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NCT04398719 Clinical Trial

CBD-Microglia PET Study

Healthy Clinical Trial

Official title:
Effect of Cannabidiol on Microglial Activation and Central Pain-Sensitization

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04398719
Other study ID # 2000026320
Secondary ID
Status Recruiting
Phase Early Phase 1
First received
Last updated
Start date May 7, 2021
Est. completion date March 1, 2025

Study information
Verified date July 2023
Source Yale University
Contact Rajiv Radhakrishnan, MD
Phone 203-974-7489
Email rajiv.radhakrishnan@yale.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 15
Est. completion date March 1, 2025
Est. primary completion date August 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Connecticut Mental Health Center New Haven Connecticut

Sponsors (2)
Lead Sponsor Collaborator
Yale University National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Microglial activation using [11C]PBR28 PET imaging Difference in microglial activation ([11C]PBR28 VT levels) between the 2 groups (e.g., CBD vs. placebo) 10 Days
Secondary Capsaicin-induced hyperalgesia Difference in capsaicin-induced hyperalgesia between the 2 groups (e.g., CBD vs. placebo) 10 Days
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