BREX 2mg for Alcoholism

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
AlcoholismBrexpiprazole - Drug
Eligibility
21 - 65
All Sexes
What conditions do you have?
Select

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

1 of 3

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

2 of 3
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: Drug
BREX 2mg
Drug
ActiveComparator Group · 1 Intervention: Brexpiprazole · Intervention Types: Drug
BREX 4mg
Drug
ActiveComparator Group · 1 Intervention: Brexpiprazole · Intervention Types: Drug

Trial 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.