Treatment of Chronic pain with CBD and THC

Principal Investigator: Deborah Yurgelun-Todd
Keywords: Chronic pain , musculoskeletal pain , THC , CBD Department: Psychiatry
IRB Number: 00103451 Co Investigator: Maragret Legarretta
Specialty: Psychiatry, Anesthesiology
Sub Specialties: Chronic Pain
Recruitment Status: Active, not recruiting

Contact Information

Matthew Hodgkinson
matthew.hodgkinson@utah.edu
801-419-3072

Brief Summary

The overall aim of this study is to examine the effects of orally does 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.  

Primary Endpoints:  Primary endpoints will consist of clinical symptom measures of pain severity, intensity, and quality; functional behavior; and the impact or interference of pain with daily functions, and differences in brain metabolism, connectivity, and structure to determine the effect of THC/CBD or placebo after 5 days of administration.

Secondary Endpoints:  Determine if there are changes in neuropsychological performance, mood, visual acuity, rates of adverse events, and changes in blood chemistry, following 5 days administration of CBD/THC or placebo.

Detailed Description

The overall aim of this study is to examine the effects of 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. Other important 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. 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.

Inclusion Criteria

1. Ability to provide written informed consent

2. Age between 18-50 yrs.

3. History of cannabis use.

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

 

 

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.