Naloxone Nasal Spray Compared With Naloxone Injection for Opioid Overdoses Outside the Hospital

• Status: Completed
• Trial end date: 2020-10-06
• Target enrollment: 0
• Participant gender: All

Summary

This trial will compare the clinical response to intramuscular and intranasal naloxone in pre-hospital opioid overdoses. Objective of the study is to measure and evaluate clinical response (return of spontaneous respiration within 10 minutes of naloxone administration) to a new nasal naloxone formulation in real opioid overdoses in the pre-hospital environment. The aim is to demonstrate that intranasal administration of naloxone is not clinically inferior to intramuscular administration, which is now standard treatment of care.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Norwegian University of Science and Technology
• Collaborators: Oslo University Hospital; St. Olavs Hospital
• Treatments: Naloxone

Criteria

Inclusion Criteria:

• Suspected opioid overdose clinically diagnosed by emergency medical service (EMS) based on the following criteria

1. Reduced (below and equal to 8 breaths per minute) or absent spontaneous respiration

2. Miosis

3. Glasgow Coma Scale (GCS) below 12

• Palpable carotid or radial arterial pulse

Exclusion Criteria:

• Cardiac arrest

• Failure to assist ventilation using mask-bag technique

• Facial trauma or epistaxis or visible nasal blockage

• Iatrogenic opioid overdose when opioid is administered in- hospital, or by EMS or other health care workers in the pre- hospital setting

• Suspected or visibly pregnant participant

• Has received naloxone by any route in the current overdose

• in prison or custody by police

• EMS staff without training as study workers

• No study drug available

• Study drug frozen as indicated by Freeze Watch in kit or past its expiry date

• Deemed unfit for inclusion due to any other cause by study personnel at the scene; such as unsafe work environment for EMS