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CBD-Microglia PET Study

Early Phase 1
Recruiting
Conditions
Healthy
CBD
Interventions
Radiation: [11C]PBR28
Drug: Low-dose lipopolysaccharide
Drug: Intradermal Capsaicin
Registration Number
NCT04398719
Lead Sponsor
Yale University
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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
15
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.
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Exclusion Criteria
  1. Current use of any medications
  2. Presence of metal in the body
  3. Pregnancy or lactation
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
CBD[11C]PBR28-
CBDLow-dose lipopolysaccharide-
Placebo[11C]PBR28-
PlaceboIntradermal Capsaicin-
CBDIntradermal Capsaicin-
PlaceboLow-dose lipopolysaccharide-
Primary Outcome Measures
NameTimeMethod
Microglial activation using [11C]PBR28 PET imaging10 Days

Difference in microglial activation (\[11C\]PBR28 VT levels) between the 2 groups (e.g., CBD vs. placebo)

Secondary Outcome Measures
NameTimeMethod
Capsaicin-induced hyperalgesia10 Days

Difference in capsaicin-induced hyperalgesia between the 2 groups (e.g., CBD vs. placebo)

Trial Locations

Locations (1)

Connecticut Mental Health Center

🇺🇸

New Haven, Connecticut, United States

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