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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03526354
• Other study ID #: 14611
• Status: Completed
• Phase: Phase 4
• Start date: March 19, 2018
• Est. completion date: February 29, 2024

Study information

• Verified date: March 2024
• Source: University of Massachusetts, Worcester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: February 29, 2024
• Est. primary completion date: February 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia
• Substance Use Disorders
• Substance-Related Disorders

Intervention

Drug:
• Brexpiprazole
Brexpiprazole 4mg daily for 12 weeks

Other:
• Treatment as Usual
Current antipsychotic medication for 12 weeks

Locations

Country	Name	City	State
United States	Augusta University	Augusta	Georgia
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	University of North Carolina	Chapel Hill	North Carolina
United States	UMass Medical School	Worcester	Massachusetts

Sponsors (5)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester	Augusta University, Massachusetts General Hospital, Otsuka Pharmaceutical Co., Ltd., University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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