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

Last updated: October 7, 2020
Sponsor: Norwegian University of Science and Technology
Overall Status: Completed

Phase

3

Condition

Opioid Use Disorder

Addictions

Stimulant Use Disorder

Treatment

N/A

Clinical Study ID

NCT03518021
2016-004072-22
2016-004072-22
2016/2000
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 spontaneousrespiration

  2. Miosis

  3. Glasgow Coma Scale (GCS) below 12

  • Palpable carotid or radial arterial pulse

Exclusion

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 orother 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

Study Design

Total Participants: 286
Study Start date:
May 15, 2018
Estimated Completion Date:
October 06, 2020

Connect with a study center

  • Oslo University Hospital, Prehospital devision

    Oslo,
    Norway

    Site Not Available

  • St Olavs Hospital, Department for Emergency Medicine and Prehospital Services

    Trondheim,
    Norway

    Site Not Available

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