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Brexpiprazole Study

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ClinicalTrials.gov Identifier: NCT03526354
Recruitment Status : Recruiting
First Posted : May 16, 2018
Last Update Posted : May 16, 2018
Sponsor:
Collaborators:
Massachusetts General Hospital
University of North Carolina, Chapel Hill
Otsuka Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Xiaoduo Fan, University of Massachusetts, Worcester

Brief 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).

Condition or disease Intervention/treatment Phase
Schizophrenia Schizoaffective Disorder Substance Use Disorders Drug: Brexpiprazole Other: Treatment as Usual Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-center, Randomized, Controlled Trial of Brexpiprazole for the Treatment of Co-occurring Schizophrenia and Substance Use Disorder
Actual Study Start Date : March 19, 2018
Estimated Primary Completion Date : March 19, 2020
Estimated Study Completion Date : September 19, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: Experimental
Brexpiprazole 4mg daily for 12 weeks
Drug: Brexpiprazole
Brexpiprazole 4mg daily for 12 weeks
Other Name: 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 Name: Current Antipsychotic Treatment




Primary Outcome Measures :
  1. Time line Follow back (TLFB) [ Time Frame: 12 weeks ]
    to measure weekly substance us


Secondary Outcome Measures :
  1. Visual Analog Scale [ Time Frame: 12 weeks ]
    measure to assess carving for substances



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03526354


Contacts
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Contact: Joseph Mayotte, BA 508-856-2494 Joseph.Mayotte@umassmed.edu

Locations
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United States, Massachusetts
Massachusetts General Hospital Not yet recruiting
Boston, Massachusetts, United States, 02114
Contact: Christopher McCain, BS         
Principal Investigator: Oliver Freudenreich, MD         
UMass Medical School Recruiting
Worcester, Massachusetts, United States, 01655
Contact: Joseph Mayotte, BA         
Principal Investigator: Xiaoduo Fan, MD         
United States, North Carolina
University of North Carolina Not yet recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Fred Jarskog, MD         
Sponsors and Collaborators
University of Massachusetts, Worcester
Massachusetts General Hospital
University of North Carolina, Chapel Hill
Otsuka Pharmaceutical Co., Ltd.
Investigators
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Principal Investigator: Xiaoduo Fan, MD University of Massachusetts, Worcester

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Responsible Party: Xiaoduo Fan, Associate Professor of Psychiatry, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT03526354     History of Changes
Other Study ID Numbers: 14611
First Posted: May 16, 2018    Key Record Dates
Last Update Posted: May 16, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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

Keywords provided by Xiaoduo Fan, University of Massachusetts, Worcester:
Schizophrenia
Schizoaffective Disorder
Substance Use Disorders
Alcohol Use Disorder
Cannabis Use Disorder
Cocaine Use Disorder
Heroin Use Disorder

Additional relevant MeSH terms:
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Disease
Schizophrenia
Psychotic Disorders
Substance-Related Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Chemically-Induced Disorders
Antipsychotic Agents
Brexpiprazole
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Dopamine Agonists
Dopamine Agents