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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.
There are no studies investigating Cannabidiol (CBD) in an acute pain model in human beings. This is however of great clinical value because:
This study is to investigate the effect of CBD on acute pain in healthy volunteers in a well-established acute pain model.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBD 800 mg p.o. | Active Comparator | The study Investigational Medical Product (IMP) is a cannabidiol solution 100 mg/ml 8 ml in single-dose containers for per os administration. |
|
| Placebo p.o. | Placebo Comparator | Participants in the control arm will be receiving a single dose of oral placebo solution 8 ml matched to the active comparator. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBD 800 mg p.o | Drug | 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tobias Schneider, Dr. med | Department of Anaesthesiology, University Hospital of Basel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anaesthesiology, University Hospital of Basel (USB) | Basel | 4031 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34086631 | Derived | Schneider T, Zurbriggen L, Dieterle M, Mauermann E, Frei P, Mercer-Chalmers-Bender K, Ruppen W. Pain response to cannabidiol in induced acute nociceptive pain, allodynia, and hyperalgesia by using a model mimicking acute pain in healthy adults in a randomized trial (CANAB I). Pain. 2022 Jan 1;163(1):e62-e71. doi: 10.1097/j.pain.0000000000002310. |
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| Placebo p.o | Drug | 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. |
|
| 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 |
| ID | Term |
|---|---|
| D006930 | Hyperalgesia |
| ID | Term |
|---|---|
| D020886 | Somatosensory Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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