Alcohol Use Disorder study: Brexpiprazole
Official title Brexpiprazole in Alcohol Use Disorder
ClinicalTrials.gov ID: NCT04066192
What this study is testing
What is Brexpiprazole?
Brexpiprazole is an investigational medicine being studied for the treatment of Alcohol Use Disorder. Brexpiprazole is designed to modulate serotonin and dopamine activity.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see if brexpiprazole reduces drinking compared to a placebo, and whether a specific gene (DAT1) changes how well it works.
- Who it's for
- Adults who have alcohol use disorder but are not currently seeking treatment.
- What's involved
- Participants will receive either brexpiprazole at two different doses or a placebo, and will have regular visits for drinking assessments and brain scans (fMRI).
- Time commitment
- The study lasts several weeks, with multiple clinic visits for medication, drinking monitoring, and brain imaging.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 65
You may be able to join if
- 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...
- 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.
You likely can't join if
- 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...
- 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.
See the full eligibility 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 .
- 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...
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Aurora, Colorado, United States
Compensation & support
A stipend or payment for your time may be offered.
No amount is published here because ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team, so confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Aurora, Colorado, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.