NCT03857581

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Augusta University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Psychosis
• Substance Use Disorders

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-07-01
• Primary completion: 2021-07-01
• Completion: 2021-07-01
• First posted: 2019-02-28
• Last updated: 2020-03-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study