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NCT01342549 · ClinicalTrials.gov registry record · Phase 3

Treatment Strategy for Alcohol Use Disorders in Veterans With TBI

A Phase 3 study, sponsored by VA Office of Research and Development.

Completed
Registry status
Phase 3
Development phase
62
Enrollment target

NCT01342549: Completed Phase 3 study, sponsored by VA Office of Research and Development.

NCT01342549 is a Phase 3 study that has completed, run by VA Office of Research and Development. The registered enrollment target is 62 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01342549, a Phase 3 study, has completed, sponsored by VA Office of Research and Development.

COMPLETED
Registry status
Phase 3
Development phase
62 participants
Enrollment target

Study Summary

The purpose of this research study is to understand the effectiveness of valproate (a common mood stabilizer) to further reduce alcohol misuse when given in addition to attending an alcohol rehabilitation program as well as the treatment of mood disorders or PTSD. The main goal of this project is to understand if people receiving valproate will have a better recovery than people receiving the standard treatment for alcohol dependence: naltrexone.

Interventions

  • DRUG Valproate
  • DRUG Naltrexone

Trial Details

FieldValue
Enrollment Target 62 participants
Start Date 2011-09
Est. Completion 2015-06
Phase Phase 3
VA Office of Research and Development

1,668 total trials

What the finished NCT01342549 record still lists

NCT01342549 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower).

The record links to 0 conditions, and to 2 interventions - of which Valproate is the first listed.

NCT01342549 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01342549 about?

NCT01342549 is a clinical study titled "Treatment Strategy for Alcohol Use Disorders in Veterans With TBI". The purpose of this research study is to understand the effectiveness of valproate (a common mood stabilizer) to further reduce alcohol misuse when given in addition to attending an alcohol rehabilitation program as well as the treatment of mood disorders or PTSD. The main goal of this project is to...

What is the current status of trial NCT01342549?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 62 participants. The study started on 2011-09. Estimated completion is 2015-06.

What interventions are being tested in trial NCT01342549?

The interventions under investigation include: Valproate (DRUG), Naltrexone (DRUG).

Who is sponsoring clinical trial NCT01342549?

This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01342549's enrollment target sits among peer trials

62 1802nd of 2000 higher than 198 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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 NCT01342549, the US trial registry maintained by the National Library of Medicine. NCT01342549 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.