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

Recruiting
18 - 50 years of age
Both
Phase N/A

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Overview

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

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.

Eligibility

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 be eligible.

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 details

Chronic Pain, Widespread

NCT03215940

University of Utah

29 April 2024

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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