- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03985995
Pain Response to Cannabidiol in Induced Acute Nociceptive Pain, Allodynia and Hyperalgesia By Using a Model Mimicking Acute Pain in Healthy Adults (CANAB I)
January 28, 2020 updated by: University Hospital, Basel, Switzerland
This study is to investigate the effect of CBD on acute pain in healthy volunteers in a well-established acute pain model.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Basel, Switzerland, 4031
- Department of Anaesthesiology, University Hospital of Basel (USB)
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: CBD 800 mg p.o.
The study Investigational Medical Product (IMP) is a cannabidiol solution 100 mg/ml 8 ml in single-dose containers for per os administration.
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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.
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Placebo Comparator: Placebo p.o.
Participants in the control arm will be receiving a single dose of oral placebo solution 8 ml matched to the active comparator.
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in pain (numeric rating scale (NRS): 0 = no pain and 10 = maximum tolerable pain)
Time Frame: pain will be assessed every 10 minutes using the NRS from minute 70 to 130
|
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.
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pain will be assessed every 10 minutes using the NRS from minute 70 to 130
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in area of hyperalgesia (cm)
Time Frame: from minute 70 to 130
|
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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from minute 70 to 130
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Change in area of allodynia (cm)
Time Frame: from minute 70 to 130
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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.
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from minute 70 to 130
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Tobias Schneider, Dr. med, Department of Anaesthesiology, University Hospital of Basel
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 16, 2019
Primary Completion (Actual)
December 23, 2019
Study Completion (Actual)
December 23, 2019
Study Registration Dates
First Submitted
June 11, 2019
First Submitted That Met QC Criteria
June 11, 2019
First Posted (Actual)
June 14, 2019
Study Record Updates
Last Update Posted (Actual)
January 29, 2020
Last Update Submitted That Met QC Criteria
January 28, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-00839; qu18Ruppen2
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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