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

NTNU Intranasal Naloxone Trial Double blinded, double dummy, randomised controlled trial of intranasal naloxone for pre hospital use - NTNU Intranasal Naloxone Trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-004072-22-NO

Enrollment

200

Registered

2016-11-02

Start date

2017-12-07

Completion date

Unknown

Last updated

2022-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

We investigate the reversal of opioid overdoses in the pre hospital setting MedDRA version: 20.0 Level: SOC Classification code 10022117 Term: Injury, poisoning and procedural complications System Organ Class: 10022117 - Injury, poisoning and procedural complications MedDRA version: 20.0 Level: HLGT Classification code 10071947 Term: Exposures, chemical injuries and poisoning System Organ Class: 10022117 - Injury, poisoning and procedural complications MedDRA version: 20.0 Level: HLT Classif

Interventions

Product Name: Nasal naloxone Pharmaceutical Form: Nasal spray, solution in single-dose container Pharmaceutical form of the placebo: Nasal spray, solution in single-dose container Route of administrat

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: Measure and evaluate clinical response to nasal naloxone in real opioid overdoses in the pre hospital environment. ;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	—

Measure

Time frame

Main Objective: Measure and evaluate clinical response to nasal naloxone in real opioid overdoses in the pre hospital environment. ;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

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Secondary

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

Measure

Time frame

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

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Countries

Norway

Contacts

Public ContactDept. secretary

Department of Circulation and Imaging, NTNU

isb-post@medisin.ntnu.no4773595000

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026