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Cannabinoid

CBD for Brain Inflammation and Pain Sensitization

Phase < 1
Recruiting
Led By Rajiv Radhakrishnan, MD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No significant medical or neurological illness
Men and women aged 18- 55 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 days
Awards & highlights

Study Summary

This trial will test whether CBD can help reduce inflammation in the brain and help lessen pain sensitization.

Who is the study for?
This trial is for healthy men and women aged 18-55 with no significant medical or neurological illnesses. Participants must not be using any medications, have metal implants that could interfere with MRI scans, or be pregnant or lactating.Check my eligibility
What is being tested?
The study tests how cannabidiol (CBD) affects brain inflammation and pain sensitivity in healthy people. It involves CBD pre-treatment followed by PET scans using [11C]PBR28 to measure microglial activation and a low-dose lipopolysaccharide challenge.See study design
What are the potential side effects?
Potential side effects may include discomfort from the intradermal capsaicin used to induce pain sensation, reactions at the injection site of [11C]PBR28, and general responses to CBD such as fatigue, changes in appetite, or gastrointestinal discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I do not have any major health or brain conditions.
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I am between 18 and 55 years old.
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I am between 18 and 55 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Microglial activation using [11C]PBR28 PET imaging
Secondary outcome measures
Capsaicin-induced hyperalgesia

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: CBDActive Control3 Interventions
Group II: PlaceboPlacebo Group3 Interventions

Find a Location

Who is running the clinical trial?

National Center for Complementary and Integrative Health (NCCIH)NIH
832 Previous Clinical Trials
668,958 Total Patients Enrolled
Yale UniversityLead Sponsor
1,852 Previous Clinical Trials
2,738,426 Total Patients Enrolled
Rajiv Radhakrishnan, MDPrincipal Investigator - Yale University
Yale University
1 Previous Clinical Trials
18 Total Patients Enrolled

Media Library

Cannabidiol (Cannabinoid) Clinical Trial Eligibility Overview. Trial Name: NCT04398719 — Phase < 1
Cannabidiol Research Study Groups: CBD, Placebo
Cannabidiol Clinical Trial 2023: Cannabidiol Highlights & Side Effects. Trial Name: NCT04398719 — Phase < 1
Cannabidiol (Cannabinoid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04398719 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants of this experiment allowed to be over the age of twenty?

"According to the eligibility requirements for this experiment, prospective patients must be between 18 and 55 years of age. Alternatively, there are 50 trials available for individuals below 18 and 386 studies open to those 65 or older."

Answered by AI

Who is the target demographic for this medical experimentation?

"15 individuals with cbd are being accepted for this clinical trial, whose age range is between 18 and 55. To be eligible, participants must not have any major medical or neurological issues, their sex should fall within the given parameters (male/female), and they should stay below the permissible annual radiation exposure limit."

Answered by AI

Is this research endeavor accessible to potential participants?

"In accordance with the information on clinicaltrials.gov, this medical trial is actively searching for participants. This study was published on May 7th 2021 and was most recently updated on September 16th 2022."

Answered by AI

What is the total estimated enrollment of participants for this clinical trial?

"Affirmative. Information on clinicaltrials.gov indicates that the trial, which was first published on May 7th 2021 and last modified on September 16th 2022, is actively recruiting 15 patients from a single medical centre."

Answered by AI

What medicinal uses is cannabidiol commonly used for?

"CBD is widely considered to be the most effective therapy for collagen diseases, but it may also help patients manage acute nonspecific tenosynovitis, musculoskeletal pain and muscle cramps."

Answered by AI

Who else is applying?

What state do they live in?
California
Connecticut
How old are they?
18 - 65
What site did they apply to?
Connecticut Mental Health Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Recent research and studies
clinicaltrials.govStudy
CBD-Microglia PET Study
Rajiv Radhakrishnan, MD 2021. "CBD-Microglia PET Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04398719.
~2 spots leftby Aug 2024
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