COMT Inhibition Among Individuals With Comorbid AUD/ADHD (NCT03904498) | Clinical Trial Compass
CompletedPhase 2
COMT Inhibition Among Individuals With Comorbid AUD/ADHD
United States23 participantsStarted 2021-08-16
Plain-language summary
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.
Who can participate
Age range21 Years – 65 Years
SexALL
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Inclusion criteria
✓. Age 21-65.
✓. Meets Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) criteria for current Alcohol Use Disorder (AUD) and current Attention-Deficit/Hyperactivity Disorder (ADHD), as assessed by the Structured Clinical Interview for DSM-5 (SCID-5) or WHO-ASRS.
✓. Currently not engaged in, and does not want treatment for, AUD or ADHD.
✓. Currently not taking any medication for AUD or ADHD.
✓. Able to read and understand questionnaires and informed consent.
✓. Lives within 50 miles of the study site.
Exclusion criteria
✕. Current DSM-5 diagnosis of any other substance use disorder except Nicotine Use Disorder.
✕. Any psychoactive substance use (except nicotine) within the last 30 days, as indicated by self-report and urine drug screen (UDS)
✕. Current DSM-5 psychotic, mood, anxiety, obsessive-compulsive, trauma-related, or eating disorder, as assessed by SCID-5.
✕. Current suicidal ideation or homicidal ideation.
✕. Current use of any psychoactive medication, as evidenced by self-report and UDS.
✕. History of severe alcohol withdrawal (e.g., seizure, delirium tremens), as evidenced by self-report and assessment with Clinical Institute Withdrawal Assessment for Alcohol-Revised (CIWA-Ar).
What they're measuring
1
Change in alcohol-induced stimulation between medication periods
Timeframe: 30 minutes after laboratory alcohol administration on Day 1 of each medication period. Each medication period is 8 days long.
2
Change in subjective response to alcohol between medication periods
Timeframe: 30 minutes after laboratory alcohol administration on Day 1 of each medication period. Each medication period is 8 days long.
3
Change in risky decision-making after alcohol administration between medication periods
Timeframe: 30 minutes after laboratory alcohol administration on Day 1 of each medication period. Each medication period is 8 days long.
4
Change in cognitive-control-associated brain activation (fMRI) between medication periods
Timeframe: 60 minutes after medication ingestion on Day 2 of each medication period. Each medication period is 8 days long.
5
Change in selective attention-associated brain activation (fMRI) between medication periods
Timeframe: 60 minutes after medication ingestion on Day 2 of each medication period. Each medication period is 8 days long.
6
Change in alcohol cue-elicited brain activation (fMRI) between medication periods
Timeframe: 60 minutes after medication ingestion on Day 2 of each medication period. Each medication period is 8 days long.
✕. Clinically significant medical problems such as cardiovascular, renal, gastrointestinal, or endocrine problems, as evidenced by medical history and physical exam.
✕. Past alcohol-related medical illness, such as gastrointestinal bleeding, pancreatitis, or peptic ulcer.