Clinical trial NCT03526354: Controlled Trial of Brexpiprazole For The Treatment of Co-occurring Schizophrenia and Substance Use Disorder
Official title: A Multi-center, Randomized, Controlled Trial of Brexpiprazole for the Treatment of Co-occurring Schizophrenia and Substance Use Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Schizoaffective Disorder
Substance Use Disorders
Keywords: Schizophrenia
Schizoaffective Disorder
Substance Use Disorders
Alcohol Use Disorder
Cannabis Use Disorder
Cocaine Use Disorder
Heroin Use Disorder
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: Massachusetts General Hospital
name: University of North Carolina, Chapel Hill
name: Otsuka Pharmaceutical Co., Ltd.
name: Augusta University
First posted: 2018-05-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

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 by various clinical rating scales
3. quality of life

Eligibility criteria: 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)

Primary outcomes:
measure: Timeline Follow Back (TLFB)
timeFrame: 12 weeks
measure: Visual Analog Scale (VAS)
timeFrame: 12 weeks
Secondary outcomes:
measure: Amount of Money Spent on Substances
timeFrame: 12 weeks
measure: Positive and Negative Symptom Scale (PANSS)
timeFrame: 12 Weeks
measure: Clinical Global Impression - Severity
timeFrame: 12 Weeks
measure: Heinrichs Carpenter Quality of Life Scale (QOL)
timeFrame: 12 Weeks
Other outcomes:
Locations:
city: Augusta
country: United States
facility: Augusta University
state: Georgia
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Worcester
country: United States
facility: UMass Medical School
state: Massachusetts
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
Study officials:
affiliation: University of Massachusetts, Worcester
name: Xiaoduo Fan, MD
role: PRINCIPAL_INVESTIGATOR
References: