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

NCT04098302 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2025-05-09

Study results available
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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.

Conditions

Interventions

DRUG

Dutasteride Capsules

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

DRUG

Placebo Capsules

Placebo capsules with matching appearance as Dutasteride Capsules

Sponsors & Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    collaborator NIH

  • UConn Health

    lead OTHER

Principal Investigators

  • Jonathan Covault, MD, PhD · UConn Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-15
Primary Completion
2024-06-28
Completion
2024-06-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04098302 on ClinicalTrials.gov