Virginia Opioid Overdose Treatment InitiatVE
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
Outcome
Outcome not reported
Stopped (Business): “Due to a financial business decision by the company supporting the research study (Indivior). The decision was not due to adverse events, safety reasons, or scientific reasons, but was a business decision.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Buprenorphine | Other / unclassified | 100 mg | Subcutaneous |
| Subject | Buprenorphine | Other / unclassified | 300 mg | Subcutaneous |