Acute Nociceptive PainCANAB IINCT04059978
Pain Response to Cannabidiol in Opioid-induced Hyperalgesia, Acute Nociceptive Pain and Allodynia By Using a Model Mimicking Acute Pain in Healthy Adults
A study testing CBD and Remifentanil in people with Acute Nociceptive Pain and Hyperalgesia, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
Prospective, randomized, placebo-controlled, double-blinded, crossover study to investigate the effect of cannabidiol (CBD) on remifentanil-induced hyperalgesia 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
- Acute Nociceptive Pain, Hyperalgesia, Allodynia
- What is being tested?
- CBD and Remifentanil
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteSwitzerland
- Study dates
- 26 May 2020to 15 Oct 2020
- 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
- BMI between 18.5 until 25 kg/m2
- 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
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- Known or suspected kidney or liver disease
- Pregnancy (cf. 8.6 Trial specific preventive measures) / Lactation
- Allergy / hypersensitivity to cannabidiol
- Contraindications for Remifentanil (e.g. hypersensitivity)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Anaesthesiology, University Hospital of Basel (USB)
Basel, 4031
About this study
Prospective, randomized, placebo-controlled, double-blinded, crossover study to investigate the effect of cannabidiol (CBD) on remifentanil-induced hyperalgesia in healthy volunteers in a well-established acute pain model. Participants are randomized according to the order of the two treatments (CBD + Remifentanil or Placebo + Remifentanil).
Read the detailed description
Opioid-induced hyperalgesia (OIH) is a clinically often neglected, but well described phenomenon. OIH could also be shown for Remifentanil in an acute pain model. As CBD showed antihyperalgesic potential in the animal model, this brings up the question if CBD might be used to prevent or diminish OIH. Until today there are no studies investigating CBD as an adjunct to remifentanil or other opioids regarding the OIH. This is however of great clinical value because CBD with its possible antihyperalgesic effect on the OIH might be a worthful adjunct for opioid based anaesthesia and analgesia.
Every participant will pass through two interventions with electrically induced pain (Koppert model). CBD will be applied orally at the beginning of the intervention. Pain, allodynia and hyperalgesia will be assessed and recorded every 10 min during the remifentanil infusion and afterwards.
- Being tested
- CBD, Placebo, Remifentanil
- Keywords
- Cannabidiol, Remifentanil
- Medical subject headings
- Hyperalgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBDDrug
1600mg cannabidiol, single oral dose (8 ml oily solution)
PlaceboDrug
Placebo p.o, single oral dose (8 ml oily solution)
RemifentanilDrug
Remifentanil 0.1 µg/kg/min i.v. for 30 min
| Study group | Role | What they receive |
|---|---|---|
| CBD + Remifentanil | Active comparator | CBD 1600 mg p.o. + Remifentanil 0.1 µg/kg/min i.v. for 30 min Receives: Drug: CBD; Drug: Remifentanil |
| Placebo + Remifentanil | Placebo comparator | Placebo p.o + Remifentanil 0.1 µg/kg/min i.v. for 30 min Receives: Drug: Placebo; Drug: Remifentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hyperalgesia measured by the area under the curve (AUCHyper)
Change in hyperalgesia measured by the area under the curve (AUCHyper)
Measured: from minute 100 to minute 160 after termination of remifentanil infusion
Secondary outcomes (5)
Change in pain response (NRS) measured by the area under the curve (AUCNRS)
Change in pain response (NRS) measured by the area under the curve (AUCNRS)
Measured: from minute 70 to minute 90 during remifentanil infusion
Change in hyperalgesia measured by the area under the curve (AUCHyper)
Change in hyperalgesia measured by the area under the curve (AUCHyper)
Measured: from minute 70 to minute 90 during remifentanil infusion
Change in allodynia measured by the area under the curve (AUCAllo)
Change in allodynia measured by the area under the curve (AUCAllo)
Measured: from minute 70 to minute 90 during remifentanil infusion
Change in pain response (NRS) measured by the area under the curve (AUCNRS)
Change in pain response (NRS) measured by the area under the curve (AUCNRS)
Measured: from minute 100 to minute 160 after termination of remifentanil infusion
Change in allodynia measured by the area under the curve (AUCAllo)
Change in allodynia measured by the area under the curve (AUCAllo)
Measured: from minute 100 to minute 160 after termination of remifentanil infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2019
- Study start26 May 2020
- Primary completion15 Oct 2020
- Study completion15 Oct 2020
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 Acute Nociceptive PainStudies 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
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tobias Schneider, MD, Principal investigator, Department of Anaesthesiology, University Hospital of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04059978
- Sponsor's protocol ID
- 2019-01217; qu18Ruppen3
- Other IDs
- 2019
- Acronym
- CANAB II
- Status last verified
- Oct 2020
- First submitted
- 12 Aug 2019
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dieterle M, Zurbriggen L, Mauermann E, Mercer-Chalmers-Bender K, Frei P, Ruppen W, Schneider T. Pain response to cannabidiol in opioid-induced hyperalgesia, acute nociceptive pain, and allodynia using a model mimicking acute pain in healthy adults in a randomized trial (CANAB II). Pain. 2022 Oct 1;163(10):1919-1928. doi: 10.1097/j.pain.0000000000002591. Epub 2022 Jan 24.
