Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
Trial record 20 of 3318 for:    Area Under Curve AND Healthy

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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04059978
Recruitment Status : Recruiting
First Posted : August 16, 2019
Last Update Posted : November 6, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Tracking Information
First Submitted Date  ICMJE August 12, 2019
First Posted Date  ICMJE August 16, 2019
Last Update Posted Date November 6, 2019
Actual Study Start Date  ICMJE November 5, 2019
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 15, 2019)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT04059978 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 15, 2019)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pain Response to Cannabidiol in Opioid-induced Hyperalgesia, Acute Nociceptive Pain and Allodynia By Using a Model Mimicking Acute Pain in Healthy Adults
Official Title  ICMJE Pain Response to Cannabidiol in Opioid-induced Hyperalgesia, Acute Nociceptive Pain and Allodynia By Using a Model Mimicking Acute Pain in Healthy Adults
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE
  • Acute Nociceptive Pain
  • Hyperalgesia
  • Allodynia
  • Opioid-induced Hyperalgesia
Intervention  ICMJE
  • Drug: CBD
    800mg cannabidiol, single oral dose (8 ml oily solution)
  • Drug: Placebo
    Placebo p.o, single oral dose (8 ml oily solution)
  • Drug: Remifentanil
    Remifentanil 0.1 µg/kg/min i.v. for 30 min
Study Arms  ICMJE
  • Active Comparator: CBD + Remifentanil
    CBD 800 mg p.o. + Remifentanil 0.1 µg/kg/min i.v. for 30 min
    Interventions:
    • Drug: CBD
    • Drug: Remifentanil
  • Placebo Comparator: Placebo + Remifentanil
    Placebo p.o + Remifentanil 0.1 µg/kg/min i.v. for 30 min
    Interventions:
    • Drug: Placebo
    • Drug: Remifentanil
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 15, 2019)
23
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2020
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Tobias Schneider, MD +4161 328 51 65 tobias.schneider@usb.ch
Contact: Wilhelm Ruppen, Prof. MD +41613286496 wilhelm.ruppen@usb.ch
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04059978
Other Study ID Numbers  ICMJE 2019-01217; qu18Ruppen3
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Basel, Switzerland
Study Sponsor  ICMJE University Hospital, Basel, Switzerland
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Tobias Schneider, MD Department of Anaesthesiology, University Hospital of Basel
PRS Account University Hospital, Basel, Switzerland
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP