Effect of High Dose Naloxone on Secondary Hyperalgesia

NCT ID: NCT01935206

Last Updated: 2014-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2013-11-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Naloxone (2 mg/kg)

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

Group Type: EXPERIMENTAL

Naloxone (2 mg/kg)

Intervention Type: DRUG

Interventions

Naloxone (2 mg/kg)

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Rigshospitalet, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Manuel Pereira

M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joergen B Dahl, M.D., DMSc

Role: STUDY_DIRECTOR

Dept Anaesthesiology, HOC, 4231, Rigshospitalet

Mads U. Werner, M.D., Ph.D., DMSc

Role: PRINCIPAL_INVESTIGATOR

Multidisciplinary Pain Center, 7612, Rigshospitalet, Copenhagen

Locations

Dept Anaesthesiology HOC, 4231, Rigshospitalet

Copenhagen, Copenhagen, Denmark

Multidisciplinary Pain Center

Copenhagen, Copenhagen, Denmark

Countries

Denmark

Other Identifiers

H-2-2012-174

Identifier Type: -

Identifier Source: org_study_id