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NCT01750268 · ClinicalTrials.gov registry record · Phase 4
Topiramate Treatment of Hazardous and Harmful Alcohol Use in Veterans With TBI
A Phase 4 study of Traumatic Brain Injury (TBI) and Hazardous and Harmful Alcohol Use, sponsored by University of California, San Francisco.
- Completed
- Registry status
- Phase 4
- Development phase
- 32
- Enrollment target
- 1
- Study location
NCT01750268: Completed Phase 4 study of Traumatic Brain Injury (TBI) and Hazardous and Harmful Alcohol Use, sponsored by University of California, San Francisco.
NCT01750268 is a Phase 4 study of Traumatic Brain Injury (TBI) and Hazardous and Harmful Alcohol Use that has completed, run by University of California, San Francisco. The registered enrollment target is 32 participants, below the 47-participant average among 6 other Traumatic Brain Injury (TBI) trials with a reported enrollment target (32% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01750268, a Phase 4 study of Traumatic Brain Injury (TBI) and Hazardous and Harmful Alcohol Use, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 32 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of the proposed project is to improve the treatment of veterans with co-occurring traumatic brain injury (TBI) and hazardous or harmful alcohol use. The PI and coinvestigators will conduct a pilot controlled clinical trial of topiramate for the treatment of these co-occurring disorders.
Primary Outcome
Using a calendar, participants provide retrospective estimates of daily drinking over a specified period.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Topiramate
- BEHAVIORAL Medical Management Counseling
Study Locations (1)
California
- San Francisco VA Medical Center - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2012-11 |
| Est. Completion | 2015-10 |
| Phase | Phase 4 |
What the finished NCT01750268 record still lists
NCT01750268 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 47-participant average among 6 other Traumatic Brain Injury (TBI) trials with a reported enrollment target (32% lower).
The record links to 2 conditions, with Traumatic Brain Injury (TBI) appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT01750268 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT01750268 about?
NCT01750268 is a clinical study titled "Topiramate Treatment of Hazardous and Harmful Alcohol Use in Veterans With TBI". The goal of the proposed project is to improve the treatment of veterans with co-occurring traumatic brain injury (TBI) and hazardous or harmful alcohol use. The PI and coinvestigators will conduct a pilot controlled clinical trial of topiramate for the treatment of these co-occurring disorders.
What is the current status of trial NCT01750268?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 32 participants. The study started on 2012-11. Estimated completion is 2015-10.
What conditions does trial NCT01750268 study?
This clinical trial studies the following conditions: Traumatic Brain Injury (TBI), Hazardous and Harmful Alcohol Use.
What interventions are being tested in trial NCT01750268?
The interventions under investigation include: Placebo (DRUG), Topiramate (DRUG), Medical Management Counseling (BEHAVIORAL).
Who is sponsoring clinical trial NCT01750268?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01750268 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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