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

Study Overview
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Brief Summary
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This study is to investigate the effect of CBD on acute pain in healthy volunteers in a well-established acute pain model.

Detailed Description
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There are no studies investigating Cannabidiol (CBD) in an acute pain model in human beings. This is however of great clinical value because: Patients are often treated insufficiently with the commonly used analgesics in acute pain therapy or the available selection of analgesics is limited by their contraindications and side-effects. CBD could be an option to optimize pain therapy if the pain relief is not satisfactory. CBD in contrast to ∆9-tetrahydrocannabinol (THC) has only few side effects and due to a possible dose reduction of other analgesics patients might benefit from a better side-effect profile. This study is to investigate the effect of CBD on acute pain in healthy volunteers in a well-established acute pain model.

Official Title
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Pain Response to Cannabidiol in Induced Acute Nociceptive Pain, Allodynia and Hyperalgesia By Using a Model Mimicking Acute Pain in Healthy Adults

Conditions
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Pain Sensation, Hyperalgesia, Allodynia

Intervention / Treatment
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* Drug: CBD 800 mg p.o
* Drug: Placebo p.o


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adults BMI between 18.5 until 25 kg/m2 Able to understand the study and the NRS scale 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/ Lactation Allergy / hypersensitivity to cannabidiol

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CBD 800 mg p.o.<br>The study Investigational Medical Product (IMP) is a cannabidiol solution 100 mg/ml 8 ml in single-dose containers for per os administration. | Drug: CBD 800 mg p.o<br>* cannabidiol solution 100 mg/ml 8 ml in single-dose containers for per os administration. After a washout period of at least two weeks, the treatment group will be receiving a single-dose of the placebo solution 8 ml as a second intervention.<br>|
| Placebo Comparator: Placebo p.o.<br>Participants in the control arm will be receiving a single dose of oral placebo solution 8 ml matched to the active comparator. | Drug: Placebo p.o<br>* single dose of oral placebo solution 8 ml matched to the IMP. After a washout period of at least two weeks, the control intervention group will be receiving the cannabidiol solution 100 mg/ml 8 ml as a second intervention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain (numeric rating scale (NRS): 0 = no pain and 10 = maximum tolerable pain) | Change in pain for 60 min (from minute 70 to 130) after inducing defined pain in an experimental setting (Koppert model). 2 microdialysis catheters are inserted into intradermal surface of forearm and attached to a constant current stimulator. | pain will be assessed every 10 minutes using the NRS from minute 70 to 130 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in area of hyperalgesia (cm) | Change in area of hyperalgesia (from minute 70 to 130) after inducing a defined pain in an experimental setting (Koppert model). Immediately after every pain rating the area of pinprick hyperalgesia is determined using a 256 MilliNewton (mN) von Frey Filament. The von Frey Filament will be moved towards the site of stimulation in 0.5 cm increments until the subject reports increased pain sensations from the von Frey filament (hyperalgesia). To create an area from these linear measurements, the assumption is made, that this field has the shape of an ellipse. The area is calculated using the formula 1/4πD·d. | from minute 70 to 130 | 
| Change in area of allodynia (cm) | Change in area of allodynia (from minute 70 to 130) after inducing a defined pain in an experimental setting (Koppert model). Immediately after every pain rating the area of allodynia is determined using a dry cotton swab. The Cotton swab will be moved towards the site of stimulation in 0.5 cm increments until the subject reports an unpleasant rougher sensation from the cotton swab (allodynia). To create an area from these linear measurements, the assumption is made, that this field has the shape of an ellipse. The area is calculated using the formula 1/4πD·d. | from minute 70 to 130 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cannabidiol (CBD)