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

Utah System of Higher Education (USHE)

Status and phase: Completed; Early Phase 1

Conditions: Chronic Pain, Widespread

Treatments: Drug: Delta-9-Tetrahydrocannabinol; Drug: Cannabidiol; Drug: Placebos

Study type: Interventional

Funder types: Other

Identifiers

NCT03215940

IRB_00103451

Details and patient eligibility

About

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

Full 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.

Enrollment: 53 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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53 participants in 3 patient groups, including a placebo group

Delta-9-Tetrahydrocannabinol's (Delta-9-THC) effects on pain

Active Comparator group

Description:

This arm will be testing the analgesic effects of orally dosed Delta-9-Tetrahydrocannabinol on subjects with chronic non-cancer pain.

Treatment:

Drug: Delta-9-Tetrahydrocannabinol

Cannabidiol's (CBD) effects on pain

Active Comparator group

Description:

This arm will be testing the analgesic effects of orally dosed Cannabidiol on subjects with chronic non-cancer pain.

Treatment:

Drug: Cannabidiol

Placebo

Placebo Comparator group

Description:

This Placebo arm will act as the control as standard of care medications will be continued through the study. This arm will allow us to compare the analgesic effects of the other two arms with the standard of care treatments for chronic non-cancer pain.

Treatment:

Drug: Placebos