Clozapine Versus Olanzapine as Treatment for Comorbid Psychotic Disorder and Substance Use Disorder

• ClinicalTrials.gov Identifier: NCT03857581
• Recruitment Status: Not yet recruiting
• First Posted: February 28, 2019
• Last Update Posted: March 23, 2020
• Sponsor: Augusta University
• Information provided by (Responsible Party): Sandarsh Surya, Augusta University

Tracking Information

• First Submitted Date: February 26, 2019
• First Posted Date: February 28, 2019
• Last Update Posted Date: March 23, 2020
• Estimated Study Start Date: July 2020
• Estimated Primary Completion Date: July 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 18, 2019)

Frequencies of positive urine drug screens and breathalyzer alcohol levels [ Time Frame: 12 weeks ]

Participants will have weekly urine drug screens and alcohol level measurement using breathalyzer to monitor ongoing substance and alcohol abuse.

• Original Primary Outcome Measures (submitted: February 26, 2019): Frequencies of positive urine drug screens and blood alcohol levels [ Time Frame: 12 weeks ]

Current Secondary Outcome Measures (submitted: June 18, 2019)

• All-cause treatment discontinuation [ Time Frame: 12 weeks ]
  Discontinuation rate due to any cause (treatment non-compliance, worsening of mental health conditions, withdrawal of consent)
• Brief Psychiatric Rating Scale (BPRS) - Positive Psychopathology items [ Time Frame: 12 weeks ]
  BPRS scale is used to measure and monitor for symptoms of schizophrenia. For the purpose of the study, we will be measuring 4 items to monitor for positive psychopathology. The items are

  1. Suspiciousness
  2. Hallucinations
  3. Unusual thought content
  4. Conceptual disorganization

  Each item is rated on a scale of 1 to 7. 1 being condition not present and 7 being extreme form of the condition present. The maximum score a participant can score is 28 and minimum score is 4.

Original Secondary Outcome Measures (submitted: February 26, 2019)

• All-cause treatment discontinuation [ Time Frame: 12 weeks ]
• Brief Psychiatric Rating Scale psychosis items [ Time Frame: 12 weeks ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Clozapine Versus Olanzapine as Treatment for Comorbid Psychotic Disorder and Substance Use Disorder
• Official Title: Clozapine Versus Olanzapine as Treatment for Comorbid Psychotic Disorder and Substance Use Disorder
• Brief Summary: The purpose of this trial is to determine if patients with comorbid psychotic disorder and substance use disorder will continue in treatment longer if treated with clozapine than with olanzapine, and will have greater reductions in psychosis and in substance use if treated with clozapine than treated with olanzapine. The specific aims and hypotheses of this trial are: 1. To compare the enduring effectiveness and tolerability of clozapine and olanzapine, as measured by time to all-cause treatment discontinuation, over 12 weeks of follow-up; The investigators hypothesize that patients assigned to clozapine treatment will have significantly longer times to all cause treatment discontinuation, 2. To compare the total psychosis items scores between patients treated with clozapine and patients treated with olanzapine over 12 weeks of follow-up; The investigators hypothesize that patients treated with clozapine will have significantly lower total psychosis items scores than patients treated with olanzapine, and 3. To compare the frequencies of positive urine drug screens and blood alcohol levels (obtained weekly throughout 12 weeks of follow-up) between patients treated with clozapine and patients treated with olanzapine; The investigators hypothesize that patients treated with clozapine will have significantly fewer positive urine drug screens and blood alcohol levels than patients treated with olanzapine.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Psychosis
• Substance Use Disorders

Intervention

• Drug: Clozapine
  Subjects will be randomly assigned to clozapine or olanzapine and followed for up to 12 weeks with weekly visits.
• Drug: Olanzapine
  Subjects will be randomly assigned to clozapine or olanzapine and followed for up to 12 weeks with weekly visits.

Study Arms

• Experimental: Clozapine Arm
  Intervention: Drug: Clozapine
• Active Comparator: Olanzapine Arm
  Intervention: Drug: Olanzapine

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: February 26, 2019): 100
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 2021
• Estimated Primary Completion Date: July 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 18-60 years of age, male or female (post-menopausal, surgically sterilized, or receiving either one of the listed contraception - depot contraceptive, Intrauterine device, or implanted hormonal contraceptive),
• who meet DSM-V criteria for schizophrenia, schizoaffective disorder, bipolar disorder with psychotic features, depression with psychotic features, or delusional disorder, and have ratings of Moderate or greater on at least one of the Brief Psychiatric Rating Scale psychosis items,
• who meet DSM-V criteria for at least one of alcohol, marijuana, cocaine, stimulant, or opioid use disorder, and have an admission urine drug screen positive for at least one of these substances,
• who have a stable living situation (family or supervised living, e.g. personal care home) to return to after release into the community,
• and who provide signed informed consent to participate (after testing for comprehension).

Exclusion Criteria:

• Prior failure to respond or tolerate clozapine or olanzapine
• Logistics that prevent outpatient follow-up at Serenity Behavioral Health Adult Outpatient services

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: No
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03857581
• Other Study ID Numbers: 1303985
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• 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.: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Responsible Party: Sandarsh Surya, Augusta University
• Study Sponsor: Augusta University
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Augusta University
• Verification Date: March 2020