Investigating the Effects of Cannabidiol on Social Anxiety Disorder

NCT ID: NCT05649059

Last Updated: 2025-12-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-10
• Study Completion Date: 2026-09-30

Brief 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).

Detailed 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.

Conditions

Phobia, Social

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Cannabidiol

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

Group Type: ACTIVE_COMPARATOR

Cannabidiol

Intervention Type: DRUG

Participants randomized to the cannabidiol arm will receive 3mL of Epidiolex (100mg cannabidiol/mL) in a single-dose.

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Participants randomized to the placebo arm will receive 3mL of placebo (sesame seed oil) in a single dose.

Interventions

Cannabidiol

Participants randomized to the cannabidiol arm will receive 3mL of Epidiolex (100mg cannabidiol/mL) in a single-dose.

Intervention Type: DRUG

Placebo

Participants randomized to the placebo arm will receive 3mL of placebo (sesame seed oil) in a single dose.

Intervention Type: DRUG

Other Intervention Names

Epidiolex

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: collaborator

Massachusetts Institute of Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Gabrieli, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts Institute of Technology

Locations

Massachusetts Institute of Technology

Cambridge, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Omar Rutledge, MS

Role: CONTACT

orutledge@mit.edu

617-324-2898

Facility Contacts

Omar Rutledge, MS

Role: primary

orutledge@mit.edu

617-324-2898

Related Links

https://redcap.link/CANSAD

CAN-SAD Recruitment Site

Other Identifiers

2206000688

Identifier Type: -

Identifier Source: org_study_id