Analgesic and Antihyperalgesic Effects of Morphine and Buprenorphine

NCT01296334 | Completed DMC

• 2 other identifiers: H-2-2010-1152010-022903-23
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Tissue injury is associated with pain from the injured site (primary hyperalgesia) and pain from non-injured tissue in the vicinity of the trauma (secondary hyperalgesia). In the present study we investigate primary and secondary hyperalgesia in healthy volunteers following an experimental first degree burn injury. The objectives are:

• to compare analgesic and anti-hyperalgesic effects of two opioids (morphine and buprenorphine).
• to investigate if these effects are related to the volunteers individual pain sensitivity

Conditions

Pain

Keywords

opioids; analgesia; secondary hyperalgesia; quantitative sensory testing; inflammatory injury

Outcome Measures

Primary Outcomes (1)

• Analgesic and antihyperalgesic effects

  Analgesic effect is assessed by change in primary hyperalgesia (pain rating \[VAS\]) Antihyperalgesic effect is assessed by reduction in area of hyperalgesia (sq. cm) VAS-area under curve is calculated for 0, 60, 120 and 180 min after first degree burn injury

  0 to 180 min after a first degree burn injury

Secondary Outcomes (1)

• Difference in analgesic/antihyperalgesic profile between pain-sensitive and pain-non-sensitive individuals

  0-180 min after first degree burn injury

Study Arms (5)

morphine low dose

EXPERIMENTAL

morphine infusion 10 mg over a 210 min period

Drug: morphine LO

morphine high dose

EXPERIMENTAL

morphine infusion 20 mg over a 210 min period

Drug: Morphine Hi

buprenorphine low dose

EXPERIMENTAL

buprenorphine infusion 0.3 mg over a 210 min period

Drug: Buprenorphine LO

buprenorphine high dose

EXPERIMENTAL

buprenorphine infusion 0.6 mg over a 210 min period

Drug: Buprenorphine Hi

placebo

PLACEBO COMPARATOR

placebo (normal saline) infusion 0.6 mg over a 210 min period

Other: saline

Interventions

morphine LO DRUG

intravenous infusion, 10 mg, once, 4 hours

Also known as: Morfin SAD

morphine low dose

Morphine Hi DRUG

intravenous infusion, 20 mg, once, 4 hours

Also known as: Morfin SAD

morphine high dose

Buprenorphine LO DRUG

intravenous infusion, 0.3 mg, once, 4 hours

Also known as: Temgesic

buprenorphine low dose

Buprenorphine Hi DRUG

intravenous infusion, 0.6 mg, once, 4 hours

Also known as: Temgesic

buprenorphine high dose

saline OTHER

intravenous infusion, 0.9% saline, once, 4 hours

Also known as: 0.9% NaCl

placebo

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy individuals
• adequate psychomotor performance to perform pain tests
• pain-sensitive or pain-nonsensitive according to prespecified criteria

You may not qualify if:

• known allergy to morphine or buprenorphine
• prior adverse experiences with opioids
• history of abuse
• females not taking P-pills
• skin lesions on the test-sites
• suffering from chronic pain
• medication with analgesics
• BMI \> 28
• smoker

Sponsors & Collaborators

• mads u werner: lead
• Norpharma A/S: collaborator

Study Sites (1)

Zelo Phase One Clinical Trial Unit, Bispebjerg Hospital

Copenhagen NV, 2400, Denmark

Location

Related Publications (2)

• Koppert W, Ihmsen H, Korber N, Wehrfritz A, Sittl R, Schmelz M, Schuttler J. Different profiles of buprenorphine-induced analgesia and antihyperalgesia in a human pain model. Pain. 2005 Nov;118(1-2):15-22. doi: 10.1016/j.pain.2005.06.030. Epub 2005 Sep 9.

  PMID: 16154698 BACKGROUND

• Ravn P, Secher EL, Skram U, Therkildsen T, Christrup LL, Werner MU. Morphine- and buprenorphine-induced analgesia and antihyperalgesia in a human inflammatory pain model: a double-blind, randomized, placebo-controlled, five-arm crossover study. J Pain Res. 2013;6:23-38. doi: 10.2147/JPR.S36827. Epub 2013 Jan 9.

  PMID: 23359655 RESULT

MeSH Terms

Conditions

Pain; Agnosia; Hyperalgesia

Interventions

Buprenorphine; Sodium Chloride; Saline Solution

Condition Hierarchy (Ancestors)

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

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; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Mads U Werner, MD, DMSc

  Multidisciplinary Pain Centre 7612, Rigshospitalet, Blegdamsvej 9, DK 2100 Copenhagen O

  STUDY DIRECTOR

• Lona L Christrup, MSc, PhD

  Pharmaceutical Faculty, Copenhagen University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 14, 2011
• First Posted: February 15, 2011
• Study Start: February 1, 2011
• Primary Completion: September 1, 2011
• Study Completion: October 1, 2011
• Last Updated: November 28, 2016

Record last verified: 2016-11

Locations

DK (1)