A 3-month randomized placebo-controlled trial (N=84 men) found efficacy for baclofen in people with cirrhosis (71% versus 29% abstinence). Because of this finding and findings of other preclinical and clinical studies, investigators randomly assigned 80 men and women with alcohol dependence (on average, they drank 7 drinks per drinking day) to 10 mg baclofen 3 times daily or placebo. All participants were also offered 8 therapy sessions. Follow-up was at 12 weeks.
- About one-quarter of subjects were lost to follow-up.
- Although baclofen was generally well tolerated, there were no differences in heavy drinking days (26%), time to first drink, time to relapse to heavy drinking, or craving between groups.
This small study may not be the last word on baclofen. In fact, the authors suggest that it may be effective in people with more severe dependence or at a higher dose. But the results do indicate that the medication will not likely have dramatic efficacy across diverse populations of people with alcohol dependence.
Richard Saitz, MD, MPH
Garbutt JC, Kampov-Polevoy AB, Gallop R, et al. Efficacy and safety of baclofen for alcohol dependence: a randomized, double-blind, placebo-controlled trial. Alcohol Clin Exp Res. 2010;34(11):1849–1857.