NCT03526354

Controlled Trial of Brexpiprazole For The Treatment of Co-occurring Schizophrenia and Substance Use Disorder

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: University of Massachusetts, Worcester · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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).

Detailed description

STUDY OBJECTIVES The primary objectives of the study include: 1. examine the effect of brexpiprazole treatment on the number of days of substance use in the past week as measured by the Timeline Follow-Back (TLFB) assessment; 2. examine the effect of brexpiprazole treatment on substance craving using 100-mm visual analogue scale (VAS). The secondary objectives are to examine the effect of brexpiprazole treatment on: 1. the dollar amount spent on substances in the past week; 2. the psychiatric symptoms as measured by various clinical rating scales 3. quality of life

Conditions

• Schizophrenia
• Schizoaffective Disorder
• Substance Use Disorders

Interventions

Type	Name	Description
DRUG	Brexpiprazole	Brexpiprazole 4mg daily for 12 weeks
OTHER	Treatment as Usual	Current antipsychotic medication for 12 weeks

Timeline

• Start date: 2018-06-19
• Primary completion: 2024-02-29
• Completion: 2024-02-29
• First posted: 2018-05-16
• Last updated: 2025-05-23
• Results posted: 2025-05-23

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study