Dutasteride for the Reduction of Alcohol Use in Male Drinkers

Phase 4

Completed

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.

Recruitment & Eligibility

Inclusion Criteria

Male outpatients age 18 to 65 years
Have an average weekly ethanol consumption of >24 standard drinks
Be able to read English at the 8th grade or higher level and show no evidence of significant cognitive impairment
Be willing to nominate an individual who will know the patient's whereabouts in order to facilitate follow up during the study
Be willing to provide signed, informed consent to participate in the study (including a willingness to reduce drinking to non-hazardous levels)

Exclusion Criteria

Have a current, clinically significant physical disease or abnormality on the basis of medical history, physical examination, or routine laboratory evaluation
Have a serious psychiatric illness (e.g., schizophrenia, bipolar disorder, severe or psychotic major depression, organic mood or mental disorders, current eating disorder symptoms, or substantial suicide or violence risk) on the basis of history or psychiatric examination
Have a current diagnosis of drug dependence (other than nicotine or alcohol dependence)
Have a current diagnosis of alcohol dependence who on clinical examination by a physician, are deemed to be too severely alcohol dependent to permit them to participate in a placebo-controlled pilot study
Have a history of hypersensitivity to dutasteride
Current or past 4 month use of finasteride (Propecia), dutasteride (Avodart) or testosterone
Are currently taking psychotropics other than a single antidepressant with stable dose for at least 4 weeks or a non-benzodiazepine sleep medication
Are considered by the investigators to be an unsuitable candidate for receipt of an investigational drug

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	placebo daily for 8-week treatment period
dutasteride	Dutasteride	dutasteride (1 mg oral daily dose) for 8-week treatment period

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Change in Standard Drinks Per Week - Moderation by Genetic Variation	Baseline (average weekly drinking for 90 day period prior to screening) vs. End Point (average weekly drinking weeks 7 and 8 of treatment)	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)