Brexpiprazole Study

Study Overview
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Brief Summary
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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).

Detailed Description
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STUDY OBJECTIVES The primary objectives of the study include: 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; 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: the dollar amount spent on substances in the past week; the psychiatric symptoms as measured using PANSS

Official Title
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A Multi-center, Randomized, Controlled Trial of Brexpiprazole for the Treatment of Co-occurring Schizophrenia and Substance Use Disorder

Conditions
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Schizophrenia, Schizoaffective Disorder, Substance Use Disorders

Intervention / Treatment
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* Drug: Brexpiprazole
* Other: Treatment as Usual


Participation Criteria
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Eligibility Criteria
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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 Structured Clinical Interview for the DSM-5 (SCID) 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Brexpiprazole 4mg daily for 12 weeks | Drug: Brexpiprazole<br>* Brexpiprazole 4mg daily for 12 weeks<br>* Other names: Study Medication;|
| Active Comparator: Treatment as Usual<br>Stay on current antipsychotic medication for 12 weeks | Other: Treatment as Usual<br>* Current antipsychotic medication for 12 weeks<br>* Other names: Current Antipsychotic Treatment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time line Follow back (TLFB) | A scale used to measure weekly substance use starting 30 days prior to the screening until the end of the 12-week study period. Measurement values for the scale vary based on substance used (i.e. alcohol = number of standard drinks/ day; Cannabis = number of joints/ day; cocaine and heroine = did you use this day), but for our purposes data collected will be reduced to whether or not a subject used on a particular day. For this study, a decrease in the number of days of substance use over a 7-day period will be considered an improved outcome. | 12 weeks | 
| Visual Analog Scale | measure to assess craving for substances. 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. This assessment will be taken on a weekly basis throughout the 12-week study. Every substance that a subject has a substance use disorder for will be measured separately. For this study a decreased score represents an improved outcome. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of money spent on substances | The amount of money spent on substances over a 7-day period will also be recorded as part of each weekly visit. Decreased money spent on substances over a 7-day period will also be considered an improved outcome. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Schizophrenia, Schizoaffective Disorder, Substance Use Disorders, Alcohol Use Disorder, Cannabis Use Disorder, Cocaine Use Disorder, Heroin Use Disorder