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NCT01749215 · ClinicalTrials.gov registry record · Phase 4

A Controlled Trial of Topiramate Treatment for Alcohol Dependence in Veterans With PTSD

A Phase 4 study, sponsored by University of California, San Francisco.

Completed
Registry status
Phase 4
Development phase
151
Enrollment target

NCT01749215: Completed Phase 4 study, sponsored by University of California, San Francisco.

NCT01749215 is a Phase 4 study that has completed, run by University of California, San Francisco. The registered enrollment target is 151 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01749215, a Phase 4 study, has completed, sponsored by University of California, San Francisco.

COMPLETED
Registry status
Phase 4
Development phase
151 participants
Enrollment target

Study Summary

The goal of this project is to improve the treatment of veterans with co-occurring alcohol dependence and posttraumatic stress disorder (PTSD). The PI and co-investigators will conduct a controlled clinical trial of topiramate for the treatment of these co-occurring disorders.

Primary Outcome

Timeline Followback (TLFB) data was recorded using a calendar, with participants providing retrospective reports of daily drinking over the past week(s). The percent of heavy drinking days per week was calculated from the calendar data. The change in percentage of heavy drinking days was calculated by subtracting Week 0 (baseline) data from Week 12. Negative scores indicate improvement.

Interventions

  • DRUG placebo
  • BEHAVIORAL Medical Management
  • DRUG Topiramate

Trial Details

FieldValue
Enrollment Target 151 participants
Start Date 2013-02
Est. Completion 2019-07
Phase Phase 4

What the finished NCT01749215 record still lists

NCT01749215 is an interventional study that assigns participants to a tested intervention. The registered 151 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (71% lower).

The record links to 0 conditions, and to 3 interventions - of which placebo is the first listed.

NCT01749215 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01749215 about?

NCT01749215 is a clinical study titled "A Controlled Trial of Topiramate Treatment for Alcohol Dependence in Veterans With PTSD". The goal of this project is to improve the treatment of veterans with co-occurring alcohol dependence and posttraumatic stress disorder (PTSD). The PI and co-investigators will conduct a controlled clinical trial of topiramate for the treatment of these co-occurring disorders.

What is the current status of trial NCT01749215?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 151 participants. The study started on 2013-02. Estimated completion is 2019-07.

What interventions are being tested in trial NCT01749215?

The interventions under investigation include: placebo (DRUG), Medical Management (BEHAVIORAL), Topiramate (DRUG).

Who is sponsoring clinical trial NCT01749215?

This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01749215's enrollment target sits among peer trials

151 533rd of 2000 higher than 1,468 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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Source: ClinicalTrials.gov NCT01749215, the US trial registry maintained by the National Library of Medicine. NCT01749215 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.