NCT04398719

CBD-Microglia PET Study

Effect of Cannabidiol on Microglial Activation and Central Pain-Sensitization

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• CBD
• Healthy

Interventions

Type	Name	Description
RADIATION	[11C]PBR28	The radiotracer, \[11C\]PBR28, will be administered at the beginning of each PET scan
DRUG	Low-dose lipopolysaccharide	Subjects will receive intravenous lipopolysaccharide.
DRUG	Intradermal Capsaicin	A small dose of capsaicin will be administered by intradermal injection.

Timeline

• Start date: 2021-05-07
• Primary completion: 2025-09-30
• Completion: 2025-09-30
• First posted: 2020-05-21
• Last updated: 2025-07-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study