Dutasteride Treatment for the Reduction of Heavy Drinking in Men
Condition: Alcoholism; Alcohol Abuse; Alcohol Dependence
MeSH terms: Alcoholism
Intervention: Dutasteride; sugar pill
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: 189.0
Sex: Male
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: neuroactive steroids

Summary:

      This study will examine the safety and potential benefit of the medication dutasteride to
      help men reduce or stop drinking alcohol.
    

Eligibility criteria:

        Inclusion Criteria:

          -  an average weekly ethanol consumption of at least 24 standard drinks;

          -  be able to read English at the 8th grade or higher level;

          -  no evidence of significant cognitive impairment;

          -  be willing to provide signed, informed consent to participate in the study (including
             a willingness to stop or reduce drinking to non-hazardous levels);

          -  be willing to nominate an individual who will know the patient's whereabouts to
             facilitate follow up during the study

        Exclusion Criteria:

          -  history of significant alcohol withdrawal symptoms (e.g. substantial tremor, autonomic
             changes, perceptual distortions, seizures, delirium, or hallucinations);

          -  current Diagnostic and Statistical Manual Version IV (DSM-IV) 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 study (e.g.
             evidence of serious adverse medical or psychiatric effects that are exacerbated by
             heavy drinking and would, for safety reasons, lead the physician to urge the patient
             to be totally abstinent and engage in an empirically supported treatment).

          -  current, clinically significant physical disease or abnormality on the basis of
             medical history, physical examination, or routine laboratory evaluation,(we will not
             exclude patients with hypertension, diabetes mellitus, asthma or other common medical
             conditions, if these are adequately controlled and the patient has an ongoing
             relationship with a primary care provider)

          -  serious psychiatric illness on the basis of history or psychiatric examination (i.e.,
             schizophrenia, bipolar disorder, severe or psychotic major depression, organic mental
             disorder, current clinically significant eating disorder, or substantial suicide or
             violence risk);

          -  current DSM-IV diagnosis of drug dependence (other than nicotine dependence);

          -  currently taking psychotropics other than medication for depression/anxiety disorder
             (with stable dose for at least 4 weeks),medications for treatment of Attention
             Deficit/Hyperactivity Disorder (with stable dose for at least 4 weeks), a
             non-benzodiazepine sleep medication or a low dose of benzodiazepine equivalent to 2 mg
             clonazepam or lorazepam per day;

          -  are considered by the investigators to be an unsuitable candidate for receipt of an
             investigational drug