Back to resultsMechanisms of CBD for Chronic Pain
Primary Purpose
Chronic Pain
Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cannabidiol
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain
Eligibility 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.
Sites / Locations
- University Of UtahRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Cannabidiol
Placebo
Arm Description
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: 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
Outcomes
Primary Outcome Measures
Neurochemical Brain Changes
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
Pain Improvement
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04044729
Brief Title
Mechanisms of CBD for Chronic Pain
Official Title
Exploring the Mechanisms Underlying the Analgesic Properties of Cannabidiol Using Magnetic Resonance Spectroscopy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 16, 2020 (Actual)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
February 28, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
52 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cannabidiol
Arm Type
Active Comparator
Arm Description
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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Cannabidiol
Intervention Description
500mg dose, suspended in medical grade olive oil and then mixed into chocolate pudding
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Neurochemical Brain Changes
Description
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.
Time Frame
5 Days
Secondary Outcome Measure Information:
Title
Pain Improvement
Description
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.
Time Frame
7 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Matt Hodgkinson, B.S.,RN
Phone
801-213-0658
Email
chronic_pain_study_utah@umail.utah.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Deborah Yurgelun-Todd, PhD
Facility Information:
Facility Name
University Of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing 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.
Learn more about this trial
Mechanisms of CBD for Chronic Pain
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