Back to results

Pain Response to Cannabidiol in Opioid-induced Hyperalgesia, Acute Nociceptive Pain and Allodynia By Using a Model Mimicking Acute Pain in Healthy Adults (CANAB II)

Primary Purpose

Acute Nociceptive Pain, Hyperalgesia, Allodynia

Status

Completed

Phase

Not Applicable

Locations

Switzerland

Study Type

Interventional

Intervention

CBD

Placebo

Remifentanil

About this trial

This is an interventional basic science trial for Acute Nociceptive Pain focused on measuring Cannabidiol, Remifentanil

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

BMI between 18.5 until 25 kg/m2
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 (cf. 8.6 Trial specific preventive measures) / Lactation
Allergy / hypersensitivity to cannabidiol
Contraindications for Remifentanil (e.g. hypersensitivity)

Sites / Locations

Department of Anaesthesiology, University Hospital of Basel (USB)

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

CBD + Remifentanil

Placebo + Remifentanil

Arm Description

CBD 1600 mg p.o. + Remifentanil 0.1 µg/kg/min i.v. for 30 min

Placebo p.o + Remifentanil 0.1 µg/kg/min i.v. for 30 min

Outcomes

Primary Outcome Measures

Change in hyperalgesia measured by the area under the curve (AUCHyper)

Secondary Outcome Measures

Change in pain response (NRS) measured by the area under the curve (AUCNRS)

Change in hyperalgesia measured by the area under the curve (AUCHyper)

Change in allodynia measured by the area under the curve (AUCAllo)

Change in pain response (NRS) measured by the area under the curve (AUCNRS)

Change in allodynia measured by the area under the curve (AUCAllo)

Full Information

NCT ID

NCT04059978

First Posted

August 12, 2019

Last Updated

October 15, 2020

Sponsor

University Hospital, Basel, Switzerland

1. Study Identification

Unique Protocol Identification Number

NCT04059978

Brief Title

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

Acronym

CANAB II

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Completed

Study Start Date

May 26, 2020 (Actual)

Primary Completion Date

October 15, 2020 (Actual)

Study Completion Date

October 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Basel, Switzerland

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Nociceptive Pain, Hyperalgesia, Allodynia, Opioid-induced Hyperalgesia

Keywords

Cannabidiol, Remifentanil

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CBD + Remifentanil

Arm Type

Active Comparator

Arm Description

CBD 1600 mg p.o. + Remifentanil 0.1 µg/kg/min i.v. for 30 min

Arm Title

Placebo + Remifentanil

Arm Type

Placebo Comparator

Arm Description

Placebo p.o + Remifentanil 0.1 µg/kg/min i.v. for 30 min

Intervention Type

Drug

Intervention Name(s)

CBD

Intervention Description

1600mg cannabidiol, single oral dose (8 ml oily solution)

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo p.o, single oral dose (8 ml oily solution)

Intervention Type

Drug

Intervention Name(s)

Remifentanil

Intervention Description

Remifentanil 0.1 µg/kg/min i.v. for 30 min

Primary Outcome Measure Information:

Title

Change in hyperalgesia measured by the area under the curve (AUCHyper)

Description

Change in hyperalgesia measured by the area under the curve (AUCHyper)

Time Frame

from minute 100 to minute 160 after termination of remifentanil infusion

Secondary Outcome Measure Information:

Title

Change in pain response (NRS) measured by the area under the curve (AUCNRS)

Description

Change in pain response (NRS) measured by the area under the curve (AUCNRS)

Time Frame

from minute 70 to minute 90 during remifentanil infusion

Title

Change in hyperalgesia measured by the area under the curve (AUCHyper)

Description

Change in hyperalgesia measured by the area under the curve (AUCHyper)

Time Frame

from minute 70 to minute 90 during remifentanil infusion

Title

Change in allodynia measured by the area under the curve (AUCAllo)

Description

Change in allodynia measured by the area under the curve (AUCAllo)

Time Frame

from minute 70 to minute 90 during remifentanil infusion

Title

Change in pain response (NRS) measured by the area under the curve (AUCNRS)

Description

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

Title

Change in allodynia measured by the area under the curve (AUCAllo)

Description

Change in allodynia measured by the area under the curve (AUCAllo)

Time Frame

from minute 100 to minute 160 after termination of remifentanil infusion

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: BMI between 18.5 until 25 kg/m2 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 (cf. 8.6 Trial specific preventive measures) / Lactation Allergy / hypersensitivity to cannabidiol Contraindications for Remifentanil (e.g. hypersensitivity)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tobias Schneider, MD

Organizational Affiliation

Department of Anaesthesiology, University Hospital of Basel

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Anaesthesiology, University Hospital of Basel (USB)

City

Basel

ZIP/Postal Code

4031

Country

Switzerland

12. IPD Sharing Statement

Citations:

PubMed Identifier

35239547

Citation

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.

Results Reference

derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs