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Completed

NCT Number: NCT04059978

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

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).

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Key information

Conditions

Acute Nociceptive Pain Allodynia Hyperalgesia Nervous System Diseases Neurologic Manifestations Opioid-induced Hyperalgesia Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Somatosensory Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anaesthesiology, University Hospital of Basel (USB)

Basel, 4031, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

CBD

Drug

1600mg cannabidiol, single oral dose (8 ml oily solution)

Placebo

Drug

Placebo p.o, single oral dose (8 ml oily solution)

Remifentanil

Drug

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

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Acronym: CANAB II

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Aug 16, 2019
Registry last updated
Oct 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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