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Recruiting Phase 2 NCT03904498

NCT03904498 COMT Inhibition Among Individuals With Comorbid AUD/ADHD

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Clinical Trial Summary
NCT ID NCT03904498
Status Recruiting
Phase Phase 2
Sponsor University of Colorado, Denver
Condition Alcohol Use Disorder
Study Type INTERVENTIONAL
Enrollment 62 participants
Start Date 2021-08-16
Primary Completion 2025-03-01

Trial Parameters

Condition Alcohol Use Disorder
Sponsor University of Colorado, Denver
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 62
Sex ALL
Min Age 21 Years
Max Age 65 Years
Start Date 2021-08-16
Completion 2025-03-01
Interventions
TolcaponePlacebo

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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.

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 psych

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