Pharmacokinetics and Pharmacodynamics of a New Formulation of Nasal Naloxone for Prehospital Use

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

December 31, 2014

Primary Completion Date

April 30, 2015

Study Completion Date

September 30, 2015

Conditions
Drug Overdose
Interventions
DRUG

Intranasal naloxone

Administer 0,1 ml 8 mg/ml naloxone intranasally, dose = 0,8 mg naloxone

DRUG

Intramuscular naloxone

Administer 2 mL, dose intramuscular naloxone 0,8 mg

DRUG

Remifentanil

Administer remifentanil intravenously by way of Target Control Infusion, Minto model at a target of 2,5 ng/ml. This to achieve a state of safe and predictable opioid influence to assess pharmacodynamic response to naloxone. After treatment of 4 participants protocol amended 22. january 2015 to reduce remifentanil target to 1,25 ng/ml in the next 4. In the last 4 participants the dose will be decided later, but not exceed 2,5 ng/ml.

DEVICE

Aptar Unidose

This is the spray device chosen, and its function in this setting (spray up side down) will be assessed by weighing the device before and after administration.

Trial Locations (1)

Unknown

Department of Circulation and Medical Imaging, Trondheim

All Listed Sponsors
collaborator

St. Olavs Hospital

OTHER

lead

Norwegian University of Science and Technology

OTHER

NCT02307721 - Pharmacokinetics and Pharmacodynamics of a New Formulation of Nasal Naloxone for Prehospital Use | Biotech Hunter | Biotech Hunter