Phase 4 N=39 Randomized Treatment

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

Schizophrenia · Schizoaffective Disorder · Substance Use Disorders

Bottom Line

View on ClinicalTrials.gov: NCT03526354 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2025

Primary outcome: Primary: Timeline Follow Back (TLFB) — -1.765; -.532 score on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Brexpiprazole (Drug); Treatment as Usual (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Massachusetts, Worcester
Primary completion: Feb 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Timeline Follow Back (TLFB)	-1.765; -.532	—
PRIMARY Visual Analog Scale (VAS)	-33.421; -8.898	—
SECONDARY Amount of Money Spent on Substances	-20.974; 14.605	—
SECONDARY Positive and Negative Symptom Scale (PANSS)	-3.690; -.274	—
SECONDARY Clinical Global Impression - Severity	-.320; -.128	—
SECONDARY Heinrichs Carpenter Quality of Life Scale (QOL)	4.049; -5.146	—

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).

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03526354). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.