Mechanisms of CBD for Chronic Pain

Chronic Pain Clinical Trial

Official title:

Exploring the Mechanisms Underlying the Analgesic Properties of Cannabidiol Using Magnetic Resonance Spectroscopy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04044729
• Other study ID #: IRB_00124865
• Status: Recruiting
• Phase: Early Phase 1
• Start date: March 16, 2020
• Est. completion date: February 28, 2025

Study information

• Verified date: April 2024
• Source: University of Utah
• Contact: Matt Hodgkinson, B.S.,RN
• Phone: 801-213-0658
• Email: chronic_pain_study_utah[@]umail.utah.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: February 28, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain

Intervention

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

Locations

Country	Name	City	State
United States	University Of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	5 Days
Secondary	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.	7 Days