CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 180 enrolled
Drug / intervention
Dutasteride Capsules +1 moredrug
Likely dose
Dutasteride Capsules 1 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04098302
NCT04098302Phase 3Completed
CompareCT.gov

Dutasteride Treatment for Reducing Heavy Drinking in AUD: Predictors of Efficacy

UConn Health·interventional·Posted Sep 23, 2019·Updated May 9, 2025

In Brief

A Phase 3 clinical trial evaluating Dutasteride Capsules and Placebo Capsules for Alcohol Use Disorder. Completed, enrolled 180 participants across 1 site.

Detailed Summary

The purpose of this study is to evaluate the safety and efficacy of dutasteride in reducing drinking and heavy drinking in men and women with alcohol use disorder. The investigators hypothesize that dutasteride 1 mg per day will be well tolerated in this patient population and that, compared to placebo treatment, dutasteride will result in a greater reduction in drinks per week and in the frequency of heavy drinking days.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlcohol Use Disorder
CountriesUnited States
CollaboratorsNational Institute on Alcohol Abuse and Alcoholism (NIAAA)

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedSep 23, 2019
Enrollment StartOct 15, 2019
Primary CompletionJun 28, 2024
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 6.8 years ago

Interventions

Dutasteride Capsulesdrug

1 mg/day oral dutasteride (2 x 0.5 mg capsules)

Placebo Capsulesdrug

Placebo capsules with matching appearance as Dutasteride Capsules