NCT04066192 Brexpiprazole in Alcohol Use Disorder
| NCT ID | NCT04066192 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Colorado, Denver |
| Condition | Alcohol Use Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 250 participants |
| Start Date | 2020-10-30 |
| Primary Completion | 2026-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 250 participants in total. It began in 2020-10-30 with a primary completion date of 2026-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Few medications are currently Food \& Drug Administration (FDA)-approved for the treatment of Alcohol Use Disorder (AUD), and those that are have, on average, modest effects on drinking. "Precision medicine" research has explored whether patient-level variables, such as genetic variation, may identify subgroups of individuals with larger medication effects, but few findings have been replicated. A promising novel medication for AUD is brexpiprazole (BREX), a serotonin/dopamine activity modulator (SDAM). The investigators conducted a prior study in which the effects of another SDAM, aripiprazole, were influenced by genetic variation in the gene encoding the dopamine transporter (DAT1). This study will evaluate the effects of two doses of BREX, relative to placebo, among non-treatment-seeking individuals with AUD, and will test whether DAT1 genotype influences these effects. Primary outcomes are drinking under natural conditions and in a laboratory paradigm. Functional magnetic resonance imaging (fMRI) will be used to explore whether BREX effects on brain activation associated with cognitive control or elicited by alcohol cues accounts for its effects on drinking. The investigators hypothesize that BREX, relative to placebo, will reduce drinking under natural conditions and in the lab, and will do so to a greater extent among individuals who carry the DAT1 9-repeat allele, relative to those homozygous for the 10-repeat allele. If these hypotheses are supported, BREX may represent a novel pharmacogenetic treatment for AUD.
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.
Contact & Investigator
Joseph P Schacht, PhD
PRINCIPAL INVESTIGATOR
University of Colorado, Denver
Frequently Asked Questions
Who can join the NCT04066192 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 65 Years, studying Alcohol Use Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04066192 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04066192 currently recruiting?
Yes, NCT04066192 is actively recruiting participants. Contact the research team at joseph.schacht@cuanschutz.edu for enrollment information.
Where is the NCT04066192 trial being conducted?
This trial is being conducted at Aurora, United States.
Who is sponsoring the NCT04066192 clinical trial?
NCT04066192 is sponsored by University of Colorado, Denver. The principal investigator is Joseph P Schacht, PhD at University of Colorado, Denver. The trial plans to enroll 250 participants.