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Topiramate's Effects on Heavy Drinking (TOPMRI)

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ClinicalTrials.gov Identifier: NCT02074904
Recruitment Status : Terminated (We terminated the study to run it as a sub-study of NCT02371889, which is a 13 week, placebo controlled, double-blind, trial of topiramate in heavy drinkers.)
First Posted : February 28, 2014
Results First Posted : December 11, 2017
Last Update Posted : September 21, 2018
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Alcohol Drinking
Interventions Drug: Topiramate
Drug: Placebo
Enrollment 1
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Topiramate Placebo
Hide Arm/Group Description

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

Period Title: Overall Study
Started 1 0
Completed 1 0
Not Completed 0 0
Arm/Group Title Topiramate Placebo Total
Hide Arm/Group Description

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

Total of all reporting groups
Overall Number of Baseline Participants 0 0 0
Hide Baseline Analysis Population Description
The study was terminated to run as a sub-study of NCT02371889. No data will be entered due to privacy concerns.
Sex: Female, Male  
Number Analyzed 0 participants 0 participants 0 participants
Female
Male
Race (NIH/OMB)  
Number Analyzed 0 participants 0 participants 0 participants
American Indian or Alaska Native
Asian
Native Hawaiian or Other Pacific Islander
Black or African American
White
More than one race
Unknown or Not Reported
Region of Enrollment  
Unit of measure:  Participants
United States Number Analyzed 0 participants 0 participants 0 participants
1.Primary Outcome
Title fMRI Response in the Ventral Striatum/Medial Orbitofrontal Cortex During Alcohol Cue Exposure
Hide Description 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.
Time Frame baseline to after 6 weeks of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
The study was terminated to run as a sub-study of NCT02371889. No data will be entered due to privacy concerns.
Arm/Group Title Topiramate Placebo
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Drinking Days
Hide Description change in drinking days from baseline to 9 weeks
Time Frame baseline and 9 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The study was terminated to run as a sub-study of NCT02371889. No data will be entered due to privacy concerns.
Arm/Group Title Topiramate Placebo
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Change in Gamma-glutamyl Transferase (GGT) or Carbohydrate-deficient Transferrin (CDT) Levels
Hide Description Change in gamma-glutamyl transferase (GGT) or carbohydrate-deficient transferrin (CDT) levels after 9 weeks of treatment.
Time Frame baseline and Visit 9 (9 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
The study was terminated to run as a sub-study of NCT02371889. No data will be entered due to privacy concerns.
Arm/Group Title Topiramate Placebo
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Heavy Drinking Days
Hide Description change in number of heavy drinking days from baseline to 9 weeks
Time Frame baseline to 9 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The study was terminated to run as a sub-study of NCT02371889. No data will be entered due to privacy concerns.
Arm/Group Title Topiramate Placebo
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Mean Alcohol Consumption
Hide Description change in mean alcohol consumption from baseline to 9 weeks
Time Frame baseline to 9 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The study was terminated to run as a sub-study of NCT02371889. No data will be entered due to privacy concerns.
Arm/Group Title Topiramate Placebo
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 1 year
Adverse Event Reporting Description The study was terminated to run as a sub-study of NCT02371889. There were no Adverse Events.
 
Arm/Group Title Topiramate Placebo
Hide Arm/Group Description

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

All-Cause Mortality
Topiramate Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/0 
Show Serious Adverse Events Hide Serious Adverse Events
Topiramate Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Topiramate Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/0 
We terminated the study to run it as a sub-study of NCT02371889. We didn't enter results of the one subject randomized to study medication due to privacy concerns.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Timothy Pond, MPH
Organization: UPENN
Phone: 215-746-1959
Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02074904     History of Changes
Other Study ID Numbers: TOP MRI
First Submitted: February 20, 2014
First Posted: February 28, 2014
Results First Submitted: October 27, 2017
Results First Posted: December 11, 2017
Last Update Posted: September 21, 2018