drugset / Trial / NCT02598856

Bioavailability of Nasal Naloxone and Injected Naloxone Compared

NCT02598856

RandomizedCrossoverOpen-labelBasic science

Summary

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.

Timeline

Start
2016-03
Primary completion
2016-12
Completion
2016-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Naloxone Small molecule 0.4 mg Intranasal
Subject Naloxone Small molecule 0.8 mg Intranasal
Subject Naloxone Small molecule 1.4 mg Intranasal
Subject Naloxone Small molecule 2.8 mg Intranasal

Indications

No indication recorded.