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)

University Hospital Basel

Status: Completed

Conditions: Hyperalgesia; Allodynia; Acute Nociceptive Pain; Opioid-induced Hyperalgesia

Treatments: Drug: CBD; Drug: Placebo; Drug: Remifentanil

Study type: Interventional

Funder types: Other

Identifiers

NCT04059978

2019-01217 qu18Ruppen3;

Details and patient eligibility

About

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).

Full 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.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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21 participants in 2 patient groups, including a placebo group

CBD + Remifentanil

Active Comparator group

Description:

CBD 1600 mg p.o. + Remifentanil 0.1 µg/kg/min i.v. for 30 min

Treatment:

Drug: CBD

Drug: Remifentanil

Placebo + Remifentanil

Placebo Comparator group

Description:

Placebo p.o + Remifentanil 0.1 µg/kg/min i.v. for 30 min

Treatment:

Drug: Remifentanil

Drug: Placebo