CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 50 enrolled
Drug / intervention
Brexpiprazole +1 moredrug
Likely dose
Brexpiprazole 4mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03526354
NCT03526354Phase 4Completed

A Multi-center, Randomized, Controlled Trial of Brexpiprazole for the Treatment of Co-occurring Schizophrenia and Substance Use Disorder

University of Massachusetts, Worcester·interventional·Posted May 16, 2018·Updated May 23, 2025

In Brief

A Phase 4 clinical trial evaluating Brexpiprazole and Treatment as Usual for Schizophrenia and 2 related conditions. Completed, enrolled 50 participants across 4 sites.

Detailed Summary

The proposed study is a 4-site, 12-week, novel, feasibility, investigation of patients who have co-occurring diagnoses of schizophrenia and current substance use disorder (alcohol, cocaine, heroin, or cannabis). Thirty-nine participants will be randomly assigned to switch to brexpiprazole (the brexpiprazole group) or remain on the same antipsychotic treatment (the control group). The study will be conducted at 4 sites in the US. The investigators expect to enroll 80 subjects across 3 sites. UMass Medical School, Worcester MA is the lead site. Sub-sites include Massachusetts General Hospital (MGH) and the University of North Carolina at Chapel Hill (UNC).

Study Details

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedMay 16, 2018
Enrollment StartJun 19, 2018
Primary CompletionFeb 29, 2024
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 8.1 years ago

Interventions

Brexpiprazoledrug

Brexpiprazole 4mg daily for 12 weeks

Treatment as Usualother

Current antipsychotic medication for 12 weeks