Sex Differences in Neural Response to Cannabidiol

• Status: Not yet recruiting
• Trial end date: 2023-02-28
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Yale University
• Treatments: Cannabidiol; Epidiolex

Criteria

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