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NCT03018704 · ClinicalTrials.gov registry record · Phase 4
Topiramate Treatment of Alcohol Use Disorders in African Americans
A Phase 4 study, sponsored by VA Office of Research and Development.
- Terminated
- Registry status
- Phase 4
- Development phase
- 79
- Enrollment target
NCT03018704: Clinical Trial Phase 4 study, sponsored by VA Office of Research and Development.
NCT03018704 is a Phase 4 study that was terminated before completion, run by VA Office of Research and Development. The registered enrollment target is 79 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03018704, a Phase 4 study, was terminated before completion, sponsored by VA Office of Research and Development.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 79 participants
- Enrollment target
Study Summary
The focus of this application is on the improvement of services for African American (AAs) Veterans afflicted with an alcohol use disorder. The project focuses on the use of topiramate as a treatment for alcohol use disorders. Despite having lower rates of heavy drinking than European Americans (EAs), AAs have significantly higher rates of mortality from a variety of alcohol-related conditions, including liver cirrhosis, accidents, and violence. Despite the higher rates of morbidity and mortality, pharmacological treatments are understudied in this population and there is some evidence that medications are less preferred and less effective in AAs.
Primary Outcome
Drinking was recorded using the timeline follow back methodology which is an interview based method to record drinking on each day during the trial. The summary measure (% days heavy drinking) counts the number of days of heavy drinking (\>4drinks per day) divided by the number of observation days to report the percent of observation days for which there is heavy drinking. For the the outcome measure the observation period is the last 42 days of the trial.
Interventions
- DRUG placebo
- DRUG Topiramate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 79 participants |
| Start Date | 2017-08-01 |
| Est. Completion | 2021-12-31 |
| Phase | Phase 4 |
Why NCT03018704 stopped before completion
NCT03018704 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 79 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT03018704 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03018704 about?
NCT03018704 is a clinical study titled "Topiramate Treatment of Alcohol Use Disorders in African Americans". The focus of this application is on the improvement of services for African American (AAs) Veterans afflicted with an alcohol use disorder. The project focuses on the use of topiramate as a treatment for alcohol use disorders. Despite having lower rates of heavy drinking than European Americans (EAs...
What is the current status of trial NCT03018704?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 79 participants. The study started on 2017-08-01. Estimated completion is 2021-12-31.
What interventions are being tested in trial NCT03018704?
The interventions under investigation include: placebo (DRUG), Topiramate (DRUG).
Who is sponsoring clinical trial NCT03018704?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03018704's enrollment target sits among peer trials
79 980th of 2000 higher than 1,019 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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