Dutasteride for the Reduction of Alcohol Use in Male Drinkers

Condition(s) targeted: Alcoholism; Alcohol Abuse; Alcohol Dependence

Intervention: Dutasteride (Drug); placebo (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: University of Connecticut Health Center

Official(s) and/or principal investigator(s):
Jonathan Covault, MD, PhD, Principal Investigator, Affiliation: University of Connecticut Health Center

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.

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

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

Primary outcome: Heavy drinking days and number of standard drinks per week.

Secondary outcome:

Moderation of drug effect by genetic variation

Medication safety and tolerability

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Male.

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

University of Connecticut Health Center, Farmington, Connecticut 06030, United States

Starting date: January 2011
Last updated: December 24, 2012