RECRUITING

Investigating the Effects of Cannabidiol on Social Anxiety Disorder

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Conditions

Phobia, SocialSocial Anxiety DisorderCannabidiolfMRI

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to test whether a single-dose of Epidiolex (cannabidiol) is associated with reduced psychological, physiological, and neuroimaging measures of anxiety in people diagnosed with social anxiety disorder (SAD).

Official Title

Investigating the Effects of Cannabidiol on Social Anxiety Disorder

Quick Facts

Study Start:2025-06
Study Completion:2026-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05649059

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Ability and willingness to provide written informed consent.
  2. * Sufficiently fluent in English to participate in the trial.
  3. * Between 18-55 years of age (inclusive).
  4. * Right-hand dominant.
  5. * Current medications are stable for past 30 days (no changes to dose or frequency).
  6. * Negative result on pregnancy test (if female).
  7. * Negative result on urine drug screening.
  8. * Liebowitz Social Anxiety Scale (LSAS ≥ 60).
  1. * History of bipolar disorder, schizophrenia, psychosis, delusional disorders.
  2. * History of eating disorder within past 6 months.
  3. * History of any traumatic brain injury.
  4. * Currently diagnosed with diabetes mellitus.
  5. * Presence of severe medical illness that would prevent completion of study procedures.
  6. * Presence of significant neurological illness or cognitive dysfunction (e.g.; seizures, dementia).
  7. * History of substance use disorder within past 6 months (other than nicotine and caffeine).
  8. * Use of any cannabis-containing products in past 30 days (CBD or THC).
  9. * Use of benzodiazepines in past 2 weeks.
  10. * Use of alpha- or beta-blockers in past week.
  11. * History of claustrophobia.
  12. * Contraindications for MRI (e.g.; shrapnel).
  13. * Presence of any other medical condition that, in the investigator's opinion, may interfere with the study procedures.
  14. * Use of concomitant medication that has a strong interaction with CBD.
  15. * History of liver disease.
  16. * History of hypersensitivity to cannabinoids.
  17. * History of hypersensitivity to sesame seed oil.
  18. * Currently breastfeeding (if female).

Contacts and Locations

Study Contact

Omar Rutledge, MS
CONTACT
617-324-2898
orutledge@mit.edu

Principal Investigator

John Gabrieli, PhD
PRINCIPAL_INVESTIGATOR
Massachusetts Institute of Technology

Study Locations (Sites)

Massachusetts Institute of Technology
Cambridge, Massachusetts, 02139
United States

Collaborators and Investigators

Sponsor: Massachusetts Institute of Technology

  • John Gabrieli, PhD, PRINCIPAL_INVESTIGATOR, Massachusetts Institute of Technology

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06
Study Completion Date2026-09

Study Record Updates

Study Start Date2025-06
Study Completion Date2026-09

Terms related to this study

Keywords Provided by Researchers

  • Social Anxiety Disorder
  • Cannabidiol
  • fMRI

Additional Relevant MeSH Terms

  • Phobia, Social