Skip to content

CBD-Microglia PET Study

Effect of Cannabidiol on Microglial Activation and Central Pain-Sensitization

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04398719
Enrollment
28
Registered
2020-05-21
Start date
2021-05-07
Completion date
2024-12-11
Last updated
2026-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CBD, Healthy

Keywords

Control, PET Scan, MRI Scan, Central Pain-Sensitization, Cannabidiol

Brief 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.

Interventions

RADIATION[11C]PBR28

The radiotracer, \[11C\]PBR28, will be administered at the beginning of each PET scan

DRUGLow-dose lipopolysaccharide

Subjects will receive intravenous lipopolysaccharide.

DRUGIntradermal Capsaicin

A small dose of capsaicin will be administered by intradermal injection.

Sponsors

Yale University
Lead SponsorOTHER
National Center for Complementary and Integrative Health (NCCIH)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Microglial activation using [11C]PBR28 PET imaging10 DaysDifference in microglial activation (\[11C\]PBR28 VT levels) between the 2 groups (e.g., CBD vs. placebo)

Secondary

MeasureTime frameDescription
Capsaicin-induced hyperalgesia10 DaysDifference in capsaicin-induced hyperalgesia between the 2 groups (e.g., CBD vs. placebo)

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORMohini Ranganathan, MD

Yale University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 30, 2026