Olanzapine in OUD Patients

  • End date
    Dec 21, 2023
  • participants needed
  • sponsor
    University of Pennsylvania
Updated on 4 October 2022


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).

Condition Opioid Use Disorder
Treatment olanzapine
Clinical Study IdentifierNCT05179772
SponsorUniversity of Pennsylvania
Last Modified on4 October 2022


Yes No Not Sure

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
Clear my responses

How to participate?

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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