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Completed

NCT Number: NCT04777643

Sex Differences in Neural Response to Cannabidiol

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.

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Key information

Conditions

CBD Neural Responses

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

Yale School of Medicine

New Haven, Connecticut, 06510, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Cannabidiol

Drug

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

Placebo

Other

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

Primary outcomes

  1. Amygdala activation during stress

    Time frame: 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

    Time frame: 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 outcomes

  1. Patterns of amygdala functional connectivity during stress

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 2, 2021
Registry last updated
Dec 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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