Trial Outcomes & Findings for Topiramate Treatment of Hazardous and Harmful Alcohol Use in Veterans With TBI (NCT NCT01750268)
NCT ID: NCT01750268
Last Updated: 2020-10-14
Results Overview
Using a calendar, participants provide retrospective estimates of daily drinking over a specified period.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
32 participants
Primary outcome timeframe
Baseline to Week 12
Results posted on
2020-10-14
Participant Flow
Participant milestones
| Measure |
Topiramate
Topiramate capsules daily - up to 300 mg
Medical Management Counseling: Brief alcohol and medication counseling
Topiramate: Experimental medication
|
Placebo
Placebo capsules daily - up 300 mg
Medical Management Counseling: Brief alcohol and medication counseling
Placebo: Placebo comparator
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
17
|
|
Overall Study
COMPLETED
|
13
|
12
|
|
Overall Study
NOT COMPLETED
|
2
|
5
|
Reasons for withdrawal
| Measure |
Topiramate
Topiramate capsules daily - up to 300 mg
Medical Management Counseling: Brief alcohol and medication counseling
Topiramate: Experimental medication
|
Placebo
Placebo capsules daily - up 300 mg
Medical Management Counseling: Brief alcohol and medication counseling
Placebo: Placebo comparator
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
|
Overall Study
Physician Decision
|
0
|
3
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
Baseline Characteristics
Topiramate Treatment of Hazardous and Harmful Alcohol Use in Veterans With TBI
Baseline characteristics by cohort
| Measure |
Topiramate
n=15 Participants
Topiramate capsules daily - up to 300 mg
Medical Management Counseling: Brief alcohol and medication counseling
Topiramate: Experimental medication
|
Placebo
n=17 Participants
Placebo capsules daily - up 300 mg
Medical Management Counseling: Brief alcohol and medication counseling
Placebo: Placebo comparator
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
44.6 Years
STANDARD_DEVIATION 13.5 • n=99 Participants
|
48.5 Years
STANDARD_DEVIATION 14.0 • n=107 Participants
|
46.6 Years
STANDARD_DEVIATION 13.8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=99 Participants
|
17 participants
n=107 Participants
|
32 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 12Using a calendar, participants provide retrospective estimates of daily drinking over a specified period.
Outcome measures
| Measure |
Topiramate
n=15 Participants
Topiramate capsules daily - up to 300 mg
Medical Management Counseling: Brief alcohol and medication counseling
Topiramate: Experimental medication
|
Placebo
n=17 Participants
Placebo capsules daily - up 300 mg
Medical Management Counseling: Brief alcohol and medication counseling
Placebo: Placebo comparator
|
|---|---|---|
|
Change in the Number of Drinking Days Per Week as Assessed by the Timeline Followback (TLFB)
|
2.2 Drinking Days per week
Standard Deviation 1.8
|
1.6 Drinking Days per week
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: Baseline to Week 12Participants indicate the extent to which each of the 22 symptoms has disturbed them in the previous 2 weeks on a 5-item scale (0-none to 4-severe). The NSI total score is the sum of severity ratings of the symptoms. The scores are summed to yield a total score ranging from 0 to 88, where the higher the point value, the greater (more severe) the symptoms.
Outcome measures
| Measure |
Topiramate
n=15 Participants
Topiramate capsules daily - up to 300 mg
Medical Management Counseling: Brief alcohol and medication counseling
Topiramate: Experimental medication
|
Placebo
n=17 Participants
Placebo capsules daily - up 300 mg
Medical Management Counseling: Brief alcohol and medication counseling
Placebo: Placebo comparator
|
|---|---|---|
|
Change in TBI Symptom Severity as Assessed by the Neurobehavioral Symptom Inventory (NSI)
|
16.3 scores on a scale
Standard Deviation 13.1
|
19.3 scores on a scale
Standard Deviation 15.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Week 12Using a calendar, participants provide retrospective estimates of daily drinking over a specified period.
