Trial Outcomes & Findings for Topiramate for Alcohol Use in Posttraumatic Stress Disorder (NCT NCT01408641)
NCT ID: NCT01408641
Last Updated: 2022-03-03
Results Overview
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.
TERMINATED
NA
4 participants
14 weeks
2022-03-03
Participant Flow
Three participants were withdrawn prior to assignment to a treatment group. Two did not return for study visits after signing consent and one did not meet eligibility criteria.
Participant milestones
| Measure |
Topiramate
Topiramate arm will be titrated (dose will increase slowly) over 6 weeks to 400mg or highest tolerated dose.
Topiramate: Topiramate titrated over 6 weeks to 400mg or highest tolerated dose.
|
Placebo (Sugar Pill)
Placebo arm will receive matching capsules without topiramate.
Placebo: Placebo capsules without topiramate
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Topiramate
Topiramate arm will be titrated (dose will increase slowly) over 6 weeks to 400mg or highest tolerated dose.
Topiramate: Topiramate titrated over 6 weeks to 400mg or highest tolerated dose.
|
Placebo (Sugar Pill)
Placebo arm will receive matching capsules without topiramate.
Placebo: Placebo capsules without topiramate
|
|---|---|---|
|
Overall Study
Physician Decision
|
1
|
0
|
Baseline Characteristics
Topiramate for Alcohol Use in Posttraumatic Stress Disorder
Baseline characteristics by cohort
| Measure |
Topiramate
n=1 Participants
Topiramate arm will be titrated (dose will increase slowly) over 6 weeks to 400mg or highest tolerated dose.
Topiramate: Topiramate titrated over 6 weeks to 400mg or highest tolerated dose.
|
Placebo (Sugar Pill)
Placebo arm will receive matching capsules without topiramate.
Placebo: Placebo capsules without topiramate
|
Total
n=1 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=99 Participants
|
—
|
1 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
—
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=99 Participants
|
—
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
—
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=99 Participants
|
—
|
1 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 14 weeksPopulation: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 14 weeksPopulation: 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.
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.
Outcome measures
Outcome data not reported
Adverse Events
Topiramate
Placebo (Sugar Pill)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Topiramate
n=1 participants at risk
Topiramate arm will be titrated (dose will increase slowly) over 6 weeks to 400mg or highest tolerated dose.
Topiramate: Topiramate titrated over 6 weeks to 400mg or highest tolerated dose.
|
Placebo (Sugar Pill)
Placebo arm will receive matching capsules without topiramate.
Placebo: Placebo capsules without topiramate
|
|---|---|---|
|
Psychiatric disorders
Suicidal ideation
|
100.0%
1/1 • Number of events 1
|
—
0/0
|
|
Gastrointestinal disorders
Nausea
|
100.0%
1/1 • Number of events 1
|
—
0/0
|
|
Ear and labyrinth disorders
Dizziness
|
100.0%
1/1 • Number of events 1
|
—
0/0
|
|
Musculoskeletal and connective tissue disorders
Stiffness
|
100.0%
1/1 • Number of events 1
|
—
0/0
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place