Investigating the Effects of Cannabidiol on Social Anxiety Disorder

Launched by MASSACHUSETTS INSTITUTE OF TECHNOLOGY · Dec 12, 2022

Keywords

ClinConnect Summary

Using a randomized, double-blind, placebo-controlled, parallel-group study design, this scientific investigation will examine the effect of 3 milliliters (mL) of Epidiolex (100mg cannabidiol/mL) on behavioral, physiological, and neuroimaging measures of anxiety in subjects diagnosed with SAD. The study will enroll 50 subjects with SAD who will be randomized in a double-blind manner to receive either Epidiolex or placebo before experiencing the Trier Social Stress Test (TSST), the gold-standard for ethically inducing stress in a controlled laboratory setting. Following the TSST, neuroimaging...

Gender

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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).

Trial Officials