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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cannabidiol | Experimental | Participants will receive a single 600mg oral dose of Epidiolex (cannabidiol) 2 hours prior to fMRI scanning. |
|
| Placebo | Placebo Comparator | Participants will receive a single oral dose of placebo 2 hours prior to fMRI scanning. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cannabidiol | Drug | Participants will receive a single 600mg oral dose of Epidiolex (cannabidiol) 2 hours prior to fMRI scanning. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Amygdala activation during stress | 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. | fMRI will begin 2 hours post-drug administration and will last no more than 1 hour. |
| Insula activation during social exclusion | 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. | fMRI will begin 2 hours post-drug administration and will last no more than 1 hour. |
| Measure | Description | Time Frame |
|---|---|---|
| Patterns of amygdala functional connectivity during stress | 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. |
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Inclusion Criteria:
Exclusion Criteria:
Females only
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| Name | Affiliation | Role |
|---|---|---|
| Sarah D. Lichenstein, PhD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale School of Medicine | New Haven | Connecticut | 06510 | United States |
Because this is a pilot project, we do not plan to share to data. Pending the results of the pilot project, we hope to pursue funding for a larger study to examine sex differences in neural response to CBD more directly (including both male and female participants) and on a larger scale (larger sample than pilot project), and we will plan to make these data available to other researchers.
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| ID | Term |
|---|---|
| D002185 | Cannabidiol |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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| Placebo | Other | Participants will receive a single oral dose of placebo 2 hours prior to fMRI scanning. |
|
| fMRI will begin 2 hours post-drug administration and will last no more than 1 hour. |
| Patterns of insula functional connectivity during social exclusion | 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. | fMRI will begin 2 hours post-drug administration and will last no more than 1 hour. |