Effect of High Dose Naloxone on Secondary Hyperalgesia

NCT01935206 | Completed Phase 1 DMC

• 1 other identifier: H-2-2012-174
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

secondary hyperalgesia; allodynia; mechanical pain threshold; naloxone; endogenous opioids; pain

Outcome Measures

Primary Outcomes (1)

• Change in Secondary hyperalgesia area (cm2) surrounding a first-degree burn injury before and after infusion of naloxone/placebo

  Areas of secondary hyperalgesia surrounding a first degree burn-injury will be assessed before and after infusion of naloxone/placebo.

  1h, 2h, 3h, 168h, 168h15min, 168h30min post-burn

Secondary Outcomes (1)

• Change in allodynic area (cm2) surrounding a first-degree burn injury before and after infusion of naloxone/placebo

  1h, 2h, 3h, 168h, 168h15min, 168h30min post-burn

Other Outcomes (1)

• Change in Mechanical Pain Thresholds at primary hyperalgesia site before and after naloxone/placebo infusion

  0h, 168h, 168h30min

Study Arms (2)

Placebo

PLACEBO COMPARATOR

The effect of naloxone (2 mg/kg) on secondary hyperalgesia 168 hours after a first-degree burn-injury is compared to the placebo effect.

Drug: Placebo

Naloxone (2 mg/kg)

EXPERIMENTAL

The effect of naloxone (2 mg/kg) on secondary hyperalgesia 168 hours after a first-degree burn-injury is compared to the placebo effect.

Drug: Naloxone (2 mg/kg)

Interventions

Naloxone (2 mg/kg) DRUG

Naloxone (2 mg/kg)

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy man
• written informed consent
• ASA 1-2
• BMI 18 \< BMI \< 30
• normal ultrasound examination of the heart
• normal ECG
• urin sample without traces of opioids

You may not qualify if:

• volunteers, who do not understand the Danish language
• participation in another experimental trial in the previous 60 days
• nerve damage or skin lesions in the assessment areas
• neurological or psychiatric condition
• use of psycho-active drugs
• abuse of alcohol or drugs
• chronic pain
• regular use of pain-killers (\> 1 a week)
• allergy against morphine or other opioids (including naloxone)
• use of prescription drugs 1 week prior to the trial
• use of over-the-counter medication 48 hours prior to the trial
• urin sample with traces of opioids
• volunteer is not suitable for the trial according to the investigator's consideration

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (2)

Dept Anaesthesiology HOC, 4231, Rigshospitalet

Copenhagen, Copenhagen, 2100, Denmark

Location

Multidisciplinary Pain Center

Copenhagen, Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Hyperalgesia; Pain

Interventions

Naloxone

Condition Hierarchy (Ancestors)

Somatosensory Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Joergen B Dahl, M.D., DMSc

  Dept Anaesthesiology, HOC, 4231, Rigshospitalet

  STUDY DIRECTOR

• Mads U. Werner, M.D., Ph.D., DMSc

  Multidisciplinary Pain Center, 7612, Rigshospitalet, Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: August 19, 2013
• First Posted: September 5, 2013
• Study Start: June 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: February 25, 2014

Record last verified: 2014-02

Locations

DK (2)