Trial · NCT01342549
Treatment Strategy for Alcohol Use Disorders in Veterans With TBI
NCT01342549, Phase 3, Completed, VA Office of Research and Development; results first posted 2016-06-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Treatment Strategy for Alcohol Use Disorders in Veterans With TBI. Trials, record NCT01342549. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01342549
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Treatment Strategy for Alcohol Use Disorders in Veterans With TBI
- NCT number
- NCT01342549
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 62 participants, actual
- Lead sponsor
- VA Office of Research and Development
- Conditions
- Alcohol Dependence
- Interventions
- Valproate, Naltrexone
- First posted
- 2011-04-27
- Last updated
- 2016-06-09
- Results first posted
- 2016-06-09
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Relapse to Heavy Drinking as Defined by Having 5 or More Drinks in a Sitting for Men and Will be Assessed Using the Time Line Follow Back for Recent Drinking Method. A Structured Questionnaire Will Review Alcohol Consumed on the Previous Week. | 24 weeks |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to Relapse to Heavy Drinking as Defined by Having 5 or More Drinks in a Sitting for Men and Will be Assessed Using the Time Line Follow Back for Recent Drinking Method. A Structured Questionnaire Will Review Alcohol Consumed on the Previous Week. | 24 weeks | Weeks | MEAN |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Time to Relapse to Heavy Drinking as Defined by Having 5 or More Drinks in a Sitting for Men and Will be Assessed Using the Time Line Follow Back for Recent Drinking Method. A Structured Questionnaire Will Review Alcohol Consumed on the Previous Week. | Arm 1 | 8.78 | Standard Deviation 0.97 | Weeks | |
Time to Relapse to Heavy Drinking as Defined by Having 5 or More Drinks in a Sitting for Men and Will be Assessed Using the Time Line Follow Back for Recent Drinking Method. A Structured Questionnaire Will Review Alcohol Consumed on the Previous Week. | Arm 2 | 15.99 | Standard Deviation 1.36 | Weeks |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm 1 | 31 | |
| Overall Study | STARTED | Arm 2 | 31 | |
| Overall Study | COMPLETED | Arm 1 | 31 | |
| Overall Study | COMPLETED | Arm 2 | 31 | |
| Overall Study | NOT COMPLETED | Arm 1 | 0 | |
| Overall Study | NOT COMPLETED | Arm 2 | 0 |
Source ClinicalTrials.gov
Adverse events10
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Drowsiness | Nervous system disorders | Arm 1 | 12 | 31 | |
| other | Drowsiness | Nervous system disorders | Arm 2 | 10 | 31 | |
| other | Nausea | Gastrointestinal disorders | Arm 1 | 3 | 31 | |
| other | Nausea | Gastrointestinal disorders | Arm 2 | 9 | 31 | |
| other | Diarrhea | Gastrointestinal disorders | Arm 1 | 10 | 31 | |
| other | Diarrhea | Gastrointestinal disorders | Arm 2 | 9 | 31 | |
| other | Sweating | Skin and subcutaneous tissue disorders | Arm 1 | 5 | 31 | |
| other | Sweating | Skin and subcutaneous tissue disorders | Arm 2 | 10 | 31 | |
| other | Abdominal Pain | Gastrointestinal disorders | Arm 1 | 3 | 31 | |
| other | Abdominal Pain | Gastrointestinal disorders | Arm 2 | 5 | 31 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm 1 | ||
| Total, all-cause mortality | Arm 2 | ||
| Total, other adverse events | Arm 1 | 12 | 31 |
| Total, other adverse events | Arm 2 | 10 | 31 |
| Total, serious adverse events | Arm 1 | 0 | 31 |
| Total, serious adverse events | Arm 2 | 0 | 31 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Arm 1 vs Arm 2: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01342549
GET https://conductscience.org/api/trials/v1/NCT01342549/registered