The purpose of this study is to determine whether the catechol-O-methyltransferase (COMT) inhibitor tolcapone, relative to placebo, affects response to alcohol, decision-making, brain activation associated with alcohol cue reactivity, response inhibition, and selective attention, or alcohol drinking.
This study evaluates the effects of an FDA-approved medication called tolcapone in people who have both Alcohol Use Disorder (AUD) and Attention-Deficit/Hyperactivity Disorder (ADHD). The study involves seven visits over a three to four week period, including an assessment visit and two eight-day medication periods during which participants will be assigned to take, in a double-blinded fashion, both tolcapone and a placebo (three visits during each period). During two of these visits, participants will undergo a one-hour MRI scan. Participants must not be seeking treatment for AUD or ADHD and must not be currently taking any psychotropic medications, including stimulant medications for ADHD.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
23
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
Change in alcohol-induced stimulation between medication periods
Biphasic Alcohol Effects Scale stimulation score (range = 0-70; higher scores = more stimulation) after laboratory alcohol administration
Time frame: 30 minutes after laboratory alcohol administration on Day 1 of each medication period. Each medication period is 8 days long.
Change in subjective response to alcohol between medication periods
Subjective High Assessment Scale (range - 0-130; higher scores = greater intoxication) after laboratory alcohol administration
Time frame: 30 minutes after laboratory alcohol administration on Day 1 of each medication period. Each medication period is 8 days long.
Change in risky decision-making after alcohol administration between medication periods
Balloon Analogue Risk Task adjusted average number of pumps (higher scores = more risky decision-making)
Time frame: 30 minutes after laboratory alcohol administration on Day 1 of each medication period. Each medication period is 8 days long.
Change in cognitive-control-associated brain activation (fMRI) between medication periods
Stop-signal task blood oxygenation level dependent (BOLD) signal to successful stop trials, relative to unsuccessful stop trials
Time frame: 60 minutes after medication ingestion on Day 2 of each medication period. Each medication period is 8 days long.
Change in selective attention-associated brain activation (fMRI) between medication periods
Multi-source interference task BOLD signal to interference trials, relative to control trials
Time frame: 60 minutes after medication ingestion on Day 2 of each medication period. Each medication period is 8 days long.
Change in alcohol cue-elicited brain activation (fMRI) between medication periods
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Alcohol cue reactivity task BOLD signal to alcohol cues, relative to neutral beverage cues
Time frame: 60 minutes after medication ingestion on Day 2 of each medication period. Each medication period is 8 days long.