This trial compares the antidote for heroin and other opioids- naloxone- given as a nasal spray and as an injection. The participants are patients treated by ambulance personell for real overdoses outside of hospital

Phase 1

• Conditions: We investigate the reversal of opioid overdoses in the pre hospital setting; MedDRA version: 20.0Level: SOCClassification code 10022117Term: Injury, poisoning and procedural complicationsSystem Organ Class: 10022117 - Injury, poisoning and procedural complications; MedDRA version: 20.0Level: HLGTClassification code 10071947Term: Exposures, chemical injuries and poisoningSystem Organ Class: 10022117 - Injury, poisoning and procedural complications; MedDRA version: 20.0Level: HLTClassification code 10035777Term: Poisoning and toxicitySystem Organ Class: 10022117 - Injury, poisoning and procedural complications; MedDRA version: 21.1Level: PTClassification code 10070863Term: Toxicity to various agentsSystem Organ Class: 10022117 - Injury, poisoning and procedural complications; MedDRA version: 20.1Level: LLTClassification code 10072946Term: Opioid toxicitySystem Organ Class: 10022117 - Injury, poisoning and procedural complications; Therapeutic area: Diseases [C] - Injuries, poisonings, and occupational diseases [C21]

• Registration Number: EUCTR2016-004072-22-NO
• Lead Sponsor: orwegian University of Science and Technology (NTNU)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-11-02
• Study Completion: 2020-10-06
• Last Update Posted: 2 May 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 286

Inclusion Criteria

-Suspected opioid overdose clinically diagnosed by Emergency Medical Staff (EMS) based on the following criteria
1.Reduced (below or equal to 8 breaths per minute) or absent spontaneous respiration
2.Miosis
3.Glasgow Coma Scale (GCS) below 12
and
-Palpable carotid or radial arterial pulse

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 in the pre hospital setting
-Suspected participant below 18 years of age
-Participant visibly pregnant
-Participant that have received nasal naloxone by non- EMS staff in the current overdose
-EMS staff without adequate training as study workers
-No study drug available
-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 clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Measure and evaluate clinical response to nasal naloxone in real opioid overdoses in the pre hospital environment.<br>;Secondary Objective: Suitability of spray device in the pre hospital setting and adverse reactions;Primary end point(s): 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.;Timepoint(s) of evaluation of this end point: 10 minute with approximately additional 30 minutes observation time

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •Changes in Glasgow Coma Scale and oxygen saturation in patients treated with study medicine for opioid overdose.<br>•Overdose complications (e.g. aspiration, cardiac arrest, death)<br>•Time from administration of naloxone to respiration above or equal to 10 breaths per minute.<br>•Opioid withdrawal reaction to naloxone reversal<br>•Suitability of spray device in pre hospital setting<br>•Adverse reactions to naloxone formulation<br>•Need for rescue naloxone, dose and route of administration during study visit<br>•Recurrence of opioid overdose/ need for further pre hospital naloxone within 12 hours of inclusion<br>•Collect data regarding reasons not to give rescue naloxone to non-responders<br>•Baseline ambulance data such as dispatch times and baseline demographic variables of included and excluded participants.<br>;Timepoint(s) of evaluation of this end point: as for primary endpoint + additional check 12 hours later for overdose recurrence