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

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

Detailed Description
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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.

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

Conditions
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Chronic Pain, Widespread

Intervention / Treatment
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* Drug: Delta-9-Tetrahydrocannabinol
* Drug: Cannabidiol
* Drug: Placebos


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Age between 18-50 yrs. History of cannabis use. Chronic musculoskeletal and joint pain for at least 3 months or longer. Participants must live within a 60 mile radius of Salt Lake City, Utah to be eligible. Exclusion criteria: Current or past neurological illness. Substance abuse or dependence within the prior 60 days. Contraindication to brain MRI. Type I and type II diabetes. Unstable medical conditions. Consumption of more than 2 drinks of alcohol per night. Current pregnancy or planning to become pregnant or breastfeeding History of seizures or head trauma Active or history of major mental illness LFT results 3 times greater than the upper limit of normal at screening. Participants may be excluded if the PI feels they do not meet safety criteria.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Delta-9-Tetrahydrocannabinol's (Delta-9-THC) effects on pain<br>This arm will be testing the analgesic effects of orally dosed Delta-9-Tetrahydrocannabinol on subjects with chronic non-cancer pain. | Drug: Delta-9-Tetrahydrocannabinol<br>* 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.<br>* Other names: Delta-9-THC;|
| Active Comparator: Cannabidiol's (CBD) effects on pain<br>This arm will be testing the analgesic effects of orally dosed Cannabidiol on subjects with chronic non-cancer pain. | Drug: Cannabidiol<br>* 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.<br>* Other names: CBD;|
| Placebo Comparator: Placebo<br>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. | Drug: Placebos<br>* An oral placebo will be given once a day for five day with pain ratings taken before and after each dose every day.<br>* Other names: placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |