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

NCT02405988 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2018-08-29

No results posted yet for this study

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.

Conditions

  • Drug Overdose

Interventions

DRUG

Intravenous naloxone

Administer 2,5 mL, dose intravenous naloxone 1,0 mg

DRUG

Remifentanil

Administer remifentanil intravenously by way of Target Control Infusion, Minto's model at a target of 1,3 ng/ml. This to achieve a state of safe and predictable opioid influence to assess pharmacodynamic response to naloxone.

Sponsors & Collaborators

  • St. Olavs Hospital

    collaborator OTHER

  • Norwegian University of Science and Technology

    lead OTHER

Principal Investigators

  • Toril A Nagelhus Hernes, phd prof · Norwegian University of Science and Technology

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2016-02-29
Completion
2016-02-29

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02405988 on ClinicalTrials.gov