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NCT04066192 · ClinicalTrials.gov registry record · Phase 2
Brexpiprazole in Alcohol Use Disorder
A Phase 2 study of Alcohol Use Disorder, sponsored by University of Colorado, Denver.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 250
- Enrollment target
- 1
- Study location
NCT04066192 is a Phase 2 study of Alcohol Use Disorder that is actively recruiting participants, run by University of Colorado, Denver. The registered enrollment target is 250 participants, below the 327-participant average among 184 other Alcohol Use Disorder trials with a reported enrollment target (24% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04066192, a Phase 2 study of Alcohol Use Disorder, is actively recruiting participants, sponsored by University of Colorado, Denver.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 250 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Brexpiprazole
Study Locations (1)
Colorado
- University of Colorado Anschutz Medical Campus - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2020-10-30 |
| Est. Completion | 2025-08-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04066192
The ClinicalTrials.gov registry entry for NCT04066192 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 250 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 327-participant average among 184 other Alcohol Use Disorder trials with a reported enrollment target (24% lower). The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Alcohol Use Disorder appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04066192 reports 1 study location spanning 1 distinct geographic area - top geographies include Colorado.
Frequently Asked Questions
What is clinical trial NCT04066192 about?
NCT04066192 is a clinical study titled "Brexpiprazole in Alcohol Use Disorder". 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 identi...
What is the current status of trial NCT04066192?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 250 participants. The study started on 2020-10-30. Estimated completion is 2025-08-31.
What conditions does trial NCT04066192 study?
This clinical trial studies the following conditions: Alcohol Use Disorder.
What interventions are being tested in trial NCT04066192?
The interventions under investigation include: Placebo (DRUG), Brexpiprazole (DRUG).
Who is sponsoring clinical trial NCT04066192?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04066192 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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