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

Completed · Phase 4

Conditions studied: Schizophrenia, Schizoaffective Disorder, Substance Use Disorders

In brief

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).

Key facts

Study ID

NCT03526354

Run by

University of Massachusetts, Worcester

People needed

50

Starts

2018-06-19

Expected to finish

2024-02-29

Last updated by the study team

2025-05-23

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18-65 years old
• Meets the DSM-5 criteria for diagnoses of schizophrenia or schizoaffective disorder and substance use disorder (alcohol, cocaine, heroin, or cannabis) based on the Mini International Neuropsychiatric Interview for the DSM-5 (MINI 7.0)
• Uses substance on at least 4 of the past 30 days prior to randomization with at least one use in the week prior to randomization for one of substances (cocaine, heroin, cannabis or alcohol) assessed by the TLFB interview
• Stable dose of antipsychotic agent for at least one month
• Well established compliance with outpatient medications
• Female subjects of child-bearing potential are required to practice appropriate birth control methods during the study.

You may not qualify if…

• Psychiatrically unstable
• Currently meets DSM-5 criteria for any substance use disorder other than caffeine, nicotine, alcohol, cocaine, heroin and cannabis
• Significant, unstable medical conditions including severe cardiovascular, hepatic, renal or other medical diseases
• History of a seizure disorder
• Pregnancy or breastfeeding
• Currently on aripiprazole or cariprazine
• Currently on medications to treat substance use (disulfiram, naltrexone, acamprosate, methadone, buprenorphine, varenicline or buproprion)

Where it is running

• Augusta University — Augusta, Georgia, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• UMass Medical School — Worcester, Massachusetts, United States
• University of North Carolina — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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