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

NCT ID: NCT03857581

Last Updated: 2020-03-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-31
• Study Completion Date: 2021-07-31

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.

Conditions

Psychosis; Substance Use Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Clozapine Arm

Group Type: EXPERIMENTAL

Clozapine

Intervention Type: DRUG

Subjects will be randomly assigned to clozapine or olanzapine and followed for up to 12 weeks with weekly visits.

Olanzapine Arm

Group Type: ACTIVE_COMPARATOR

Olanzapine

Intervention Type: DRUG

Subjects will be randomly assigned to clozapine or olanzapine and followed for up to 12 weeks with weekly visits.

Interventions

Clozapine

Subjects will be randomly assigned to clozapine or olanzapine and followed for up to 12 weeks with weekly visits.

Intervention Type: DRUG

Olanzapine

Subjects will be randomly assigned to clozapine or olanzapine and followed for up to 12 weeks with weekly visits.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Augusta University

OTHER

Sponsor Role: lead

Responsible Party

Sandarsh Surya

Assistant Professor, Department of Psychiatry and Health Behavior

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sandarsh Surya

Evans, Georgia, United States

Countries

United States

Facility Contacts

SANDARSH SURYA, MBBS

Role: primary

ssurya@augusta.edu

314-662-1682

Joseph McEvoy, MD

Role: backup

jmcevoy@augusta.edu

Other Identifiers

1303985

Identifier Type: -

Identifier Source: org_study_id