Conditions: Alcoholism Alcohol Abuse Alcohol Dependence
Keywords: Randomized Trial Medication for Heavy Drinking Dutasteride Treatment
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 47
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: dutasteride (1 mg oral daily dose) for 8-week treatment period arm 2: placebo daily for 8-week treatment period

Interventions: intervention 1: Dutasteride intervention 2: Placebo
Intervention descriptions: intervention 1: dutasteride 4 mg loading dose followed by 1 mg daily for 8-week treatment period intervention 2: placebo capsules in same number as active drug, daily for 8-week treatment period

Protocol document: