Status:
COMPLETED
Pharmacokinetics and Pharmacodynamics of a New Formulation of Nasal Naloxone for Prehospital Use
Lead Sponsor:
Norwegian University of Science and Technology
Collaborating Sponsors:
St. Olavs Hospital
Conditions:
Drug Overdose
Eligibility:
All Genders
18-40 years
Phase:
PHASE1
PHASE2
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, higher than road traffic accidents. Those who i...
Detailed Description
Healthy volunteers will be brought into a state of opioid influence in a well-known, short acting, controlled and safe manner using remifentanil. Naloxone is a well-known, well-tolerated drug with an...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT02307721
Start Date
December 1 2014
End Date
September 1 2015
Last Update
October 17 2018
Active Locations (1)
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1
Department of Circulation and Medical Imaging
Trondheim, Norway