COMT Inhibition Among Individuals With Comorbid AUD/ADHD

Launched by UNIVERSITY OF COLORADO, DENVER · Apr 3, 2019

Keywords

ClinConnect Summary

This clinical trial, called COMT Inhibition Among Individuals With Comorbid AUD/ADHD, is looking to find out how a medication called tolcapone affects people who have both Alcohol Use Disorder (AUD) and Attention Deficit Hyperactivity Disorder (ADHD). Researchers want to see if tolcapone can change how people respond to alcohol, make decisions, and pay attention, as well as how their brains react when they see things related to alcohol. The study is currently recruiting participants aged 21 to 65 who meet specific criteria, such as having both AUD and ADHD but not currently seeking treatment for these conditions.

To be eligible, participants should not be taking any medications for these disorders and must be able to understand questionnaires. They should also live within 50 miles of the study site. Throughout the trial, participants can expect to undergo assessments and possibly an MRI scan to help researchers collect information about their brain activity. This study aims to understand better how to help individuals dealing with both AUD and ADHD, and your participation could contribute to important findings in this area.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age 21-65.
• • 2. 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.
• • 3. Currently not engaged in, and does not want treatment for, AUD or ADHD.
• • 4. Currently not taking any medication for AUD or ADHD.
• • 5. Able to read and understand questionnaires and informed consent.
• • 6. Lives within 50 miles of the study site.
• Exclusion Criteria:
• • 1. Current DSM-5 diagnosis of any other substance use disorder except Nicotine Use Disorder.
• • 2. Any psychoactive substance use (except nicotine) within the last 30 days, as indicated by self-report and urine drug screen (UDS)
• • 3. Current DSM-5 psychotic, mood, anxiety, obsessive-compulsive, trauma-related, or eating disorder, as assessed by SCID-5.
• • 4. Current suicidal ideation or homicidal ideation.
• • 5. Current use of any psychoactive medication, as evidenced by self-report and UDS.
• • 6. 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).
• • 7. Clinically significant medical problems such as cardiovascular, renal, gastrointestinal, or endocrine problems, as evidenced by medical history and physical exam.
• • 8. Past alcohol-related medical illness, such as gastrointestinal bleeding, pancreatitis, or peptic ulcer.
• • 9. 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.
• • 10. Females of childbearing potential who are pregnant (by plasma HCG), nursing, or who are not using a reliable form of contraception.
• • 11. Current charges pending for a violent crime (not including DUI-related offenses).
• • 12. Lack of a stable living situation.
• • 13. Presence of ferrous metal in the body, as evidenced by metal screening and self-report.
• • 14. Severe claustrophobia or morbid obesity that preclude placement in the MRI scanner.
• • 15. History of neurological disease or head injury with \> 2 minutes of unconsciousness.