NCT04523792

Virginia Opioid Treatment-Emergency Department

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Virginia Commonwealth University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Opioid Use Disorder

Interventions

Type	Name	Description
DRUG	SUBLOCADE	SUBLOCADE (buprenorphine extended-release) injection is a colorless to amber sterile solution for SC injection designed to deliver buprenorphine at doses of 100 mg or 300 mg at a controlled rate over a one-month period.

Timeline

• Start date: 2021-01-01
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2020-08-24
• Last updated: 2021-02-12

Regulatory

• FDA-regulated drug study