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COMPLETED Phase 4

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

NCT03526354 · View on ClinicalTrials.gov ↗

Study 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).

Interventions

  • OTHER Treatment as Usual
  • DRUG Brexpiprazole

Study Locations (4)

Massachusetts

  • Massachusetts General Hospital — Boston
  • UMass Medical School — Worcester

Georgia

  • Augusta University — Augusta

North Carolina

  • University of North Carolina — Chapel Hill

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2018-06-19
Est. Completion 2024-02-29
Phase Phase 4

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03526354

The ClinicalTrials.gov registry entry for NCT03526354 describes a study currently listed as completed. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Massachusetts, Worcester, which has 200 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 3 conditions, with Schizophrenia appearing as the primary indexed condition, and to 2 interventions — of which Treatment as Usual is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03526354 reports 4 study locations spanning 3 distinct geographic areas — top geographies include Massachusetts, Georgia, North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03526354 about?

NCT03526354 is a clinical study titled "Controlled Trial of Brexpiprazole For The Treatment of Co-occurring Schizophrenia and Substance Use Disorder". 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 brexp...

What is the current status of trial NCT03526354?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 50 participants. The study started on 2018-06-19. Estimated completion is 2024-02-29.

What conditions does trial NCT03526354 study?

This clinical trial studies the following conditions: Schizophrenia, Substance Use Disorders, Schizoaffective Disorder. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03526354?

The interventions under investigation include: Treatment as Usual (OTHER), Brexpiprazole (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03526354?

This trial is sponsored by University of Massachusetts, Worcester, which has 200 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03526354 being conducted?

This trial has 4 study locations across Georgia, Massachusetts, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial