Sponsor study identifier
Secondary identifiers
interventional
286
1 country
2
Study Start
May 15, 2018
Actual (reported)Primary Completion
October 6, 2020
Actual (reported)Study Completion
October 6, 2020
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 6, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 3, 2018
Actual (reported)May 8, 2018
Actual (reported)May 15, 2018
Actual (reported)October 6, 2020
Actual (reported)October 6, 2020
Actual (reported)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
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
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
Overdose complications
The time participants are in the care of ambulance personnel, estimated 40 minutes
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
Opioid withdrawal reaction to naloxone reversal
The time participants are in the care of ambulance personnel, estimated 40 minutes
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.
Oslo University Hospital, Prehospital devision
Oslo, Norway
St Olavs Hospital, Department for Emergency Medicine and Prehospital Services
Trondheim, Norway
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.
Øystein Risa
Norwegian University of Science and Technology
Arne K Skulberg, MD PhD
Norwegian University of Science and Technology
286 participants (actual enrollment reported by the registry).
First Submitted
May 3, 2018
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.
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
Intramuscular Sodium Chloride Injection 9mg/ml, will be administered as a 2 ml intramuscular injection in the deltoid muscle
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
First Posted
May 8, 2018
Study Start
May 15, 2018
Actual (reported)Primary Completion
October 6, 2020
Actual (reported)Study Completion
October 6, 2020
Actual (reported)Last Updated
October 8, 2020
Record last verified: 2020-10
NTNU has complete ownership and publishing rights of all results, regardless of outcome. The full protocol, Statistical Analysis Plan, information letter for consent and other trial documents will be published open access in the NTNU Open repository. The Clinical Study report and Statistical Analysis Report will also be made openly available, but open versions may be censored to ensure that it will not be possible to identify individual study participants. The datasets analysed during the current study will be made available from NTNU upon reasonable request and a methodological sound proposal based on the consent given by participants.
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Source: ClinicalTrials.gov.
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