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

NCT ID: NCT03985995

Last Updated: 2020-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-16
• Study Completion Date: 2019-12-23

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.

Conditions

Pain Sensation; Hyperalgesia; Allodynia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

CBD 800 mg p.o

Intervention Type: DRUG

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.o.

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

Group Type: PLACEBO_COMPARATOR

Placebo p.o

Intervention Type: DRUG

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.

Interventions

CBD 800 mg p.o

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.

Intervention Type: DRUG

Placebo p.o

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tobias Schneider, Dr. med

Role: PRINCIPAL_INVESTIGATOR

Department of Anaesthesiology, University Hospital of Basel

Locations

Department of Anaesthesiology, University Hospital of Basel (USB)

Basel, , Switzerland

Countries

Switzerland

References

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.

Reference Type: DERIVED

PMID: 34086631 (View on PubMed)

Other Identifiers

2019-00839; qu18Ruppen2

Identifier Type: -

Identifier Source: org_study_id