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Part 1: Document Description
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Citation |
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Title: |
NTNU Intranasal Naloxone Trial (NINA-1) Study documents |
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Identification Number: |
doi:10.18710/ABRUWW |
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Distributor: |
DataverseNO |
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Date of Distribution: |
2020-04-23 |
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Version: |
2 |
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Bibliographic Citation: |
Skulberg, Arne Kristian; Dale, Ola, 2020, "NTNU Intranasal Naloxone Trial (NINA-1) Study documents", https://doi.org/10.18710/ABRUWW, DataverseNO, V2 |
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Citation |
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Title: |
NTNU Intranasal Naloxone Trial (NINA-1) Study documents |
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Subtitle: |
Double blinded, double dummy, randomised controlled trial of intranasal naloxone for pre- hospital use |
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Alternative Title: |
EudraCT Number: 2016-004072-22 |
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Identification Number: |
doi:10.18710/ABRUWW |
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Identification Number: |
NCT03518021 |
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Authoring Entity: |
Skulberg, Arne Kristian (NTNU) |
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Dale, Ola (NTNU) |
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Other identifications and acknowledgements: |
Skulberg, Arne Kristian |
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Other identifications and acknowledgements: |
Dale, Ola |
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Other identifications and acknowledgements: |
Braarud, Anne-Cathrine |
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Other identifications and acknowledgements: |
Dale, Jostein |
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Other identifications and acknowledgements: |
Tylleskar, Ida |
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Other identifications and acknowledgements: |
Heyerdahl, Fridtjof |
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Other identifications and acknowledgements: |
Skålhegg, Tore |
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Other identifications and acknowledgements: |
Barstein, Jan |
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Producer: |
NTNU – Norwegian University of Science and Technology |
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Distributor: |
DataverseNO |
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Distributor: |
NTNU – Norwegian University of Science and Technology |
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Access Authority: |
Skulberg, Arne Kristian |
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Depositor: |
Skulberg, Arne Kristian |
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Date of Deposit: |
2020-04-13 |
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Holdings Information: |
https://doi.org/10.18710/ABRUWW |
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Study Scope |
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Keywords: |
Medicine, Health and Life Sciences, Naloxone, Administration, Intranasal, Injections, Intramuscular, Narcotic Antagonists, Drug Overdose, Randomized Controlled Trials as Topic, Vulnerable Populations, Consent Forms |
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Abstract: |
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. |
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Kind of Data: |
Elements from Trial Master File of NINA-1 file. Study documents relating to protocol, approvals, information, funding, statistics and other. |
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Methodology and Processing |
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Sources Statement |
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Data Access |
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Other Study Description Materials |
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Related Publications |
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Citation |
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Title: |
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. |
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Identification Number: |
10.1111/add.14552 |
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Bibliographic Citation: |
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. |
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Citation |
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Title: |
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. |
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Identification Number: |
doi.org/10.1111/add.15806 |
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Bibliographic Citation: |
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. |
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Citation |
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Title: |
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. |
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Identification Number: |
10.1007/s00228-018-2443-3 |
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Bibliographic Citation: |
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. |
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Citation |
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Title: |
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). |
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Identification Number: |
10.4045/tidsskr.19.0162 |
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Bibliographic Citation: |
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). |
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Citation |
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Title: |
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. |
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Identification Number: |
10.1007/s00228-018-2545-y |
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Bibliographic Citation: |
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. |
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Citation |
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Title: |
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. |
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Identification Number: |
10.1080/08897077.2018.1485130 |
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Bibliographic Citation: |
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. |
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Citation |
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Title: |
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. |
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Identification Number: |
10.1007/s00228-016-2191-1 |
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Bibliographic Citation: |
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. |
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Label: |
00readme-1.txt |
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Text: |
Consult this document for easier access to specific documents |
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Notes: |
text/plain |
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Label: |
