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Effect of High Dose Naloxone on Secondary Hyperalgesia

NCT01935206 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2014-02-25

No results posted yet for this study

Summary

Recent studies have focused on the role of endogenous opioids on central sensitization. Central sensitization is known to be impaired or altered in chronic pain conditions, as fibromyalgia or chronic tension headache.

Animal studies have shown reinstatement of mechanical hypersensitivity following naloxone administration after resolution of an injury. This suggests latent sensitization.

In the present study, investigators hypothesize that naloxone (2 mg/kg) can reinstate secondary hyperalgesia 168 hours after a first-degree burn-injury. Investigators aim therefore to show that latent sensitization is present in humans and is modulated by endogenous opioids.

Conditions

  • Hyperalgesia
  • Pain
  • Naloxone
  • Opioid Antagonist

Interventions

DRUG

Naloxone (2 mg/kg)

DRUG

Placebo

Sponsors & Collaborators

  • Rigshospitalet, Denmark

    lead OTHER

Principal Investigators

  • Joergen B Dahl, M.D., DMSc · Dept Anaesthesiology, HOC, 4231, Rigshospitalet

  • Mads U. Werner, M.D., Ph.D., DMSc · Multidisciplinary Pain Center, 7612, Rigshospitalet, Copenhagen

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
35 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2013-11-30
Completion
2013-11-30

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT01935206 on ClinicalTrials.gov