Virginia Opioid Treatment-Emergency Department

Virginia Commonwealth University0 sitesJanuary 1, 2021

ConditionsOpioid Use Disorder

InterventionsSUBLOCADE

DrugsSUBLOCADE

Overview

Phase: Phase 3
Intervention: SUBLOCADE
Conditions: Opioid Use Disorder
Sponsor: Virginia Commonwealth University
Primary Endpoint: Treatment engagement - 1 month
Status: Withdrawn
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

The current study seeks to test the feasibility of an alternative treatment for patients with opioid use disorder who present to the emergency department seeking treatment or with opioid withdrawal, which includes FDA approved long-acting medication for opioid misuse (SUBLOCADE) and rapid transfer of care to outpatient substance abuse treatment.

Detailed Description

This proof of concept study will provide feasibility data on whether rapid initiation of SUBLOCADE® (buprenorphine extended-release) injection for subcutaneous use CIII in the ED, Clinical Decision Unit, or inpatient unit and after administration of a test dose of SUBOXONE® (buprenorphine and naloxone) sublingual film, for sublingual or buccal use CIII among treatment-seeking adults with moderate or severe OUD increases subsequent outpatient treatment engagement as compared to a historical control cohort and concurrent controls who decline treatment participation. The study will also assess whether rapid initiation of SUBLOCADE® reduces subsequent ED visits for any reason. As a exploratory aim we will examine whether rapid initiation of Sublocade in this patient group reduces opioid overdose events compared to historical controls and patients who decline Sublocade.

Registry

clinicaltrials.gov

Start Date

January 1, 2021

End Date

December 31, 2021

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Virginia Commonwealth University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

•Current diagnosis, other than OUD, requiring chronic opioid treatment.
•Active suicidal ideation in opinion of the Investigator or designee.
•Female subject that is lactating, pregnant or planning to become pregnant during their participation in the study.
•Uncontrolled intercurrent illness including, but not limited to, psychiatric illness that would limit compliance with study requirements or compromise the ability of the subject to provide written informed consent.
•Known allergy or hypersensitivity to SUBOXONE or SUBLOCADE.
•Any condition that, in the opinion of the Investigator would interfere with interpretation of subject safety or study results.
•Currently receiving methadone, depot naltrexone, or Probuphine for OUD or received those treatments for OUD within 30 days prior to consent.
•Current or concurrent treatment with an investigational agent.
•Current or concurrent enrollment in another clinical study, or observational study that includes MAT.
•Treatment for OUD required by court order.

Arms & Interventions

Opioid withdrawal patients

Subjects with opioid use disorder seeking treatment and/or experiencing symptoms of opioid withdrawal receive acute administration of SUBOXONE sublingual film followed by SUBLOCADE administration in the 1) ED, 2) Clinical Decision Unit or 3) Inpatient unit combined with 6 months of treatment with SUBLOCADE in the outpatient treatment clinic.

Intervention: SUBLOCADE