Sex Differences in Neural Response to Cannabidiol

CBD Clinical Trial

Official title:

Sex Differences in Neural Response to Cannabidiol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04777643
• Other study ID #: 2000029579
• Status: Completed
• Phase: Early Phase 1
• Start date: June 7, 2022
• Est. completion date: April 27, 2023

Study information

• Verified date: December 2023
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: April 27, 2023
• Est. primary completion date: April 27, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• CBD
• Neural Responses

Intervention

Drug:
• Cannabidiol
Participants will receive a single 600mg oral dose of Epidiolex (cannabidiol) 2 hours prior to fMRI scanning.

Other:
• Placebo
Participants will receive a single oral dose of placebo 2 hours prior to fMRI scanning.

Locations

Country	Name	City	State
United States	Yale School of Medicine	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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.
Secondary	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.