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

Phase 3

Completed

• Conditions: Drug Abuse; Overdose
• Interventions: Drug: Naloxone, intramuscular; Drug: placebo, intranasal; Drug: placebo, intramuscular; Drug: Naloxone, intranasal

• Registration Number: NCT03518021
• Lead Sponsor: Norwegian University of Science and Technology

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-03
• Study First Submitted QC: 2018-05-03
• Study First Posted: 2018-05-08
• Study Start: 2018-05-15
• Status Verified: 2020-10
• Primary Completion: 2020-10-06
• Study Completion: 2020-10-06
• Last Update Submitted: 2020-10-07
• Last Update Posted: 2020-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 286

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Naloxone, intramuscular	Naloxone, intramuscular	-
placebo, intranasal	placebo, intranasal	-
placebo, intramuscular	placebo, intramuscular	-
Naloxone, intranasal	Naloxone, intranasal	-

Primary Outcome Measures

Name	Time	Method
Proportion of patients with return of spontaneous respiration (above or equal to 10 breaths per minute) within 10 minutes of naloxone administration in pre-hospital opioid overdose	40 minutes

Secondary Outcome Measures

Name	Time	Method
Changes in Glasgow Coma Scale (GCS) in patients treated with study medicine for opioid overdose	The time participants are in the care of ambulance personnel, estimated 40 minutes
Changes in oxygen saturation (SaO2) in patients treated with study medicine for opioid overdose	The time participants are in the care of ambulance personnel, estimated 40 minutes
Overdose complications	The time participants are in the care of ambulance personnel, estimated 40 minutes	aspiration, cardiac arrest, death
Time from administration of naloxone to respiration above or equal to 10 breaths per minute	The time participants are in the care of ambulance personnel, estimated 40 minutes
Opioid withdrawal reaction to naloxone reversal	The time participants are in the care of ambulance personnel, estimated 40 minutes
Suitability of spray device in pre-hospital setting	The time participants are in the care of ambulance personnel, estimated 40 minutes
Adverse reactions to naloxone formulation	The time participants are in the care of ambulance personnel, estimated 40 minutes
Need for rescue naloxone, dose and route of administration during study visit	The time participants are in the care of ambulance personnel, estimated 40 minutes
Recurrence of opioid overdose/ need for further pre-hospital naloxone within 12 hours of inclusion	12 hours
reasons not to give rescue naloxone to non-responders	The time participants are in the care of ambulance personnel, estimated 40 minutes
follow-up after care	The time participants are in the care of ambulance personnel, estimated 40 minutes

Trial Locations

Locations (2)

Oslo University Hospital, Prehospital devision; 🇳🇴 Oslo, Norway

St Olavs Hospital, Department for Emergency Medicine and Prehospital Services; 🇳🇴 Trondheim, Norway