drugset / Trial / NCT03518021
Naloxone Nasal Spray Compared With Naloxone Injection for Opioid Overdoses Outside the Hospital
Phase 3
Completed
286 enrolled
Norwegian University of Science and Technology
Oslo University Hospital · collabSt. Olavs Hospital · collab
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2018-05-15
- Primary completion
- 2020-10-06
- Completion
- 2020-10-06
Publications
- Skulberg AK, Tylleskar I, Valberg M, Braarud AC, Dale J, Heyerdahl F, Skalhegg T, Barstein J, Mellesmo S, Dale O. Comparison of intranasal and intramuscular naloxone in opioid overdoses managed by ambulance staff: a double-dummy, randomised, controlled trial. Addiction. 2022 Jun;117(6):1658-1667. doi: 10.1111/add.15806. Epub 2022 Feb 8.
- Skulberg AK, Tylleskar I, Braarud AC, Dale J, Heyerdahl F, Mellesmo S, Valberg M, Dale O. NTNU intranasal naloxone trial (NINA-1) study protocol for a double-blind, double-dummy, non-inferiority randomised controlled trial comparing intranasal 1.4 mg to intramuscular 0.8 mg naloxone for prehospital use. BMJ Open. 2020 Nov 12;10(11):e041556. doi: 10.1136/bmjopen-2020-041556.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Naloxone | Small molecule | 0.8 mg | Intranasal |
| Subject | Naloxone | Small molecule | 1.4 mg | Intranasal |