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

NCT03526354 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 14611
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 4

Brief 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).

Conditions

Schizophrenia; Schizoaffective Disorder; Substance Use Disorders

Keywords

Schizophrenia; Schizoaffective Disorder; Substance Use Disorders; Alcohol Use Disorder; Cannabis Use Disorder; Cocaine Use Disorder; Heroin Use Disorder

Outcome Measures

Primary Outcomes (2)

• Timeline Follow Back (TLFB)

  The Timeline Follow Back (TLFB) scale is used to measure weekly substance use for alcohol, marijuana, cocaine, and/or heroin by assessing the number of days a person used substances in the past week, on a scale from 0 to 7 \[0 = no substances that week; 7 = substance use every day\]. The outcome measure was the number of days per week that participants used a substance. If participants use more than one substance, only the primary substance (one used mostly frequently) was analyzed. While the TLFB was assessed weekly, the outcome measure reported is the change in substance use between Week 0 (Baseline) and Week 12 (End of Study). A decrease in number of days/week that substances were used indicates an improved (better) outcome. While the TLFB was assessed weekly, the outcome measure reported is the change in substance use between Week 0 (Baseline) and Week 12 (End of Study). A decrease in number of days/week that substances were used indicates an improved (better) outcome.

  12 weeks

• Visual Analog Scale (VAS)

  The Visual Analog Scale (VAS) measures substance craving. Subjects will make a mark on an unlabeled 100-millimeter line indicating their desire to use a particular substance over the past 7-days. A score of 0 indicates no desire to use and 100 indicating the strongest desire to use possible. The assessment was done weekly. Subjects reported craving for any substances they used that week with a separate mark for each substance (e.g., a mark for alcohol craving and another mark for marijuana). For outcome measures, only the primary substance (the substance used most frequently, as determined by the Timeline Follow Back assessment) was included. While cravings were assessed weekly, only the change in craving from Week 0 (Baseline) to Week 12 (End of Study) is reported; a decreased score (reduction in cravings) represents an improved outcome.

  12 weeks

Secondary Outcomes (4)

• Amount of Money Spent on Substances

  12 weeks

• Positive and Negative Symptom Scale (PANSS)

  12 Weeks

• Clinical Global Impression - Severity

  12 Weeks

• Heinrichs Carpenter Quality of Life Scale (QOL)

  12 Weeks

Study Arms (2)

Experimental

EXPERIMENTAL

Brexpiprazole 4mg daily for 12 weeks

Drug: Brexpiprazole

Treatment as Usual

ACTIVE COMPARATOR

Stay on current antipsychotic medication for 12 weeks

Other: Treatment as Usual

Interventions

Brexpiprazole DRUG

Brexpiprazole 4mg daily for 12 weeks

Also known as: Study Medication

Experimental

Treatment as Usual OTHER

Current antipsychotic medication for 12 weeks

Also known as: Current Antipsychotic Treatment

Treatment as Usual

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead
• Massachusetts General Hospital: collaborator
• University of North Carolina, Chapel Hill: collaborator
• Otsuka Pharmaceutical Co., Ltd.: collaborator
• Augusta University: collaborator

Study Sites (4)

Augusta University

Augusta, Georgia, 30912, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

UMass Medical School

Worcester, Massachusetts, 01655, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (1)

• Fan X, Freudenreich O, Jarskog LF, McEvoy J, Harrington A. Brexpiprazole for the Treatment of Co-occurring Schizophrenia and Substance Use Disorder: A Multisite, Randomized, Controlled Trial. J Clin Psychiatry. 2025 Oct 13;86(4):25m15786. doi: 10.4088/JCP.25m15786.

  PMID: 41129678 DERIVED

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Substance-Related Disorders; Alcoholism

Interventions

brexpiprazole; Therapeutics

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders

Results Point of Contact

• Title: Dr. Xiaoduo Fan
• Organization: UMass Chan Medical School

xiaoduo.fan@umassmed.edu

5088566463

Study Officials

• Xiaoduo Fan, MD

  University of Massachusetts, Worcester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry

Study Record Dates

• First Submitted: May 3, 2018
• First Posted: May 16, 2018
• Study Start: June 19, 2018
• Primary Completion: February 29, 2024
• Study Completion: February 29, 2024
• Last Updated: May 23, 2025
• Results First Posted: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)