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

• Status: Completed
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: All

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, higher than road 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 (intranasal) 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. In a series of studies on intranasal naloxone at The Norwegian University of Science and Technology, this study explores pharmacokinetics and pharmacodynamics of intranasal and intramuscular naloxone in healthy volunteers under the influence of remifentanil.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Norwegian University of Science and Technology
• Collaborator: St. Olavs Hospital
• Treatments: Naloxone; Remifentanil

Criteria

Inclusion Criteria:

• American Society of Anesthesiologists (ASA) class I

• ECG without pathologic abnormalities

• BMI range of 18,5 - 24,9 kg/m2.

• lab values within reference values at St Olav's Hospital for the relevant haematological and biochemical test for inclusion:

• Haemoglobin (male: 13.4-17.0 g/dL, female 11.7 - 15.3 g/dL)

• Creatinine (male: 60-105 micromole/L, female 45 - 90 micromole/L)

• Aspartate aminotransferases (ASAT) (male: 15-45 U/L, female: 15-35 U/L)

• Alanine transaminase (ALAT) (male: 10-70 U/L, female: 10-45 U/L)

• Gamma glutamyl transpeptidase (GT) (male: 10-80 U/L, female: 10-45 U/L)

• For women in reproductive age: serum HCG (normal under 3 ye/L)

• Signed informed consent and expected cooperation of the subjects for the treatment

Exclusion Criteria:

• Taking any medications including herbal medicines the last week prior to treatment visits

• Current or history of drug and/or alcohol abuse (To assess problematic drug or alcohol use we use the CAGE AID screening tool)

• History of contact with police or authorities in relation to alcohol or drug offences

• History of prolonged use of opioid analgesics

• History of prior drug allergy

• Having any local nasal disease or nasal surgery for the last 2 months or recent cold for the last week

• Pregnant women (HCG over 3 ye/L at inclusion)

• Women in reproductive age not using high efficacy contraceptives (Oral contraceptives, Patch (Evra), Implants, Vaginal ring, Hormonal IUD, Copper intra-uterine device (IUD), Sterilization) throughout the study period until their last visit.

• Breastfeeding women

• Participants with access to remifentanil or other potent opioids in their daily workplace.

• Hypersensitivity to naloxone or remifentanil hydrochloride and/or to any of its excipients.

• Any reason why, in the opinion of the investigator, the patient should not participate.