Naloxone Nasal Spray Compared With Naloxone Injection for Opioid Overdoses Outside the Hospital (NINA-1)

Norwegian University of Science and Technology

Status and phase: Completed; Phase 3

Conditions: Overdose; Drug Abuse

Treatments: Drug: placebo, intranasal; Drug: Naloxone, intranasal; Drug: placebo, intramuscular; Drug: Naloxone, intramuscular

Study type: Interventional

Funder types: Other

Identifiers

NCT03518021

2016/2000 (Other Identifier)

2016-004072-22 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 286 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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286 participants in 4 patient groups, including a placebo group

Naloxone, intranasal

Experimental group

Treatment:

Drug: Naloxone, intranasal

Naloxone, intramuscular

Active Comparator group

Treatment:

Drug: Naloxone, intramuscular

placebo, intranasal

Placebo Comparator group

Treatment:

Drug: placebo, intranasal

placebo, intramuscular

Placebo Comparator group

Treatment:

Drug: placebo, intramuscular