Recruiting

Epidiolex

Sponsor:

Massachusetts Institute of Technology

Code:

NCT05649059

Conditions

Phobia, Social

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Interventions

Cannabidiol

Placebo

Study Details

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).

Conditions

Phobia, Social

Study ID

NCT05649059

Start date

Jul 10, 2025

Status verified date

Aug, 2026

Completion date

May, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: Cannabidiol

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

placebo comparator: Placebo

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

Interventions

Cannabidiol

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

Placebo

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

Primary outcome measure

  • Change in Acute Subjective Anxiety [ Time Frame: -180 minutes, -15 minutes, -5 minutes, +10 minutes, +20 minutes, +30 minutes ]

Central Contacts and Locations

Central contacts

Omar Rutledge, MS

617-324-2898orutledge@mit.edu

Locations

Massachusetts Institute of Technology

Recruiting

Cambridge, Massachusetts, United States, 02139

Contacts

Omar Rutledge, MS

617-324-2898orutledge@mit.edu

Principal Investigator:

John Gabrieli, PhD

More Information

Sponsor

Massachusetts Institute of Technology

Last update posted

Aug 11, 2026

Last verified

Aug, 2026

Keywords

  • Social Anxiety Disorder
  • Cannabidiol
  • fMRI

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts Institute of Technology on 2026-08-11.