Mechanisms of CBD for Chronic Pain

Early Phase 1

Completed

• Conditions: Chronic Pain
• Interventions: Drug: Placebo; Drug: Cannabidiol

• Registration Number: NCT04044729
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2019-08-01
• Study First Submitted QC: 2019-08-01
• Study First Posted: 2019-08-05
• Study Start: 2020-03-16
• Primary Completion: 2024-12-01
• Study Completion: 2024-12-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-09
• Last Update Posted: 2025-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	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
Cannabidiol	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

Primary Outcome Measures

Name	Time	Method
Neurochemical Brain Changes	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

Name	Time	Method
Pain Improvement	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.

Trial Locations

Locations (1)

University Of Utah; 🇺🇸 Salt Lake City, Utah, United States