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Cannabinoid

CBD for Neural Response Differences

Phase < 1
Waitlist Available
Led By Sarah D. Lichenstein, PhD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Body Mass Index between 18.5 and 30
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up fmri will begin 2 hours post-drug administration and will last no more than 1 hour.
Awards & highlights

Study Summary

This trial will test the effects of CBD on the brain. Healthy female volunteers will take either 600mg of CBD or a placebo, and then their brains will be assessed for changes.

Who is the study for?
Healthy female volunteers aged 18-65 with a BMI of 18.5 to 30 can join this study if they agree to use effective contraception and have no history of cannabis use disorder, recent cannabis use, or known allergies to CBD. They must not be taking medications that interact with CBD and should be able to undergo MRI scans.Check my eligibility
What is being tested?
The trial is testing the effects of a single dose of cannabidiol (CBD) compared to a placebo on brain responses in women. Participants will receive both treatments at different times in random order, without knowing which one they're getting during each part of the study.See study design
What are the potential side effects?
While specific side effects are not listed for this trial, common side effects from CBD may include tiredness, changes in appetite or weight, diarrhea, and sometimes mood changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
Your body weight is within a healthy range, neither too low nor too high.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~fmri will begin 2 hours post-drug administration and will last no more than 1 hour.
This trial's timeline: 3 weeks for screening, Varies for treatment, and fmri will begin 2 hours post-drug administration and will last no more than 1 hour. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Amygdala activation during stress
Insula activation during social exclusion
Secondary outcome measures
Patterns of amygdala functional connectivity during stress
Patterns of insula functional connectivity during social exclusion

Side effects data

From 2022 Phase 2 & 3 trial • 90 Patients • NCT04387617
38%
Tiredness
24%
Drowsiness
24%
Poor sleep
22%
Constipation
18%
Poor Appetite
16%
Dizziness
9%
Headache
7%
Diarrhea
7%
Nausea
4%
Itching
100%
80%
60%
40%
20%
0%
Study treatment Arm
CBD Oil Group
Control Group

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: CannabidiolExperimental Treatment1 Intervention
Participants will receive a single 600mg oral dose of Epidiolex (cannabidiol) 2 hours prior to fMRI scanning.
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive a single oral dose of placebo 2 hours prior to fMRI scanning.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cannabidiol
2021
Completed Phase 3
~1010

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,844 Previous Clinical Trials
2,735,269 Total Patients Enrolled
Sarah D. Lichenstein, PhDPrincipal InvestigatorYale University

Media Library

Cannabidiol (Cannabinoid) Clinical Trial Eligibility Overview. Trial Name: NCT04777643 — Phase < 1
Cannabidiol (Cannabinoid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04777643 — Phase < 1
Cannabidiol Research Study Groups: Cannabidiol, Placebo
Cannabidiol Clinical Trial 2023: Cannabidiol Highlights & Side Effects. Trial Name: NCT04777643 — Phase < 1

Frequently Asked Questions

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

Are there openings for participants in this clinical trial?

"Indeed, clinicaltrials.gov confirms that this experiment is presently in the recruitment phase of its lifecycle, which began on 6th July 2022 and was recently modified on 11th July 2022. 10 participants are required from a single location for the study to progress."

Answered by AI

What is the patient population size for this clinical experiment?

"Affirmative. According to the repository on clinicaltrials.gov, this research project is actively enrolling patients that meet its criteria; it was first published on June 7th 2022 and most recently revised July 11th 2022. They need 10 individuals from a single medical centre for the study to proceed."

Answered by AI

Is there an opportunity for me to partake in this clinical experiment?

"This clinical trial is seeking 10 volunteer patients who meet the following criteria and are between ages 18 and 65: Willingness to comply with all procedures, female gender, medically eligible for CBD as determined by Dr. Ayana Jordan, healthy body mass index ranging from 18.5-30."

Answered by AI

Does the trial permit participation from individuals over eighty-five years of age?

"Eligibility for enrolment in this medical study requires that participants be under 65 years of age and above the legal minimum."

Answered by AI

Are there any research initiatives that have delved into the effects of Cannabidiol?

"Currently, 79 clinical trials are analysing Cannabidiol's efficacy. Of those studies, 16 have progressed to Phase 3 trials. Aside from Ribeirao Preto in Sao Paulo, there are 290 other sites running tests for the medication."

Answered by AI

Who else is applying?

What state do they live in?
Connecticut
What site did they apply to?
Yale School of Medicine
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1

How responsive is this trial?

Average response time
  • < 2 Days
Typically responds via
Phone Call
Most responsive sites:
  1. Yale School of Medicine: < 48 hours
Recent research and studies
clinicaltrials.govStudy
Sex Differences in Neural Response to Cannabidiol
2022. "Sex Differences in Neural Response to Cannabidiol". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04777643.
~7 spots leftby Apr 2025
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