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

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 Overview

• Status: Completed
• Conditions: Schizophrenia; Schizoaffective Disorder; Substance Use Disorders
• Intervention / Treatment: Drug: Brexpiprazole; Other: Treatment as Usual

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

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Abaigeal Grant, BA; Phone Number: 508-856-3027; Email: abaigeal.grant2@umassmed.edu

Study Locations

• United States
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Augusta University
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Worcester, Massachusetts, United States, 01655
      • UMass Medical School
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Massachusetts, Worcester
• Collaborators: Massachusetts General Hospital; University of North Carolina, Chapel Hill; Augusta University; Otsuka Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Xiaoduo Fan, MD, University of Massachusetts, Worcester

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2018
• Primary Completion (Actual): February 29, 2024
• Study Completion (Actual): February 29, 2024

Study Registration Dates

• First Submitted: May 3, 2018
• First Submitted That Met QC Criteria: May 15, 2018
• First Posted (Actual): May 16, 2018

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: March 18, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Schizophrenia; Schizoaffective Disorder; Alcohol Use Disorder; Substance Use Disorders; Cannabis Use Disorder; Cocaine Use Disorder; Heroin Use Disorder
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Substance-Related Disorders; Schizophrenia; Psychotic Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Dopamine Agonists; Dopamine Agents; Brexpiprazole; Antipsychotic Agents
• Other Study ID Numbers: 14611

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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