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

University of Massachusetts, Worcester

Status and phase: Completed; Phase 4

Conditions: Schizophrenia; Schizoaffective Disorder; Substance Use Disorders

Treatments: Drug: Brexpiprazole; Other: Treatment as Usual

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03526354

14611

Details and patient eligibility

About

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).

Full 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 by various clinical rating scales
3. quality of life

Enrollment: 50 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Experimental

Experimental group

Description:

Brexpiprazole 4mg daily for 12 weeks

Treatment:

Drug: Brexpiprazole

Treatment as Usual

Active Comparator group

Description:

Stay on current antipsychotic medication for 12 weeks

Treatment:

Other: Treatment as Usual