This study will examine the safety and potential benefit of the medication dutasteride to help men reduce or stop drinking alcohol.
Extensive preclinical studies indicate that neuroactive steroids medicate important effects of alcohol and support the examination of neuroactive steroid modulators as treatment options for alcohol use problems. Dutasteride, a widely prescribed medication for benign prostatic hypertrophy, blocks a key step in the production of neuroactive steroids and represents a promising candidate for treatment of alcohol use disorders. This study will use a 12-week randomized placebo controlled design to examine the safety and efficacy of dutasteride to reduce drinking among a sample of 160 men with hazardous levels of alcohol use. It will additionally examine the potential moderation of dutasteride treatment effects by a common missense polymorphism in a neuroactive steroid biosynthetic enzyme that we have previously reported to be associated with alcohol dependence. Identification of genetic predictors of medication response offers the potential for matching alcohol treatment medications with those most likely to respond.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
189
University of Connecticut Health Center
Farmington, Connecticut, United States
Heavy Drinking Days Per Week
Number of days / study week with 5 or more drinks consumed
Time frame: 12-week treatment period
Drinks Per Week
Total number of drinks aggregated by week
Time frame: 12-week treatment period
Number of Participants With no Heavy Drinking Days
Number of participants with no heavy drinking days (days with 5 or more drinks) during the last 4 weeks of treatment.
Time frame: Last 4 weeks of treatment
Number of Participants With no Hazardous Drinking
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.
Time frame: Last 4 weeks of treatment
HDD/ Week by Treatment Group and AKR1C3*2 Genotype
Change in Number of days / week with 5 or more drinks consumed contrasting AKR1C3\*2 CC vs. G-carrier genotype and treatment group
Time frame: 12-week treatment period
Carbohydrate-deficient Transferrin
Carbohydrate-deficient transferrin (CDT) at end of treatment as percentage of baseline. Serum CDT is a biochemical measure of heavy alcohol use.
Time frame: end of 12-week treatment vs. baseline
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.