Olanzapine in OUD Patients

Opioid Use Disorder Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05179772
• Other study ID #: 850369
• Status: Withdrawn
• Phase: Phase 2
• Start date: July 28, 2022
• Est. completion date: January 30, 2023

Study information

• Verified date: January 2023
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 30, 2023
• Est. primary completion date: January 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Opioid Use Disorder
• Opioid-Related Disorders

Intervention

Drug:
• Olanzapine
Olanzapine (2.5 mg to 20 mg)

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	weeks 3-8