Baclofen has been considered a promising treatment option for alcohol use disorder (AUD) in patients with liver disease since it is metabolized through the kidneys. Prior literature on the effect of baclofen for treatment of AUD has shown mixed results with many published studies limited by small sample sizes. This 12-week placebo-controlled randomized clinical trial assessed the effect of baclofen 10 mg 3 times daily on abstinence from alcohol among 180 patients receiving treatment at US Veterans Administration hepatology clinics. Participants had co-morbid hepatitis C and AUD and reported consuming >7 standard drinks in a week for each of the preceding 2 weeks or 1 heavy drinking* day in a week for each of the preceding 2 weeks. At baseline, participants consumed an average of 32 standard drinks in a week. The mean age was 57 years, 98% were male, and participants were primarily Caucasian (57%) or African American (36%).
- At 12 weeks, all participants experienced significant increases in percentage of days abstinent from alcohol (from 37% to 69%). Compared with placebo, baclofen did not improve the percentage of days abstinent.
- There were no differences between the 2 groups on the following secondary outcomes: percentage of participants who achieved complete abstinence or had no heavy drinking between weeks 4 and 12 of the study, alcohol craving, anxiety, depression, and post-traumatic stress disorder.
- Of patients who completed week 4, 9% achieved complete abstinence (10% in the placebo group and 8% in the baclofen group).
* >4 drinks in a day for men and >3 drinks in a day for women.
Comments: Although the findings in this study may have been affected by patients with lower alcohol consumption, recruitment from hepatology rather than alcohol treatment settings, and inclusion criteria of HCV rather than cirrhosis, these findings add to the body of literature suggesting that baclofen, at least at standard doses, is no better than placebo at increasing abstinence or reducing alcohol consumption or cravings.
Jeanette M. Tetrault, MD
Reference: Hauser P, Fuller B, Ho SB, et al. The safety and efficacy of baclofen to reduce alcohol use in veterans with chronic hepatitis C: a randomized controlled trial. Addiction. 2017;112(7):1173–1183.