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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03518021
Other study ID # 2016-004072-22
Secondary ID 2016/20002016-00
Status Completed
Phase Phase 3
First received
Last updated
Start date May 15, 2018
Est. completion date October 6, 2020

Study information

Verified date October 2020
Source Norwegian University of Science and Technology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 286
Est. completion date October 6, 2020
Est. primary completion date October 6, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Intervention

Drug:
Naloxone, intranasal
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, intranasal
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.
Naloxone, intramuscular
Intramuscular comparator Naloxone Hydrochloride 0.4 mg/ml will be administered as a 2 ml intramuscular (IM) injection in the deltoid muscle, total dose of 0,8 mg naloxone IM
placebo, intramuscular
Intramuscular Sodium Chloride Injection 9mg/ml, will be administered as a 2 ml intramuscular injection in the deltoid muscle

Locations

Country Name City State
Norway Oslo University Hospital, Prehospital devision Oslo
Norway St Olavs Hospital, Department for Emergency Medicine and Prehospital Services Trondheim

Sponsors (3)

Lead Sponsor Collaborator
Norwegian University of Science and Technology Oslo University Hospital, St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary Overdose complications aspiration, cardiac arrest, death The time participants are in the care of ambulance personnel, estimated 40 minutes
Secondary 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
Secondary Opioid withdrawal reaction to naloxone reversal The time participants are in the care of ambulance personnel, estimated 40 minutes
Secondary Suitability of spray device in pre-hospital setting The time participants are in the care of ambulance personnel, estimated 40 minutes
Secondary Adverse reactions to naloxone formulation The time participants are in the care of ambulance personnel, estimated 40 minutes
Secondary 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
Secondary Recurrence of opioid overdose/ need for further pre-hospital naloxone within 12 hours of inclusion 12 hours
Secondary reasons not to give rescue naloxone to non-responders The time participants are in the care of ambulance personnel, estimated 40 minutes
Secondary follow-up after care The time participants are in the care of ambulance personnel, estimated 40 minutes
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