Dutasteride for the Reduction of Alcohol Use in Male Drinkers

Alcoholism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01262287
• Other study ID #: 11-036-2
• Secondary ID: P60AA003510
• Status: Completed
• Phase: Phase 4
• First received: December 15, 2010
• Last updated: December 24, 2012
• Start date: January 2011
• Est. completion date: December 2012

Study information

• Verified date: December 2012
• Source: University of Connecticut Health Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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 day and the frequency of heavy drinking days. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcohol Abuse
• Alcohol Dependence
• Alcoholism

Intervention

Drug:
• Dutasteride
dutasteride 4 mg loading dose followed by 1 mg daily for 8-week treatment period
• placebo
placebo capsules in same number as active drug, daily for 8-week treatment period

Locations

Country	Name	City	State
United States	University of Connecticut Health Center	Farmington	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
University of Connecticut Health Center	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heavy drinking days and number of standard drinks per week.	Heavy drinking days are those for which 5 or more standardized alcohol drinks are consumed during a single day.	8-week treatment period and 16-week post-treatment follow-up	No
Secondary	Moderation of drug effect by genetic variation	Moderation of primary outcome measures by genetic variation in neuroactive steroid biosynthetic enzyme genes	8-week treatment and 16-week post-treatment followup periods	No
Secondary	Medication safety and tolerability	Comparisons will be conducted on 1) the number of patients in each of the two groups who report adverse effects, 2) the number of patients in each of the two groups who report moderate-to-severe adverse effects, and 3) the number of patients in each group who discontinue treatment due to adverse effects. Individual adverse events that occur in > 3% of patients in either medication condition will be examined using chi-square analysis.	8-week treatment phase and 2 month followup	Yes