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Not Yet Recruiting NCT05649059

Investigating the Effects of Cannabidiol on Social Anxiety Disorder

Conditions: Phobia, Social

Sex: All
Ages: 18 Years – 55 Years
Phase: PHASE4
Enrollment: 50
Sponsor: Massachusetts Institute of Technology

Location: United States

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.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).

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05649059). StuddyBuddy aggregates publicly available trial information.