CBD-Microglia PET Study | NCT04398719

Studies
CBD-Microglia PET Study

NCT04398719

Sponsor

Yale University

Status

Completed

Last Update Posted

Apr 29, 2026Actual

Enrollment

28Actual

Phase

Early Phase 1

Conditions

CBD
Healthy

Interventions

[11C]PBR28
Low-dose lipopolysaccharide
Intradermal Capsaicin

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 7, 2021Actual

Primary Completion Date

Dec 11, 2024Actual

Completion Date

Dec 11, 2024Actual

First Submitted Date

May 19, 2020

First Submission Date that Met QC Criteria

May 19, 2020

First Posted Date

May 21, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 23, 2026

Last Update Posted Date

Apr 29, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mohini Ranganathan, Associate Professor of Psychiatry, Yale UniversityPrincipal Investigator

Lead Sponsor

Yale UniversityOTHER

Collaborators

Name	Class
National Center for Complementary and Integrative Health (NCCIH)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

28Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CBD	Active Comparator		Radiation: [11C]PBR28 Drug: Low-dose lipopolysaccharide Drug: Intradermal Capsaicin
Placebo	Placebo Comparator		Radiation: [11C]PBR28 Drug: Low-dose lipopolysaccharide Drug: Intradermal Capsaicin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
[11C]PBR28	Radiation	The radiotracer, [11C]PBR28, will be administered at the beginning of each PET scan	CBD Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mohini Ranganathan, MD	Yale University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Connecticut Mental Health Center		New Haven	Connecticut	06519	United States

Intervention Browse Module

MeSH Terms

ID	Term
C526315	(methyl-(11)C)N-acetyl-N-(2-methoxybenzyl)-2-phenoxy-5-pyridinamine
D009682	Magnetic Resonance Spectroscopy
D008070	Lipopolysaccharides

Ancestor Terms

ID	Term
D013057	Spectrum Analysis
D002623	Chemistry Techniques, Analytical
D008919	Investigative Techniques
D006001	Glycoconjugates

Browse Leaves

Not provided

Browse Branches

Not provided