Brexpiprazole Study



Status:Recruiting
Conditions:Schizophrenia, Psychiatric, Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 65
Updated:5/18/2018
Start Date:March 19, 2018
End Date:September 19, 2020
Contact:Joseph Mayotte, BA
Email:Joseph.Mayotte@umassmed.edu
Phone:508-856-2494

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

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).

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

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)
We found this trial at
3
sites
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Oliver Freudenreich, MD
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Chapel Hill, North Carolina 27599
(919) 962-2211
Univ of North Carolina Carolina’s vibrant people and programs attest to the University’s long-standing place...
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Worcester, Massachusetts 01655
Principal Investigator: Xiaoduo Fan, MD
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Worcester, MA
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