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

Norwegian University of Science and Technology286 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

286

Conditions

Overdose Drug Abuse

Interventions

Active compound naloxone 14 mg/ml, (±10%). Nasal spray will be administered with one puff (100 microL ±10%) in one nostril (1.4 mg dose) using the Aptar Unitdose device. The spray device should be inserted about 1 cm into a nostril, pointing towards the ipsilateral ear and the plunger pushed in a firm and gentle manner for the formulation to be sprayed into the nose. After the plunger is inserted the device is immediately removed from the nose and assisted ventilation continued.

placebo, intranasalDRUG

Same spray but without naloxone. Nasal spray will be administered with one puff (100 microL +/- 10%) in one nostril using the Aptar Unitdose device. The spray device should be inserted about 1 cm into a nostril, pointing towards the ipsilateral ear and the plunger pushed in a firm and gentle manner for the formulation to be sprayed into the nose. After the plunger is inserted the device is immediately removed from the nose and assisted ventilation continued.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Oslo University Hospital, Prehospital devision

Oslo, Norway

St Olavs Hospital, Department for Emergency Medicine and Prehospital Services

Trondheim, Norway

Outcomes

Primary Outcomes

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

Time frame: 40 minutes