NCT03904498

COMT Inhibition Among Individuals With Comorbid AUD/ADHD

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 62 (estimated)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Tolcapone	Tolcapone 100 mg tablets
DRUG	Placebo	Placebo tablets

Timeline

• Start date: 2021-08-16
• Primary completion: 2025-03-01
• Completion: 2025-03-01
• First posted: 2019-04-05
• Last updated: 2024-11-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study