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

Primary Objective

Using a within-subjects, double-blind, placebo (PLA)-controlled design, this study proposes to investigate the effects of tolcapone (TOLC) on brain activation associated with cognitive control (response inhibition), selective attention, and alcohol cue-reactivity, alcohol subjective effects, and risky decision-making after consumption of a standard drink among individuals with co-occurring Alcohol Use Disorder (AUD) and Attention-Deficit/Hyperactivity Disorder (ADHD).

Study category: Behaviors and Mental Health

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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 the study period there will be two fMRI scans and two on-campus alcohol administration sessions. Participants must not be seeking treatment for AUD or ADHD and must not be currently taking any psychotropic medications, including stimulant medications for ADHD.

Details
Age

Adult

Eligibility

Age 21-65 and not currently seeking or engaged in treatment for Alcohol Use Disorder (AUD) or Attention-Deficit/Hyperactivity Disorder (ADHD).

Please contact the Translational Addiction Imaging Laboratory (TrAIL Lab) at alcoholstudy@ucdenver.edu for more information about the study and additional eligibility criteria.

Type of Study

Treatment

Scope

Local

Locations

Brain Imaging Center (BIC)
Department Specific Free Standing Clinic
Outpatient CTRC
University of Colorado Hospital

Principal Investigator
Joseph Schacht,  PhD

Joseph Schacht, PhD

Study ID

Protocol Number: 19-2335

More information available at ClinicalTrials.gov: NCT03904498

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