Cannabidiol to reduce social anxiety symptoms

Investigating the Effects of Cannabidiol on Social Anxiety Disorder

This will try a single dose of Epidiolex (cannabidiol) to see if it reduces anxiety during a standardized social stress test in adults with social anxiety disorder.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Massachusetts Institute of Technology (Academic / other)
• Locations: 1 site (Cambridge, Massachusetts)
• Trial ID: NCT05649059 on ClinicalTrials.gov

What this trial studies

This randomized, double-blind, placebo-controlled, parallel-group trial will give 50 adults with social anxiety disorder either a single oral dose of Epidiolex (3 mL at 100 mg/mL) or placebo before a Trier Social Stress Test (TSST). Behavioral and physiological measures of anxiety will be recorded during the stress task. After the TSST, participants will undergo fMRI scanning to measure emotional and self-referential brain processing. The study is conducted at MIT with clinical and research support from Massachusetts General Hospital.

Who should consider this trial

Good fit: Adults aged 18–55 with diagnosed social anxiety disorder, an LSAS score ≥60, right-hand dominance, stable medications, and negative drug and pregnancy tests are ideal candidates.

Not a fit: People with bipolar disorder, psychosis, recent substance use or cannabis use, significant neurological or medical illnesses (including diabetes), pregnancy, or those outside the age/handedness criteria are unlikely to qualify or benefit.

Why it matters

Potential benefit: If successful, this could provide a rapid medication option that reduces anxiety during social stress for people with social anxiety disorder.

How similar studies have performed: Previous small studies of single-dose cannabidiol have shown promising anxiety-reducing effects in public-speaking paradigms, but larger controlled evidence remains limited.

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.
* 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 benzodiazepines in past 2 weeks.
* Use of alpha- or beta-blockers in past week.
* 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 CBD.
* History of liver disease.
* History of hypersensitivity to cannabinoids.
* History of hypersensitivity to sesame seed oil.
* Currently breastfeeding (if female).

Where this trial is running

Cambridge, Massachusetts

• Massachusetts Institute of Technology — Cambridge, Massachusetts, United States (Recruiting)

Study contacts

• Principal investigator: John Gabrieli, PhD — Massachusetts Institute of Technology
• Study coordinator: Omar Rutledge, MS

Conditions Phobia, Social; Social Anxiety Disorder; Cannabidiol; fMRI