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Dutasteride for the Reduction of Alcohol Use in Male Drinkers

Primary Purpose

Alcoholism, Alcohol Abuse, Alcohol Dependence

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Dutasteride

Placebo

About this trial

This is an interventional treatment trial for Alcoholism focused on measuring Randomized Trial, Medication for Heavy Drinking, Dutasteride Treatment

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

University of Connecticut Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

dutasteride

Placebo

Arm Description

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

placebo daily for 8-week treatment period

Outcomes

Primary Outcome Measures

Change Number of Standard Drinks Per Week.

Change in Average Standard Drinks (14 gr ethanol) per week: last 2 weeks of treatment (wk 7-8) minus baseline average drinking average from baseline 90 day drinking history

Secondary Outcome Measures

Change in Standard Drinks Per Week - Moderation by Genetic Variation

Moderation of primary outcome measure [change in standard drinks per week from baseline to end point (average weeks 7 and 8 of treatment)] by genetic variation rs12529 in neuroactive steroid biosynthetic enzyme gene AKR1C (AKR1C3*2 C-allele associated with alcohol use disorder)

Full Information

NCT ID

NCT01262287

First Posted

December 15, 2010

Last Updated

February 9, 2017

Sponsor

UConn Health

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

1. Study Identification

Unique Protocol Identification Number

NCT01262287

Brief Title

Dutasteride for the Reduction of Alcohol Use in Male Drinkers

Official Title

Placebo Controlled Pilot Study of Dutasteride for the Reduction of Alcohol Use in Male Drinkers

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Completed

Study Start Date

January 2011 (undefined)

Primary Completion Date

December 2012 (Actual)

Study Completion Date

December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

UConn Health

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alcoholism, Alcohol Abuse, Alcohol Dependence

Keywords

Randomized Trial, Medication for Heavy Drinking, Dutasteride Treatment

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

47 (Actual)

8. Arms, Groups, and Interventions

Arm Title

dutasteride

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

placebo daily for 8-week treatment period

Intervention Type

Drug

Intervention Name(s)

Dutasteride

Other Intervention Name(s)

Avodart

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Lactose

Intervention Description

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

Primary Outcome Measure Information:

Title

Change Number of Standard Drinks Per Week.

Description

Change in Average Standard Drinks (14 gr ethanol) per week: last 2 weeks of treatment (wk 7-8) minus baseline average drinking average from baseline 90 day drinking history

Time Frame

Baseline (average weekly drinking for 90 day period prior to screening) vs. End Point (average weekly drinking weeks 7 and 8 of treatment)

Secondary Outcome Measure Information:

Title

Change in Standard Drinks Per Week - Moderation by Genetic Variation

Description

Time Frame

Baseline (average weekly drinking for 90 day period prior to screening) vs. End Point (average weekly drinking weeks 7 and 8 of treatment)

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jonathan Covault, MD, PhD

Organizational Affiliation

UConn Health

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Connecticut Health Center

City

Farmington

State/Province

Connecticut

ZIP/Postal Code

06030

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Dutasteride for the Reduction of Alcohol Use in Male Drinkers

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