Sex Differences in Neural Response to Cannabidiol

• Sponsor: Yale University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04777643
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 8.7
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
CBD; Neural Responses	Drug: Cannabidiol; Other: Placebo	Early Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 10 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Basic Science
• Official Title: Sex Differences in Neural Response to Cannabidiol
• Actual Study Start Date: Jun 7, 2022
• Anticipated Primary Completion Date: Feb 28, 2023
• Anticipated Study Completion Date: Feb 28, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cannabidiol Participants will receive a single 600mg oral dose of Epidiolex (cannabidiol) 2 hours prior to fMRI scanning.	Drug: Cannabidiol; Participants will receive a single 600mg oral dose of Epidiolex (cannabidiol) 2 hours prior to fMRI scanning.
Placebo Comparator: Placebo Participants will receive a single oral dose of placebo 2 hours prior to fMRI scanning.	Other: Placebo; Participants will receive a single oral dose of placebo 2 hours prior to fMRI scanning.

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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 Outcome Measures

1. 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.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: Female
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yale School of Medicine	New Haven	Connecticut	United States	06510

Sponsors and Collaborators

• Yale University

Investigators

• Principal Investigator: Sarah D. Lichenstein, PhD, Yale University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yale University
• ClinicalTrials.gov Identifier: NCT04777643
• Other Study ID Numbers: 2000029579
• First Posted: Mar 2, 2021
• Last Update Posted: Jul 13, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Cannabidiol

Study Results

No Results Posted as of Jul 13, 2022