CBD-Microglia PET Study

July 13, 2023 updated by: Rajiv Radhakrishnan, MD, Yale University

Effect of Cannabidiol on Microglial Activation and Central Pain-Sensitization

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Recruiting
        • Connecticut Mental Health Center
        • Principal Investigator:
          • Mohini Ranganathan, MD
        • Principal Investigator:
          • Rajiv Radhakrishnan, MD
        • Contact:
          • Phone Number: 203-974-7775

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
10 Days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

Investigators

  • Principal Investigator: Rajiv Radhakrishnan, MD, Yale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 7, 2021

Primary Completion (Estimated)

August 31, 2024

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

May 19, 2020

First Submitted That Met QC Criteria

May 19, 2020

First Posted (Actual)

May 21, 2020

Study Record Updates

Last Update Posted (Actual)

July 14, 2023

Last Update Submitted That Met QC Criteria

July 13, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2000026320

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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