Mechanisms of CBD for Chronic Pain

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

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

Study Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Drug: Placebo; Drug: Cannabidiol

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: Interventional
• Enrollment (Actual): 24
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84108
      • University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Utah

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2020
• Primary Completion (Actual): December 1, 2024
• Study Completion (Actual): December 1, 2024

Study Registration Dates

• First Submitted: August 1, 2019
• First Submitted That Met QC Criteria: August 1, 2019
• First Posted (Actual): August 5, 2019

Study Record Updates

• Last Update Posted (Actual): April 13, 2025
• Last Update Submitted That Met QC Criteria: April 9, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain; Anticonvulsants; Cannabidiol
• Other Study ID Numbers: IRB_00124865

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No