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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-26

Study Completion Date

2020-10-15

Brief Summary

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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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Detailed Description

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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.

Conditions

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Acute Nociceptive Pain Hyperalgesia Allodynia Opioid-induced Hyperalgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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CBD + Remifentanil

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

Group Type ACTIVE_COMPARATOR

CBD

Intervention Type DRUG

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

Remifentanil

Intervention Type DRUG

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

Placebo + Remifentanil

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Remifentanil

Intervention Type DRUG

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

Interventions

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CBD

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Remifentanil

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

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes