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

Chronic Pain, Widespread Clinical Trial

Official title:

Treatment of Chronic Pain With Cannabidiol (CBD) and Delta-9-tetrahydrocannabinol (THC): Effectiveness, Side Effects and Neurobiological Changes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03215940
• Other study ID #: IRB_00103451
• Status: Recruiting
• Phase: Early Phase 1
• Start date: February 1, 2018
• Est. completion date: March 2025

Study information

• Verified date: April 2024
• Source: University of Utah
• Contact: Matt Hodgkinson, B.S.,RN
• Phone: 801-213-0658
• Email: chronic_pain_study_utah[@]umail.utah.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: March 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

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.

Related Conditions & MeSH terms

• Chronic Pain
• Chronic Pain, Widespread

Intervention

Drug:
• Delta-9-Tetrahydrocannabinol
An oral dose of Delta-9-Tetrahydrocannabinol (THC) will be given once a day for five day with pain ratings taken before and after each dose every day.
• Cannabidiol
An oral dose of Cannabidiol (CBD) will be given once a day for five day with pain ratings taken before and after each dose every day.
• Placebos
An oral placebo will be given once a day for five day with pain ratings taken before and after each dose every day.

Locations

Country	Name	City	State
United States	University Of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Neurocognitive performance	Using baseline assessment measures gathered at visit 1, assessments collected at visits 5 and follow-up will be used to determine wether the administration of Delta-9-THC, CBD, or placebo will adversely effect neurocognitive performance in individuals with chronic pain.	3 days
Primary	Brain Changes	Participants will undergo MRI scanning designed to assess white matter microstructure and focal brain activation at the baseline visit (day 1) and visit five (day 5) in order to determine whether the administration of Delta-9-THC, CBD, or Placebo will result in changes to these brain indices in participants with chronic pain.	5 days
Secondary	Improvement in pain relief	Using baseline assessment measures gathered at visit 0 (Screening), assessments collected at visits 1-5 and follow-up will be used to determine wether the administration of Delta-9-THC, CBD, or placebo will improve pain relief in individuals with chronic pain.	7 days