Dutasteride Treatment for the Reduction of Heavy Drinking in Men
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|ClinicalTrials.gov Identifier: NCT01758523|
Recruitment Status : Completed
First Posted : January 1, 2013
Results First Posted : April 26, 2019
Last Update Posted : April 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Alcoholism Alcohol Abuse Alcohol Dependence||Drug: Dutasteride Drug: sugar pill||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||189 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Dutasteride Treatment for the Reduction of Heavy Drinking|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||February 28, 2018|
|Actual Study Completion Date :||February 28, 2018|
4 mg oral loading dose of dutasteride followed by 1 mg/day dutasteride for 12 weeks.
Other Name: Avodart
Placebo Comparator: Sugar Pill
Placebo pills prepared to appear the same as active medication and taken in the same number as active medication for 12 weeks.
Drug: sugar pill
Other Name: placebo
- Heavy Drinking Days Per Week [ Time Frame: 12-week treatment period ]Number of days / study week with 5 or more drinks consumed
- Drinks Per Week [ Time Frame: 12-week treatment period ]Total number of drinks aggregated by week
- Number of Participants With no Heavy Drinking Days [ Time Frame: Last 4 weeks of treatment ]Number of participants with no heavy drinking days (days with 5 or more drinks) during the last 4 weeks of treatment.
- Number of Participants With no Hazardous Drinking [ Time Frame: Last 4 weeks of treatment ]Number of participants with no hazardous drinking (not more than 4 drinks on one day and not more than 14 drinks per week) during the last 4 weeks of treatment.
- HDD/ Week by Treatment Group and AKR1C3*2 Genotype [ Time Frame: 12-week treatment period ]Change in Number of days / week with 5 or more drinks consumed contrasting AKR1C3*2 CC vs. G-carrier genotype and treatment group
- Carbohydrate-deficient Transferrin [ Time Frame: end of 12-week treatment vs. baseline ]Carbohydrate-deficient transferrin (CDT) at end of treatment as percentage of baseline. Serum CDT is a biochemical measure of heavy alcohol use.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01758523
|United States, Connecticut|
|University of Connecticut Health Center|
|Farmington, Connecticut, United States, 06030|
|Principal Investigator:||Jonathan Covault, M.D., PhD.||UConn Health|