NCT04398719

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started May 2021

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 19, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 21, 2020

Completed
12 months until next milestone

Study Start

First participant enrolled

May 7, 2021

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 11, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 11, 2024

Completed
Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

3.6 years

First QC Date

May 19, 2020

Last Update Submit

April 23, 2026

Conditions

CBDHealthy

Keywords

ControlPET ScanMRI ScanCentral Pain-SensitizationCannabidiol

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Capsaicin-induced hyperalgesia

    10 Days

Study Arms (2)

CBD

ACTIVE COMPARATOR
Radiation: [11C]PBR28Drug: Low-dose lipopolysaccharideDrug: Intradermal Capsaicin

Placebo

PLACEBO COMPARATOR
Radiation: [11C]PBR28Drug: Low-dose lipopolysaccharideDrug: Intradermal Capsaicin

Interventions

[11C]PBR28RADIATION

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

Also known as: PET scan
CBDPlacebo
Low-dose lipopolysaccharideDRUG

Subjects will receive intravenous lipopolysaccharide.

Also known as: LPS
CBDPlacebo
Intradermal CapsaicinDRUG

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

CBDPlacebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Current use of any medications
  • Presence of metal in the body
  • Pregnancy or lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Connecticut Mental Health Center

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Interventions

(methyl-(11)C)N-acetyl-N-(2-methoxybenzyl)-2-phenoxy-5-pyridinamineMagnetic Resonance SpectroscopyLipopolysaccharides

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative TechniquesGlycoconjugatesCarbohydratesPolysaccharides, BacterialPolysaccharidesLipidsAntigens, BacterialAntigensBiological FactorsEndotoxinsBacterial ToxinsToxins, Biological

Study Officials

  • Mohini Ranganathan, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Psychiatry

Study Record Dates

First Submitted

May 19, 2020

First Posted

May 21, 2020

Study Start

May 7, 2021

Primary Completion

December 11, 2024

Study Completion

December 11, 2024

Last Updated

April 29, 2026

Record last verified: 2026-04

Locations

US(1)