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Completed

NCT Number: NCT04398719

CBD-Microglia PET Study

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.

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Key information

Conditions

CBD Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Connecticut Mental Health Center

New Haven, Connecticut, 06519, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

[11C]PBR28

Radiation

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

Other names: PET scan

Low-dose lipopolysaccharide

Drug

Subjects will receive intravenous lipopolysaccharide.

Other names: LPS

Intradermal Capsaicin

Drug

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

Primary outcomes

  1. Microglial activation using [11C]PBR28 PET imaging

    Time frame: 10 Days

    Difference in microglial activation ([11C]PBR28 VT levels) between the 2 groups (e.g., CBD vs. placebo)

Secondary outcomes

  1. Capsaicin-induced hyperalgesia

    Time frame: 10 Days

    Difference in capsaicin-induced hyperalgesia between the 2 groups (e.g., CBD vs. placebo)

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

Effect of Cannabidiol on Microglial Activation and Central Pain-Sensitization

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
May 21, 2020
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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