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Olanzapine in OUD Patients

Primary Purpose

Opioid Use Disorder

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Olanzapine
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid Use Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy 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

Sites / Locations

  • University of Pennsylvania
  • Virginia Commonwealth University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Olanzapine

Arm Description

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

Outcomes

Primary Outcome Measures

Change in illicit opioid use
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.

Secondary Outcome Measures

Full Information

First Posted
December 16, 2021
Last Updated
January 30, 2023
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT05179772
Brief Title
Olanzapine in OUD Patients
Official Title
Olanzapine Augmentation of Buprenorphine-naloxone Treatment in OUD Patients With Comorbid Symptoms of Serious Mental Illness (SMI): A Prospective Open-label Single-arm 9-week Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Withdrawn
Why Stopped
NIDA has advised us to terminate this protocol due to the difficulties in finding appropriate subjects.
Study Start Date
July 28, 2022 (Actual)
Primary Completion Date
January 30, 2023 (Actual)
Study Completion Date
January 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Olanzapine
Arm Type
Experimental
Arm Description
Everyone in the study is being given Olanzapine (open label)
Intervention Type
Drug
Intervention Name(s)
Olanzapine
Intervention Description
Olanzapine (2.5 mg to 20 mg)
Primary Outcome Measure Information:
Title
Change in illicit opioid use
Description
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.
Time Frame
weeks 3-8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyle Kampman, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anna Rose Childress, PhD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gerard Moeller, MD
Organizational Affiliation
Virgina Commonwealth University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Albert Arias, MD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23284
Country
United States

12. IPD Sharing Statement

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Olanzapine in OUD Patients

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