A Phase 1 interventional study of Intranasal (IN) naloxone 1x and Intranasal (IN) naloxone 2 in Drug Overdose, sponsored by Norwegian University of Science and Technology. Completed at 1 site in Norway. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-02-03.
Sponsored by Norwegian University of Science and Technology · Phase 1, Interventional, and Basic science
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.
139 studies on the registry are indexed under Drug Overdose; 24 are open to participants now.
This study's enrollment of 22 is below the median of 100 across 98 interventional studies indexed under Drug Overdose.
Browse Drug Overdose studies →Norwegian University of Science and Technology is the lead sponsor of 487 studies on the registry; 52 are open to participants now.
Counted across the registry records on this site, refreshed daily.
In order to participate in this study the subjects must meet all of the following inclusion criteria:
Laboratory values within reference values for the following haematology and biochemistry tests:
Exclusion Criteria:
In order to participate in the study subjects must not meet any of the following exclusion criteria:
Each subject will receive one dose of IN naloxone 1.4 mg, IN naloxone 2 x 1.4 mg, IV naloxone 0.4 mg and IM naloxone 0.8 mg in a randomized order. The four doses will be given at four different visits with a washout period of at least 72 hours between. One follow-up visit will be conducted within one month after the last exposure.
Drug: Intranasal (IN) naloxone 1x · Drug: Intranasal (IN) naloxone 2 · Drug: Intravenous (IV) naloxone · Drug: Intramuscular (IM) naloxone
Each subject will receive one dose of IN naloxone 1.4 mg, IN naloxone 2 x 1.4 mg, IV naloxone 0.4 mg and IM naloxone 0.8 mg in a randomized order. The four doses will be given at four different visits with a washout period of at least 72 hours between. One follow-up visit will be conducted within one month after the last exposure.
Drug: Intranasal (IN) naloxone 1x · Drug: Intranasal (IN) naloxone 2 · Drug: Intravenous (IV) naloxone · Drug: Intramuscular (IM) naloxone
Each subject will receive one dose of IN naloxone 1.4 mg, IN naloxone 2 x 1.4 mg, IV naloxone 0.4 mg and IM naloxone 0.8 mg in a randomized order. The four doses will be given at four different visits with a washout period of at least 72 hours between. One follow-up visit will be conducted within one month after the last exposure.
Drug: Intranasal (IN) naloxone 1x · Drug: Intranasal (IN) naloxone 2 · Drug: Intravenous (IV) naloxone · Drug: Intramuscular (IM) naloxone
Each subject will receive one dose of IN naloxone 1.4 mg, IN naloxone 2 x 1.4 mg, IV naloxone 0.4 mg and IM naloxone 0.8 mg in a randomized order. The four doses will be given at four different visits with a washout period of at least 72 hours between. One follow-up visit will be conducted within one month after the last exposure.
Drug: Intranasal (IN) naloxone 1x · Drug: Intranasal (IN) naloxone 2 · Drug: Intravenous (IV) naloxone · Drug: Intramuscular (IM) naloxone
Administered as 100 μl 14.0 mg/ml (1.4 mg naloxone) by Aptar Unitdose device as one puff in one nostril
Administered as 2x 100 μl 14 mg/ml (2.8 mg naloxone) by Aptar Unitdose device as two puffs within the same nostril with 3 minutes interval
Administered as 1 ml Naloxon B Braun 0.4 mg/ml (0.4 mg naloxone), in an intravenous cannula in the opposite arm of which the blood samples are drawn from. IV bolus will be given rapidly (in less than 5 seconds)
Naloxone administered as 2 ml Naloxon B Braun 0.4 mg/ml (0.8 mg naloxone) in a Braun Omnifix 2.5 ml syringe using a BD Microlance 3 21G (green) 0.8x40 mm needle in the deltoid muscle of the non-dominant arm
Difference in Peak plasma concentration (Cmax)
Cmax will be compared for single dose IN, IM and IV naloxone
Time frame: 4 days
Difference in systemic exposure: Area under the plasma concentration versus time curve (AUC-0last)
AUC 0-last will be compared for single dose IN, IM and IV naloxone
Time frame: 4 days
Difference in dose adjusted systemic exposure: Area under the plasma concentration versus time curve (AUC-0inf)
AUC0-inf will be compared for single dose IN, IM and IV naloxone
Time frame: 4 days
Difference in time at which the Cmax is observed (Tmax)
Tmax will be compared for single dose IN, IM and IV naloxone
Time frame: 4 days
Dose proportionality
assessed by comparing systemic exposure (AUC0-last) following one and two doses of 1.4 mg of IN naloxone in the same nostril.
Time frame: 4 days
Absolute bioavailability
assessed by comparing dose adjusted systemic exposure (AUC0-last) of IN and IV naloxone
Time frame: 4 days
Relative bioavailability
assessed by comparing dose adjusted systemic exposure (AUC0-last) of IN and IM naloxone
Time frame: 4 days
This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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Norwegian University of Science and Technology