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CBD-Microglia PET Study

Sponsor
Yale University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04398719
Collaborator
National Center for Complementary and Integrative Health (NCCIH) (NIH)
15
Enrollment
1
Location
2
Arms
21.8
Anticipated Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Radiation: [11C]PBR28
  • Drug: Low-dose lipopolysaccharide
  • Drug: Intradermal Capsaicin
 Early Phase 1

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 Design

Study Type:
Interventional
Anticipated Enrollment :
15 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Other
Official Title:
Effect of Cannabidiol on Microglial Activation and Central Pain-Sensitization
Actual Study Start Date :
May 7, 2021
Anticipated Primary Completion Date :
Aug 31, 2022
Anticipated Study Completion Date :
Mar 1, 2023

Arms and Interventions

Arm Intervention/Treatment
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.
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Microglial activation using [11C]PBR28 PET imaging [10 Days]

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

    Secondary Outcome Measures

    1. Capsaicin-induced hyperalgesia [10 Days]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Connecticut Mental Health Center New Haven Connecticut United States 06519

    Sponsors and Collaborators

    • Yale University
    • National Center for Complementary and Integrative Health (NCCIH)

    Investigators

    • Principal Investigator: Rajiv Radhakrishnan, MD, Yale University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Rajiv Radhakrishnan, Assistant Professor of Psychiatry, Yale University
    ClinicalTrials.gov Identifier:
    NCT04398719
    Other Study ID Numbers:
    • 2000026320
    First Posted:
    May 21, 2020
    Last Update Posted:
    Sep 8, 2021
    Last Verified:
    Sep 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Rajiv Radhakrishnan, Assistant Professor of Psychiatry, Yale University
    Control
    PET Scan
    MRI Scan
    Central Pain-Sensitization
    Additional relevant MeSH terms:
    Capsaicin

    Study Results

    No Results Posted as of Sep 8, 2021