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OpenTrials
Completed

NCT Number: NCT02158117

Bioavailability of a New Formulation of Nasal Naloxone for Prehospital Use

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.

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Key information

Conditions

Drug Overdose Chemically-Induced Disorders Drug Misuse Mental Disorders Prescription Drug Misuse Substance-Related Disorders

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Department of Circulation and Medical Imaging

Trondheim, Norway

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

nasal naloxone

Drug

one puff in one nostril with the subject is lying down

Primary outcomes

  1. 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 %

Secondary outcomes

  1. Maximum serum concentration (Cmax)

    Time frame: 2 weeks

  2. Time to maximum serum concentration (Tmax)

    Time frame: 2 weeks

  3. adverse events

    Time frame: 2 weeks

    will be reported from the start of the first session to the follow-up visit.

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • St. Olavs Hospital

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jun 6, 2014
Registry last updated
Feb 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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