COMT Inhibition Among Individuals With Comorbid AUD/ADHD
Key facts
- Who runs it
- University of Colorado, Denver
- Where
- Aurora, United StatesSee the site
- Trial code
- Status
- Completed
- Phase
- Phase 2
- People taking part
- 23 people enrolled
- Started
- 16 Aug 2021
- Ended
- 9 Mar 2026
- Type of study
- Interventional, 2 groups
- Treatments tested
- Tolcapone
- Placebo
- Record updated
- 4 May 2026
Who can take part
- Age
- 21 years to 65 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 21 criteriaShow less
Who can take part
- 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
Who cannot take part
- Any psychoactive substance use (except nicotine) within the last 30 days, as indicated by self-report and urine drug screen (UDS)
- Current use of any psychoactive medication, as evidenced by self-report and UDS
- Current DSM-5 diagnosis of any other substance use disorder except Nicotine Use Disorder
- Current DSM-5 psychotic, mood, anxiety, obsessive-compulsive, trauma-related, or eating disorder, as assessed by SCID-5
- 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)
- Past alcohol-related medical illness, such as gastrointestinal bleeding, pancreatitis, or peptic ulcer
- History of neurological disease or head injury with > 2 minutes of unconsciousness
- Current or past hepatocellular disease, as indicated by verbal report, or elevations of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than the upper limit of the normal range at screening
- Current suicidal ideation or homicidal ideation
- Clinically significant medical problems such as cardiovascular, renal, gastrointestinal, or endocrine problems, as evidenced by medical history and physical exam
- Females of childbearing potential who are pregnant (by plasma HCG), nursing, or who are not using a reliable form of contraception
- Current charges pending for a violent crime (not including DUI-related offenses)
- Lack of a stable living situation
- Presence of ferrous metal in the body, as evidenced by metal screening and self-report
- Severe claustrophobia or morbid obesity that preclude placement in the MRI scanner
Where in United States
- University of Colorado Anschutz Medical CampusAurora, United States
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Tolcapone then PlaceboTreatment being tested
Participants in this arm will receive tolcapone during the first medication period (1 capsule containing 200 mg tolcapone on study days 1 and 2; 3 capsules containing a total of 600 mg tolcapone on study days 3-8), and placebo during the second medication period (1 capsule on study days 1 and 2; 3 capsules on study days 3-8).
Treatment: Tolcapone and Placebo
- Placebo then TolcaponeTreatment being tested
Participants in this arm will receive placebo during the first medication period (1 capsule on study days 1 and 2; 3 capsules on study days 3-8), and tolcapone during the second medication period (1 capsule containing 200 mg tolcapone on study days 1 and 2; 3 capsules containing a total of 600 mg tolcapone on study days 3-8).
Treatment: Tolcapone and Placebo
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- COMT Inhibition as a Potential Therapeutic Target Among Individuals With Comorbid Alcohol Use Disorder and Attention-Deficit/Hyperactivity Disorder
- Record updated
- 4 May 2026