Trial · NCT03176953
Topiramate and Prolonged Exposure
NCT03176953, Phase 2, Phase 3, Completed, VA Office of Research and Development; results first posted 2023-11-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Topiramate and Prolonged Exposure. Trials, record NCT03176953. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03176953
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Topiramate and Prolonged Exposure
- NCT number
- NCT03176953
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 100 participants, actual
- Lead sponsor
- VA Office of Research and Development
- Conditions
- PTSD and Alcohol Use Disorder
- Interventions
- topiramate, prolonged exposure, placebo
- First posted
- 2017-06-06
- Last updated
- 2023-11-18
- Results first posted
- 2023-11-18
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | CAPS-5 Change | Change from baseline to 16 weeks | PTSD symptom diagnostic interview CAPS-5 score range = 0 - 80 Higher scores = more severe PTSD symptoms |
| Primary | Timeline Followback Interview (TLFB) | Change from baseline to 16 weeks | substance use severity score range = 0 - 100% of heavy drinking days higher scores = greater percentage of total days that included heavy drinking |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | CAPS-5 Change | Change from baseline to 16 weeks | All randomized participants | score on a scale | MEAN |
| PRIMARY | Timeline Followback Interview (TLFB) | Change from baseline to 16 weeks | percentage of days | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| CAPS-5 Change | Prolonged Exposure + Topiramate | baseline CAPS | 36.720 | Standard Error 1.794 | score on a scale |
| CAPS-5 Change | Prolonged Exposure + Placebo | baseline CAPS | 38.600 | Standard Error 1.794 | score on a scale |
| CAPS-5 Change | Prolonged Exposure + Topiramate | 16-week CAPS | 21.006 | Standard Error 1.988 | score on a scale |
| CAPS-5 Change | Prolonged Exposure + Placebo | 16-week CAPS | 29.872 | Standard Error 2.016 | score on a scale |
| Timeline Followback Interview (TLFB) | Prolonged Exposure + Topiramate | Baseline | 53.5 | Standard Error 3.6 | percentage of days |
| Timeline Followback Interview (TLFB) | Prolonged Exposure + Placebo | Baseline | 52.1 | Standard Error 3.6 | percentage of days |
| Timeline Followback Interview (TLFB) | Prolonged Exposure + Topiramate | 16 week | 10.8 | Standard Error 4.1 | percentage of days |
| Timeline Followback Interview (TLFB) | Prolonged Exposure + Placebo | 16 week | 16.2 | Standard Error 4.2 | percentage of days |
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 | Prolonged Exposure + Topiramate | 50 | |
| Overall Study | STARTED | Prolonged Exposure + Placebo | 50 | |
| Overall Study | COMPLETED | Prolonged Exposure + Topiramate | 41 | |
| Overall Study | COMPLETED | Prolonged Exposure + Placebo | 40 | |
| Overall Study | NOT COMPLETED | Prolonged Exposure + Topiramate | 9 | |
| Overall Study | NOT COMPLETED | Prolonged Exposure + Placebo | 10 |
Source ClinicalTrials.gov
Adverse events14
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 | acidosis | Endocrine disorders | Prolonged Exposure + Topiramate | 1 | 50 | 1 |
| other | acidosis | Endocrine disorders | Prolonged Exposure + Placebo | 0 | 50 | 0 |
| other | skin rash | Skin and subcutaneous tissue disorders | Prolonged Exposure + Topiramate | 1 | 50 | 1 |
| other | skin rash | Skin and subcutaneous tissue disorders | Prolonged Exposure + Placebo | 0 | 50 | 0 |
| other | physical injury due to fighting or non-suicidal self-harm | Skin and subcutaneous tissue disorders | Prolonged Exposure + Topiramate | 2 | 50 | 2 |
| other | physical injury due to fighting or non-suicidal self-harm | Skin and subcutaneous tissue disorders | Prolonged Exposure + Placebo | 1 | 50 | 1 |
| other | incarceration due to parole violation | Social circumstances | Prolonged Exposure + Topiramate | 0 | 50 | 0 |
| other | incarceration due to parole violation | Social circumstances | Prolonged Exposure + Placebo | 1 | 50 | 1 |
| serious | psychiatric hospitalization | Psychiatric disorders | Prolonged Exposure + Topiramate | 2 | 50 | 2 |
| serious | psychiatric hospitalization | Psychiatric disorders | Prolonged Exposure + Placebo | 0 | 50 | 0 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Prolonged Exposure + Topiramate | 0 | 50 |
| Total, all-cause mortality | Prolonged Exposure + Placebo | 0 | 50 |
| Total, other adverse events | Prolonged Exposure + Topiramate | 4 | 50 |
| Total, other adverse events | Prolonged Exposure + Placebo | 2 | 50 |
| Total, serious adverse events | Prolonged Exposure + Topiramate | 3 | 50 |
| Total, serious adverse events | Prolonged Exposure + Placebo | 2 | 50 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Prolonged Exposure + Topiramate vs Prolonged Exposure + Placebo: deaths from any cause | Trial comparisons |
| Prolonged Exposure + Topiramate vs Prolonged Exposure + Placebo: serious adverse events | 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/NCT03176953
GET https://conductscience.org/api/trials/v1/NCT03176953/registered