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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

Brief Summary:
This is a study designed to examine the neurochemical mechanisms associated with Cannabidiol (CBD) versus placebo for chronic non-cancer pain.

Condition or disease Intervention/treatment Phase
Chronic Pain Drug: Cannabidiol Drug: Placebo Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Exploring the Mechanisms Underlying the Analgesic Properties of Cannabidiol Using Magnetic Resonance Spectroscopy
Estimated Study Start Date : January 1, 2020
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : December 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
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

Drug: Cannabidiol
500mg dose, suspended in medical grade olive oil and then mixed into chocolate pudding

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

Drug: Placebo
Placebo




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04044729


Contacts
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Contact: Matt Hodgkinson, B.S.,RN 801-213-0658 chronic_pain_study_utah@umail.utah.edu
Contact: Deborah Yurgelun-Todd, PhD

Sponsors and Collaborators
University of Utah

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Responsible Party: Deborah Yurgelun-Todd, Professor, University of Utah
ClinicalTrials.gov Identifier: NCT04044729     History of Changes
Other Study ID Numbers: IRB_00124865
First Posted: August 5, 2019    Key Record Dates
Last Update Posted: August 5, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
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.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Epidiolex
Anticonvulsants