Clinical trial NCT03985995: Pain Response to Cannabidiol in Induced Acute Nociceptive Pain, Allodynia and Hyperalgesia By Using a Model Mimicking Acute Pain in Healthy Adults
Official title: Pain Response to Cannabidiol in Induced Acute Nociceptive Pain, Allodynia and Hyperalgesia By Using a Model Mimicking Acute Pain in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain Sensation
Hyperalgesia
Allodynia
Keywords: Cannabidiol (CBD)
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2019-06-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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:

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.

Eligibility 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

Primary outcomes:
measure: Change in pain (numeric rating scale (NRS): 0 = no pain and 10 = maximum tolerable pain)
timeFrame: pain will be assessed every 10 minutes using the NRS from minute 70 to 130
Secondary outcomes:
measure: Change in area of hyperalgesia (cm)
timeFrame: from minute 70 to 130
measure: Change in area of allodynia (cm)
timeFrame: from minute 70 to 130
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Department of Anaesthesiology, University Hospital of Basel (USB)
Study officials:
affiliation: Department of Anaesthesiology, University Hospital of Basel
name: Tobias Schneider, Dr. med
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.