About the Project

The opioid epidemic remains a major public health emergency in the United States that continues to rapidly evolve. Now dominated by illicitly manufactured fentanyl, which is 50-100 times more potent than morphine, the vast majority of opioid overdoses are polydrug overdoses combining fentanyl with other potent opioids, and non-opioids such as xylazine. 

Naloxone is life saving and highly efficacious in reversing respiratory depression caused by opioid overdose. Given the opioid overdose crisis and dramatically increased numbers of opioid deaths in recent years, naloxone has been made increasingly available to lay people and non-medical first responders in order to administer this life saving treatment. In many cases, when EMS is called to respond to an opioid overdose, the naloxone has already been administered prior to EMS arrival on the scene. With the recent approval of naloxone for over-the-counter status, the use of naloxone by bystanders and other non-medical personnel is apt to significantly increase.

The RENDOR project is a prospective multi-center study utilizing the ToxIC infrastructure to characterize naloxone’s use, risks, benefits, and effectiveness for reversing opioid overdoses in pre-hospital settings. Patients who are administered an opioid antagonist (naloxone or nalmefene) in a pre-hospital setting (e.g., by bystanders, non-medical first responders such as police or fire, and/or EMS) and are seen by EMS personnel across 4 sites (San Francisco, CA; Detroit, MI; Portland, OR; and Pittsburgh, PA) will be included. 

Funding

This initiative was made possible through funding provided by the FDA Broad Agency Announcement (BAA). The views expressed in written conference materials or publications and by speakers and moderators do not necessarily reflect the official policies of the FDA; nor does mention of trade names, commercial practices, or organizations imply endorsement by the U.S. Government.

Principal Investigators

Jeffrey Brent, MD, FACMT
University of Colorado School of Medicine
Aurora, CO 

Paul Wax, MD, FACMT
Executive Director,
American College of Medical Toxicology

Rachel Culbreth, PhD, MPH
Research Director, Toxicology Investigators Consortium