Phase
Condition
Addictions
Alcohol Dependence
Alcohol Use Disorder
Treatment
Placebo
Tolcapone
Clinical Study ID
Ages 21-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age 21-65.
Meets Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5)criteria for current Alcohol Use Disorder (AUD) and currentAttention-Deficit/Hyperactivity Disorder (ADHD), as assessed by the StructuredClinical Interview for DSM-5 (SCID-5) or WHO-ASRS.
Currently not engaged in, and does not want treatment for, AUD or ADHD.
Currently not taking any medication for AUD or ADHD.
Able to read and understand questionnaires and informed consent.
Lives within 50 miles of the study site.
Exclusion
Exclusion Criteria:
Current DSM-5 diagnosis of any other substance use disorder except Nicotine UseDisorder.
Any psychoactive substance use (except nicotine) within the last 30 days, asindicated by self-report and urine drug screen (UDS)
Current DSM-5 psychotic, mood, anxiety, obsessive-compulsive, trauma-related, oreating disorder, as assessed by SCID-5.
Current suicidal ideation or homicidal ideation.
Current use of any psychoactive medication, as evidenced by self-report and UDS.
History of severe alcohol withdrawal (e.g., seizure, delirium tremens), as evidencedby self-report and assessment with Clinical Institute Withdrawal Assessment forAlcohol-Revised (CIWA-Ar).
Clinically significant medical problems such as cardiovascular, renal,gastrointestinal, or endocrine problems, as evidenced by medical history andphysical exam.
Past alcohol-related medical illness, such as gastrointestinal bleeding,pancreatitis, or peptic ulcer.
Current or past hepatocellular disease, as indicated by verbal report, or elevationsof alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater thanthe upper limit of the normal range at screening.
Females of childbearing potential who are pregnant (by plasma HCG), nursing, or whoare not using a reliable form of contraception.
Current charges pending for a violent crime (not including DUI-related offenses).
Lack of a stable living situation.
Presence of ferrous metal in the body, as evidenced by metal screening andself-report.
Severe claustrophobia or morbid obesity that preclude placement in the MRI scanner.
History of neurological disease or head injury with > 2 minutes of unconsciousness.
Study Design
Study Description
Connect with a study center
University of Colorado Anschutz Medical Campus
Aurora, Colorado 80045
United StatesActive - Recruiting
Medical University of South Carolina
Charleston, South Carolina 29425
United StatesSite Not Available
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