Study Summary
This trial will test whether the medication brexpiprazole (BREX) can help reduce drinking in people with Alcohol Use Disorder (AUD), and whether this effect is influenced by genetic variation in the gene encoding the dopamine transporter (DAT1).
Eligible Conditions
- Alcoholism
Treatment Effectiveness
Effectiveness Progress
Study Objectives
3 Primary · 0 Secondary · Reporting Duration: 14 days - change between baseline and day 14 scan.
Day 14
Change in alcohol cue-elicited brain activation (fMRI)
Day 14
Number of drinks consumed in bar lab
Day 13
Drunk driving
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Trial Design
3 Treatment Groups
BREX 2mg
1 of 3
BREX 4mg
1 of 3
Placebo
1 of 3
Active Control
Non-Treatment Group
250 Total Participants · 3 Treatment Groups
Primary Treatment: BREX 2mg · Has Placebo Group · Phase 2
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: DrugBREX 2mg
Drug
ActiveComparator Group · 1 Intervention: Brexpiprazole · Intervention Types: DrugBREX 4mg
Drug
ActiveComparator Group · 1 Intervention: Brexpiprazole · Intervention Types: DrugTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 14 days - change between baseline and day 14 scan.
Who is running the clinical trial?
University of Colorado, DenverLead Sponsor
1,595 Previous Clinical Trials
1,927,118 Total Patients Enrolled
11 Trials studying Alcoholism
2,022 Patients Enrolled for Alcoholism
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
719 Previous Clinical Trials
1,173,891 Total Patients Enrolled
377 Trials studying Alcoholism
976,413 Patients Enrolled for Alcoholism
Joseph P Schacht, PhDPrincipal InvestigatorUniversity of Colorado, Denver
2 Previous Clinical Trials
62 Total Patients Enrolled
2 Trials studying Alcoholism
62 Patients Enrolled for Alcoholism
Eligibility Criteria
Age 21 - 65 · All Participants · 9 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You live within 50 miles of the study site.\n
You have a negative UDS for all substances of abuse prior to taking the first dose of medication.
References
- Schacht, Joseph P, Konstantin E Voronin, Patrick K Randall, and Raymond F Anton. 2017. “Dopaminergic Genetic Variation Influences Aripiprazole Effects on Alcohol Self-administration and the Neural Response to Alcohol Cues in a Randomized Trial”. Neuropsychopharmacology. Springer Science and Business Media LLC. doi:10.1038/npp.2017.298.
- 2020. "Brexpiprazole in Alcohol Use Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04066192.
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Conditions
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Treatments