A Phase 4 interventional study of Cannabidiol and Placebo in Phobia, Social, sponsored by Massachusetts Institute of Technology. Recruiting at 1 site in United States. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-08-11.
Sponsored by Massachusetts Institute of Technology · Phase 4, Interventional, and Other
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).
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.
367 studies on the registry are indexed under Phobia, Social; 58 are open to participants now.
This study's planned enrollment of 50 is below the median of 76 across 338 interventional studies indexed under Phobia, Social.
Browse Phobia, Social studies →Massachusetts Institute of Technology is the lead sponsor of 34 studies on the registry; 11 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
300mg Cannabidiol (3mL Epidiolex), oral, single-dose
Drug: Cannabidiol
Placebo (3mL sesame seed oil), oral, single-dose
Drug: Placebo
Participants randomized to the cannabidiol arm will receive 3mL of Epidiolex (100mg cannabidiol/mL) in a single-dose.
Also known as: Epidiolex
Participants randomized to the placebo arm will receive 3mL of placebo (sesame seed oil) in a single dose.
Change in Acute Subjective Anxiety
Subjective anxiety will be assessed with a modified Visual Analog Mood Scale (VAMS) which utilizes a vertical 100 millimeter (mm) bipolar visual scale between two opposing moods consisting of the following word pairs: calm-excited, relaxed-tense, and tranquil-troubled. Total subjective anxiety for each timepoint will be the average distance from the top for the three-question battery. VAMS will be assessed 15 minutes before drug administration (-180 minutes before start of TSST), 150 minutes after drug administration (-15 minutes before start of TSST), after the Anticipation Phase (-5 minutes before start of TSST), after the Stress Procedures (+10 minutes after start of TSST), after 5 minutes in the Recovery Phase (+20 minutes after start of TSST), and 15 minutes after start of the Recovery Phase (+30 minutes after start of TSST).
Time frame: -180 minutes, -15 minutes, -5 minutes, +10 minutes, +20 minutes, +30 minutes
Differences in Salivary Alpha Amylase
Physiological stress will be assessed indirectly with salivary alpha amylase (sAA) activity which is regulated by the sympathetic branch of the autonomic nervous system. Samples will be collected using the SalivaBio Oral Swab (SOS) from Salimetrics. Participants will place the SOS in their mouth for 1-2 minutes at each timepoint to collect saliva. sAA will be assessed 15 minutes before drug administration (-180 minutes before start of TSST), 150 minutes after drug administration (-15 minutes before start of TSST), after the Anticipation Phase (-5 minutes before start of TSST), after the Stress Procedures (+10 minutes after start of TSST), after 5 minutes in the Recovery Phase (+20 minutes after start of TSST), and 15 minutes after start of the Recovery Phase (+30 minutes after start of TSST).
Time frame: -180 minutes, -15 minutes, -5 minutes, +10 minutes, +20 minutes, +30 minutes
Differences in fMRI BOLD Response
Patterns of brain activation measured as blood-oxygenation-level dependent (BOLD) signals will be assessed using 3.0 Tesla (3T) functional magnetic resonance imaging (fMRI). Several exploratory imaging paradigms, including the emotional face-matching task (EFMT) and the self-referential comment task (SRCT), will be used to examine differences between participants who receive Epidiolex (cannabidiol) and those that receive placebo. Neuroimaging will begin approximately 210 minutes after drug administration (+45 minutes after the TSST).
Time frame: +45 minutes
Plan to share: Yes — All data, code, and materials used in the analyses will be made available upon request by John Gabrieli and Massachusetts Institute of Technology after scientific review and a completed data use agreement/material transfer agreement beginning one year after publication of the results. Any requests should be submitted to John Gabrieli at gabrieli@mit.edu.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code
Time frame: Data will become available beginning one year after publication of the results.
Access criteria: Data will be provided pending a scientific review and a completed data use agreement/material transfer agreement. Requests should be submitted to John Gabrieli at gabrieli@mit.edu.
Started Jul 2025 (actual). Primary completion is estimated for May 2027, 22 months after the start.
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Studies of the drug tested here: Cannabidiol
Massachusetts Institute of Technology