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

Sponsor

University Hospital, Basel, Switzerland (Other)

Overall Status

Completed

CT.gov ID

NCT03985995

Collaborator

(none)

Enrollment

Location

Arms

3.2

Actual Duration (Months)

6.2

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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 Design

Study Type:

Interventional

Actual 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

Actual Study Start Date :

Sep 16, 2019

Actual Primary Completion Date :

Dec 23, 2019

Actual Study Completion Date :

Dec 23, 2019

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Change in pain (numeric rating scale (NRS): 0 = no pain and 10 = maximum tolerable pain) [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

Change in area of hyperalgesia (cm) [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.
Change in area of allodynia (cm) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Anaesthesiology, University Hospital of Basel (USB)	Basel		Switzerland	4031

Sponsors and Collaborators

University Hospital, Basel, Switzerland

Investigators

Principal Investigator: Tobias Schneider, Dr. med, Department of Anaesthesiology, University Hospital of Basel

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Basel, Switzerland

ClinicalTrials.gov Identifier:

NCT03985995

Other Study ID Numbers:

2019-00839; qu18Ruppen2

First Posted:

Jun 14, 2019

Last Update Posted:

Jan 29, 2020

Last Verified:

Jan 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University Hospital, Basel, Switzerland

Cannabidiol (CBD)

Additional relevant MeSH terms:

Hyperalgesia

Acute Pain

Nociceptive Pain

Study Results

No Results Posted as of Jan 29, 2020