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

Substance Use Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03857581
• Other study ID #: 1303985
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: July 2020
• Est. completion date: July 2021

Study information

• Verified date: March 2020
• Source: Augusta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: July 2021
• Est. primary completion date: July 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Mental Disorders
• Psychosis
• Psychotic Disorders
• Substance Use Disorders
• Substance-Related Disorders

Intervention

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

Locations

Country	Name	City	State
United States	Sandarsh Surya	Evans	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Augusta University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequencies of positive urine drug screens and breathalyzer alcohol levels	Participants will have weekly urine drug screens and alcohol level measurement using breathalyzer to monitor ongoing substance and alcohol abuse.	12 weeks
Secondary	All-cause treatment discontinuation	Discontinuation rate due to any cause (treatment non-compliance, worsening of mental health conditions, withdrawal of consent)	12 weeks
Secondary	Brief Psychiatric Rating Scale (BPRS) - Positive Psychopathology items	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; Suspiciousness; Hallucinations; Unusual thought content; 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.	12 weeks