drugset / Trial / NCT03818399

Virginia Opioid Overdose Treatment InitiatVE

NCT03818399

NaSingle-groupOpen-labelTreatment

Summary

This is a Phase 3b, open-label study in patients that present to the ED for an opioid OD and receive treatment with an opioid antagonist. The study is designed to determine effect of SUBLOCADE on repeat overdose and death compared to historical control data. The study will assess subjects that receive acute administration of SUBOXONE sublingual film in the Emergency Department (ED) followed by SUBLOCADE administration in the ED and referral to an affiliated outpatient treatment clinic, compared to historical control data from electronic health records.

Timeline

Start
2019-01-04
Primary completion
2021-02-24
Completion
2021-02-24

Drugs

EvaluationDrugModalityDoseRoute
Subject Buprenorphine Other / unclassified 100 mg Subcutaneous
Subject Buprenorphine Other / unclassified 300 mg Subcutaneous