Schacht Research Study 19-1658

Primary Objective

Evaluate the effects of a medication, brexpiprazole (BREX), on non-treatment-seeking individuals with Alcohol Use Disorder.

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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
Age
Adult
Eligibility
Age 21-65 not currently seeking or engaged in treatment for Alcohol Use Disorder (AUD). Please contact the Translational Addiction Imaging Laboratory (TrAIL Lab) at alcoholstudy@ucdenver.edu for more information about the study and additional eligibility criteria.
Locations

Department Specific Free Standing Clinic
Outpatient CTRC
University of Colorado Hospital

Principal Investigator
Photograph of Joseph Schacht

Joseph Schacht

Study ID

Protocol Number: 19-1658

More information available at ClinicalTrials.gov: NCT04066192

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