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Dutasteride as a Treatment to Support Reduced Drinking: A Randomized Placebo-Controlled Trial.

J. Covault,Howard Tennen,Richard Feinn

Published 2025 in Journal of addiction medicine

ABSTRACT

OBJECTIVES Preclinical studies indicate that neuroactive steroids mediate some effects of alcohol. Dutasteride is an inhibitor of 5-alpha reductase enzymes, which play a central role in the production of 5α-reduced neuroactive steroids. A prior randomized clinical trial in men found that dutasteride reduced drinking compared with placebo. The purpose of this study was to examine dutasteride's tolerability and efficacy for reducing drinking in a sample of men and women. METHODS A total of 167 participants who were current heavy drinkers and had a goal to stop or reduce drinking to nonhazardous levels were randomized to placebo or 1 mg dutasteride daily for 12 weeks. We hypothesized that both dutasteride-treated men and women would be more successful in reducing drinking compared with placebo. RESULTS Dutasteride was well tolerated. Generalized linear mixed models identified significant effects of medication such that dutasteride-treated participants reduced drinking and heavy drinking more than placebo-treatment. During the last month of treatment, dutasteride-treated participants had reduced heavy drinking days by 40% versus 23% for placebo-treated participants (P=0.041, Cohen's d=0.48) and the number of drinks per week by 32% versus 16% for placebo participants (P=0.016, Cohen's d=0.42). When the sample was stratified by sex, a significant effect of medication compared with placebo was evident for men (n=88) but not for women (n=67) due to a large placebo response rate in women. CONCLUSION Dutasteride 1 mg daily was efficacious in reducing the number of heavy drinking days and drinks per week in treatment-seeking men, confirming findings from a prior RCT involving 142 men.

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