Investigating the Effects of Cannabidiol on Social Anxiety Disorder

• Status: Not yet recruiting
• Trial end date: 2025-05-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts Institute of Technology
• Collaborator: Massachusetts General Hospital
• Treatments: Cannabidiol

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.

• Current diagnosis of social anxiety disorder (QuickSCID-5).

• 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 beta-blockers or benzodiazepines in past 2 weeks.

• 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 CYP3A4 or CYP2C19 (as assessed through Lexicomp).

• History of liver disease.

• History of hypersensitivity to cannabinoids.

• History of hypersensitivity to sesame seed oil.

• Currently breastfeeding (if female).