Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2026-04-05 @ 1:03 PM
Study NCT ID:
NCT02074904
Status:
TERMINATED
Last Update Posted:
2018-09-21
First Post:
2014-02-20
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Topiramate's Effects on Heavy Drinking
Sponsor:
University of Pennsylvania
Organization:
Study Overview
Official Title:
Brain Mechanisms of Topiramate's Effects on Heavy Drinking
Status:
TERMINATED
Status Verified Date:
2017-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
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.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TOPMRI
Brief Summary:
The proposed project will utilize perfusion functional magnetic resonance imaging (fMRI) to examine the effects of topiramate on brain and behavioral responses in heavy drinkers to appetitive alcohol reminders (cues that motivate continued alcohol use and relapse). This project will yield novel findings on brain and behavioral responses to alcohol cues, the effects of topiramate on alcohol cue reactivity, and the mechanisms underlying topiramate's ability to blunt alcohol cue reactivity and heavy drinking.
Detailed Description:
This project is a double-blind, randomized, placebo-controlled study of topiramate's effects on brain and behavior responses in heavy drinkers. Eligible volunteers who meet study criteria will be randomized to receive either topiramate or placebo with weekly visits and medication management sessions. Participants will complete two magnetic resonance imaging sessions. The first scan session will occur prior to starting study drug, and the second scan will occur following six weeks of study drug. This project will yield novel findings on brain and behavioral responses to alcohol cues, the effects of topiramate on alcohol cue reactivity, and the mechanisms underlying topiramate's ability to blunt alcohol cue reactivity and heavy drinking.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: