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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 (CANAB I)

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ClinicalTrials.gov Identifier: NCT03985995
Recruitment Status : Not yet recruiting
First Posted : June 14, 2019
Last Update Posted : July 1, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

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

Condition or disease Intervention/treatment Phase
Pain Sensation Hyperalgesia Allodynia Drug: CBD 800 mg p.o Drug: Placebo p.o Not Applicable

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:

  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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Pain Response to Cannabidiol in Induced Acute Nociceptive Pain, Allodynia and Hyperalgesia By Using a Model Mimicking Acute Pain in Healthy Adults
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

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.
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 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.
Drug: 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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Change in area of allodynia (cm) [ Time Frame: from minute 70 to 130 ]
    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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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03985995


Contacts
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Contact: Wilhelm Ruppen, Prof. Dr. +4161 328 64 96 wilhelm.ruppen@usb.ch
Contact: Tobias Schneider, Dr. med +4161 3285165 tobias.schneider@usb.ch

Locations
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Switzerland
Department of Anaesthesiology, University Hospital of Basel (USB) Active, not recruiting
Basel, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
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Principal Investigator: Tobias Schneider, Dr. med Department of Anaesthesiology, University Hospital of Basel

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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT03985995     History of Changes
Other Study ID Numbers: 2019-00839; qu18Ruppen2
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: July 1, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Basel, Switzerland:
Cannabidiol (CBD)

Additional relevant MeSH terms:
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Epidiolex
Acute Pain
Hyperalgesia
Nociceptive Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Somatosensory Disorders
Sensation Disorders
Nervous System Diseases
Pharmaceutical Solutions
Anticonvulsants