Pain SensationCANAB INCT03985995
Pain Response to Cannabidiol in Induced Acute Nociceptive Pain, Allodynia and Hyperalgesia By Using a Model Mimicking Acute Pain in Healthy Adults
A study testing CBD 800 mg p.o in people with Pain Sensation and Hyperalgesia, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
This study is to investigate the effect of CBD on acute pain in healthy volunteers in a well-established acute pain model. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain Sensation, Hyperalgesia, Allodynia
- What is being tested?
- CBD 800 mg p.o
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- 16 Sep 2019to 23 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults
- BMI between 18.5 until 25 kg/m2
- Able to understand the study and the NRS scale
- Able to give informed consent
Who cannot join
- 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
Show all 9Show fewer
- Known or suspected kidney or liver disease
- Pregnancy/ Lactation
- Allergy / hypersensitivity to cannabidiol
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Anaesthesiology, University Hospital of Basel (USB)
Basel, 4031
About this study
This study is to investigate the effect of CBD on acute pain in healthy volunteers in a well-established acute pain model.
Read the 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.
- Conditions
- Pain Sensation, Hyperalgesia, Allodynia
- Being tested
- CBD 800 mg p.o, Placebo p.o
- Keywords
- Cannabidiol (CBD)
- Medical subject headings
- Hyperalgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBD 800 mg p.oDrug
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.oDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| CBD 800 mg p.o. | Active comparator | The study Investigational Medical Product (IMP) is a cannabidiol solution 100 mg/ml 8 ml in single-dose containers for per os administration. Receives: Drug: CBD 800 mg p.o |
| Placebo p.o. | Placebo comparator | Participants in the control arm will be receiving a single dose of oral placebo solution 8 ml matched to the active comparator. Receives: Drug: Placebo p.o |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: pain will be assessed every 10 minutes using the NRS from minute 70 to 130
Secondary outcomes (2)
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 1/4πD·d.
Measured: from minute 70 to 130
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 1/4πD·d.
Measured: from minute 70 to 130
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2019
- Study start16 Sep 2019
- Primary completion23 Dec 2019
- Study completion23 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain SensationStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tobias Schneider, Dr. med, Principal investigator, Department of Anaesthesiology, University Hospital of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03985995
- Sponsor's protocol ID
- 2019-00839; qu18Ruppen2
- Other IDs
- 2019
- Acronym
- CANAB I
- Status last verified
- Jan 2020
- First submitted
- 11 Jun 2019
- Last updated
- 29 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Schneider T, Zurbriggen L, Dieterle M, Mauermann E, Frei P, Mercer-Chalmers-Bender K, Ruppen W. Pain response to cannabidiol in induced acute nociceptive pain, allodynia, and hyperalgesia by using a model mimicking acute pain in healthy adults in a randomized trial (CANAB I). Pain. 2022 Jan 1;163(1):e62-e71. doi: 10.1097/j.pain.0000000000002310.
PubMed 34086631
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Response to Cannabidiol in Induced Acute Nociceptive Pain, Allodynia and Hyperalgesia By Using a Model Mimicking Acute Pain in Healthy Adults
- ClinicalTrials.gov ID
- NCT03985995
- Acronym / sponsor ID
- CANAB I / 2019-00839; qu18Ruppen2
- Conditions
- Pain Sensation, Hyperalgesia, Allodynia
- Keywords
- Cannabidiol (CBD)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 16 Sep 2019 (actual)
- Primary completion
- 23 Dec 2019 (actual)
- Study completion
- 23 Dec 2019 (actual)
- First posted
- 14 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to investigate the effect of CBD on acute pain in healthy volunteers in a well-established acute pain model.
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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBD 800 mg p.o. | Active comparator | Drug: CBD 800 mg p.oThe study Investigational Medical Product (IMP) is a cannabidiol solution 100 mg/ml 8 ml in single-dose containers for per os administration. |
| Placebo p.o. | Placebo comparator | Drug: Placebo p.oParticipants in the control arm will be receiving a single dose of oral placebo solution 8 ml matched to the active comparator. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy adults
- BMI between 18.5 until 25 kg/m2
- Able to understand the study and the NRS scale
- Able to give informed consent
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBD 800 mg p.ocannabidiol 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. | Drug | CBD 800 mg p.o. |
| Placebo p.osingle 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. | Drug | Placebo p.o. |
Primary outcome
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.
2 secondary outcomes
Change in area of hyperalgesia (cm)
Time frame: from minute 70 to 130
Change in area of allodynia (cm)
Time frame: from minute 70 to 130
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2020.
- Derived from this study: PubMed 34086631Schneider T, Zurbriggen L, Dieterle M, Mauermann E, Frei P, Mercer-Chalmers-Bender K, Ruppen W. Pain response to cannabidiol in induced acute nociceptive pain, allodynia, and hyperalgesia by using a model mimicking acute pain in healthy adults in a randomized trial (CANAB I). Pain. 2022 Jan 1;163(1):e62-e71. doi: 10.1097/j.pain.0000000000002310.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tobias Schneider, Dr. med principal investigator
Department of Anaesthesiology, University Hospital of Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBD 800 mg p.o in people with Pain Sensation and Hyperalgesia, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03985995, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2020.