Bioavailability of a New Formulation of Nasal Naloxone for Prehospital Use

Status Completed

Clinical Trial Summary

Overdose with potential deadly outcome is a serious problem among opioid abusers, not least in Norway. The annual death toll from overdose is about 250, twice the annual death toll from traffic accidents. Those who inject heroin or other opioids are considered to have the highest risk for death from overdose. To save lives, immediate treatment with a μ-opioid antidote such as naloxone is required. Usually naloxone is injected into a muscle or a blood vessel. Administration of naloxone via the nose has been suggested as an alternative for use by emergency teams and possibly also bystanders. This is not only an easier way to give naloxone, but would also eliminate the risk for needle stick injuries and blood contamination. A pilot study in this hospital has shown no significant side effects or adverse reaction. While significant benefits are expected from developing an adequately formulated naloxone nasal spray for pre-hospital use, the risks to participants are minimal. Therefore this preclinical study in healthy volunteers will be undertaken.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Drug Overdose

Clinical Trial Details

NCT number	NCT02158117
Study type	Interventional
Source	Norwegian University of Science and Technology
Contact
Status	Completed
Phase	Phase 1
Start date	March 2014
Completion date	November 2014

View Details

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