Persistent Identifier
|
doi:10.18710/ABRUWW |
Publication Date
|
2020-04-23 |
Title
| NTNU Intranasal Naloxone Trial (NINA-1) Study documents |
Subtitle
| Double blinded, double dummy, randomised controlled trial of intranasal naloxone for pre- hospital use |
Alternative Title
| EudraCT Number: 2016-004072-22 |
Alternative URL
| https://clinicaltrials.gov/ct2/show/NCT03518021 |
Other Identifier
| ClinicalTrials.gov: NCT03518021 |
Author
| Skulberg, Arne Kristian (NTNU) - ORCID: 0000-0002-1735-4820
Dale, Ola (NTNU) |
Point of Contact
|
Use email button above to contact.
Skulberg, Arne Kristian (NTNU) |
Description
| This section contains study documents forming the basis of the NINA-1 Trial. Documents will be added at Sponsors discretion, and aim to reflect the Trial Master File. Please consult the file 00readme for a key to how documents are coded in this dataset. If you have any specific document you would like access to, please contact us, and Sponsor will consider publication. Some documents will be altered to facilitate open publication. In such case this will be clearly marked. All documents are combined with approved translations into English and original document in Norwegian where necessary. The NINA-1 Trial is a phase 3 drugs trial of nasal naloxone. It is double-blinded, double dummy, randomised controlled trial, two-centre study, non-inferiority design. The centres are Oslo University Hospital and St Olav’s Hospital, University Hospital of Trondheim. As we compare two different routes of administration, a dummy design is needed to blind the ambulance crew for the intervention. This means patients will receive a nasal spray and an intramuscular injection simultaneously, randomised for one to contain the antidote naloxone, the other inactive sterile saline solution. It is designed and powered to be a non-inferiority study with an estimated 200 participants to be included. The primary endpoint is the proportion of participants with return of spontaneous respiration (≥10 breaths per minute) within 10 minutes of naloxone administration. The aim is to demonstrate that intranasal administration of naloxone is not clinically inferior to intramuscular administration. It is expected that 88% of the patients on IM treatment will be responders and an equivalent dose intranasal administration is expected to result in a similar responder rate. The non-inferiority margin is set at Δ=0.15. The null hypothesis is that the proportion of responders given intranasal naloxone is smaller than given intramuscular naloxone. (2020-04-13) |
Subject
| Medicine, Health and Life Sciences |
Keyword
| Naloxone (MeSH)
Administration, Intranasal (MeSH)
Injections, Intramuscular (MeSH)
Narcotic Antagonists (MeSH)
Drug Overdose (MeSH)
Randomized Controlled Trials as Topic (MeSH)
Vulnerable Populations (MeSH)
Consent Forms (MeSH) |
Related Publication
| Skulberg AK, Asberg A, Khiabani HZ, Rostad H, Tylleskar I, Dale O. Pharmacokinetics of a novel, approved, 1.4-mg intranasal naloxone formulation for reversal of opioid overdose-a randomized controlled trial. Addiction 2019; 114(5): 859-67. doi: 10.1111/add.14552 https://doi.org/10.1111/add.14552
Skulberg AK, Tylleskar I, Valberg M, Braarud AC, Dale J, Heyerdahl F, et al. Comparison of intranasal and intramuscular naloxone in opioid overdoses managed by ambulance staff: a double-dummy, randomised, controlled trial. Addiction. 2022;117(6):1658-67. doi: doi.org/10.1111/add.15806 https://onlinelibrary.wiley.com/doi/10.1111/add.15806
Skulberg AK, Tylleskar I, Nilsen T, et al. Pharmacokinetics and -dynamics of intramuscular and intranasal naloxone: an explorative study in healthy volunteers. Eur J Clin Pharmacol 2018; 74(7): 873-83. doi: 10.1007/s00228-018-2443-3 https://doi.org/10.1007/s00228-018-2443-3
Tylleskar I, Skulberg AK, Nilsen T, Skarra S, Dale O. Naloxone nasal spray - bioavailability and absorption pattern in a phase 1 study. Tidsskr Nor Laegeforen 2019; 139(13). doi: 10.4045/tidsskr.19.0162 https://doi.org/10.4045/tidsskr.19.0162
Tylleskar I, Skulberg AK, Skarra S, Nilsen T, Dale O. Pharmacodynamics and arteriovenous difference of intravenous naloxone in healthy volunteers exposed to remifentanil. Eur J Clin Pharmacol 2018; 74(12): 1547-53. doi: 10.1007/s00228-018-2545-y https://doi.org/10.1007/s00228-018-2545-y
Madah-Amiri D, Skulberg AK, Braarud A-C, et al. Ambulance-attended opioid overdoses: An examination into overdose locations and the role of a safe injection facility. Subst Abus 2018; Online 27 Jun 2018.: 1-6. doi: 10.1080/08897077.2018.1485130 https://doi.org/10.1080/08897077.2018.1485130
Tylleskar I, Skulberg AK, Nilsen T, Skarra S, Jansook P, Dale O. Pharmacokinetics of a new, nasal formulation of naloxone. Eur J Clin Pharmacol 2017; 73(5): 555-62. doi: 10.1007/s00228-016-2191-1 https://doi.org/10.1007/s00228-016-2191-1 |
Language
| English; Norwegian |
Producer
| NTNU – Norwegian University of Science and Technology (NTNU) https://www.ntnu.no |
Contributor
| Project Leader : Skulberg, Arne Kristian
Project Member : Dale, Ola
Project Member : Braarud, Anne-Cathrine
Project Member : Dale, Jostein
Project Member : Tylleskar, Ida
Project Member : Heyerdahl, Fridtjof
Project Member : Skålhegg, Tore
Project Manager : Barstein, Jan |
Distributor
| NTNU – Norwegian University of Science and Technology (NTNU – Norwegian University of Science and Technology) (NTNU) https://dataverse.no/dataverse/ntnu |
Depositor
| Skulberg, Arne Kristian |
Deposit Date
| 2020-04-13 |
Data Type
| Elements from Trial Master File of NINA-1 file. Study documents relating to protocol, approvals, information, funding, statistics and other. |