Dutasteride for the Reduction of Alcohol Use in Male Drinkers

Study Overview
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Brief Summary
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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.

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

Conditions
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Alcoholism, Alcohol Abuse, Alcohol Dependence

Intervention / Treatment
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* Drug: Dutasteride
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dutasteride<br>dutasteride (1 mg oral daily dose) for 8-week treatment period | Drug: Dutasteride<br>* dutasteride 4 mg loading dose followed by 1 mg daily for 8-week treatment period<br>* Other names: Avodart;|
| Placebo Comparator: Placebo<br>placebo daily for 8-week treatment period | Drug: Placebo<br>* placebo capsules in same number as active drug, daily for 8-week treatment period<br>* Other names: Lactose;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change Number of Standard Drinks Per Week. | 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 | Baseline (average weekly drinking for 90 day period prior to screening) vs. End Point (average weekly drinking weeks 7 and 8 of treatment) | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Randomized Trial, Medication for Heavy Drinking, Dutasteride Treatment