Schacht Research Study 19-1658
Primary Objective
Evaluate the effects of a medication, brexpiprazole (BREX), on non-treatment-seeking individuals with Alcohol Use Disorder.
Description
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). 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. 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. If the study hypotheses are supported, BREX may represent a novel pharmacogenetic treatment for AUD.
Details
Locations
Department Specific Free Standing Clinic
Outpatient CTRC
University of Colorado Hospital
Principal Investigator
Joseph Schacht
Study ID
Protocol Number: 19-1658
More information available at ClinicalTrials.gov: NCT04066192
Categories
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