Clozapine Versus Olanzapine as Treatment for Comorbid Psychotic Disorder and Substance Use Disorder
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Psychiatric, Psychiatric, Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 3/2/2019 |
| Start Date: | May 2019 |
| End Date: | May 2021 |
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; we
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; we 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; we hypothesize that patients treated with clozapine will have
significantly fewer positive urine drug screens and blood alcohol levels than patients
treated with olanzapine.
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; we
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; we 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; we hypothesize that patients treated with clozapine will have
significantly fewer positive urine drug screens and blood alcohol levels than patients
treated with olanzapine.
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
We found this trial at
1
site
Click here to add this to my saved trials
