Dutasteride Treatment for Reducing Heavy Drinking in AUD: Predictors of Efficacy
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|ClinicalTrials.gov Identifier: NCT04098302|
Recruitment Status : Recruiting
First Posted : September 23, 2019
Last Update Posted : October 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Alcohol Use Disorder||Drug: Dutasteride Capsules Drug: Placebo Capsules||Phase 2 Phase 3|
Heavy drinking remains a significant public health problem and is frequently under treated. Although several medications have been shown to help patients stop or reduce drinking, additional medication options are needed as there is considerable variability in effectiveness or tolerability of existing medications for individual patients. Additionally, identification of individual subject level predictors of efficacy are needed to better personalize pharmacotherapy treatment recommendations. This study will seek to replicate and extend our results showing efficacy of a novel medication dutasteride for reducing drinking and will examine potential easily measured predictors of response.
Dutasteride is a widely prescribed medication for benign prostatic hypertrophy and androgenic hair loss that also modulates the elimination of cortisol and the production of some neuroactive steroids. Changes in the regulation of cortisol and neuroactive steroids have each been suggested as factors which may contribute to the maintenance of alcohol dependence. Data from a recently completed first randomized placebo controlled trial of dutasteride for AUD in a sample of male drinkers, indicates that dutasteride is well tolerated in alcoholics and has efficacy in helping subjects reduce drinking. Additionally, results indicate that dutasteride may be particularly helpful for patients who drink to cope with anxiety and negative emotions, a group of patients with poor response to other treatments.
This 24-week treatment study will use an innovative randomized placebo controlled step therapy design to examine the safety and efficacy of dutasteride to reduce drinking by treatment seeking women and men with hazardous levels of alcohol use. At 12-weeks placebo non-responders will transition to dutasteride and dutasteride non-responders will transition to naltrexone, an FDA approved medication with demonstrated efficacy for reducing heavy drinking. 12-week responders (reduction in drinks/week of 60% or greater compared with screening) will continue for an additional 12-weeks on their initial study medication assignment (dutasteride or placebo).
Additionally, the investigators will examine several baseline measures as predictors of dutasteride efficacy, including drinking to cope, anxiety, adverse child events, and perceived life stress as well as stress resilient vs. reactive genotypes of FKBP5 a chaperone protein involved in regulation of glucocorticoid, androgen and progesterone receptor function.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||190 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||The study consists of two 12-week phases, the first being a 12-week parallel-groups comparison of dutasteride and placebo to evaluate the safety and efficacy of dutasteride 1 mg/day in reducing the likelihood of drinking and heavy drinking in treatment-seeking men and women with alcohol use disorder. In the second 12-week phase, responders in phase 1 (defined as a ≥60% reduction in SD/wk for weeks 9-12 compared with screening) will continue on their initial medication assignment, while non-responder subjects treated with placebo in phase 1 will be given dutasteride during phase 2, and non-responder subjects treated with dutasteride in phase 1 will receive naltrexone daily in phase 2. This design maintains double blind conditions in both phases 1 and 2.|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||UConn Health Investigational Pharmacy will randomize to dutasteride vs. placebo for phase 1 at baseline|
|Official Title:||Dutasteride Treatment for Reducing Heavy Drinking in AUD: Predictors of Efficacy|
|Actual Study Start Date :||October 15, 2019|
|Estimated Primary Completion Date :||May 30, 2024|
|Estimated Study Completion Date :||May 30, 2025|
Active Comparator: dutasteride
two 0.5 mg capsules of dutasteride daily
Drug: Dutasteride Capsules
1 mg/day oral dutasteride (2 x 0.5 mg capsules)
Other Name: Avodart
Placebo Comparator: placebo capsule
inactive placebo matched in appearance with dutasteride capsules
Drug: Placebo Capsules
Placebo capsules with matching appearance as Dutasteride Capsules
Other Name: inactive placebo
- Change in Heavy Drinking Days Per Week by Medication Group [ Time Frame: 12 weeks (from initiation to end of treatment phase 1) ]Change in the number of heavy drinking days (i.e., four or more drinks in a day for women and five or more drinks in a day for men) during treatment phase of study. Daily drinking data will be aggregated to the weekly level.
- Change in Drinks Per Week by Medication Group [ Time Frame: 12 weeks (from initiation to end of treatment phase 1) ]Change in the number of drinks per week during treatment phase of study. Daily drinking data will be aggregated to the weekly level.
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): NCT04098302
|Contact: Marcia Lawlor, BSfirstname.lastname@example.org|
|United States, Connecticut|
|University of Connecticut Health Center||Recruiting|
|Farmington, Connecticut, United States, 06030|
|Contact: Jonathan Covault, MD 860-679-7560 email@example.com|
|Sub-Investigator: Cheryl Oncken, MD|
|Sub-Investigator: Rao Surita, MBBS|
|Sub-Investigator: Tennen Howard, PhD|
|Principal Investigator: Covault Jonathan, MD, PhD|
|Principal Investigator:||Jonathan Covault, MD, PhD||UConn Health|