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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
CBD Healthy | Radiation: [11C]PBR28 Drug: Low-dose lipopolysaccharide Drug: Intradermal Capsaicin | Early Phase 1 |
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 |

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

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

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
Contact: Rajiv Radhakrishnan, MD | 203-974-7489 | rajiv.radhakrishnan@yale.edu | |
Contact: Mohini Ranganathan, MD | (203)932-5711 ext 2546 | mohini.ranganathan@yale.edu |
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 |
Principal Investigator: | Rajiv Radhakrishnan, MD | Yale University |
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 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Control PET Scan MRI Scan Central Pain-Sensitization |
Capsaicin Antipruritics Dermatologic Agents |
Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs |