Evidence of baclofen’s efficacy for the treatment of alcohol use disorder is inconsistent. This 2-arm, placebo-controlled, double-blind randomized trial evaluated the efficacy of high-dose baclofen on the maintenance of abstinence over a 20-week period in 39 French specialized centers. Participants (N=320) reported having been abstinent from alcohol for 3–14 days at baseline. The treatment was administered over 26 weeks (7-week titration period with increases in doses up to 180 mg/day, 17-week maintenance period, 2-week tapering-off period). The primary outcome was rate of abstinence during 20 consecutive weeks from day 29 to the end of the maintenance period.
- 190 (59%) participants completed the trial.
- In analyses using multiple imputation techniques, there were no differences in the rates of abstinence between groups (12% in the baclofen group and 11% in the placebo group).
- There were reductions in total alcohol use (-55.1 g/day in the baclofen group and -44.2 g/day in the placebo group) and heavy drinking days (-9.9 days in the baclofen group and -8.7 days in the placebo group) in both groups, but no difference between groups.
- There was a difference between groups on craving symptoms in favor of the baclofen group, compared with placebo.
Comments: This is the second null trial of high-dose baclofen published in a year. The choice of primary outcome (maintenance of abstinence for 20 weeks) is surprising, as this is particularly difficult for patients attending specialty centers to attain. Even though there was an effect on craving symptoms in favor of baclofen, there were no significant differences in alcohol use between groups.
Nicolas Bertholet, MD, MSc
Reference: Reynaud M, Aubin HJ, Trinquet F, et al. A randomized, placebo-controlled study of high-dose baclofen in alcohol-dependent patients—the ALPADIR study. Alcohol Alcohol. 2017;52(4):439-446.