Randomized Placebo-Controlled Clinical Trial of Dutasteride for Reducing Heavy Drinking in Men

J Clin Psychopharmacol. 2024 May-Jun;44(3):223-231. doi: 10.1097/JCP.0000000000001849.

Abstract

Background: Prior studies indicate that neuroactive steroids mediate some of alcohol's effects. Dutasteride, widely used to treat benign prostatic hypertrophy, is an inhibitor of 5-alpha reductase enzymes, which play a central role in the production of 5α-reduced neuroactive steroids. The purpose of this study was to test dutasteride's tolerability and efficacy for reducing drinking.

Methods: Men (n = 142) with heavy drinking (>24 drinks per week) and a goal to either stop or reduce drinking to nonhazardous levels were randomized to placebo or 1 mg dutasteride daily for 12 weeks. We hypothesized that dutasteride-treated patients would be more successful in reducing drinking.

Results: Generalized linear mixed models that included baseline drinking, treatment, time and their 2-way interaction identified significant interactions of treatment-time, such that dutasteride treatment reduced drinking more than placebo. During the last month of treatment, 25% of dutasteride-treated participants had no hazardous drinking (no heavy drinking days and not more than 14 drinks per week) compared with 6% of placebo-treated participants (P = 0.006; NNT = 6). Sensitivity analysis identified baseline drinking to cope as a factor associated with larger reductions in drinking for dutasteride compared with placebo-treated participants. Dutasteride was well tolerated. Adverse events more common in the dutasteride group were stomach discomfort and reduced libido.

Conclusion: Dutasteride 1 mg daily was efficacious in reducing the number of heavy drinking days and drinks per week in treatment-seeking men. The benefit of dutasteride compared with placebo was greatest for participants with elevated baseline drinking to cope motives.

Trial registration: ClinicalTrials.gov NCT01758523.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • 5-alpha Reductase Inhibitors* / administration & dosage
  • 5-alpha Reductase Inhibitors* / adverse effects
  • 5-alpha Reductase Inhibitors* / pharmacology
  • Adult
  • Aged
  • Alcohol Drinking* / drug therapy
  • Azasteroids / administration & dosage
  • Azasteroids / adverse effects
  • Azasteroids / pharmacology
  • Azasteroids / therapeutic use
  • Double-Blind Method
  • Dutasteride* / administration & dosage
  • Dutasteride* / adverse effects
  • Dutasteride* / pharmacology
  • Humans
  • Male
  • Middle Aged
  • Treatment Outcome

Substances

  • Dutasteride
  • 5-alpha Reductase Inhibitors
  • Azasteroids

Associated data

  • ClinicalTrials.gov/NCT01758523