NCT01758523

Dutasteride Treatment for the Reduction of Heavy Drinking in Men

Dutasteride Treatment for the Reduction of Heavy Drinking

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 189 (actual)
• Sponsor: UConn Health · Academic / Other
• Sex: Male
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study will examine the safety and potential benefit of the medication dutasteride to help men reduce or stop drinking alcohol.

Detailed description

Extensive preclinical studies indicate that neuroactive steroids medicate important effects of alcohol and support the examination of neuroactive steroid modulators as treatment options for alcohol use problems. Dutasteride, a widely prescribed medication for benign prostatic hypertrophy, blocks a key step in the production of neuroactive steroids and represents a promising candidate for treatment of alcohol use disorders. This study will use a 12-week randomized placebo controlled design to examine the safety and efficacy of dutasteride to reduce drinking among a sample of 160 men with hazardous levels of alcohol use. It will additionally examine the potential moderation of dutasteride treatment effects by a common missense polymorphism in a neuroactive steroid biosynthetic enzyme that we have previously reported to be associated with alcohol dependence. Identification of genetic predictors of medication response offers the potential for matching alcohol treatment medications with those most likely to respond.

Conditions

• Alcoholism
• Alcohol Abuse
• Alcohol Dependence

Interventions

Type	Name	Description
DRUG	Dutasteride
DRUG	sugar pill

Timeline

• Start date: 2013-01-01
• Primary completion: 2018-02-28
• Completion: 2018-02-28
• First posted: 2013-01-01
• Last updated: 2019-04-26
• Results posted: 2019-04-26

Locations

1 site across 1 country: United States