Naloxone Nasal Spray Compared With Naloxone Injection for Opioid Overdoses Outside the Hospital

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

286 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-15

Study Completion Date

2020-10-06

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Bioavailability of Nasal Naloxone and Injected Naloxone Compared

NCT02598856

Drug Overdose

COMPLETED PHASE1

Bioavailability of a New Formulation of Nasal Naloxone for Prehospital Use

NCT02158117

Drug Overdose

COMPLETED PHASE1

Pharmacokinetics and Pharmacodynamics of a New Formulation of Nasal Naloxone for Prehospital Use

NCT02307721

Drug Overdose

COMPLETED PHASE1/PHASE2

Pharmacodynamics and Arteriovenous Differences of Naloxone in Healthy Participants Exposed to an Opioid

NCT02405988

Drug Overdose

COMPLETED NA

A Pilot Study of the Bioavailability of Nasal Naloxone

NCT01939444

Drug Overdose

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Overdose Drug Abuse

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double blinded, double dummy, randomized controlled trial

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Naloxone, intranasal

Group Type EXPERIMENTAL

Naloxone, intranasal

Intervention Type DRUG

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.

Naloxone, intramuscular

Group Type ACTIVE_COMPARATOR

Naloxone, intramuscular

Intervention Type DRUG

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, intranasal

Group Type PLACEBO_COMPARATOR

placebo, intranasal

Intervention Type DRUG

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, intramuscular

Group Type PLACEBO_COMPARATOR

placebo, intramuscular

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type 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

Intervention Type DRUG

placebo, intramuscular

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No