Investigating the Effects of Cannabidiol on Social Anxiety Disorder (CAN-SAD)

Massachusetts Institute of Technology (MIT)

Status and phase: Not yet enrolling; Phase 4

Conditions: Phobia, Social

Treatments: Drug: Placebo; Drug: Cannabidiol

Study type: Interventional

Funder types: Other

Identifiers

NCT05649059

2206000688

Details and patient eligibility

About

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).

Full description

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 measures of emotional processing and self-referential processing will be acquired using functional magnetic resonance imaging (fMRI).

This study will be conducted primarily at Massachusetts Institute of Technology with research and clinical support from Massachusetts General Hospital.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups, including a placebo group

Cannabidiol

Active Comparator group

Description:

300mg Cannabidiol (3mL Epidiolex), oral, single-dose

Treatment:

Drug: Cannabidiol

Placebo

Placebo Comparator group

Description:

Placebo (3mL sesame seed oil), oral, single-dose

Treatment:

Drug: Placebo