Brexpiprazole in Alcohol Use Disorder (NCT04066192)
A Pharmacogenetic Human Laboratory Investigation of Brexpiprazole in Alcohol Use Disorder
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of Colorado Anschutz Medical Campus — Aurora, Colorado
Age range: 21 Years to 65 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- University of Colorado Anschutz Medical Campus — Aurora, Colorado
📞 Contact the Study Coordinator
Phone: (303) 724-3773
Email: joseph.schacht@cuanschutz.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Alcohol Use Disorder
- Observational Pilot Study to Explore the Social and Health Impacts of a New Model of Care in Oregon: Psilocybin Services on Alcoholism — Portland, Oregon
- Alcoholic Liver Disease and the Gut Microbiome — Los Angeles, California
- Telehealth Treatment for Alcohol Use Disorder — Stanford, California
- Remote Alcohol Monitoring to Facilitate Abstinence From Alcohol: Exp 1 — Lexington, Kentucky
- Psilocybin-Assisted vs Ketamine-Assisted Psychotherapy for Alcohol Use Disorder — Iowa City, Iowa
- rTMS in Older Adults With MCI and AUD — Charleston, South Carolina
Explore by condition: All Alcohol Use Disorder clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.