Pharmacodynamics and Arteriovenous Differences of Naloxone in Healthy Participants Exposed to an Opioid

• Status: Completed
• Trial end date: 2016-02-01
• Target enrollment: 0
• Participant gender: All

Summary

Overdose with potential deadly outcome is a serious problem among opioid abusers, not least in Norway. To save lives, immediate treatment with a μ-opioid antidote such as naloxone is required. The purpose of this study is to explore the pharmacokinetics and pharmacodynamics of naloxone in healthy volunteers under opioid influence.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

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

Criteria

Inclusion Criteria:

• American Society of Anesthesiologists (ASA) class I

• ECG without pathologic abnormalities

• BMI range of 18,5 - 26 kg/m2

• pass the modified allens test to determine collateral circulation of the hand

• 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

• 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, remifentanil hydrochloride or lidocaine and/or to any of its excipients.

• Participants that have participated in previous trials where they have received remifentanil or other opioids.

• Participants who have donated 450 ml or more blood within 6 weeks prior to visit 2, or who plan to donate blood within 6 weeks after visit 2

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