Trial Outcomes & Findings for Topiramate Treatment of Alcohol Use Disorders in African Americans (NCT NCT03018704)
NCT ID: NCT03018704
Last Updated: 2023-03-23
Results Overview
Drinking was recorded using the timeline follow back methodology which is an interview based method to record drinking on each day during the trial. The summary measure (% days heavy drinking) counts the number of days of heavy drinking (\>4drinks per day) divided by the number of observation days to report the percent of observation days for which there is heavy drinking. For the the outcome measure the observation period is the last 42 days of the trial.
TERMINATED
PHASE4
79 participants
12 weeks
2023-03-23
Participant Flow
Subjects were recruited from VA outpatient and inpatient mental health and addiction programs. Recruitment occurred between October 2017 through May 2020
Prior to randomization, consented individuals (n=79) were assessed for participation. The majority of non randomized subjects (n=31) didn't meet inclusion criteria (not drinking) or exclusion criteria (other drugs). I addition 5 subjects withdrew consent before randomization and 6 were lost to follow up. That lead to 37 who were randomized.
Participant milestones
| Measure |
Placebo
a placebo control arm
placebo: inactive medication
|
Topiramate
Topiramate an FDA approved anticonvulsant has been shown effective in the treatment of alcohol use disorder but there is no data supporting use in minority patients.
Topiramate: anticonvulsant medication
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
18
|
|
Overall Study
COMPLETED
|
18
|
17
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Placebo
a placebo control arm
placebo: inactive medication
|
Topiramate
Topiramate an FDA approved anticonvulsant has been shown effective in the treatment of alcohol use disorder but there is no data supporting use in minority patients.
Topiramate: anticonvulsant medication
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
Baseline Characteristics
Topiramate Treatment of Alcohol Use Disorders in African Americans
Baseline characteristics by cohort
| Measure |
Placebo
n=19 Participants
a placebo control arm
placebo: inactive medication
|
Topiramate
n=18 Participants
Topiramate an FDA approved anticonvulsant has been shown effective in the treatment of alcohol use disorder but there is no data supporting use in minority patients.
Topiramate: anticonvulsant medication
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.5 years
STANDARD_DEVIATION 10.2 • n=99 Participants
|
48 years
STANDARD_DEVIATION 11.6 • n=107 Participants
|
49.3 years
STANDARD_DEVIATION 10.8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
37 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
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
19 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
19 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Percent Heavy Drinking days
|
70.8 percent of trial days of heavy drinking
STANDARD_DEVIATION 20.4 • n=99 Participants
|
62.8 percent of trial days of heavy drinking
STANDARD_DEVIATION 23.4 • n=107 Participants
|
67 percent of trial days of heavy drinking
STANDARD_DEVIATION 22 • n=206 Participants
|
|
Depression rating (PHQ9)
|
8.6 units on a scale
STANDARD_DEVIATION 7.6 • n=99 Participants
|
11.4 units on a scale
STANDARD_DEVIATION 7.0 • n=107 Participants
|
10. units on a scale
STANDARD_DEVIATION 7.4 • n=206 Participants
|
PRIMARY outcome
Timeframe: 12 weeksDrinking was recorded using the timeline follow back methodology which is an interview based method to record drinking on each day during the trial. The summary measure (% days heavy drinking) counts the number of days of heavy drinking (\>4drinks per day) divided by the number of observation days to report the percent of observation days for which there is heavy drinking. For the the outcome measure the observation period is the last 42 days of the trial.
Outcome measures
| Measure |
Placebo
n=18 Participants
a placebo control arm
placebo: inactive medication
|
Topiramate
n=17 Participants
Topiramate an FDA approved anticonvulsant has been shown effective in the treatment of alcohol use disorder but there is no data supporting use in minority patients.
Topiramate: anticonvulsant medication
|
|---|---|---|
|
Percent Days of Heavy Drinking
|
26.7 percentage of days of heavy drinking
Standard Deviation 24.9
|
14.8 percentage of days of heavy drinking
Standard Deviation 14.6
|
Adverse Events
Placebo
Topiramate
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place