NCT01262287

Dutasteride for the Reduction of Alcohol Use in Male Drinkers

Placebo Controlled Pilot Study of Dutasteride for the Reduction of Alcohol Use in Male Drinkers

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: UConn Health · Academic / Other
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Alcoholism
• Alcohol Abuse
• Alcohol Dependence

Interventions

Type	Name	Description
DRUG	Dutasteride	dutasteride 4 mg loading dose followed by 1 mg daily for 8-week treatment period
DRUG	Placebo	placebo capsules in same number as active drug, daily for 8-week treatment period

Timeline

• Start date: 2011-01-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2010-12-17
• Last updated: 2017-03-20
• Results posted: 2017-02-10

Locations

1 site across 1 country: United States