Sex Differences in Neural Response to Cannabidiol

Study Overview
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Brief Summary
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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.

Official Title
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Sex Differences in Neural Response to Cannabidiol

Conditions
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CBD, Neural Responses

Intervention / Treatment
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* Drug: Cannabidiol
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cannabidiol<br>Participants will receive a single 600mg oral dose of Epidiolex (cannabidiol) 2 hours prior to fMRI scanning. | Drug: Cannabidiol<br>* Participants will receive a single 600mg oral dose of Epidiolex (cannabidiol) 2 hours prior to fMRI scanning.<br>|
| Placebo Comparator: Placebo<br>Participants will receive a single oral dose of placebo 2 hours prior to fMRI scanning. | Other: Placebo<br>* Participants will receive a single oral dose of placebo 2 hours prior to fMRI scanning.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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. |