Status:
COMPLETED
Sex Differences in Neural Response to Cannabidiol
Lead Sponsor:
Yale University
Conditions:
CBD
Neural Responses
Eligibility:
FEMALE
18-65 years
Phase:
EARLY_PHASE1
Brief Summary
This is a randomized, double-blind, within-subjects, cross-over design to assess neural changes following a single dose of cannabidiol (CBD) (600mg) versus placebo among healthy female volunteers.
Eligibility Criteria
Inclusion
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Female, aged 18-65
- In good general health as evidenced by medical history and medically eligible to receive CBD, as determined by the licensed physician, Dr. Ayana Jordan
- Body Mass Index between 18.5 and 30
- For females of reproductive potential: agreement to use highly effective contraception during study participation and/or negative pregnancy test prior to fMRI scanning
Exclusion
- Recent use of cannabis (any past month use)
- Lifetime history of cannabis use disorder
- Lifetime history of chronic pain disorder
- Current DSM-5 disorder, as determined via Structured Clinical Interview (SCID-5)
- Presence of any contraindication to MRI scanning
- Known allergic reactions to cannabidiol
- Lifetime use of Epidiolex
- Currently taking any medications that could interact with cannabidiol
- Current smoker or tobacco use \>1x/week
- Not fluent in English
- Less than 6th grade reading level
Key Trial Info
Start Date :
June 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 27 2023
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT04777643
Start Date
June 7 2022
End Date
April 27 2023
Last Update
December 21 2023
Active Locations (1)
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1
Yale School of Medicine
New Haven, Connecticut, United States, 06510