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Report for Clinical Trial NCT01262287

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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

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.

NCT01262287 Alcoholism Alcohol Abuse Alcohol Dependence
MeSH: Alcoholism

2 Interventions

Name: Dutasteride

Description: dutasteride 4 mg loading dose followed by 1 mg daily for 8-week treatment period

Type: Drug

dutasteride

Name: Placebo

Description: placebo capsules in same number as active drug, daily for 8-week treatment period

Type: Drug

Placebo


Primary Outcomes

Description: 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

Measure: Change Number of Standard Drinks Per Week.

Time: Baseline (average weekly drinking for 90 day period prior to screening) vs. End Point (average weekly drinking weeks 7 and 8 of treatment)

Secondary Outcomes

Description: 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)

Measure: Change in Standard Drinks Per Week - Moderation by Genetic Variation

Time: Baseline (average weekly drinking for 90 day period prior to screening) vs. End Point (average weekly drinking weeks 7 and 8 of treatment)

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 rs12529

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).



HPO Nodes