CBD-Microglia PET Study

NCT ID: NCT04398719

Last Updated: 2025-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-07

Study Completion Date

2025-09-30

Brief Summary

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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

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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.

Conditions

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CBD Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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CBD

Group Type ACTIVE_COMPARATOR

[11C]PBR28

Intervention Type RADIATION

The radiotracer, \[11C\]PBR28, will be administered at the beginning of each PET scan

Low-dose lipopolysaccharide

Intervention Type DRUG

Subjects will receive intravenous lipopolysaccharide.

Intradermal Capsaicin

Intervention Type DRUG

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

Placebo

Group Type PLACEBO_COMPARATOR

[11C]PBR28

Intervention Type RADIATION

The radiotracer, \[11C\]PBR28, will be administered at the beginning of each PET scan

Low-dose lipopolysaccharide

Intervention Type DRUG

Subjects will receive intravenous lipopolysaccharide.

Intradermal Capsaicin

Intervention Type DRUG

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

Interventions

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[11C]PBR28

The radiotracer, \[11C\]PBR28, will be administered at the beginning of each PET scan

Intervention Type RADIATION

Low-dose lipopolysaccharide

Subjects will receive intravenous lipopolysaccharide.

Intervention Type DRUG

Intradermal Capsaicin

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

Intervention Type DRUG

Other Intervention Names

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PET scan LPS

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Mohini Ranganathan

Associate Professor of Psychiatry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohini Ranganathan, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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Connecticut Mental Health Center

New Haven, Connecticut, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Mohini Ranganathan, MD

Role: CONTACT

203-932-5711 ext. 2546

Carly Hewes

Role: CONTACT

(203)932-5711 ext. 7411

Facility Contacts

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Kimberlee Forselius-Bielen

Role: primary

(203) 974-7540

Other Identifiers

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2000026320

Identifier Type: -

Identifier Source: org_study_id

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