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 range
21 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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).
. 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.
Timeframe: 60 minutes after medication ingestion on Day 2 of each medication period. Each medication period is 8 days long.