Status:
COMPLETED
Dutasteride for the Reduction of Alcohol Use in Male Drinkers
Lead Sponsor:
UConn Health
Collaborating Sponsors:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions:
Alcoholism
Alcohol Abuse
Eligibility:
MALE
18-65 years
Phase:
PHASE4
Brief 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 th...
Eligibility Criteria
Inclusion
- Male outpatients age 18 to 65 years
- Have an average weekly ethanol consumption of \>24 standard drinks
- Be able to read English at the 8th grade or higher level and show no evidence of significant cognitive impairment
- Be willing to nominate an individual who will know the patient's whereabouts in order to facilitate follow up during the study
- Be willing to provide signed, informed consent to participate in the study (including a willingness to reduce drinking to non-hazardous levels)
Exclusion
- Have a current, clinically significant physical disease or abnormality on the basis of medical history, physical examination, or routine laboratory evaluation
- Have a serious psychiatric illness (e.g., schizophrenia, bipolar disorder, severe or psychotic major depression, organic mood or mental disorders, current eating disorder symptoms, or substantial suicide or violence risk) on the basis of history or psychiatric examination
- Have a current diagnosis of drug dependence (other than nicotine or alcohol dependence)
- Have a current diagnosis of alcohol dependence who on clinical examination by a physician, are deemed to be too severely alcohol dependent to permit them to participate in a placebo-controlled pilot study
- Have a history of hypersensitivity to dutasteride
- Current or past 4 month use of finasteride (Propecia), dutasteride (Avodart) or testosterone
- Are currently taking psychotropics other than a single antidepressant with stable dose for at least 4 weeks or a non-benzodiazepine sleep medication
- Are considered by the investigators to be an unsuitable candidate for receipt of an investigational drug
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT01262287
Start Date
January 1 2011
End Date
December 1 2012
Last Update
March 20 2017
Active Locations (1)
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1
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030