Effects of tolcapone on alcohol use and decision-making in people with AUD and ADHD

COMT Inhibition as a Potential Therapeutic Target Among Individuals With Comorbid Alcohol Use Disorder and Attention-Deficit/Hyperactivity Disorder

This study is testing if the medication tolcapone can help people with both Alcohol Use Disorder and ADHD make better decisions and change their drinking habits.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 62 (estimated)
• Ages: 21 Years to 65 Years
• Sex: All
• Sponsor: University of Colorado, Denver (Academic / other)
• Locations: 1 site (Aurora, Colorado)
• Trial ID: NCT03904498 on ClinicalTrials.gov

What this trial studies

This study evaluates the impact of tolcapone, a COMT inhibitor, on individuals diagnosed with both Alcohol Use Disorder (AUD) and Attention-Deficit/Hyperactivity Disorder (ADHD). Participants will undergo a series of assessments and MRI scans over a three to four week period, during which they will receive either tolcapone or a placebo in a double-blind manner. The study aims to measure changes in alcohol response, decision-making, brain activation related to alcohol cues, and overall drinking behavior. Participants must not be seeking treatment for their conditions and should not be on any psychotropic medications.

Who should consider this trial

Good fit: Ideal candidates are adults aged 21-65 who meet the criteria for both AUD and ADHD but are not currently seeking treatment for these conditions.

Not a fit: Patients with other substance use disorders or those currently taking medications for AUD or ADHD may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide new insights into treating individuals with co-occurring AUD and ADHD, potentially improving their decision-making and reducing alcohol consumption.

How similar studies have performed: While the specific combination of AUD and ADHD with COMT inhibition is novel, similar studies have explored the effects of pharmacological interventions on alcohol use and decision-making.

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.

Where this trial is running

Aurora, Colorado

• University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States (Recruiting)

Study contacts

• Principal investigator: Joseph P Schacht, PhD — University of Colorado, Denver
• Study coordinator: Joseph P Schacht, PhD

Conditions Alcohol Use Disorder; Attention Deficit Hyperactivity Disorder