Clinical Trial: Bioavailability of a New Formulation of Nasal Naloxone for Prehospital Use

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Bioavailability of a New Formulation of Nasal Naloxone for Prehospital Use

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.

Detailed Summary:
Sponsor: Norwegian University of Science and Technology

Current Primary Outcome: bioavailability of naloxone [ Time Frame: 2 weeks ]

A LCMSMS method for determination of Naloxone in serum was developed using acetonitrile protein precipitation. Naloxone D5 was used as internal standard and quantitative determination was done by using Sciex Analyst version 1.5. The method is fully validated by assessing linearity, accuracy, precision, sensitivity, specificity/selectivity, in process and storage stability, dilution integrity and assay ruggedness according to Dadgar (1995) and Shah (1991). The method was found linear, accurate and precise across the dynamic range of 0.05 to 45 ng/ml. Limit of quantification (LOQ) was 0.05ng/ml with CV = 12.7% and inaccuracy < 7.8% (n = 17). Quality Controls (QC) in middle (n=18) and upper (n=18) calibration range had CV < 4.2% and inaccuracy <8.2 %


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Maximum serum concentration (Cmax) [ Time Frame: 2 weeks ]
  • Time to maximum serum concentration (Tmax) [ Time Frame: 2 weeks ]
  • adverse events [ Time Frame: 2 weeks ]
    will be reported from the start of the first session to the follow-up visit.


Original Secondary Outcome: Same as current

Information By: Norwegian University of Science and Technology

Dates:
Date Received: June 2, 2014
Date Started: March 2014
Date Completion:
Last Updated: February 2, 2017
Last Verified: February 2017