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

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.

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.