Trial Outcomes & Findings for Topiramate's Effects on Heavy Drinking (NCT NCT02074904)
NCT ID: NCT02074904
Last Updated: 2018-09-21
Results Overview
At baseline (prior to randomization), brain and behavioral responses will be significantly greater during alcohol cue exposure compared to non-alcohol cue exposure. Following 6 weeks of study drug, individuals receiving topiramate will demonstrate greater reductions in brain activity and drinking behavior compared to individuals receiving placebo. Individuals receiving placebo will exhibit responses similar to baseline responses.
TERMINATED
PHASE2
1 participants
baseline to after 6 weeks of study drug
2018-09-21
Participant Flow
Participant milestones
| Measure |
Topiramate
up to 200mg/day orally (over 8 weeks during which the dosage is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)
Topiramate
|
Placebo
placebo
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
0
|
|
Overall Study
COMPLETED
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Topiramate's Effects on Heavy Drinking
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: baseline to after 6 weeks of study drugPopulation: The study was terminated to run as a sub-study of NCT02371889. No data will be entered due to privacy concerns.
At baseline (prior to randomization), brain and behavioral responses will be significantly greater during alcohol cue exposure compared to non-alcohol cue exposure. Following 6 weeks of study drug, individuals receiving topiramate will demonstrate greater reductions in brain activity and drinking behavior compared to individuals receiving placebo. Individuals receiving placebo will exhibit responses similar to baseline responses.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline and 9 weeksPopulation: The study was terminated to run as a sub-study of NCT02371889. No data will be entered due to privacy concerns.
change in drinking days from baseline to 9 weeks
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline and Visit 9 (9 weeks)Population: The study was terminated to run as a sub-study of NCT02371889. No data will be entered due to privacy concerns.
Change in gamma-glutamyl transferase (GGT) or carbohydrate-deficient transferrin (CDT) levels after 9 weeks of treatment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline to 9 weeksPopulation: The study was terminated to run as a sub-study of NCT02371889. No data will be entered due to privacy concerns.
change in number of heavy drinking days from baseline to 9 weeks
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline to 9 weeksPopulation: The study was terminated to run as a sub-study of NCT02371889. No data will be entered due to privacy concerns.
change in mean alcohol consumption from baseline to 9 weeks
Outcome measures
Outcome data not reported
Adverse Events
Topiramate
Placebo
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