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

Hyperalgesia Clinical Trial

— CANAB II  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04059978
• Other study ID #: 2019-01217; qu18Ruppen3
• Status: Completed
• Phase: N/A
• Start date: May 26, 2020
• Est. completion date: October 15, 2020

Study information

• Verified date: October 2020
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: October 15, 2020
• Est. primary completion date: October 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Acute Nociceptive Pain
• Acute Pain
• Allodynia
• Hyperalgesia
• Nociceptive Pain
• Opioid-induced Hyperalgesia

Intervention

Drug:
• CBD
1600mg cannabidiol, single oral dose (8 ml oily solution)
• Placebo
Placebo p.o, single oral dose (8 ml oily solution)
• Remifentanil
Remifentanil 0.1 µg/kg/min i.v. for 30 min

Locations

Country	Name	City	State
Switzerland	Department of Anaesthesiology, University Hospital of Basel (USB)	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in hyperalgesia measured by the area under the curve (AUCHyper)	Change in hyperalgesia measured by the area under the curve (AUCHyper)	from minute 100 to minute 160 after termination of remifentanil infusion
Secondary	Change in pain response (NRS) measured by the area under the curve (AUCNRS)	Change in pain response (NRS) measured by the area under the curve (AUCNRS)	from minute 70 to minute 90 during remifentanil infusion
Secondary	Change in hyperalgesia measured by the area under the curve (AUCHyper)	Change in hyperalgesia measured by the area under the curve (AUCHyper)	from minute 70 to minute 90 during remifentanil infusion
Secondary	Change in allodynia measured by the area under the curve (AUCAllo)	Change in allodynia measured by the area under the curve (AUCAllo)	from minute 70 to minute 90 during remifentanil infusion
Secondary	Change in pain response (NRS) measured by the area under the curve (AUCNRS)	Change in pain response (NRS) measured by the area under the curve (AUCNRS)	from minute 100 to minute 160 after termination of remifentanil infusion
Secondary	Change in allodynia measured by the area under the curve (AUCAllo)	Change in allodynia measured by the area under the curve (AUCAllo)	from minute 100 to minute 160 after termination of remifentanil infusion