Clinical trial NCT02158117: Bioavailability of a New Formulation of Nasal Naloxone for Prehospital Use
Official title: Bioavailability of a New Formulation of Nasal Naloxone for Prehospital Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Drug Overdose
Keywords: Emergency Treatment
Morphine Derivates
Heroin
Antidotes
Administration, Intranasal
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
First posted: 2014-06-06
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Healthy
* Normal electrocardiogram (ECG)
* Hemoglobin: male 13.4 - 17.0 g/dL, female 11,7- 15.3 g/dL
* Creatinine: male 60- 105 micromol/L female 45- 90 micromol/L
* ASAT: male 15- 45 U/L, female 15- 35 U/L
* ALAT: male 10- 70 U/L female 10- 45 U/L
* Gamma GT: male 10- 80 U/L female 10- 45 U/L
* HCG normal under 3 ye/L
* Fertile women must use safe contraception and have a negative serum HCG at inclusion

Exclusion Criteria:

* Taking any medications including herbal medicines the last week prior to first treatment visit
* History of drug abuse
* History of prior drug allergy
* Having any local nasal disease or nasal surgery or recent cold for the last week
* Pregnancy
* Fertile women not using high efficacy contraceptives (Oral contraceptives, Patch (Evra), Implants, Vaginal ring, Hormonal IUD, Copper IUD, Sterilization) throughout the study period until their last visit.
* Lactating women
* Any reason why, in the opinion of the investigator, the patient should not participate

Primary outcomes:
measure: bioavailability of naloxone
timeFrame: 2 weeks
Secondary outcomes:
measure: Maximum serum concentration (Cmax)
timeFrame: 2 weeks
measure: Time to maximum serum concentration (Tmax)
timeFrame: 2 weeks
measure: adverse events
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Department of Circulation and Medical Imaging
Study officials:
affiliation: Norwegian University of Science and Technology
name: Toril A Nagelhus Hernes, phd prof
role: STUDY_DIRECTOR
References:
citation: Tylleskar I, Skulberg AK, Nilsen T, Skarra S, Jansook P, Dale O. Pharmacokinetics of a new, nasal formulation of naloxone. Eur J Clin Pharmacol. 2017 May;73(5):555-562. doi: 10.1007/s00228-016-2191-1. Epub 2017 Jan 31.