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COMT Inhibition Among Individuals With Comorbid AUD/ADHD

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ClinicalTrials.gov Identifier: NCT03904498
Recruitment Status : Recruiting
First Posted : April 5, 2019
Last Update Posted : August 12, 2022
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
University of Colorado, Denver

Study Description
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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.

Condition or disease Intervention/treatment Phase
Alcohol Use Disorder Attention Deficit Hyperactivity Disorder Drug: Tolcapone Drug: Placebo Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: COMT Inhibition as a Potential Therapeutic Target Among Individuals With Comorbid Alcohol Use Disorder and Attention-Deficit/Hyperactivity Disorder
Actual Study Start Date : August 16, 2021
Estimated Primary Completion Date : March 31, 2025
Estimated Study Completion Date : March 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol
Drug Information available for: Tolcapone

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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).
 Drug: Tolcapone
Tolcapone 100 mg tablets
Other Name: Tasmar

Drug: Placebo
Placebo tablets
Experimental: 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).
 Drug: Tolcapone
Tolcapone 100 mg tablets
Other Name: Tasmar

Drug: Placebo
Placebo tablets


Outcome Measures
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Primary Outcome Measures :
  1. Change in alcohol-induced stimulation between medication periods [ Time Frame: 30 minutes after laboratory alcohol administration on Day 1 of each medication period. Each medication period is 8 days long. ]
    Biphasic Alcohol Effects Scale stimulation score (range = 0-70; higher scores = more stimulation) after laboratory alcohol administration

  2. Change in subjective response to alcohol between medication periods [ Time Frame: 30 minutes after laboratory alcohol administration on Day 1 of each medication period. Each medication period is 8 days long. ]
    Subjective High Assessment Scale (range - 0-130; higher scores = greater intoxication) after laboratory alcohol administration

  3. Change in risky decision-making after alcohol administration between medication periods [ Time Frame: 30 minutes after laboratory alcohol administration on Day 1 of each medication period. Each medication period is 8 days long. ]
    Balloon Analogue Risk Task adjusted average number of pumps (higher scores = more risky decision-making)

  4. Change in cognitive-control-associated brain activation (fMRI) between medication periods [ Time Frame: 60 minutes after medication ingestion on Day 2 of each medication period. Each medication period is 8 days long. ]
    Stop-signal task blood oxygenation level dependent (BOLD) signal to successful stop trials, relative to unsuccessful stop trials

  5. Change in selective attention-associated brain activation (fMRI) between medication periods [ Time Frame: 60 minutes after medication ingestion on Day 2 of each medication period. Each medication period is 8 days long. ]
    Multi-source interference task BOLD signal to interference trials, relative to control trials

  6. Change in alcohol cue-elicited brain activation (fMRI) between medication periods [ Time Frame: 60 minutes after medication ingestion on Day 2 of each medication period. Each medication period is 8 days long. ]
    Alcohol cue reactivity task BOLD signal to alcohol cues, relative to neutral beverage cues


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03904498


Contacts
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Contact: Joseph P Schacht, PhD 303-724-3773 joseph.schacht@cuanschutz.edu
Contact: Kristen Raymond, BA 303-724-3196 kristen.raymond@cuanschutz.edu

Locations
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United States, Colorado
University of Colorado Anschutz Medical Campus Recruiting
Aurora, Colorado, United States, 80045
Contact: Joseph P Schacht, PhD    303-724-3773    joseph.schacht@cuanschutz.edu   
Contact: Kristen Raymond, BA    303-724-3196    kristen.raymond@cuanschutz.edu   
Sponsors and Collaborators
University of Colorado, Denver
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
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Principal Investigator: Joseph P Schacht, PhD University of Colorado - Anschutz Medical Campus
More Information
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03904498    
Other Study ID Numbers: 19-2335
R01AA026859 ( U.S. NIH Grant/Contract )
First Posted: April 5, 2019    Key Record Dates
Last Update Posted: August 12, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Hyperkinesis
Disease
Alcoholism
Attention Deficit Disorder with Hyperactivity
Alcohol Drinking
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
 Nervous System Diseases
Drinking Behavior
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Tolcapone
Antiparkinson Agents
Anti-Dyskinesia Agents
Catechol O-Methyltransferase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action