Investigating the Effects of Cannabidiol on Social Anxiety Disorder

2206000688

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).

2023-12-01

2024-12-01

2025-05-01

Not yet recruiting

Early phase I

50

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).

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}

2023-09-28