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

Hyperalgesia Clinical Trial

— CANAB I  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03985995
• Other study ID #: 2019-00839; qu18Ruppen2
• Status: Completed
• Phase: N/A
• Start date: September 16, 2019
• Est. completion date: December 23, 2019

Study information

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

Clinical Trial Summary

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

Description:

There are no studies investigating Cannabidiol (CBD) in an acute pain model in human beings. This is however of great clinical value because:

1. 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.

2. CBD could be an option to optimize pain therapy if the pain relief is not satisfactory.

3. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 23, 2019
• Est. primary completion date: December 23, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Allodynia
• Hyperalgesia
• Nociceptive Pain
• Pain Sensation

Intervention

Drug:
• CBD 800 mg p.o
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.
• Placebo p.o
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.

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 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	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 1/4pD·d.	from minute 70 to 130
Secondary	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 1/4pD·d.	from minute 70 to 130