Could a new pill curb heavy drinking? genetic clues may hold the answer
NCT ID NCT04066192
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is testing a medication called brexpiprazole to see if it can help people with alcohol use disorder drink less. Researchers want to know if a person's genes affect how well the drug works. The study involves 250 adults who are not currently seeking treatment for their drinking. Participants will take the medication or a placebo and report their drinking habits, plus some will have brain scans.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 250 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Oct 2020
- Expected to finish
-
Aug 2026
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
21 to 65 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Alcohol use disorder are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
University of Colorado Anschutz Medical Campus
RECRUITINGAurora, Colorado, 80045, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can Brain-Training games rewire the mind to fight alcohol addiction?
- Can a Stress-Hormone blocker take the edge off alcohol?
- Can MDMA plus therapy help veterans fight both PTSD and alcohol addiction?
- Brain scans probe opioid receptor imbalance in alcohol use disorder
- Spinal taps open a window on alcohol use disorder
- Can a natural alcohol byproduct calm withdrawal? hospital trial tests IV acetate