CBD-Microglia PET Study

Study Overview
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Brief Summary
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This study aims to examine the effect of cannabidiol (CBD) pre-treatment on brain microglial activation in healthy human subjects. Secondarily, this study aims to examine the effect of cannabidiol (CBD) pre-treatment on central pain-sensitization in healthy human subjects.

Detailed Description
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This study aims to examine the effect of cannabidiol (CBD), pre-treatment, as Epidiolex, on brain microglial activation in healthy human subjects using [11C]PBR28 PET imaging. Secondarily, this study aims to examine the effect of cannabidiol (CBD) pre-treatment on central pain-sensitization in healthy human subjects. Lastly, this research study will also examine the relationship between brain microglial activation and central pain sensitization with CBD pre-treatment.

Official Title
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Effect of Cannabidiol on Microglial Activation and Central Pain-Sensitization

Conditions
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CBD, Healthy

Intervention / Treatment
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* Radiation: [11C]PBR28
* Drug: Low-dose lipopolysaccharide
* Drug: Intradermal Capsaicin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women aged 18- 55 years No significant medical or neurological illness No implanted metal devices that may pose a risk during MRI scanning Within the annual permissible radiation exposure Able to provide written informed consent. Exclusion Criteria: Current use of any medications Presence of metal in the body Pregnancy or lactation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CBD<br> | Radiation: [11C]PBR28<br>* The radiotracer, [11C]PBR28, will be administered at the beginning of each PET scan<br>* Other names: PET scan;Drug: Low-dose lipopolysaccharide<br>* Subjects will receive intravenous lipopolysaccharide.<br>* Other names: LPS;Drug: Intradermal Capsaicin<br>* A small dose of capsaicin will be administered by intradermal injection.<br>|
| Placebo Comparator: Placebo<br> | Radiation: [11C]PBR28<br>* The radiotracer, [11C]PBR28, will be administered at the beginning of each PET scan<br>* Other names: PET scan;Drug: Low-dose lipopolysaccharide<br>* Subjects will receive intravenous lipopolysaccharide.<br>* Other names: LPS;Drug: Intradermal Capsaicin<br>* A small dose of capsaicin will be administered by intradermal injection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microglial activation using [11C]PBR28 PET imaging | Difference in microglial activation ([11C]PBR28 VT levels) between the 2 groups (e.g., CBD vs. placebo) | 10 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Capsaicin-induced hyperalgesia | Difference in capsaicin-induced hyperalgesia between the 2 groups (e.g., CBD vs. placebo) | 10 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Control, PET Scan, MRI Scan, Central Pain-Sensitization, Cannabidiol