CBD, Neural Responses
Conditions
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.
Interventions
DRUGCannabidiol
Participants will receive a single 600mg oral dose of Epidiolex (cannabidiol) 2 hours prior to fMRI scanning.
OTHERPlacebo
Participants will receive a single oral dose of placebo 2 hours prior to fMRI scanning.
Sponsors
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Provision of signed and dated informed consent form 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
1. Recent use of cannabis (any past month use) 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Amygdala activation during stress | fMRI will begin 2 hours post-drug administration and will last no more than 1 hour. | Participants will complete 1 fMRI scan following CBD administration and another fMRI scan following placebo administration. During each scan, participants will complete the Emotion Regulation Task (ERT). The first primary outcome measure will be amygdala response during the negative emotionality contrast of the ERT during their CBD relative to their placebo scan. |
| Insula activation during social exclusion | fMRI will begin 2 hours post-drug administration and will last no more than 1 hour. | Participants will complete 1 fMRI scan following CBD administration and another fMRI scan following placebo administration. During each scan, participants will complete the Cyberball Task. The second primary outcome measure will be insula response during the exclusion versus inclusion contrast of the Cyberball Task during their CBD relative to their placebo scan. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patterns of amygdala functional connectivity during stress | fMRI will begin 2 hours post-drug administration and will last no more than 1 hour. | Participants will complete 1 fMRI scan following CBD administration and another fMRI scan following placebo administration. During each scan, participants will complete the Emotion Regulation Task (ERT). The first secondary outcome measure will be participants' pattern of seed-based functional connectivity with the amygdala during the negative emotionality contrast of the ERT during their CBD relative to their placebo scan. |
| Patterns of insula functional connectivity during social exclusion | fMRI will begin 2 hours post-drug administration and will last no more than 1 hour. | Participants will complete 1 fMRI scan following CBD administration and another fMRI scan following placebo administration. During each scan, participants will complete the Cyberball Task. The second secondary outcome measure will be participants' pattern of seed-based functional connectivity with the insula during the exclusion versus inclusion contrast of the Cyberball Task during their CBD relative to their placebo scan. |
Countries
United States
Outcome results
None listed