Olanzapine in OUD Patients
Status and phase
Conditions
Treatments
Details and patient eligibility
About
This study is designed to examine whether olanzapine (2.5 to 20mg/day) impacts opioid use in patients with opioid use disorder and comorbid SMI symptoms who are taking buprenorphine-naloxone. The specified outcomes (e.g., illicit opioid use, other drug use, sleep, MAT adherence, withdrawal and craving, thought and mood disorder symptoms) on olanzapine will be examined within-subjects for change (improvement) across the trial.
Approximately 48 subjects will be enrolled. After enrollment, subjects will complete safety and baseline assessments and will be assigned open-label to 9-weeks olanzapine. Olanzapine will then be tapered over a 1-week period (or maintained if clinically indicated). Urines will be collected 2x/week throughout.
The study has 4 distinct phases: 1) Screening (approx. 1-2 wks); 2) Baseline and Medication Initiation Visit (1 visit; includes safety, baseline and phenotyping measures, study medication dispensed) 3) Outpatient treatment (9 wks; 2 visits/wk, includes daily olanzapine and daily buprenorphine-naloxone (through the participants usual community treatment site and on-medication phenotyping measures); 4) Follow-up visit (1 wk after last dose of study medication).
Sex
Ages
Volunteers
Inclusion criteria
- meet criteria for opioid use disorder
- have symptoms of SMI
- on stable dose of buprenorphine-naloxone
- females must either be of non-child bearing potential or on highly-effective contraception
Exclusion criteria
- abnormal ECG
- cocaine, alcohol, psychoactive use disorders
- metabolic syndrome or diabetes 1 and 2
- history of seizures
- stable regimen of an antipsychotic
Trial design
Primary purpose
Allocation
Interventional model
Masking
0 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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