Treatment of Chronic Pain With Cannabidiol (CBD) and Delta-9-tetrahydrocannabinol (THC)

Last updated: April 9, 2025
Sponsor: University of Utah
Overall Status: Completed

Phase

1

Condition

Chronic Pain

Pain

Treatment

Delta-9-Tetrahydrocannabinol

Cannabidiol

Placebos

Clinical Study ID

NCT03215940
IRB_00103451
  • Ages 18-50
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

This is a study comparing the effects of Delta-9-Tetrahydrocannabinol (THC) versus Cannabidiol (CBD) versus a placebo on chronic non-cancer pain.

Eligibility Criteria

Inclusion

Inclusion criteria:

  1. Age between 18-50 yrs.

  2. History of cannabis use.

  3. Chronic musculoskeletal and joint pain for at least 3 months or longer.

  4. Participants must live within a 60 mile radius of Salt Lake City, Utah to beeligible.

Exclusion

Exclusion criteria:

  1. Current or past neurological illness.

  2. Substance abuse or dependence within the prior 60 days.

  3. Contraindication to brain MRI.

  4. Type I and type II diabetes.

  5. Unstable medical conditions.

  6. Consumption of more than 2 drinks of alcohol per night.

  7. Current pregnancy or planning to become pregnant or breastfeeding

  8. History of seizures or head trauma

  9. Active or history of major mental illness

  10. LFT results 3 times greater than the upper limit of normal at screening.

  11. Participants may be excluded if the PI feels they do not meet safety criteria.

Study Design

Total Participants: 53
Treatment Group(s): 3
Primary Treatment: Delta-9-Tetrahydrocannabinol
Phase: 1
Study Start date:
February 01, 2018
Estimated Completion Date:
December 01, 2024

Study Description

The overall aim of this study is to examine the effects of Delta-9-tetrahydrocannabinol (THC) and Cannabidiol (CBD) on chronic pain symptoms, specifically we will examine the effects of different doses of THC/CBD on symptoms of chronic pain and life functioning. Participants will include individuals with chronic pain, who will be randomized into one of three intervention conditions: high THC/low CBD, low THC/high CBD, or placebo. In addition to receiving THC/CBD/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/THC or placebo. A secondary objective will be to examine the association between clinical and neurocognitive variables and use of CBD/THC, including the potential side effects of THC/CBD. Other secondary objectives include the use of magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS), acquired before and after final administration with CBD/THC or placebo to examine differences in brain metabolism, brain connectivity, and brain structure. Imaging analyses will focus on regional brain changes before and after administration of THC/CBD/placebo.

Connect with a study center

  • University Of Utah

    Salt Lake City, Utah 84108
    United States

    Site Not Available

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