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CBD-Microglia PET Study

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ClinicalTrials.gov Identifier: NCT04398719
Recruitment Status : Recruiting
First Posted : May 21, 2020
Last Update Posted : January 11, 2021
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Rajiv Radhakrishnan, Yale University

Study Description
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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
CBD Healthy 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
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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : January 12, 2021
Estimated Primary Completion Date : August 31, 2022
Estimated Study Completion Date : March 1, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Capsaicin

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: CBD Radiation: [11C]PBR28
The radiotracer, [11C]PBR28, will be administered at the beginning of each PET scan
Other Name: PET scan

Drug: Low-dose lipopolysaccharide
Subjects will receive intravenous lipopolysaccharide.
Other Name: 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 Name: PET scan

Drug: Low-dose lipopolysaccharide
Subjects will receive intravenous lipopolysaccharide.
Other Name: LPS

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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. Capsaicin-induced hyperalgesia [ Time Frame: 10 Days ]
    Difference in capsaicin-induced hyperalgesia between the 2 groups (e.g., CBD vs. placebo)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04398719


Contacts
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Contact: Rajiv Radhakrishnan, MD 203-974-7489 rajiv.radhakrishnan@yale.edu
Contact: Mohini Ranganathan, MD (203)932-5711 ext 2546 mohini.ranganathan@yale.edu

Locations
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United States, Connecticut
Connecticut Mental Health Center Recruiting
New Haven, Connecticut, United States, 06519
Contact    203-974-7775      
Principal Investigator: Rajiv Radhakrishnan, MD         
Principal Investigator: Mohini Ranganathan, MD         
Sponsors and Collaborators
Yale University
National Center for Complementary and Integrative Health (NCCIH)
Investigators
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Principal Investigator: Rajiv Radhakrishnan, MD Yale University
More Information
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Responsible Party: Rajiv Radhakrishnan, Assistant Professor of Psychiatry, Yale University
ClinicalTrials.gov Identifier: NCT04398719    
Other Study ID Numbers: 2000026320
First Posted: May 21, 2020    Key Record Dates
Last Update Posted: January 11, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rajiv Radhakrishnan, Yale University:
Control
PET Scan
MRI Scan
Central Pain-Sensitization
Additional relevant MeSH terms:
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Capsaicin
Antipruritics
Dermatologic Agents
 Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs