Dutasteride Treatment for the Reduction of Heavy Drinking in Men
This study will examine the safety and potential benefit of the medication dutasteride to help men reduce or stop drinking alcohol.
Drug: sugar pill
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Dutasteride Treatment for the Reduction of Heavy Drinking|
- Drinks per week and heavy drinking days per week [ Time Frame: up to 6-months post-treatment ] [ Designated as safety issue: No ]Heavy drinking day defined as drinking 5 or more drinks for men.
- Moderation of treatment effect by genetic variation in AKR1C3 [ Time Frame: 12 weeks during active treatment phase; 2-, 4-, and 6-month post-treatment ] [ Designated as safety issue: No ]Examine primary outcome data for a drug x genotype interaction focusing on neuroactive steroid metabolism enzyme 3a-HSD(17B-HSD)
- Moderation of treatment effect by genetic variation in SRD5A1 and SRD5A2 [ Time Frame: 12 weeks during active treatment phase; 2-, 4-, and 6-month post-treatment ] [ Designated as safety issue: No ]Examine primary outcome data for a drug x genotype interaction focusing on neuroactive steroid metabolism enzyme 5a-reductase type 1 and 2 which are inhibited by dutasteride
- Severity of alcohol-related problems [ Time Frame: 12 weeks during active treatment phase; 2-, 4-, and 6-month post-treatment ] [ Designated as safety issue: No ]As measured by the Short Inventory of Problems; SIP
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||July 2017|
|Estimated Primary Completion Date:||July 2017 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01758523
|Contact: Oluwanisola Odesina, M.A.||email@example.com|
|Contact: Kathleen Curley, B.S.||firstname.lastname@example.org|
|United States, Connecticut|
|University of Connecticut Health Center||Recruiting|
|Farmington, Connecticut, United States, 06030|
|Contact: Oluwanisola Odesenia, M.A. 860-679-8931 email@example.com|
|Principal Investigator: Jonathan Covault, MD, PhD|
|Sub-Investigator: Cheryl Oncken, MD, MPH|
|Sub-Investigator: Howard Tennen, PhD|
|Sub-Investigator: Anne Kenny, MD|
|Principal Investigator:||Jonathan Covault, M.D., PhD.||University of Connecticut Health Center|