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Trial record 1 of 1 for:    naloxone ntnu
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Naloxone Nasal Spray Compared With Naloxone Injection for Opioid Overdoses Outside the Hospital (NINA-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03518021
Recruitment Status : Recruiting
First Posted : May 8, 2018
Last Update Posted : April 29, 2020
Sponsor:
Collaborators:
St. Olavs Hospital
Oslo University Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology

Brief 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.

Condition or disease Intervention/treatment Phase
Overdose Drug Abuse Drug: Naloxone, intranasal Drug: placebo, intranasal Drug: Naloxone, intramuscular Drug: placebo, intramuscular Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double blinded, double dummy, randomized controlled trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: The whole study team, including the statistician, will be blinded until after database lock and the primary analysis are done. The allocation list will be stored by by the Hospital Pharmacy Trondheim. There will not be automatic unblinding of SAEs. Study personnel do not have any access to the allocation list. An emergency option for individual unblinding is available to medical monitor in case of SAE/ SUSAR Study workers are blinded to the different preparations. This is carefully performed by covering the vials with neutral and opaque labels for "study drug". The risk of for unintentional unblinding is very small. The procedure for securing credible blinding is described in the study protocol and approved by the Norwegian Medicines Agency.
Primary Purpose: Treatment
Official Title: NTNU Intranasal Naloxone Trial - a Double Blinded, Double Dummy, Randomized Controlled Trial of Intranasal Naloxone for Pre-hospital Use
Actual Study Start Date : May 15, 2018
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Naloxone, intranasal Drug: Naloxone, intranasal

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.


Active Comparator: Naloxone, intramuscular Drug: Naloxone, intramuscular
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

Placebo Comparator: placebo, intranasal Drug: placebo, intranasal

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.


Placebo Comparator: placebo, intramuscular Drug: placebo, intramuscular
Intramuscular Sodium Chloride Injection 9mg/ml, will be administered as a 2 ml intramuscular injection in the deltoid muscle




Primary Outcome Measures :
  1. 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 [ Time Frame: 40 minutes ]

Secondary Outcome Measures :
  1. Changes in Glasgow Coma Scale (GCS) in patients treated with study medicine for opioid overdose [ Time Frame: The time participants are in the care of ambulance personnel, estimated 40 minutes ]
  2. Changes in oxygen saturation (SaO2) in patients treated with study medicine for opioid overdose [ Time Frame: The time participants are in the care of ambulance personnel, estimated 40 minutes ]
  3. Overdose complications [ Time Frame: The time participants are in the care of ambulance personnel, estimated 40 minutes ]
    aspiration, cardiac arrest, death

  4. Time from administration of naloxone to respiration above or equal to 10 breaths per minute [ Time Frame: The time participants are in the care of ambulance personnel, estimated 40 minutes ]
  5. Opioid withdrawal reaction to naloxone reversal [ Time Frame: The time participants are in the care of ambulance personnel, estimated 40 minutes ]
  6. Suitability of spray device in pre-hospital setting [ Time Frame: The time participants are in the care of ambulance personnel, estimated 40 minutes ]
  7. Adverse reactions to naloxone formulation [ Time Frame: The time participants are in the care of ambulance personnel, estimated 40 minutes ]
  8. Need for rescue naloxone, dose and route of administration during study visit [ Time Frame: The time participants are in the care of ambulance personnel, estimated 40 minutes ]
  9. Recurrence of opioid overdose/ need for further pre-hospital naloxone within 12 hours of inclusion [ Time Frame: 12 hours ]
  10. reasons not to give rescue naloxone to non-responders [ Time Frame: The time participants are in the care of ambulance personnel, estimated 40 minutes ]
  11. follow-up after care [ Time Frame: The time participants are in the care of ambulance personnel, estimated 40 minutes ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03518021


Contacts
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Contact: Arne K Skulberg, MD PhD +47 93083544 Arne.skulberg@ntnu.no

Locations
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Norway
Oslo University Hospital, Prehospital devision Recruiting
Oslo, Norway
Contact: Anne Cathrine Braarud, md phd    +47 95251010    ANNNAE@ous-hf.no   
St Olavs Hospital, Department for Emergency Medicine and Prehospital Services Recruiting
Trondheim, Norway
Contact: Jostein K Dale, md       jostein.dale@stolav.no   
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
Oslo University Hospital
Investigators
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Study Director: Øystein Risa Norwegian University of Science and Technology
Principal Investigator: Arne K Skulberg, MD PhD Norwegian University of Science and Technology
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Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT03518021    
Other Study ID Numbers: 2016-004072-22
2016/2000 ( Other Identifier: REK )
2016-004072-22 ( EudraCT Number )
First Posted: May 8, 2018    Key Record Dates
Last Update Posted: April 29, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Updated regularly, but no later than one year after publication of main results
Access Criteria: NTNU will require data processor agreements for recipients conform to standards set out in Norwegian Law and the European General Data Protection Regulation. Any shared datasets will have pseudonymisation of personal data. If doubt NTNU will seek advice from Ethics Committee.
URL: https://dataverse.no/dataset.xhtml?persistentId=doi:10.18710/ABRUWW

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Norwegian University of Science and Technology:
Naloxone
Administration, Intranasal
Injections, Intramuscular
Narcotic Antagonists
Additional relevant MeSH terms:
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Substance-Related Disorders
Drug Overdose
Chemically-Induced Disorders
Mental Disorders
Naloxone
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents