Back to resultsBrexpiprazole Study
Primary Purpose
Schizophrenia, Schizoaffective Disorder, Substance Use Disorders
Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Brexpiprazole
Treatment as Usual
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Schizoaffective Disorder, Substance Use Disorders, Alcohol Use Disorder, Cannabis Use Disorder, Cocaine Use Disorder, Heroin Use Disorder
Eligibility Criteria
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)
Sites / Locations
- Augusta UniversityRecruiting
- Massachusetts General HospitalRecruiting
- UMass Medical SchoolRecruiting
- University of North CarolinaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental
Treatment as Usual
Arm Description
Brexpiprazole 4mg daily for 12 weeks
Stay on current antipsychotic medication for 12 weeks
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT03526354
First Posted
May 3, 2018
Last Updated
August 17, 2023
Sponsor
University of Massachusetts, Worcester
Collaborators
Massachusetts General Hospital, University of North Carolina, Chapel Hill, Otsuka Pharmaceutical Co., Ltd., Augusta University
1. Study Identification
Unique Protocol Identification Number
NCT03526354
Brief Title
Brexpiprazole Study
Official Title
A Multi-center, Randomized, Controlled Trial of Brexpiprazole for the Treatment of Co-occurring Schizophrenia and Substance Use Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 19, 2018 (Actual)
Primary Completion Date
October 19, 2024 (Anticipated)
Study Completion Date
March 19, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Massachusetts, Worcester
Collaborators
Massachusetts General Hospital, University of North Carolina, Chapel Hill, Otsuka Pharmaceutical Co., Ltd., Augusta University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Brexpiprazole 4mg daily for 12 weeks
Arm Title
Treatment as Usual
Arm Type
Active Comparator
Arm Description
Stay on current antipsychotic medication for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Brexpiprazole
Other Intervention Name(s)
Study Medication
Intervention Description
Brexpiprazole 4mg daily for 12 weeks
Intervention Type
Other
Intervention Name(s)
Treatment as Usual
Other Intervention Name(s)
Current Antipsychotic Treatment
Intervention Description
Current antipsychotic medication for 12 weeks
Primary Outcome Measure Information:
Title
Time line Follow back (TLFB)
Description
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.
Time Frame
12 weeks
Title
Visual Analog Scale
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Amount of money spent on substances
Description
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.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Abaigeal Grant, BA
Phone
508-856-3027
Email
abaigeal.grant2@umassmed.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaoduo Fan, MD
Organizational Affiliation
University of Massachusetts, Worcester
Official's Role
Principal Investigator
Facility Information:
Facility Name
Augusta University
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rebecca Nichols, MBA
Phone
706-721-4605
Email
rnichols@augusta.edu
First Name & Middle Initial & Last Name & Degree
Joseph McEvoy, MD
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caroline Kale, BA
Phone
617-912-7864
Email
cnkale@mgh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Oliver Freudenreich, MD
Facility Name
UMass Medical School
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abaigeal Grant, BA
Phone
508-856-3027
Email
abaigeal.grant2@umassmed.edu
First Name & Middle Initial & Last Name & Degree
Xiaoduo Fan, MD
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fred Jarskog, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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Brexpiprazole Study
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