolar disorder;
Tolliver BK, DeSantis SM, Brown DG, Prisciandaro JJ, Brady KT. A randomized, double-blind, placebo-controlled clinical trial of acamprosate in alcohol-dependent individuals with bipolar disorder: a preliminary report. Bipolar Disord 2012: 14: 54–63. © 2012 The Authors. Journal compilation © 2012 John Wiley & Sons A/S.
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.