RecruitingPhase 4NCT05649059
Investigating the Effects of Cannabidiol on Social Anxiety Disorder
Sponsor
Massachusetts Institute of Technology
Enrollment
50 participants
Start Date
Jul 10, 2025
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 YearsMax Age: 55 Years
Inclusion Criteria8
- 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 Criteria18
- 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).
Interventions
DRUGCannabidiol
Participants randomized to the cannabidiol arm will receive 3mL of Epidiolex (100mg cannabidiol/mL) in a single-dose.
DRUGPlacebo
Participants randomized to the placebo arm will receive 3mL of placebo (sesame seed oil) in a single dose.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05649059