Trial · NCT01408641
Topiramate for Alcohol Use in Posttraumatic Stress Disorder
NCT01408641, Not applicable, Terminated, University of Maryland, Baltimore; results first posted 2018-05-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Topiramate for Alcohol Use in Posttraumatic Stress Disorder. Trials, record NCT01408641. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01408641
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Topiramate for Alcohol Use in Posttraumatic Stress Disorder
- NCT number
- NCT01408641
- Status
- Terminated
- Phases
- Not applicable
- Enrollment
- 4 participants, actual
- Lead sponsor
- University of Maryland, Baltimore
- Conditions
- Alcohol Dependence, Alcoholism, Alcohol Abuse, Alcohol Use Disorder, PTSD, Posttraumatic Stress Disorder
- Interventions
- Topiramate, Placebo
- First posted
- 2011-08-03
- Last updated
- 2022-03-03
- Results first posted
- 2018-05-24
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Heavy Drinking Days | 14 weeks | The Alcohol Timeline Follow Back (TLFB) interview was conducted to establish a baseline drinking pattern over the previous 90 days and confirm the presence of an alcohol use disorder (defined as consumption of greater than 35 standard drinks per week over the previous 4 weeks). The TLFB involves asking participants to retrospectively report their drinking days using a calendar. |
| Secondary | Amount of PTSD Symptoms | 14 weeks | The Clinician Administered PTSD Scale (CAPS) contains 30 questions relating to PTSD symptoms. Each question asks about both the frequency and the severity of each symptom. These questions are split into categories. Each criterion has several questions, and scores for each criterion are added up at the end. To meet criteria for a symptom, a patient must meet criteria in both frequency and intensity score for each item. Frequency and intensity and then combined to form a single severity score. Severity scores range from 0-4, with 0 being absent to 4 being extreme/incapacitating. |
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 | Percentage of Heavy Drinking Days | 14 weeks | There were not enough interested, eligible participants available to continue the study. Additionally, the study drug expired and the pharmacy that had done the compounding was bought by a larger chain and was set to be closed. Therefore, the study was stopped and closed in April 2013. | ||
| SECONDARY | Amount of PTSD Symptoms | 14 weeks | There were not enough interested, eligible participants available to continue the study. Additionally, the study drug expired and the pharmacy that had done the compounding was bought by a larger chain and was set to be closed. Therefore, the study was stopped and closed in April 2013. |
Source ClinicalTrials.gov
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Topiramate | 1 | |
| Overall Study | STARTED | Placebo (Sugar Pill) | 0 | |
| Overall Study | COMPLETED | Topiramate | 0 | |
| Overall Study | COMPLETED | Placebo (Sugar Pill) | 0 | |
| Overall Study | NOT COMPLETED | Topiramate | 1 | |
| Overall Study | NOT COMPLETED | Placebo (Sugar Pill) | 0 |
Source ClinicalTrials.gov
Adverse events8
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 | Suicidal ideation | Psychiatric disorders | Topiramate | 1 | 1 | 1 |
| other | Suicidal ideation | Psychiatric disorders | Placebo (Sugar Pill) | 0 | 0 | 0 |
| other | Nausea | Gastrointestinal disorders | Topiramate | 1 | 1 | 1 |
| other | Nausea | Gastrointestinal disorders | Placebo (Sugar Pill) | 0 | 0 | 0 |
| other | Dizziness | Ear and labyrinth disorders | Topiramate | 1 | 1 | 1 |
| other | Dizziness | Ear and labyrinth disorders | Placebo (Sugar Pill) | 0 | 0 | 0 |
| other | Stiffness | Musculoskeletal and connective tissue disorders | Topiramate | 1 | 1 | 1 |
| other | Stiffness | Musculoskeletal and connective tissue disorders | Placebo (Sugar Pill) | 0 | 0 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Topiramate | ||
| Total, all-cause mortality | Placebo (Sugar Pill) | ||
| Total, other adverse events | Topiramate | 1 | 1 |
| Total, other adverse events | Placebo (Sugar Pill) | 0 | 0 |
| Total, serious adverse events | Topiramate | 0 | 1 |
| Total, serious adverse events | Placebo (Sugar Pill) | 0 | 0 |
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01408641
GET https://conductscience.org/api/trials/v1/NCT01408641/registered