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Brexpiprazole for Alcohol Use Disorder

This study is investigating brexpiprazole, a medication that affects brain chemicals like serotonin and dopamine, to see if it can help reduce alcohol consumption in people with Alcohol Use Disorder (AUD). Researchers are also looking at how a person's genes might influence how well brexpiprazole works. You might be able to join if you are between 21 and 65 years old, have AUD, are not currently seeking treatment for AUD, and are not taking other AUD medications. The study will measure how many drinks you consume in your daily life and in a special lab setting, and will also use fMRI (functional magnetic resonance imaging) scans to see how brexpiprazole affects brain activity related to alcohol cues. The study aims to enroll 250 participants, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It involves 250 participants and compares different doses of brexpiprazole to a placebo (an inactive substance).
What's involved
You would take brexpiprazole or a placebo for at least 14 days. During this time, your drinking will be monitored, and you will have fMRI brain scans at the beginning and end of this period.
Compensation
Not stated in the trial record.
Follow-up
Your drinking behavior and brain activation will be measured at day 14 of the medication period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04066192

Brexpiprazole in Alcohol Use Disorder

Recruiting
PHASE2Ages 21–65InterventionalTreatment
University of Colorado, Denver
~250 participants
Updated 2026-05-01 on ClinicalTrials.gov
What's tested:BrexpiprazolePlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of drinks consumed in natural environment
Measured over First 13 days of medication period
+2 more outcomes measured

Conditions

Alcohol Use Disorder

Explore related trials

Alcohol use disorder

Where it's being run

1 sites across 1 states
Colorado1

Study leadership

  • Joseph P Schacht, PhD · PRINCIPAL_INVESTIGATOR · University of Colorado, Denver

Who to contact

Joseph P Schacht, PhD
[email protected]
303-724-3773
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

Exclusion

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.

What this trial measures

  • Number of drinks consumed in natural environmentFirst 13 days of medication period

    The number of standard alcoholic drinks participants consume during the first 13 days of the medication period, as reported on the Timeline Follow-Back Interview.

  • Number of drinks consumed in bar labDay 14 of medication period

    The number of drinks (out of 8 possible) that participants choose to consume in the bar lab.

  • Change in alcohol cue-elicited brain activation (fMRI)14 days - change between baseline and day 14 scan.

    Magnitude of change between baseline and day 14 fMRI scan in the blood oxygenation level dependent (BOLD) signal to alcohol cues, relative to neutral beverage cues on the Alcohol Cue Reactivity Task.