Last updated on June 2019

Brexpiprazole Study

Brief description of study

The proposed study is a 3-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). Eighty patients 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 3 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 Study Description


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 using PANSS

Clinical Study Identifier: NCT03526354

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UMass Medical School

Worcester, MA United States
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University of North Carolina

Chapel Hill, NC United States
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Recruitment Status: Open

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