The purpose of this study is to evaluate whether dutasteride is safe and effective for reducing alcohol use in male drinkers who want to stop or reduce their drinking. The investigators hypothesize that at a dosage of 1mg/day, dutasteride will be well tolerated and that, compared to placebo treatment, dutasteride will result in a greater reduction in the amount of alcohol consumed per week. The study sample size is of a pilot scale and is designed to provide additional support for the study hypothesis and provide an estimate of likely effect sizes in order to design a more definitive study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
47
dutasteride 4 mg loading dose followed by 1 mg daily for 8-week treatment period
placebo capsules in same number as active drug, daily for 8-week treatment period
University of Connecticut Health Center
Farmington, Connecticut, United States
Change Number of Standard Drinks Per Week.
Change in Average Standard Drinks (14 gr ethanol) per week: last 2 weeks of treatment (wk 7-8) minus baseline average drinking average from baseline 90 day drinking history
Time frame: Baseline (average weekly drinking for 90 day period prior to screening) vs. End Point (average weekly drinking weeks 7 and 8 of treatment)
Change in Standard Drinks Per Week - Moderation by Genetic Variation
Moderation of primary outcome measure \[change in standard drinks per week from baseline to end point (average weeks 7 and 8 of treatment)\] by genetic variation rs12529 in neuroactive steroid biosynthetic enzyme gene AKR1C (AKR1C3\*2 C-allele associated with alcohol use disorder)
Time frame: Baseline (average weekly drinking for 90 day period prior to screening) vs. End Point (average weekly drinking weeks 7 and 8 of treatment)
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