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

NCT03985995 | Completed

• 1 other identifier: 2019-00839; qu18Ruppen2
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Keywords

Cannabidiol (CBD)

Outcome Measures

Primary Outcomes (1)

• 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.

  pain will be assessed every 10 minutes using the NRS from minute 70 to 130

Secondary Outcomes (2)

• Change in area of hyperalgesia (cm)

  from minute 70 to 130

• Change in area of allodynia (cm)

  from minute 70 to 130

Study Arms (2)

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.

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.

Drug: Placebo p.o

Interventions

CBD 800 mg p.o 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.

CBD 800 mg p.o.

Placebo p.o 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.

Placebo p.o.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adults
• BMI between 18.5 until 25 kg/m2
• Able to understand the study and the NRS scale
• Able to give informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

Department of Anaesthesiology, University Hospital of Basel (USB)

Basel, 4031, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 34086631 DERIVED

MeSH Terms

Conditions

Hyperalgesia

Condition Hierarchy (Ancestors)

Somatosensory Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Tobias Schneider, Dr. med

  Department of Anaesthesiology, University Hospital of Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2019
• First Posted: June 14, 2019
• Study Start: September 16, 2019
• Primary Completion: December 23, 2019
• Study Completion: December 23, 2019
• Last Updated: January 29, 2020

Record last verified: 2020-01

Locations

CH (1)