Outcome measures
Outcome data not reported
Adverse Events
Topiramate
Serious events: 3 serious events
Other events: 15 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Topiramate
n=15 participants at risk
Topiramate capsules daily - up to 300 mg
Medical Management Counseling: Brief alcohol and medication counseling
Topiramate: Experimental medication
|
Placebo
n=17 participants at risk
Placebo capsules daily - up 300 mg
Medical Management Counseling: Brief alcohol and medication counseling
Placebo: Placebo comparator
|
|---|---|---|
|
Cardiac disorders
Inpatient medical hospitalization for an episode of chest pain in the context of cocaine use
|
6.7%
1/15 • Number of events 2 • From enrollment through study completion, an average of 12 weeks
|
0.00%
0/17 • From enrollment through study completion, an average of 12 weeks
|
|
Psychiatric disorders
Voluntary psych inpatient admission due to homicidal ideation in the context of heavy cocaine use
|
6.7%
1/15 • Number of events 1 • From enrollment through study completion, an average of 12 weeks
|
0.00%
0/17 • From enrollment through study completion, an average of 12 weeks
|
|
Psychiatric disorders
Inpatient medical hospitalization due to alcohol withdrawal
|
6.7%
1/15 • Number of events 1 • From enrollment through study completion, an average of 12 weeks
|
0.00%
0/17 • From enrollment through study completion, an average of 12 weeks
|
|
Gastrointestinal disorders
Inpatient medical hospitalization for planned distal pancreatectomy and splenectomy
|
0.00%
0/15 • From enrollment through study completion, an average of 12 weeks
|
5.9%
1/17 • Number of events 1 • From enrollment through study completion, an average of 12 weeks
|
Other adverse events
| Measure |
Topiramate
n=15 participants at risk
Topiramate capsules daily - up to 300 mg
Medical Management Counseling: Brief alcohol and medication counseling
Topiramate: Experimental medication
|
Placebo
n=17 participants at risk
Placebo capsules daily - up 300 mg
Medical Management Counseling: Brief alcohol and medication counseling
Placebo: Placebo comparator
|
|---|---|---|
|
Nervous system disorders
Numbness and tingling
|
33.3%
5/15 • From enrollment through study completion, an average of 12 weeks
|
29.4%
5/17 • From enrollment through study completion, an average of 12 weeks
|
|
Nervous system disorders
Change in sense of taste
|
53.3%
8/15 • From enrollment through study completion, an average of 12 weeks
|
29.4%
5/17 • From enrollment through study completion, an average of 12 weeks
|
|
General disorders
Fatigue
|
13.3%
2/15 • From enrollment through study completion, an average of 12 weeks
|
23.5%
4/17 • From enrollment through study completion, an average of 12 weeks
|
|
Gastrointestinal disorders
Loss of appetite
|
26.7%
4/15 • From enrollment through study completion, an average of 12 weeks
|
35.3%
6/17 • From enrollment through study completion, an average of 12 weeks
|
|
Nervous system disorders
Difficulty with concentration and attention
|
6.7%
1/15 • From enrollment through study completion, an average of 12 weeks
|
11.8%
2/17 • From enrollment through study completion, an average of 12 weeks
|
|
Psychiatric disorders
Nervousness
|
13.3%
2/15 • From enrollment through study completion, an average of 12 weeks
|
11.8%
2/17 • From enrollment through study completion, an average of 12 weeks
|
|
Nervous system disorders
Difficulty with memory
|
6.7%
1/15 • From enrollment through study completion, an average of 12 weeks
|
17.6%
3/17 • From enrollment through study completion, an average of 12 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
40.0%
6/15 • From enrollment through study completion, an average of 12 weeks
|
17.6%
3/17 • From enrollment through study completion, an average of 12 weeks
|
|
Ear and labyrinth disorders
Dizziness
|
26.7%
4/15 • From enrollment through study completion, an average of 12 weeks
|
23.5%
4/17 • From enrollment through study completion, an average of 12 weeks
|
|
Skin and subcutaneous tissue disorders
Itching
|
40.0%
6/15 • From enrollment through study completion, an average of 12 weeks
|
29.4%
5/17 • From enrollment through study completion, an average of 12 weeks
|
|
General disorders
Sleepiness
|
46.7%
7/15 • From enrollment through study completion, an average of 12 weeks
|
17.6%
3/17 • From enrollment through study completion, an average of 12 weeks
|
|
Nervous system disorders
Slow thinking
|
20.0%
3/15 • From enrollment through study completion, an average of 12 weeks
|
17.6%
3/17 • From enrollment through study completion, an average of 12 weeks
|
|
Eye disorders
Abnormal vision
|
33.3%
5/15 • From enrollment through study completion, an average of 12 weeks
|
5.9%
1/17 • From enrollment through study completion, an average of 12 weeks
|
|
Eye disorders
Eye pain
|
20.0%
3/15 • From enrollment through study completion, an average of 12 weeks
|
23.5%
4/17 • From enrollment through study completion, an average of 12 weeks
|
|
Nervous system disorders
Confusion
|
26.7%
4/15 • From enrollment through study completion, an average of 12 weeks
|
35.3%
6/17 • From enrollment through study completion, an average of 12 weeks
|
|
Nervous system disorders
Language problems
|
26.7%
4/15 • From enrollment through study completion, an average of 12 weeks
|
17.6%
3/17 • From enrollment through study completion, an average of 12 weeks
|
|
Psychiatric disorders
Depression
|
20.0%
3/15 • From enrollment through study completion, an average of 12 weeks
|
17.6%
3/17 • From enrollment through study completion, an average of 12 weeks
|
|
Psychiatric disorders
Suicidal thoughts and actions
|
26.7%
4/15 • From enrollment through study completion, an average of 12 weeks
|
23.5%
4/17 • From enrollment through study completion, an average of 12 weeks
|
Additional Information
Steven L. Batki, MD
San Francisco VA Health Care System/University of California, San Francisco
Phone: 415-221-4810
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place