Using brexpiprazole to treat alcohol use disorder

A Pharmacogenetic Human Laboratory Investigation of Brexpiprazole in Alcohol Use Disorder

This study is testing if a medication called brexpiprazole can help people with Alcohol Use Disorder drink less by looking at how it affects their brain while they respond to alcohol-related cues.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 250 (estimated)
• Ages: 21 Years to 65 Years
• Sex: All
• Sponsor: University of Colorado, Denver (Academic / other)
• Locations: 1 site (Aurora, Colorado)
• Trial ID: NCT04066192 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 21-65 who meet the DSM-5 criteria for Alcohol Use Disorder and are not currently seeking treatment.

Not a fit: Patients actively seeking treatment for Alcohol Use Disorder or those currently on medication for AUD may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for individuals with Alcohol Use Disorder, potentially leading to reduced alcohol consumption.

How similar studies have performed: While few medications have been FDA-approved for AUD, previous studies have shown promise with similar approaches, although this specific use of brexpiprazole is novel.

Eligibility criteria

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 this trial is running

Aurora, Colorado

• 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

Conditions Alcohol Use Disorder