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Mechanisms of CBD for Chronic Pain

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ClinicalTrials.gov Identifier: NCT04044729
Recruitment Status : Not yet recruiting
First Posted : August 5, 2019
Last Update Posted : August 5, 2019
Sponsor:
Information provided by (Responsible Party):
Deborah Yurgelun-Todd, University of Utah

Tracking Information
First Submitted Date  ICMJE August 1, 2019
First Posted Date  ICMJE August 5, 2019
Last Update Posted Date August 5, 2019
Estimated Study Start Date  ICMJE January 1, 2020
Estimated Primary Completion Date December 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 1, 2019)
Neurochemical Brain Changes [ Time Frame: 5 Days ]
Participants will undergo MRS scanning to assess neurochemical shifts from the baseline visit (day 1) to the visit five (day 5) in order to determine whether CBD, or Placebo will result in changes to neurochemical ratios in select brain regions. Neurotransmitter levels such as BABA and N-Acetylaspartate will be collected and compared pre and post study drug administration.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 1, 2019)
Pain Improvement [ Time Frame: 7 Days ]
Using baseline assessment measures gathered at visit 0 (Screening), assessments collected at visits 1-5 and follow-up will be used to determine whether the administration of CBD or placebo will improve pain relief in individuals with chronic pain. We will measure pain intensity with a visual analog scale from (0-10) with 10 being the worst pain imaginable. We will also measure Objective pain thresholds with a pressure algometer. This is a device that applies pressure to the participants finger until they say stop. The pressure range is 0-50 foot pounds of force.
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 Mechanisms of CBD for Chronic Pain
Official Title  ICMJE Exploring the Mechanisms Underlying the Analgesic Properties of Cannabidiol Using Magnetic Resonance Spectroscopy
Brief Summary This is a study designed to examine the neurochemical mechanisms associated with Cannabidiol (CBD) versus placebo for chronic non-cancer pain.
Detailed Description The aim of this trial is to examine the neurochemical mechanisms associated with Cannabidiol (CBD) versus placebo for chronic non-cancer pain. Participants will include individuals with chronic pain, who will be randomized into one of two intervention conditions: low THC/high CBD or placebo. In addition to receiving CBD or placebo, participants also will complete symptom assessments of chronic pain data (intensity, quality, interference/disability) throughout the study. These measures will be gathered prior to and following the fifth doses (dosing will occur once per day for five days) of CBD or placebo. A secondary objective will be to examine the association between clinical and inflammatory markers.
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Chronic Pain
Intervention  ICMJE
  • Drug: Cannabidiol
    500mg dose, suspended in medical grade olive oil and then mixed into chocolate pudding
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Active Comparator: Cannabidiol

    Drug: Cannabidiol An oral dose of Cannabidiol (CBD) will be given once a day for five day with pain ratings taken before and after each dose every day.

    Other Names:

    CBD

    Intervention: Drug: Cannabidiol
  • Placebo Comparator: Placebo

    Drug: Placebos An oral placebo will be given once a day for five day with pain ratings taken before and after each dose every day.

    Other Names:

    placebo

    Intervention: Drug: Placebo
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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: August 1, 2019)
52
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2021
Estimated Primary Completion Date December 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age between 18-50 yrs.
  • Chronic musculoskeletal and joint pain for at least 3 months or longer.
  • Participants must live within a 60 mile radius of Salt Lake City, Utah to be eligible.

Exclusion Criteria:

  • Current or past neurological illness.
  • Substance abuse or dependence within the prior 90 days.
  • Contraindication to brain MRI.
  • Type I and type II diabetes.
  • Unstable medical conditions.
  • Consumption of more than 2 drinks of alcohol per night.
  • Current pregnancy or planning to become pregnant or breastfeeding.
  • History of seizures or head trauma at PI discretion.
  • Active or history of major mental illness
  • Use of opioid medications in the past 30 days.
  • LFT results 3 times greater than the upper limit of normal at the screening.
  • Participants may be excluded if the PI feels they do not meet safety criteria.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Matt Hodgkinson, B.S.,RN 801-213-0658 chronic_pain_study_utah@umail.utah.edu
Contact: Deborah Yurgelun-Todd, PhD
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04044729
Other Study ID Numbers  ICMJE IRB_00124865
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: The investigators are still deciding on if and what IPD will be shared and the details involved. The investigators will update when a plan is in place.
Responsible Party Deborah Yurgelun-Todd, University of Utah
Study Sponsor  ICMJE University of Utah
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Utah
Verification Date August 2019

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