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Completed

NCT Number: NCT03526354

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

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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Key information

Conditions

Schizophrenia Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Mental Disorders Psychotic Disorders Schizoaffective Disorder Schizophrenia Spectrum and Other Psychotic Disorders Substance Use Disorders Substance-Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Augusta University, Augusta, Georgia, United States

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About this study

STUDY OBJECTIVES

The primary objectives of the study include:

  • 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;
  • 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:

  • the dollar amount spent on substances in the past week;
  • the psychiatric symptoms as measured by various clinical rating scales
  • quality of life

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18-65 years old
  • 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)
  • 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
  • Stable dose of antipsychotic agent for at least one month
  • Well established compliance with outpatient medications
  • Female subjects of child-bearing potential are required to practice appropriate birth control methods during the study.

Exclusion criteria

  • Psychiatrically unstable
  • Currently meets DSM-5 criteria for any substance use disorder other than caffeine, nicotine, alcohol, cocaine, heroin and cannabis
  • Significant, unstable medical conditions including severe cardiovascular, hepatic, renal or other medical diseases
  • History of a seizure disorder
  • Pregnancy or breastfeeding
  • Currently on aripiprazole or cariprazine
  • Currently on medications to treat substance use (disulfiram, naltrexone, acamprosate, methadone, buprenorphine, varenicline or buproprion)

Treatment and study plan

Brexpiprazole

Drug

Brexpiprazole 4mg daily for 12 weeks

Other names: Study Medication

Treatment as Usual

Other

Current antipsychotic medication for 12 weeks

Other names: Current Antipsychotic Treatment

Primary outcomes

  1. Timeline Follow Back (TLFB)

    Time frame: 12 weeks

    The Timeline Follow Back (TLFB) scale is used to measure weekly substance use for alcohol, marijuana, cocaine, and/or heroin by assessing the number of days a person used substances in the past week, on a scale from 0 to 7 [0 = no substances that week; 7 = substance use every day]. The outcome measure was the number of days per week that participants used a substance. If participants use more than one substance, only the primary substance (one used mostly frequently) was analyzed.

    While the TLFB was assessed weekly, the outcome measure reported is the change in substance use between Week 0 (Baseline) and Week 12 (End of Study). A decrease in number of days/week that substances were used indicates an improved (better) outcome.

    While the TLFB was assessed weekly, the outcome measure reported is the change in substance use between Week 0 (Baseline) and Week 12 (End of Study). A decrease in number of days/week that substances were used indicates an improved (better) outcome.

  2. Visual Analog Scale (VAS)

    Time frame: 12 weeks

    The Visual Analog Scale (VAS) measures substance craving. 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. The assessment was done weekly. Subjects reported craving for any substances they used that week with a separate mark for each substance (e.g., a mark for alcohol craving and another mark for marijuana). For outcome measures, only the primary substance (the substance used most frequently, as determined by the Timeline Follow Back assessment) was included. While cravings were assessed weekly, only the change in craving from Week 0 (Baseline) to Week 12 (End of Study) is reported; a decreased score (reduction in cravings) represents an improved outcome.

Secondary outcomes

  1. Amount of Money Spent on Substances

    Time frame: 12 weeks

    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.

  2. Positive and Negative Symptom Scale (PANSS)

    Time frame: 12 Weeks

    The Positive and Negative Symptom Scale (PANSS) is a measure used to assess symptom severity in patients with schizophrenia. Each item (symptom) is scored on a 7-point scale (1 = absent and 7 = extreme). The minimum and maximum values for the total 30 items (PANSS Total Score) are 30 and 210 respectively. Higher scores represent higher levels of psychiatric symptoms (worse outcomes).

    The PANSS has three subscales: "Positive" (measuring positive symptoms), "Negative" (measuring negative symptoms), and "General Psychopathology" (measuring general psychiatric symptoms). There are 7 items each for Positive and Negative subscales (minimum value for each is 7, and maximum value is 49), and 16 items for General Psychopathology (minimum value is 16 and maximum is 112).

    This study looked at changes in all 3 subscales and the PANSS total score between Week 0 (Baseline) and Week 12 (End of Study), with a decrease in score indicating improved psychiatric functioning.

  3. Clinical Global Impression - Severity

    Time frame: 12 Weeks

    The Clinical Global Impression - Severity (CGI-S) measures illness severity on a 7-point Likert scale, with a higher score indicating higher illness severity and worse outcomes (1 = "Normal, not at all ill" and 7 = "Among the most extremely ill patients"). The outcome measure for this study looked at the change in the CGI-S score between Week 0 (Baseline) and Week 12 (end of study), with a reduction in score indicating improved outcomes.

  4. Heinrichs Carpenter Quality of Life Scale (QOL)

    Time frame: 12 Weeks

    The Heinrichs Carpenter Quality of Life Scale (QOL)is a 21-item scale providing information on symptoms and functioning in patients with schizophrenia. Items are scored on a 0-6 scale, with 0 being no evidence of that item (e.g., social relationships are virtually absent) and 6 being adequate evidence of that item (e.g., adequate social relationships). Two items (#1 - "Intimate relationship with household members" and # 12 - "Satisfaction with occupational role functioning") are scored a "9" if the item is not applicable (e.g., lives alone with no close family or does not have an occupational role). Therefore, total scores can range from 0 to 132 (if 9s are scored). A higher total score indicates better psychosocial functioning.

    For this study, the outcome measure looked at the change in total score between Week 0 and Week 12.

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Worcester

Other

Collaborators

  • Augusta University
  • Massachusetts General Hospital
  • Otsuka Pharmaceutical Co., Ltd.
  • University of North Carolina, Chapel Hill

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
May 16, 2018
Registry last updated
May 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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