NCT01912573

Nasal Naloxone for Narcotic Overdose

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 236 (estimated)
• Sponsor: Judith Feinberg · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to determine if nasal naloxone is inferior to standard care for naloxone administration in a pre-hospital setting. Ambulance squads in Adams, Clermont, and Scioto counties in southern Ohio will be randomized to provide either standard care or nasal (IN) naloxone as the initial response to a suspected opioid overdose. Standard care includes administration of naloxone by intravenous (IV), intramuscular (IM) or intraosseus (IO) methods.

Detailed description

This is a randomized, prospective trial that will compare clinical outcomes for parenteral naloxone according to the standard of care (TAU; administration via intravenous \[IV\], intramuscular \[IM\] or intraosseus \[IO\] delivery) versus intranasal \[IN\] for the prehospital emergency treatment of suspected opioid overdose. Ambulance squads in Adams, Clermont, and Scioto counties in southern Ohio will be randomized to administer either standard care or IN naloxone as the initial response to a suspected opioid overdose.

Conditions

• Drug Overdose

Interventions

Type	Name	Description
DRUG	Intranasal (IN) naloxone
DRUG	Intravenous (IV) naloxone
DRUG	Intramuscular (IM) naloxone
DRUG	Intraosseus (IO) naloxone

Timeline

• Start date: 2013-09-01
• Primary completion: 2014-09-01
• Completion: 2015-03-01
• First posted: 2013-07-31
• Last updated: 2013-07-31

Locations

3 sites across 1 country: United States