There is inconsistent evidence regarding the efficacy of baclofen, a potent stereo-selective GABA-B agonist, for the treatment of alcohol use disorder. Researchers conducted a multisite double-blind placebo-controlled trial of high-dose baclofen (up to 150 mg), low-dose baclofen (30 mg), or placebo. Participants (N=151) were 18-70 years old, with DSM IV alcohol dependence, consuming ≥14 units/week (women) or ≥21 units/week (men) over a consecutive 30-day period with ≥2 heavy drinking days in the past 90 days. The trial consisted of a 6-week titration period, followed by a 10-week dose-stabilization period.
- In the high-dose baclofen group, the mean dose was 94 mg/day.
- There were no between-group differences in the primary outcome: time to first return to heavy drinking (defined as one heavy drinking day).
- There were no between-group differences in the proportion of participants returning to heavy drinking: 50% in the high-dose baclofen group, 48% in the low-dose group, and 47% in the placebo group. There were also no between-group differences in cumulative abstinence duration (62, 65, 62 days, respectively).
- Similarly, there were no between-group differences in the study outcomes when analyses were restricted to the 10-week period with a stable dose.
Comments: This trial did not show an effect of either low or high doses of baclofen in patients with alcohol dependence. Although post hoc analyses suggested a dose-response effect, most participants did not reach the target dose due to side effects. Given these results, the prescription of high-dose baclofen for the treatment of alcohol use disorder is not currently supported by the evidence.
Nicolas Bertholet, MD, MSc
Reference: Beraha EM, Salemink E, Goudriaan AE, et al. Efficacy and safety of high-dose baclofen for the treatment of alcohol dependence: a multicentre, randomised, double-blind controlled trial. Eur Neuropsychopharmacol. 2016;26(12):1950-1959.