University of Connecticut Health Center
Farmington, Connecticut, 06030, United States
NCT Number: NCT01262287
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.
Looking for future studies?
Notify Me18 year–65 year
Male
Interventional
Phase 4
Farmington, Connecticut, 06030, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
dutasteride 4 mg loading dose followed by 1 mg daily for 8-week treatment period
Other names: Avodart
placebo capsules in same number as active drug, daily for 8-week treatment period
Other names: Lactose
Time frame: Baseline (average weekly drinking for 90 day period prior to screening) vs. End Point (average weekly drinking weeks 7 and 8 of treatment)
Change in Average Standard Drinks (14 gr ethanol) per week: last 2 weeks of treatment (wk 7-8) minus baseline average drinking average from baseline 90 day drinking history
Time frame: Baseline (average weekly drinking for 90 day period prior to screening) vs. End Point (average weekly drinking weeks 7 and 8 of treatment)
Moderation of primary outcome measure [change in standard drinks per week from baseline to end point (average weeks 7 and 8 of treatment)] by genetic variation rs12529 in neuroactive steroid biosynthetic enzyme gene AKR1C (AKR1C3*2 C-allele associated with alcohol use disorder)
UConn Health
Other
Placebo Controlled Pilot Study of Dutasteride for the Reduction of Alcohol Use in Male Drinkers
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT02179749
Alcohol Abuse, Alcohol Dependence
La Jolla, California, United States
View Trial DetailsNCT01758523
Alcohol Abuse, Alcohol Dependence
Farmington, Connecticut, United States
View Trial DetailsNCT01613014
Alcohol Abuse, Alcohol Dependence
Baltimore, Maryland, United States
View Trial DetailsNCT00595556
Alcohol Abuse, Alcohol Dependence
Farmington, Connecticut, United States
View Trial Details