Drug Overdose Clinical Trial
Official title:
Bioavailability of Nasal Naloxone and Injected Naloxone Compared. A Randomized, Open Label, 4-way Cross-over Study
Opioid overdoses have in the last decade counted for about 230 untimely deaths annually in
Norway. The government is currently implementing a strategy for combating this epidemic.
Among the actions promoted in this strategy is the distribution of naloxone for intranasal
administration. Such administration of naloxone is currently being implemented and tried out
around the world, but very little has been done to pharmacologically study this new route of
administration of this well known drug, and only 3 open label randomized controlled trials
(RCTs) have been conducted. A recent guideline from the WHO on community management of
opioid overdoses is a comprehensive review of many of the aspects the investigators cover in
our research.
Regarding both dosage, routes of administration of naloxone and care of these patients in
the pre hospital setting. The WHO calls for nasal formulations with a higher concentration,
as well as focuses on the current wide spread off label use of nasal naloxone as a problem
and identifies several research questions of critical importance and very low evidence.The
current study, together with our research group's previous and future studies, aims to
provide data for the development of a medicinal product with marketing authorisation for use
in pre-hospital overdoses. This to contribute to public health measures for opioid users and
those around them.
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