PubMed 35239547
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Response to Cannabidiol in Opioid-induced Hyperalgesia, Acute Nociceptive Pain and Allodynia By Using a Model Mimicking Acute Pain in Healthy Adults
- ClinicalTrials.gov ID
- NCT04059978
- Acronym / sponsor ID
- CANAB II / 2019-01217; qu18Ruppen3
- Keywords
- Cannabidiol, Remifentanil
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 26 May 2020 (actual)
- Primary completion
- 15 Oct 2020 (actual)
- Study completion
- 15 Oct 2020 (actual)
- First posted
- 16 Aug 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.
Prospective, randomized, placebo-controlled, double-blinded, crossover study to investigate the effect of cannabidiol (CBD) on remifentanil-induced hyperalgesia in healthy volunteers in a well-established acute pain model. Participants are randomized according to the order of the two treatments (CBD + Remifentanil or Placebo + Remifentanil).
Detailed description
Opioid-induced hyperalgesia (OIH) is a clinically often neglected, but well described phenomenon. OIH could also be shown for Remifentanil in an acute pain model. As CBD showed antihyperalgesic potential in the animal model, this brings up the question if CBD might be used to prevent or diminish OIH. Until today there are no studies investigating CBD as an adjunct to remifentanil or other opioids regarding the OIH. This is however of great clinical value because CBD with its possible antihyperalgesic effect on the OIH might be a worthful adjunct for opioid based anaesthesia and analgesia.
Every participant will pass through two interventions with electrically induced pain (Koppert model). CBD will be applied orally at the beginning of the intervention. Pain, allodynia and hyperalgesia will be assessed and recorded every 10 min during the remifentanil infusion and afterwards.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBD + Remifentanil | Active comparator | Drug: CBD, Drug: RemifentanilCBD 1600 mg p.o. + Remifentanil 0.1 µg/kg/min i.v. for 30 min |
| Placebo + Remifentanil | Placebo comparator | Drug: Placebo, Drug: RemifentanilPlacebo p.o + Remifentanil 0.1 µg/kg/min i.v. for 30 min |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- BMI between 18.5 until 25 kg/m2
- Able to give informed consent
Key exclusion criteria (10 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 |
|---|---|---|
| CBD1600mg cannabidiol, single oral dose (8 ml oily solution) | Drug | CBD + Remifentanil |
| PlaceboPlacebo p.o, single oral dose (8 ml oily solution) | Drug | Placebo + Remifentanil |
| RemifentanilRemifentanil 0.1 µg/kg/min i.v. for 30 min | Drug | CBD + Remifentanil, Placebo + Remifentanil |
Primary outcome
Change in hyperalgesia measured by the area under the curve (AUCHyper)
Time frame: from minute 100 to minute 160 after termination of remifentanil infusion
Change in hyperalgesia measured by the area under the curve (AUCHyper)
5 secondary outcomes
Change in pain response (NRS) measured by the area under the curve (AUCNRS)
Time frame: from minute 70 to minute 90 during remifentanil infusion
Change in hyperalgesia measured by the area under the curve (AUCHyper)
Time frame: from minute 70 to minute 90 during remifentanil infusion
Change in allodynia measured by the area under the curve (AUCAllo)
Time frame: from minute 70 to minute 90 during remifentanil infusion
Change in pain response (NRS) measured by the area under the curve (AUCNRS)
Time frame: from minute 100 to minute 160 after termination of remifentanil infusion
Change in allodynia measured by the area under the curve (AUCAllo)
Time frame: from minute 100 to minute 160 after termination of remifentanil infusion
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 19 Oct 2020.
- Derived from this study: PubMed 35239547Dieterle M, Zurbriggen L, Mauermann E, Mercer-Chalmers-Bender K, Frei P, Ruppen W, Schneider T. Pain response to cannabidiol in opioid-induced hyperalgesia, acute nociceptive pain, and allodynia using a model mimicking acute pain in healthy adults in a randomized trial (CANAB II). Pain. 2022 Oct 1;163(10):1919-1928. doi: 10.1097/j.pain.0000000000002591. Epub 2022 Jan 24.
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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, MD 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 and Remifentanil in people with Acute Nociceptive Pain 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 2 inclusion and 10 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 19 Oct 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 hyperalgesia measured by the area under the curve (AUCHyper) (time frame: from minute 100 to minute 160 after termination of remifentanil infusion). 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 NCT04059978, 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 19 Oct 2020.