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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02405988
• Date of registration: 28/03/2015
• Prospective Registration: Yes
• Primary sponsor: Norwegian University of Science and Technology
• Public title: Pharmacodynamics and Arteriovenous Differences of Naloxone in Healthy Participants Exposed to an Opioid OPI-15-001
• Scientific title: Pharmacodynamics and Arteriovenous Differences of Naloxone in Healthy Participants Exposed to an Opioid
• Date of first enrolment: April 2015
• Target sample size: 12
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02405988
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Norway

Contacts

• Name: Toril A Nagelhus Hernes, phd prof
• Affiliation: Norwegian University of Science and Technology

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 40 Years
Gender: All

Health Condition(s) or Problem(s) studied

Drug Overdose

Intervention(s)

Drug: Intravenous naloxone

Drug: Remifentanil

Primary Outcome(s)

Serum-effect-site equilibration rate constant [Time Frame: up to 120 minutes]

Secondary Outcome(s)

Pharmacodynamics: measurement of naloxone antagonism of remifentanil effects, by measuring changes in pupillary size [Time Frame: 120 minutes]

Pharmacokinetics: time to maximum concentration (Tmax) of IV naloxone in arterial and venous serum [Time Frame: 120 minutes]

serum concentration of remifentanil [Time Frame: 120 minutes]

Pharmacokinetics: maximum concentration (Cmax) of IV naloxone in arterial and venous serum [Time Frame: 120 minutes]

Pharmacokinetics: Area Under the Curve of IV naloxone in arterial and venous serum [Time Frame: 120 minutes]

the effect site equilibration rate constant (ke0) for remifentanil for arterial sampling with pupillary size [Time Frame: 120 minutes]

Quantitate serum concentrations of remifentanil in arterial and venous blood at specified time points [Time Frame: 120 minutes]

Secondary ID(s)

2014-005348-16

OPI-15-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

St. Olavs Hospital