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Trial record 31 of 326 for:    epidiolex

Sex Differences in Neural Response to Cannabidiol

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ClinicalTrials.gov Identifier: NCT04777643
Recruitment Status : Not yet recruiting
First Posted : March 2, 2021
Last Update Posted : May 20, 2021
Sponsor:
Information provided by (Responsible Party):
Yale University

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.

Condition or disease Intervention/treatment Phase
CBD Neural Responses Drug: Cannabidiol Other: Placebo Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Official Title: Sex Differences in Neural Response to Cannabidiol
Estimated Study Start Date : June 2021
Estimated Primary Completion Date : February 28, 2023
Estimated Study Completion Date : February 28, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Cannabidiol

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

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




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Females only
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04777643


Contacts
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Contact: Sarah D. Lichenstein, PhD (646) 345-6934 sarah.lichenstein@yale.edu
Contact: Sarah W Yip, PhD (203) 737-4358 sarah.yip@yale.edu

Locations
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United States, Connecticut
Yale School of Medicine
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Yale University
Investigators
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Principal Investigator: Sarah D. Lichenstein, PhD Yale University
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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT04777643    
Other Study ID Numbers: 2000029579
First Posted: March 2, 2021    Key Record Dates
Last Update Posted: May 20, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Because this is a pilot project, we do not plan to share to data. Pending the results of the pilot project, we hope to pursue funding for a larger study to examine sex differences in neural response to CBD more directly (including both male and female participants) and on a larger scale (larger sample than pilot project), and we will plan to make these data available to other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Epidiolex
Anticonvulsants