At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Placebo Controlled Pilot Study of Dutasteride for the Reduction of Alcohol Use in Male Drinkers
In Brief
A Phase 4 clinical trial evaluating Dutasteride and Placebo for Alcoholism and 2 related conditions. Completed, enrolled 47 participants across 1 site.
Detailed Summary
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 Details
Timeline
Interventions
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