Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
EARLY_PHASE1
19 participants
INTERVENTIONAL
2022-06-07
2023-04-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
TRIPLE
Study Groups
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Cannabidiol
Participants will receive a single 600mg oral dose of Epidiolex (cannabidiol) 2 hours prior to fMRI scanning.
Cannabidiol
Participants will receive a single 600mg oral dose of Epidiolex (cannabidiol) 2 hours prior to fMRI scanning.
Placebo
Participants will receive a single oral dose of placebo 2 hours prior to fMRI scanning.
Placebo
Participants will receive a single oral dose of placebo 2 hours prior to fMRI scanning.
Interventions
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Cannabidiol
Participants will receive a single 600mg oral dose of Epidiolex (cannabidiol) 2 hours prior to fMRI scanning.
Placebo
Participants will receive a single oral dose of placebo 2 hours prior to fMRI scanning.
Eligibility Criteria
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Inclusion Criteria
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Female, aged 18-65
4. In good general health as evidenced by medical history and medically eligible to receive CBD, as determined by the licensed physician, Dr. Ayana Jordan
5. Body Mass Index between 18.5 and 30
6. For females of reproductive potential: agreement to use highly effective contraception during study participation and/or negative pregnancy test prior to fMRI scanning
Exclusion Criteria
2. Lifetime history of cannabis use disorder
3. Lifetime history of chronic pain disorder
4. Current DSM-5 disorder, as determined via Structured Clinical Interview (SCID-5)
5. Presence of any contraindication to MRI scanning
6. Known allergic reactions to cannabidiol
7. Lifetime use of Epidiolex
8. Currently taking any medications that could interact with cannabidiol
9. Current smoker or tobacco use \>1x/week
10. Not fluent in English
11. Less than 6th grade reading level
18 Years
65 Years
FEMALE
Yes
Sponsors
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Yale University
OTHER
Responsible Party
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Principal Investigators
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Sarah D. Lichenstein, PhD
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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Yale School of Medicine
New Haven, Connecticut, United States
Countries
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Other Identifiers
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2000029579
Identifier Type: -
Identifier Source: org_study_id