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

NCT01262287 Phase 4 COMPLETED Results posted

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.

Details

Lead sponsor	UConn Health
Phase	Phase 4
Status	COMPLETED
Enrolment	47
Start date	2011-01
Completion	2012-12

Conditions

• Alcoholism
• Alcohol Abuse
• Alcohol Dependence

Interventions

• Dutasteride
• Placebo

Primary outcomes

• Change Number of Standard Drinks Per Week. — 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 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

Countries

United States