Purpose

The proposed study is a 3-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). Eighty patients 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 3 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

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Age 18-65 years old 2. Meets the DSM-5 criteria for diagnoses of schizophrenia or schizoaffective disorder and substance use disorder (alcohol, cocaine, heroin, or cannabis) based on the Structured Clinical Interview for the DSM-5 (SCID) 3. 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 4. Stable dose of antipsychotic agent for at least one month 5. Well established compliance with outpatient medications 6. Female subjects of child-bearing potential are required to practice appropriate birth control methods during the study.

Exclusion Criteria

  1. Psychiatrically unstable 2. Currently meets DSM-5 criteria for any substance use disorder other than caffeine, nicotine, alcohol, cocaine, heroin and cannabis 3. Significant, unstable medical conditions including severe cardiovascular, hepatic, renal or other medical diseases 4. History of a seizure disorder 5. Pregnancy or breastfeeding 6. Currently on aripiprazole or cariprazine 7. Currently on medications to treat substance use (disulfiram, naltrexone, acamprosate,methadone, buprenorphine, varenicline or buproprion)

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Experimental
Brexpiprazole 4mg daily for 12 weeks
  • Drug: Brexpiprazole
    Brexpiprazole 4mg daily for 12 weeks
    Other names:
    • Study Medication
Active Comparator
Treatment as Usual
Stay on current antipsychotic medication for 12 weeks
  • Other: Treatment as Usual
    Current antipsychotic medication for 12 weeks
    Other names:
    • Current Antipsychotic Treatment

More Details

Status
Completed
Sponsor
University of Massachusetts, Worcester

Study Contact

Detailed Description

STUDY OBJECTIVES The primary objectives of the study include: 1. examine the effect of brexpiprazole treatment on the number of days of substance use in the past week as measured by the Timeline Follow-Back (TLFB) assessment; 2. examine the effect of brexpiprazole treatment on substance craving using 100-mm visual analogue scale (VAS). The secondary objectives are to examine the effect of brexpiprazole treatment on: 1. the dollar amount spent on substances in the past week; 2. the psychiatric symptoms as measured using PANSS

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.