01_1_NINA-1_Study_protocol-version_3_3.pdf |
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Notes: |
application/pdf |
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Label: |
01_2_NINA-1_Study_protocol-version_1.pdf |
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Text: |
This first trial protocol was not approved by Norwegian Medicines Agency. No participants included in the trial under this protocol |
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Notes: |
application/pdf |
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01_2_NINA-1_Study_protocol-version_2.pdf |
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Text: |
This protocol version was valid prior to the inclusion of the first patient. No participants included in the trial under this protocol |
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Notes: |
application/pdf |
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01_2_NINA-1_Study_protocol-version_3_0.pdf |
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Notes: |
application/pdf |
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Label: |
01_2_NINA-1_Study_protocol-version_3_1.pdf |
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Notes: |
application/pdf |
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01_2_NINA-1_Study_protocol-version_3_2.pdf |
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Notes: |
application/pdf |
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01_3_NINA-1_SPIRIT2013_33_item_checklist.pdf |
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Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT 2013) This statement provides evidence for the minimum content of the NINA-1 trial protocol as outlined by SPIRIT |
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Notes: |
application/pdf |
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Label: |
02_NINA-1_IB_version_7_March2020.pdf |
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Text: |
INVESTIGATOR’S BROCHURE PRODUCT: Nalokson DnE Nasal Spray 14 mg/mL |
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Notes: |
application/pdf |
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Label: |
03_1_NINA-1_informed_consent_forms .pdf |
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Text: |
Example informed consent information forms from study kit and online version |
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Notes: |
application/pdf |
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Label: |
04_1_NINA-1_Annual_Safety_Report_NoMA_2018_19.pdf |
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Annual Safety reports submitted to Norwegian Medicines Agency |
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Notes: |
application/pdf |
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04_2_NINA-1_Data_monitoring_committee_reports .pdf |
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Notes: |
application/pdf |
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04_3_NINA-1_Data_monitoring_committee_charter .pdf |
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Notes: |
application/pdf |
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05_1_NINA-1_ Insurance_statements.pdf |
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Notes: |
application/pdf |
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05_3_NINA-1_Financing_Contract_NTNU_FarmaIndusriAS.pdf |
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Agreements between NTNU and Farma Industri governing the funding of Study Medicine and ensuring NTNU full ownership of trial results. |
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Notes: |
application/pdf |
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05_3_NINA-1_Financing_Regional_Health_Authority(EN_NO).pdf |
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Financing for PhD position for Arne Skulberg supervised by Prof. Ola Dale and main funding for NINA-1 |
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Notes: |
application/pdf |
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06_1_NINA-1_National_Ethics_Approval_March_2017_(EN_NO).pdf |
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Trial approval and review by The National Committee for Medical and Health Research Ethics (NEM) in Norway |
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Notes: |
application/pdf |
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06_1_NINA-1_Regional_Ethics_Approval_March_2020(EN_NO).pdf |
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Approval of protocol version 3.3 06. March 2020 by The Regional Committee for Medical and Health Research Ethics (REC) in Norway |
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Notes: |
application/pdf |
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06_1_NINA-1_Regional_Ethics_Approval_Oct_2017(EN_NO).pdf |
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Approval of protocol NINA-1 trial by The Regional Committee for Medical and Health Research Ethics (REC) in Norway |
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Notes: |
application/pdf |
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06_2_NINA-1_First_trial_approval_NoMA_December_2017.pdf |
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Original approval by The Norwegian Medicines Agency |
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Notes: |
application/pdf |
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06_2_NINA-1_Protocol_v_3_3_approval_NoMA_March_2020.pdf |
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Approval by Norwegian Medicines Agency protocol amendments version 3.3 dated 6th March 2020 |
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Notes: |
application/pdf |
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09_1_NINA-1_Monitoringplan.pdf |
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application/pdf |
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09_2_NINA-1_Monitoring_reports_Oslo.pdf |
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Notes: |
application/pdf |
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09_2_NINA-1_Monitoring_reports_Trondheim.pdf |
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Notes: |
application/pdf |
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10_1_NINA-1_Case_report_form.pdf |
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Example Case Report from from study kit |
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Notes: |
application/pdf |
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Label: |
10_1_NINA-1_Serius_Adverse_event-form.pdf |
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Example Serious Adverse Event form from study kit |
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Notes: |
application/pdf |
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12_1 _NINA-1_Data_management_plan.pdf |
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Notes: |
application/pdf |
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12_2_NINA-1_Data_managment_report.pdf |
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Notes: |
application/pdf |
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12_3 _NINA-1_Database_lock_documentation.pdf |
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Notes: |
application/pdf |
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13_1_NINA-1_Statistical_Analysis_Plan.pdf |
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The first, and final, Statistical Analysis Plan |
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Notes: |
application/pdf |