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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1
University of Pennsylvania Center for Studies of Addiction
Philadelphia, Pennsylvania, United States
fMRI Response in the Ventral Striatum/Medial Orbitofrontal Cortex During Alcohol Cue Exposure
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
Drinking Days
change in drinking days from baseline to 9 weeks
Time frame: baseline and 9 weeks
Change in Gamma-glutamyl Transferase (GGT) or Carbohydrate-deficient Transferrin (CDT) Levels
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)
Heavy Drinking Days
change in number of heavy drinking days from baseline to 9 weeks
Time frame: baseline to 9 weeks
Mean Alcohol Consumption
change in mean alcohol consumption from baseline to 9 weeks
Time frame: baseline to 9 weeks
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