NCT05649059 Investigating the Effects of Cannabidiol on Social Anxiety Disorder
| NCT ID | NCT05649059 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Massachusetts Institute of Technology |
| Condition | Phobia, Social |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-07-10 |
| Primary Completion | 2026-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 50 participants in total. It began in 2025-07-10 with a primary completion date of 2026-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility Criteria
Inclusion Criteria: * Ability and willingness to provide written informed consent. * Sufficiently fluent in English to participate in the trial. * Between 18-55 years of age (inclusive). * Right-hand dominant. * Current medications are stable for past 30 days (no changes to dose or frequency). * Negative result on pregnancy test (if female). * Negative result on urine drug screening. * Liebowitz Social Anxiety Scale (LSAS ≥ 60). Exclusion Criteria: * History of bipolar disorder, schizophrenia, psychosis, delusional disorders. * History of eating disorder within past 6 months. * History of any traumatic brain injury. * Currently diagnosed with diabetes mellitus. * Presence of severe medical illness that would prevent completion of study procedures. * Presence of significant neurological illness or cognitive dysfunction (e.g.; seizures, dementia). * History of substance use disorder within past 6 months (other than nicotine and caffeine). * Use of any cannabis-containing products in past 30 days (CBD or THC). * Use of benzodiazepines in past 2 weeks. * Use of alpha- or beta-blockers in past week. * History of claustrophobia. * Contraindications for MRI (e.g.; shrapnel). * Presence of any other medical condition that, in the investigator's opinion, may interfere with the study procedures. * Use of concomitant medication that has a strong interaction with CBD. * History of liver disease. * History of hypersensitivity to cannabinoids. * History of hypersensitivity to sesame seed oil. * Currently breastfeeding (if female).
Contact & Investigator
John Gabrieli, PhD
PRINCIPAL INVESTIGATOR
Massachusetts Institute of Technology
Frequently Asked Questions
Who can join the NCT05649059 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 55 Years, studying Phobia, Social. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05649059 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05649059 currently recruiting?
Yes, NCT05649059 is actively recruiting participants. Contact the research team at orutledge@mit.edu for enrollment information.
Where is the NCT05649059 trial being conducted?
This trial is being conducted at Cambridge, United States.
Who is sponsoring the NCT05649059 clinical trial?
NCT05649059 is sponsored by Massachusetts Institute of Technology. The principal investigator is John Gabrieli, PhD at Massachusetts Institute of Technology. The trial plans to enroll 50 participants.