Olanzapine in OUD Patients

Overview

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).

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 30, 2023

Interventions

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

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • Change in illicit opioid use
    • Time Frame: 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Pennsylvania
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Kyle Kampman, MD, Principal Investigator, University of Pennsylvania
    • Anna Rose Childress, PhD, Principal Investigator, University of Pennsylvania
    • Gerard Moeller, MD, Principal Investigator, Virgina Commonwealth University
    • Albert Arias, MD, Principal Investigator, Virginia Commonwealth University

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