Using brexpiprazole to treat alcohol use disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effects of brexpiprazole, a serotonin/dopamine activity modulator, on reducing alcohol consumption in individuals with Alcohol Use Disorder (AUD) who are not seeking treatment. Participants will be randomized to receive either brexpiprazole or a placebo, with the dosage based on their DAT1 genotype. The study aims to assess how brexpiprazole influences brain activity related to alcohol cues and response inhibition using functional magnetic resonance imaging (fMRI). Primary outcomes include changes in drinking behavior in both natural and controlled settings.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Ages 21-65.
* Meet DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th edition) diagnostic criteria for AUD, as assessed by the Structured Clinical Interview for DSM-5 (SCID-5).
* Currently not engaged in, and does not want treatment for, AUD.
* Currently not taking any medication for AUD.
* Able to read and understand questionnaires and informed consent.
* Lives within 50 miles of the study site.
* Physically healthy with no history of significant medical illness.
* Negative urine drug screen (UDS) for all substances of abuse prior to taking the first dose of medication.

Please contact clinical site for additional inclusion criteria.

Exclusion Criteria:

* Refusal of valid written consent.
* Insufficient English skills for consenting or interviews.
* Severe claustrophobia or morbid obesity that preclude placement in the MRI scanner.
* Contraindications to MRI scanning, ferrous metal in the body including intracranial, intraorbital, or intraspinal metal, pacemakers, cochlear implants or other non-MRI-compatible devices.
* History of head injury with loss of consciousness for more than 2 minutes, neurological illness, or history of neurosurgical procedures.
* Current DSM-5 diagnosis of any other substance use disorder except Nicotine Use Disorder.
* Current DSM-5 psychotic, mood, anxiety, obsessive-compulsive, trauma-related, or eating 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 evidenced by self-report and assessment with Clinical Institute Withdrawal Assessment for Alcohol-Revised (CIWA-Ar).
* Clinically significant medical problems such as cardiovascular, renal, gastrointestinal, or endocrine problems, as evidenced by medical history and physical 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 elevations of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 3 times the upper limit of the normal range at screening.
* Females of childbearing potential who are pregnant (by plasma or urine HCG), nursing, or who are not using a reliable form of contraception.
* Current charges pending for a violent crime (not including DUI-related offenses).
* Currently incarcerated.
* Lack of a stable living situation.
* History of head injury with loss of consciousness for more than 2 minutes, neurological illness, or history of neurosurgical procedures.
* Decisionally challenged.

Where it's running

• University of Colorado Anschutz Medical Campus
  Aurora, Colorado, United States Recruiting

Study contacts

• Principal investigator: Joseph P Schacht, PhD — University of Colorado, Denver
• Study coordinator: Joseph P Schacht, PhD
• Email: joseph.schacht@cuanschutz.edu
• Phone: 303-724-3773

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.