drugset / Trial / NCT03526354
Controlled Trial of Brexpiprazole For The Treatment of Co-occurring Schizophrenia and Substance Use Disorder
Phase 4
Completed
50 enrolled
University of Massachusetts, Worcester
Augusta University · collabMassachusetts General Hospital · collabOtsuka Pharmaceutical Co., Ltd. · collabUniversity of North Carolina, Chapel Hill · collab
RandomizedParallel-groupOpen-labelTreatment
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).
Timeline
- Start
- 2018-06-19
- Primary completion
- 2024-02-29
- Completion
- 2024-02-29
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Brexpiprazole | Small molecule | 4 mg | — |