Bioavailability of a New Formulation of Nasal Naloxone for Prehospital Use
Status:
Completed
Trial end date:
2014-11-01
Target enrollment:
Participant gender:
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.