Olanzapine in OUD Patients

Phase 2

Withdrawn

• Conditions: Opioid Use Disorder
• Interventions: Drug: Olanzapine

• Registration Number: NCT05179772
• Lead Sponsor: University of Pennsylvania

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-16
• Study First Submitted QC: 2022-01-04
• Study First Posted: 2022-01-05
• Study Start: 2022-07-28
• Status Verified: 2023-01
• Primary Completion: 2023-01-30
• Study Completion: 2023-01-30
• Last Update Submitted: 2023-01-30
• Last Update Posted: 2023-02-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Olanzapine	Olanzapine	Everyone in the study is being given Olanzapine (open label)

Primary Outcome Measures

Name	Time	Method
Change in illicit opioid use	weeks 3-8	To examine whether adjunctive olanzapine (on top of buprenorphine-naloxone) changes illicit opioid use, indexed by Urine Drug Screens (UDS), in participants with OUD and symptoms of SMI.

Trial Locations

Locations (2)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States