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)

October 15, 2020 updated by: University Hospital, Basel, Switzerland
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland, 4031
        • Department of Anaesthesiology, University Hospital of Basel (USB)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: CBD + Remifentanil
CBD 1600 mg p.o. + Remifentanil 0.1 µg/kg/min i.v. for 30 min
Drug: CBD
1600mg cannabidiol, single oral dose (8 ml oily solution)
Drug: Remifentanil
Remifentanil 0.1 µg/kg/min i.v. for 30 min
PLACEBO_COMPARATOR: Placebo + Remifentanil
Placebo p.o + Remifentanil 0.1 µg/kg/min i.v. for 30 min
Drug: Remifentanil
Remifentanil 0.1 µg/kg/min i.v. for 30 min
Drug: Placebo
Placebo p.o, single oral dose (8 ml oily solution)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in hyperalgesia measured by the area under the curve (AUCHyper)
Time Frame: from minute 100 to minute 160 after termination of remifentanil infusion
Change in hyperalgesia measured by the area under the curve (AUCHyper)
from minute 100 to minute 160 after termination of remifentanil infusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in pain response (NRS) measured by the area under the curve (AUCNRS)
Time Frame: from minute 70 to minute 90 during remifentanil infusion
Change in pain response (NRS) measured by the area under the curve (AUCNRS)
from minute 70 to minute 90 during remifentanil infusion
Change in hyperalgesia measured by the area under the curve (AUCHyper)
Time Frame: from minute 70 to minute 90 during remifentanil infusion
Change in hyperalgesia measured by the area under the curve (AUCHyper)
from minute 70 to minute 90 during remifentanil infusion
Change in allodynia measured by the area under the curve (AUCAllo)
Time Frame: from minute 70 to minute 90 during remifentanil infusion
Change in allodynia measured by the area under the curve (AUCAllo)
from minute 70 to minute 90 during remifentanil infusion
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
Change in pain response (NRS) measured by the area under the curve (AUCNRS)
from minute 100 to minute 160 after termination of remifentanil infusion
Change in allodynia measured by the area under the curve (AUCAllo)
Time Frame: from minute 100 to minute 160 after termination of remifentanil infusion
Change in allodynia measured by the area under the curve (AUCAllo)
from minute 100 to minute 160 after termination of remifentanil infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Investigators

  • Principal Investigator: Tobias Schneider, MD, Department of Anaesthesiology, University Hospital of Basel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 26, 2020

Primary Completion (ACTUAL)

October 15, 2020

Study Completion (ACTUAL)

October 15, 2020

Study Registration Dates

First Submitted

August 12, 2019

First Submitted That Met QC Criteria

August 15, 2019

First Posted (ACTUAL)

August 16, 2019

Study Record Updates

Last Update Posted (ACTUAL)

October 19, 2020

Last Update Submitted That Met QC Criteria

October 15, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-01217; qu18Ruppen3

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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