CBD-Microglia PET Study

Yale University

Status and phase: Enrolling; Early Phase 1

Conditions: Healthy; CBD

Treatments: Drug: Intradermal Capsaicin; Drug: Low-dose lipopolysaccharide; Radiation: [11C]PBR28

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04398719

2000026320

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Men and women aged 18- 55 years
2. No significant medical or neurological illness
3. No implanted metal devices that may pose a risk during MRI scanning
4. Within the annual permissible radiation exposure
5. Able to provide written informed consent.

Exclusion criteria

1. Current use of any medications
2. Presence of metal in the body
3. Pregnancy or lactation

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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15 participants in 2 patient groups, including a placebo group

CBD

Active Comparator group

Treatment:

Radiation: [11C]PBR28

Drug: Low-dose lipopolysaccharide

Drug: Intradermal Capsaicin

Placebo

Placebo Comparator group

Treatment:

Radiation: [11C]PBR28

Drug: Low-dose lipopolysaccharide

Drug: Intradermal Capsaicin