Aurora, Colorado 80045

  • Attention Deficit Hyperactivity Disorder

Purpose:

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.


Study summary:

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.


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). 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.


Study is Available At:


Original ID:

19-2335


NCT ID:

NCT03904498


Secondary ID:

R01AA026859


Study Acronym:


Brief Title:

COMT Inhibition Among Individuals With Comorbid AUD/ADHD


Official Title:

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


Overall Status:

Recruiting


Study Phase:

Phase 2


Genders:

N/A


Minimum Age:

21 Years


Maximum Age:

65 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Colorado, Denver


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

62


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Joseph P Schacht, PhD
Principal Investigator
University of Colorado - Anschutz Medical Campus
Primary Contact:Joseph P Schacht, PhD
303-724-3773
joseph.schacht@cuanschutz.edu
Backup Contact:Kristen Raymond, BA
303-724-3196
kristen.raymond@cuanschutz.edu

Study Dates

Start Date:June 30, 2021
Completion Date:March 31, 2024
Completion Type:Anticipated
Primary Completion Date:March 31, 2024
Primary Completion Type:Anticipated
Verification Date:May 2021
Last Changed Date:May 18, 2021
First Received Date:April 2, 2019

Study Outcomes

Outcome Type:Primary Outcome
Measure: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
Safety Issues:False
Description:Alcohol cue reactivity task BOLD signal to alcohol cues, relative to neutral beverage cues
Outcome Type:Primary Outcome
Measure: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
Safety Issues:False
Description:Multi-source interference task BOLD signal to interference trials, relative to control trials
Outcome Type:Primary Outcome
Measure: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
Safety Issues:False
Description:Stop-signal task blood oxygenation level dependent (BOLD) signal to successful stop trials, relative to unsuccessful stop trials
Outcome Type:Primary Outcome
Measure: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 medicati
Safety Issues:False
Description:Balloon Analogue Risk Task adjusted average number of pumps (higher scores = more risky decision-making)
Outcome Type:Primary Outcome
Measure: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 medicati
Safety Issues:False
Description:Subjective High Assessment Scale (range - 0-130; higher scores = greater intoxication) after laboratory alcohol administration
Outcome Type:Primary Outcome
Measure:Change in alcohol-induced stimulation between medication periods
Time Frame:30 minutes after laboratory alcohol administration on Day 1 of each medication period. Each medicati
Safety Issues:False
Description:Biphasic Alcohol Effects Scale stimulation score (range = 0-70; higher scores = more stimulation) after laboratory alcohol administration

Study Interventions

Intervention Type:Drug
Name:Placebo
Description:Placebo tablets
Arm Name:Placebo then Tolcapone
Intervention Type:Drug
Name:Tolcapone
Description:Tolcapone 100 mg tablets
Arm Name:Placebo then Tolcapone
Other Name:Tasmar

Study Arms

Study Arm Type:Experimental
Arm Name:Tolcapone then Placebo
Description: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).
Study Arm Type:Experimental
Arm Name:Placebo then Tolcapone
Description: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).

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Colorado, Denver
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: September 24, 2021

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