COMT Inhibition Among Individuals With Comorbid AUD/ADHD

Last updated: November 20, 2024
Sponsor: University of Colorado, Denver
Overall Status: Active - Recruiting

Phase

2

Condition

Addictions

Alcohol Dependence

Alcohol Use Disorder

Treatment

Placebo

Tolcapone

Clinical Study ID

NCT03904498
19-2335
R01AA026859
  • Ages 21-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 currentAttention-Deficit/Hyperactivity Disorder (ADHD), as assessed by the StructuredClinical 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

Exclusion Criteria:

  1. Current DSM-5 diagnosis of any other substance use disorder except Nicotine UseDisorder.

  2. Any psychoactive substance use (except nicotine) within the last 30 days, asindicated by self-report and urine drug screen (UDS)

  3. Current DSM-5 psychotic, mood, anxiety, obsessive-compulsive, trauma-related, oreating 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 evidencedby self-report and assessment with Clinical Institute Withdrawal Assessment forAlcohol-Revised (CIWA-Ar).

  7. Clinically significant medical problems such as cardiovascular, renal,gastrointestinal, or endocrine problems, as evidenced by medical history andphysical 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 elevationsof alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater thanthe upper limit of the normal range at screening.

  10. Females of childbearing potential who are pregnant (by plasma HCG), nursing, or whoare 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 andself-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.

Study Design

Total Participants: 62
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
August 16, 2021
Estimated Completion Date:
March 01, 2025

Study 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.

Connect with a study center

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Site Not Available

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