Olanzapine in OUD Patients

NCT05179772 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: 850369
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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).

Conditions

Opioid Use Disorder

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Olanzapine

EXPERIMENTAL

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

Drug: Olanzapine

Interventions

Olanzapine DRUG

Olanzapine (2.5 mg to 20 mg)

Olanzapine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• abnormal ECG
• cocaine, alcohol, psychoactive use disorders
• metabolic syndrome or diabetes 1 and 2
• history of seizures
• stable regimen of an antipsychotic

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (2)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23284, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Olanzapine

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Kyle Kampman, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Anna Rose Childress, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Gerard Moeller, MD

  Virgina Commonwealth University

  PRINCIPAL INVESTIGATOR

• Albert Arias, MD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2021
• First Posted: January 5, 2022
• Study Start: July 28, 2022
• Primary Completion: January 30, 2023
• Study Completion: January 30, 2023
• Last Updated: February 1, 2023

Record last verified: 2023-01

Locations

US (2)