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

University Hospital Basel

Status: Completed

Conditions: Pain Sensation; Hyperalgesia; Allodynia

Treatments: Drug: CBD 800 mg p.o; Drug: Placebo p.o

Study type: Interventional

Funder types: Other

Identifiers

NCT03985995

2019-00839 qu18Ruppen2;

Details and patient eligibility

About

This study is to investigate the effect of CBD on acute pain in healthy volunteers in a well-established acute pain model.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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20 participants in 2 patient groups, including a placebo group

CBD 800 mg p.o.

Active Comparator group

Description:

The study Investigational Medical Product (IMP) is a cannabidiol solution 100 mg/ml 8 ml in single-dose containers for per os administration.

Treatment:

Drug: CBD 800 mg p.o

Placebo p.o.

Placebo Comparator group

Description:

Participants in the control arm will be receiving a single dose of oral placebo solution 8 ml matched to the active comparator.

Treatment:

Drug: Placebo p.o