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Clinical Trial Details
Placebo Controlled Pilot Study Of Dutasteride For The Reduction of Alcohol Use in Male Drinkers.
Clinical Trial ( IRB ) #: 11-036-2
Title: Placebo Controlled Pilot Study Of Dutasteride For The Reduction of Alcohol Use in Male Drinkers.
Principal Investigator: Dr. Jonathan Covault
Description: This is an 8-week pilot trial comparing dutasteride 1mg/day with inactive placebo to promote reduced alcohol use. Forty-four male heavy drinkers who want to reduce their drinking will be randomly assigned to dutasteride or placebo in equal proportion and changes in drinking will be monitored over an 8-week medication period and 16-week post medication follow-up period. The study will use an Interactive Voice Response (IVR) system to collect daily self-report of drinking, mood and medication use. The study sample size is of a pilot scale and is designed to provide additional support for the study hypothesis that dutasteride will reduce drinking and provide an estimate of likely effect sizes in order to design a more definite study. The aims of the study are to: 1) examine the safety and potential effect size of dutasteride in helping problem drinkers reduce their alcohol use, 2) examine the effect of treatment for 4 months beyond the daily dosing period. 3) evaluate whether treatment responses may be associated with genetic variation in candidate genes related to alcoholism or steroid hormone metabolism.
Classification:
  Addiction/Substance Abuse
Eligibility Criteria: Check with study contact
How to Contact: Oluwanisola Odesina. Telephone: 860-679-8931 Email: Oodesina@uchc.edu
Enrollment Status/Comments: Enrolling/recruiting. For current recruitment status, please check with study contact.
Web Address: clinicaltrials.gov/ct2/show/NCT01262287?term=%22University+of+Connecticut+Health+Center%22&rank=31