According to background information in the article, a previous, shorter trial indicated that topiramate, a medication used in the treatment of seizures, may be beneficial for the treatment of alcohol dependence.
Bankole A. Johnson, D.Sc., M.D., Ph.D., of the University of Virginia, Charlottesville, Va., and colleagues conducted a multisite, 14-week, randomized controlled trial to determine the efficacy of topiramate compared with placebo. The study, which included 371 men and women age 18 to 65 years diagnosed with alcohol dependence, was conducted between January 2004 and August 2006 at 17 U.S. sites. The participants received up to 300 mg/day of topiramate (n = 183) or placebo (n = 188), along with a weekly psychosocial treatment to promote adherence with the study medication and the treatment regimen.
Treating all dropouts as relapse to baseline, topiramate compared with placebo recipients showed greater reduction of percentage of heavy drinking days from baseline to week 14 (from an average of 81.9 percent to 43.8 percent for topiramate vs. 82.0 percent to 51.8 percent for placebo; average difference, 8.44 percent). Prespecified analysis also showed that topiramate compared with placebo decreased the percentage of heavy drinking days (average difference, 16.19 percent).
The researchers also found that topiramate compared with placebo treatment was associated with a significantly higher rate of achieving 28 or more days of continuous nonheavy drinking and 28 or more days of continuous abstinence. Adverse events that were more common with topiramate vs. placebo included paresthesia (abnormal skin sensations), taste perversion, anorexia, and difficulty with concentration.
"Our finding in this study that topiramate is a safe and consistently efficacious medication for treating alcohol dependence is scientifically and clinically important. Alcoholism ranks third and fifth on the U.S. and global burdens of disease, respectively. Discovering pharmacological agents such as topiramate that improve drinking outcomes can make a major contribution to global health. Because topiramate pharmacotherapy can be paired with a brief intervention deliverable by nonspecialist health practitioners, a next step would be to examine its efficacy in community practice settings," the authors conclude.