Clinical trial NCT01262287: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Alcoholism
Alcohol Abuse
Alcohol Dependence
Keywords: Randomized Trial
Medication for Heavy Drinking
Dutasteride Treatment
Lead sponsor: UConn Health
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2010-12-17
Enrollment: 47
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change Number of Standard Drinks Per Week.
timeFrame: Baseline (average weekly drinking for 90 day period prior to screening) vs. End Point (average weekly drinking weeks 7 and 8 of treatment)
Secondary outcomes:
measure: Change in Standard Drinks Per Week - Moderation by Genetic Variation
timeFrame: Baseline (average weekly drinking for 90 day period prior to screening) vs. End Point (average weekly drinking weeks 7 and 8 of treatment)
Other outcomes:
Locations:
city: Farmington
country: United States
facility: University of Connecticut Health Center
state: Connecticut
Study officials:
affiliation: UConn Health
name: Jonathan Covault, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: