Olanzapine in OUD Patients

NCT ID: NCT05179772

Last Updated: 2023-02-01

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-28
• Study Completion Date: 2023-01-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Olanzapine

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

Group Type: EXPERIMENTAL

Olanzapine

Intervention Type: DRUG

Olanzapine (2.5 mg to 20 mg)

Interventions

Olanzapine

Olanzapine (2.5 mg to 20 mg)

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kyle Kampman, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Anna Rose Childress, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Gerard Moeller, MD

Role: PRINCIPAL_INVESTIGATOR

Virgina Commonwealth University

Albert Arias, MD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Virginia Commonwealth University

Richmond, Virginia, United States

Countries

United States

Other Identifiers

850369

Identifier Type: -

Identifier Source: org_study_id