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Effect of High-dose Naloxone Following Third Molar Extraction

NCT02976337 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2024-02-22

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, the investigators hypothesize that a high-dose target-controlled naloxone infusion (total dose: 3.25 mg/kg) can reinstate pain and hyperalgesia 6-8 weeks after a unilateral primary open groin hernia repair procedure. The investigators aim to show that latent sensitization is present in humans and is modulated by endogenous opioids.

Conditions

  • Healthy Subjects
  • Hyperalgesia
  • Inflammations, Endodontic
  • Pain, Acute
  • Sensitization, Central

Interventions

DRUG

Naloxone

active drug infusion

DRUG

Normal Saline

placebo comparator

Sponsors & Collaborators

  • University of Kentucky

    collaborator OTHER

  • mads u werner

    lead OTHER

Principal Investigators

  • Mads U Werner, MD, DMSc · Neuroscience Center, Copenhagen University Hospital, Denmark

  • Bradley K Taylor, M.Sc., Ph.D. · Department of Physiology, University of Kentucky Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-10-12
Primary Completion
2023-11-27
Completion
2023-12-27

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Drugs

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 NCT02976337 on ClinicalTrials.gov