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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-19

Study Completion Date

2024-02-29

Brief Summary

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The proposed study is a 4-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). Thirty-nine participants 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 4 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).

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Detailed Description

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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 by various clinical rating scales
3. quality of life

Conditions

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Schizophrenia Schizoaffective Disorder Substance Use Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental

Brexpiprazole 4mg daily for 12 weeks

Group Type EXPERIMENTAL

Brexpiprazole

Intervention Type DRUG

Brexpiprazole 4mg daily for 12 weeks

Treatment as Usual

Stay on current antipsychotic medication for 12 weeks

Group Type ACTIVE_COMPARATOR

Treatment as Usual

Intervention Type OTHER

Current antipsychotic medication for 12 weeks

Interventions

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Brexpiprazole

Brexpiprazole 4mg daily for 12 weeks

Intervention Type DRUG

Treatment as Usual

Current antipsychotic medication for 12 weeks

Intervention Type OTHER

Other Intervention Names

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Study Medication Current Antipsychotic Treatment

Eligibility Criteria

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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 Mini International Neuropsychiatric Interview for the DSM-5 (MINI 7.0)
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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No