NCT03526354CompletedPhase 4
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
Source: ClinicalTrials.gov · Last updated 23 May 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 50 (actual)
- First submitted
- 3 May 2018
- Start date
- 19 Jun 2018
- Primary completion date
- 29 Feb 2024
- Lead sponsor
- University of Massachusetts, Worcester
- Diseases
- Schizophrenia
- NCT number
- NCT03526354
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 50
- From 19 Jun 2018 to the primary completion date, 29 Feb 2024
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently on aripiprazole or cariprazine
- Currently on medications to treat substance use (disulfiram, naltrexone, acamprosate, methadone, buprenorphine, varenicline or buproprion)
Other illness
- 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
Other
- Psychiatrically unstable
- Pregnancy or breastfeeding
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Augusta University Coordinator of this site? Confirm its status | Augusta | United States | Unknown status |
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| University of North Carolina Coordinator of this site? Confirm its status | Chapel Hill | United States | Unknown status |
| UMass Medical School Coordinator of this site? Confirm its status | Worcester | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.