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NCT04098302 · ClinicalTrials.gov registry record · Phase 2
Dutasteride Treatment for Reducing Heavy Drinking in AUD: Predictors of Efficacy
A Phase 2 study, sponsored by UConn Health.
- Completed
- Registry status
- Phase 2
- Development phase
- 180
- Enrollment target
NCT04098302: Completed Phase 2 study, sponsored by UConn Health.
NCT04098302 is a Phase 2 study that has completed, run by UConn Health. The registered enrollment target is 180 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (35% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04098302, a Phase 2 study, has completed, sponsored by UConn Health.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 180 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety and efficacy of dutasteride in reducing drinking and heavy drinking in men and women with alcohol use disorder. The investigators hypothesize that dutasteride 1 mg per day will be well tolerated in this patient population and that, compared to placebo treatment, dutasteride will result in a greater reduction in drinks per week and in the frequency of heavy drinking days.
Primary Outcome
The number of heavy drinking days per week (i.e., four or more drinks in a day for women and five or more drinks in a day for men). The values listed in outcome table are the average HDD per week for the last 4 weeks (9-12) of phase 1 treatment. The generalized linear mixed model analysis considered all data from the ITT sample (75 dutasteride and 80 placebo participants)
Interventions
- DRUG Placebo Capsules
- DRUG Dutasteride Capsules
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2019-10-15 |
| Est. Completion | 2024-06-28 |
| Phase | Phase 2 |
What the finished NCT04098302 record still lists
NCT04098302 is an interventional study that assigns participants to a tested intervention. The registered 180 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (35% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo Capsules is the first listed.
NCT04098302 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04098302 about?
NCT04098302 is a clinical study titled "Dutasteride Treatment for Reducing Heavy Drinking in AUD: Predictors of Efficacy". The purpose of this study is to evaluate the safety and efficacy of dutasteride in reducing drinking and heavy drinking in men and women with alcohol use disorder. The investigators hypothesize that dutasteride 1 mg per day will be well tolerated in this patient population and that, compared to plac...
What is the current status of trial NCT04098302?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 180 participants. The study started on 2019-10-15. Estimated completion is 2024-06-28.
What interventions are being tested in trial NCT04098302?
The interventions under investigation include: Placebo Capsules (DRUG), Dutasteride Capsules (DRUG).
Who is sponsoring clinical trial NCT04098302?
This trial is sponsored by UConn Health, which has 178 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04098302's enrollment target sits among peer trials
180 365th of 2000 higher than 1,610 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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