Sex Differences in Neural Response to Cannabidiol

Yale University

Status and phase: Completed; Early Phase 1

Conditions: CBD; Neural Responses

Treatments: Drug: Cannabidiol; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04777643

2000029579

Details and patient eligibility

About

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.

Enrollment: 19 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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19 participants in 2 patient groups, including a placebo group

Cannabidiol

Experimental group

Description:

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

Treatment:

Drug: Cannabidiol

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo