Phobia, SocialPhase 4CAN-SADNCT05649059
Investigating the Effects of Cannabidiol on Social Anxiety Disorder
A Phase 4 study testing Cannabidiol in people with Phobia, Social, run by Massachusetts Institute of Technology at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Phobia, Social
- What is being tested?
- Cannabidiol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jul 2025to May 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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).
Show all 18Show fewer
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Massachusetts Institute of Technology
Cambridge, Massachusetts, 02139
Omar Rutledge, MS, 617-324-2898, orutledge@mit.edu
John Gabrieli, PhD
About this study
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).
Read the 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
- Being tested
- Cannabidiol, Placebo
- Keywords
- Social Anxiety Disorder, Cannabidiol, fMRI
- Medical subject headings
- Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CannabidiolDrug
Also called Epidiolex
Participants randomized to the cannabidiol arm will receive 3mL of Epidiolex (100mg cannabidiol/mL) in a single-dose.
PlaceboDrug
Participants randomized to the placebo arm will receive 3mL of placebo (sesame seed oil) in a single dose.
| Study group | Role | What they receive |
|---|---|---|
| Cannabidiol | Active comparator | 300mg Cannabidiol (3mL Epidiolex), oral, single-dose Receives: Drug: Cannabidiol |
| Placebo | Placebo comparator | Placebo (3mL sesame seed oil), oral, single-dose Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: -180 minutes, -15 minutes, -5 minutes, +10 minutes, +20 minutes, +30 minutes
Secondary outcomes (1)
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).
Measured: -180 minutes, -15 minutes, -5 minutes, +10 minutes, +20 minutes, +30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2022
- Study start10 Jul 2025
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Phobia, SocialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital
- Responsible party
- Sponsor
- Investigators
- John Gabrieli, PhD, Principal investigator, Massachusetts Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05649059
- Sponsor's protocol ID
- 2206000688
- Acronym
- CAN-SAD
- Status last verified
- Aug 2026
- First submitted
- 30 Nov 2022
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effects of Cannabidiol on Social Anxiety Disorder
- ClinicalTrials.gov ID
- NCT05649059
- Acronym / sponsor ID
- CAN-SAD / 2206000688
- Conditions
- Phobia, Social
- Keywords
- Social Anxiety Disorder, Cannabidiol, fMRI
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Massachusetts Institute of TechnologyUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital
- Study start
- 10 Jul 2025 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 13 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cannabidiol | Active comparator | Drug: Cannabidiol300mg Cannabidiol (3mL Epidiolex), oral, single-dose |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo (3mL sesame seed oil), oral, single-dose |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CannabidiolAlso: EpidiolexParticipants randomized to the cannabidiol arm will receive 3mL of Epidiolex (100mg cannabidiol/mL) in a single-dose. | Drug | Cannabidiol |
| PlaceboParticipants randomized to the placebo arm will receive 3mL of placebo (sesame seed oil) in a single dose. | Drug | Placebo |
Primary outcome
Change in Acute Subjective Anxiety
Time frame: -180 minutes, -15 minutes, -5 minutes, +10 minutes, +20 minutes, +30 minutes
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).
1 secondary outcome
Differences in Salivary Alpha Amylase
Time frame: -180 minutes, -15 minutes, -5 minutes, +10 minutes, +20 minutes, +30 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- CAN-SAD Recruitment SiteLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
John Gabrieli, PhD principal investigator
Massachusetts Institute of Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cannabidiol in people with Phobia, Social, run by Massachusetts Institute of Technology at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Omar Rutledge, MS (617-324-2898, orutledge@mit.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Acute Subjective Anxiety (time frame: -180 minutes, -15 minutes, -5 minutes, +10 minutes, +20 minutes, +30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.