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Completed

NCT Number: NCT03518021

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

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.

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Key information

Conditions

Overdose Chemically-Induced Disorders Drug Abuse Drug Misuse Drug Overdose Mental Disorders Prescription Drug Misuse Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Oslo University Hospital, Prehospital devision, Oslo, Norway

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Suspected opioid overdose clinically diagnosed by emergency medical service (EMS) based on the following criteria
  • Reduced (below and equal to 8 breaths per minute) or absent spontaneous respiration
  • Miosis
  • 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

Treatment and study plan

Naloxone, intranasal

Drug

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

Drug

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

Drug

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

Drug

Intramuscular Sodium Chloride Injection 9mg/ml, will be administered as a 2 ml intramuscular injection in the deltoid muscle

Primary outcomes

  1. 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

Secondary outcomes

  1. Changes in Glasgow Coma Scale (GCS) in patients treated with study medicine for opioid overdose

    Time frame: The time participants are in the care of ambulance personnel, estimated 40 minutes

  2. Changes in oxygen saturation (SaO2) in patients treated with study medicine for opioid overdose

    Time frame: The time participants are in the care of ambulance personnel, estimated 40 minutes

  3. Overdose complications

    Time frame: The time participants are in the care of ambulance personnel, estimated 40 minutes

    aspiration, cardiac arrest, death

  4. Time from administration of naloxone to respiration above or equal to 10 breaths per minute

    Time frame: The time participants are in the care of ambulance personnel, estimated 40 minutes

  5. Opioid withdrawal reaction to naloxone reversal

    Time frame: The time participants are in the care of ambulance personnel, estimated 40 minutes

  6. Suitability of spray device in pre-hospital setting

    Time frame: The time participants are in the care of ambulance personnel, estimated 40 minutes

  7. Adverse reactions to naloxone formulation

    Time frame: The time participants are in the care of ambulance personnel, estimated 40 minutes

  8. Need for rescue naloxone, dose and route of administration during study visit

    Time frame: The time participants are in the care of ambulance personnel, estimated 40 minutes

  9. Recurrence of opioid overdose/ need for further pre-hospital naloxone within 12 hours of inclusion

    Time frame: 12 hours

  10. reasons not to give rescue naloxone to non-responders

    Time frame: The time participants are in the care of ambulance personnel, estimated 40 minutes

  11. follow-up after care

    Time frame: The time participants are in the care of ambulance personnel, estimated 40 minutes

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • Oslo University Hospital
  • St. Olavs Hospital

Registry information

Official study title

NTNU Intranasal Naloxone Trial - a Double Blinded, Double Dummy, Randomized Controlled Trial of Intranasal Naloxone for Pre-hospital Use

Acronym: NINA-1

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
May 8, 2018
Registry last updated
Oct 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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