COMT Inhibition Among Individuals With Comorbid AUD/ADHD

NCT ID: NCT03904498

Last Updated: 2024-11-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-16
• Study Completion Date: 2025-03-01

Brief 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.

Detailed Description

This study evaluates the effects of an FDA-approved medication called tolcapone in people who have both Alcohol Use Disorder (AUD) and Attention-Deficit/Hyperactivity Disorder (ADHD). The study involves seven visits over a three to four week period, including an assessment visit and two eight-day medication periods during which participants will be assigned to take, in a double-blinded fashion, both tolcapone and a placebo (three visits during each period). During two of these visits, participants will undergo a one-hour MRI scan. Participants must not be seeking treatment for AUD or ADHD and must not be currently taking any psychotropic medications, including stimulant medications for ADHD.

Conditions

Alcohol Use Disorder; Attention Deficit Hyperactivity Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Tolcapone then Placebo

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).

Group Type: EXPERIMENTAL

Tolcapone

Intervention Type: DRUG

Tolcapone 100 mg tablets

Placebo

Intervention Type: DRUG

Placebo tablets

Placebo then Tolcapone

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).

Group Type: EXPERIMENTAL

Tolcapone

Intervention Type: DRUG

Tolcapone 100 mg tablets

Placebo

Intervention Type: DRUG

Placebo tablets

Interventions

Tolcapone

Tolcapone 100 mg tablets

Intervention Type: DRUG

Placebo

Placebo tablets

Intervention Type: DRUG

Other Intervention Names

Tasmar

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joseph P Schacht, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Joseph P Schacht, PhD

Role: CONTACT

joseph.schacht@cuanschutz.edu

303-724-3773

Kristen Raymond, BA

Role: CONTACT

kristen.raymond@cuanschutz.edu

303-724-3196

Facility Contacts

Joseph P Schacht, PhD

Role: primary

joseph.schacht@cuanschutz.edu

303-724-3773

Kristen Raymond, BA

Role: backup

kristen.raymond@cuanschutz.edu

303-724-3196

Other Identifiers

R01AA026859

Identifier Type: NIH

Identifier Source: secondary_id

View Link

19-2335

Identifier Type: -

Identifier Source: org_study_id