MedTrace Logo

Dutasteride for the Reduction of Alcohol Use in Male Drinkers

NCT01262287 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2017-03-20

Study results available
· View outcomes & findings →

Summary

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.

Conditions

  • Alcoholism
  • Alcohol Abuse
  • Alcohol Dependence

Interventions

DRUG

Dutasteride

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

DRUG

Placebo

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

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
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT01262287 on ClinicalTrials.gov