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Completed

NCT Number: NCT04044729

Mechanisms of CBD for Chronic Pain

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

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Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University Of Utah

Salt Lake City, Utah, 84108, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cannabidiol

Drug

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

Placebo

Drug

Placebo

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Aug 5, 2019
Registry last updated
Apr 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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