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Pain Response to Cannabidiol in Opioid-induced Hyperalgesia, Acute Nociceptive Pain and Allodynia By Using a Model Mimicking Acute Pain in Healthy Adults (CANAB II)

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ClinicalTrials.gov Identifier: NCT04059978
Recruitment Status : Not yet recruiting
First Posted : August 16, 2019
Last Update Posted : August 16, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Brief Summary:
Prospective, randomized, placebo-controlled, double-blinded, crossover study to investigate the effect of cannabidiol (CBD) on remifentanil-induced hyperalgesia in healthy volunteers in a well-established acute pain model. Participants are randomized according to the order of the two treatments (CBD + Remifentanil or Placebo + Remifentanil).

Condition or disease Intervention/treatment Phase
Acute Nociceptive Pain Hyperalgesia Allodynia Opioid-induced Hyperalgesia Drug: CBD Drug: Placebo Drug: Remifentanil Not Applicable

Detailed Description:

Opioid-induced hyperalgesia (OIH) is a clinically often neglected, but well described phenomenon. OIH could also be shown for Remifentanil in an acute pain model. As CBD showed antihyperalgesic potential in the animal model, this brings up the question if CBD might be used to prevent or diminish OIH. Until today there are no studies investigating CBD as an adjunct to remifentanil or other opioids regarding the OIH. This is however of great clinical value because CBD with its possible antihyperalgesic effect on the OIH might be a worthful adjunct for opioid based anaesthesia and analgesia.

Every participant will pass through two interventions with electrically induced pain (Koppert model). CBD will be applied orally at the beginning of the intervention. Pain, allodynia and hyperalgesia will be assessed and recorded every 10 min during the remifentanil infusion and afterwards.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Pain Response to Cannabidiol in Opioid-induced Hyperalgesia, Acute Nociceptive Pain and Allodynia By Using a Model Mimicking Acute Pain in Healthy Adults
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: CBD + Remifentanil
CBD 800 mg p.o. + Remifentanil 0.1 µg/kg/min i.v. for 30 min
Drug: CBD
800mg cannabidiol, single oral dose (8 ml oily solution)

Drug: Remifentanil
Remifentanil 0.1 µg/kg/min i.v. for 30 min

Placebo Comparator: Placebo + Remifentanil
Placebo p.o + Remifentanil 0.1 µg/kg/min i.v. for 30 min
Drug: Placebo
Placebo p.o, single oral dose (8 ml oily solution)

Drug: Remifentanil
Remifentanil 0.1 µg/kg/min i.v. for 30 min




Primary Outcome Measures :
  1. Change in hyperalgesia measured by the area under the curve (AUCHyper) [ Time Frame: from minute 100 to minute 160 after termination of remifentanil infusion ]
    Change in hyperalgesia measured by the area under the curve (AUCHyper)


Secondary Outcome Measures :
  1. Change in pain response (NRS) measured by the area under the curve (AUCNRS) [ Time Frame: from minute 70 to minute 90 during remifentanil infusion ]
    Change in pain response (NRS) measured by the area under the curve (AUCNRS)

  2. Change in hyperalgesia measured by the area under the curve (AUCHyper) [ Time Frame: from minute 70 to minute 90 during remifentanil infusion ]
    Change in hyperalgesia measured by the area under the curve (AUCHyper)

  3. Change in allodynia measured by the area under the curve (AUCAllo) [ Time Frame: from minute 70 to minute 90 during remifentanil infusion ]
    Change in allodynia measured by the area under the curve (AUCAllo)

  4. Change in pain response (NRS) measured by the area under the curve (AUCNRS) [ Time Frame: from minute 100 to minute 160 after termination of remifentanil infusion ]
    Change in pain response (NRS) measured by the area under the curve (AUCNRS)

  5. Change in allodynia measured by the area under the curve (AUCAllo) [ Time Frame: from minute 100 to minute 160 after termination of remifentanil infusion ]
    Change in allodynia measured by the area under the curve (AUCAllo)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • BMI between 18.5 until 25 kg/m2
  • Able to give informed consent

Exclusion Criteria:

  • Regular consumption of cannabinoids or other drugs / substances
  • Regular intake of medications potentially interfering with pain sensation (analgesics, antihistamines, calcium and potassium channel blockers, serotonin / noradrenaline reuptake inhibitors, corticosteroids)
  • Neuropathy
  • Chronic pain
  • Neuromuscular disease
  • Psychiatric disease
  • Known or suspected kidney or liver disease
  • Pregnancy (cf. 8.6 Trial specific preventive measures) / Lactation
  • Allergy / hypersensitivity to cannabidiol
  • Contraindications for Remifentanil (e.g. hypersensitivity)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04059978


Contacts
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Contact: Tobias Schneider, MD +4161 328 51 65 tobias.schneider@usb.ch
Contact: Wilhelm Ruppen, Prof. MD +41613286496 wilhelm.ruppen@usb.ch

Locations
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Switzerland
Department of Anaesthesiology, University Hospital of Basel (USB) Not yet recruiting
Basel, Switzerland, 4031
Contact: Wilhelm Ruppen, Prof. MD    +4161 328 64 96    wilhelm.ruppen@usb.ch   
Contact: Tobias Schneider, MD    +4161 328 51 65    tobias.schneider@usb.ch   
Sub-Investigator: Laura Zurbriggen         
Sub-Investigator: Eckhard Mauermann, MD         
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
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Principal Investigator: Tobias Schneider, MD Department of Anaesthesiology, University Hospital of Basel

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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT04059978     History of Changes
Other Study ID Numbers: 2019-01217; qu18Ruppen3
First Posted: August 16, 2019    Key Record Dates
Last Update Posted: August 16, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Basel, Switzerland:
Cannabidiol
Remifentanil
Additional relevant MeSH terms:
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Epidiolex
Hyperalgesia
Acute Pain
Nociceptive Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Somatosensory Disorders
Sensation Disorders
Nervous System Diseases
Remifentanil
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anticonvulsants