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

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.

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

      • Basel, Switzerland, 4031
        • Department of Anaesthesiology, University Hospital of Basel (USB)

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.
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.
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.
pain will be assessed every 10 minutes using the NRS from minute 70 to 130

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.
from minute 70 to 130
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.
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

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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