Sex Differences in Neural Response to Cannabidiol

NCT04777643 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: 2000029579
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

CBD; Neural Responses

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Patterns of amygdala functional connectivity during stress

  fMRI will begin 2 hours post-drug administration and will last no more than 1 hour.

• Patterns of insula functional connectivity during social exclusion

  fMRI will begin 2 hours post-drug administration and will last no more than 1 hour.

Study Arms (2)

Cannabidiol

EXPERIMENTAL

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

Drug: Cannabidiol

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Cannabidiol DRUG

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

Cannabidiol

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Females only
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale School of Medicine

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Interventions

Cannabidiol

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Sarah D. Lichenstein, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2021
• First Posted: March 2, 2021
• Study Start: June 7, 2022
• Primary Completion: April 27, 2023
• Study Completion: April 27, 2023
• Last Updated: December 21, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)