NCT04059978

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 12, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 16, 2019

Completed
9 months until next milestone

Study Start

First participant enrolled

May 26, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2020

Completed
Last Updated

October 19, 2020

Status Verified

October 1, 2020

Enrollment Period

5 months

First QC Date

August 12, 2019

Last Update Submit

October 15, 2020

Conditions

Acute Nociceptive PainHyperalgesiaAllodyniaOpioid-induced Hyperalgesia

Keywords

CannabidiolRemifentanil

Outcome Measures

Primary Outcomes (1)

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

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

    from minute 100 to minute 160 after termination of remifentanil infusion

Secondary Outcomes (5)

  • 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)

    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)

    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

Study Arms (2)

CBD + Remifentanil

ACTIVE COMPARATOR

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

Drug: CBDDrug: Remifentanil

Placebo + Remifentanil

PLACEBO COMPARATOR

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

Drug: PlaceboDrug: Remifentanil

Interventions

CBDDRUG

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

CBD + Remifentanil
PlaceboDRUG

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

Placebo + Remifentanil
RemifentanilDRUG

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

CBD + RemifentanilPlacebo + Remifentanil

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anaesthesiology, University Hospital of Basel (USB)

Basel, 4031, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 35239547DERIVED

MeSH Terms

Conditions

Hyperalgesia

Interventions

Remifentanil

Condition Hierarchy (Ancestors)

Somatosensory DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PropionatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Tobias Schneider, MD

    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

August 12, 2019

First Posted

August 16, 2019

Study Start

May 26, 2020

Primary Completion

October 15, 2020

Study Completion

October 15, 2020

Last Updated

October 19, 2020

Record last verified: 2020-10

Locations

CH(1)