Dutasteride for the Reduction of Alcohol Use in Male Drinkers
Condition: Alcoholism; Alcohol Abuse; Alcohol Dependence
MeSH terms: Alcoholism
Intervention: Dutasteride; Placebo
Intervention description: dutasteride 4 mg loading dose followed by 1 mg daily for 8-week treatment period; placebo capsules in same number as active drug, daily for 8-week treatment period
Intervention MeSH terms: Dutasteride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 47.0
Sex: Male
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Randomized Trial; Medication for Heavy Drinking; Dutasteride Treatment

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.
    

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