Dutasteride for the Reduction of Alcohol Use in Male Drinkers

NCT ID: NCT01262287

Last Updated: 2017-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2012-12-31

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 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

dutasteride

dutasteride (1 mg oral daily dose) for 8-week treatment period

Group Type: EXPERIMENTAL

Dutasteride

Intervention Type: DRUG

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

Placebo

placebo daily for 8-week treatment period

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

Dutasteride

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

Avodart; Lactose

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

UConn Health

OTHER

Sponsor Role: lead

Responsible Party

Jonathan Covault

Professor of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jonathan Covault, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UConn Health

Locations

University of Connecticut Health Center

Farmington, Connecticut, United States

Countries

United States

Other Identifiers

P60AA003510

Identifier Type: NIH

Identifier Source: secondary_id

View Link

11-036-2

Identifier Type: -

Identifier Source: org_study_id