Investigating the Effects of Cannabidiol on Social Anxiety Disorder
CAN-SAD
1 other identifier
interventional
50
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jul 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 30, 2022
CompletedFirst Posted
Study publicly available on registry
December 13, 2022
CompletedStudy Start
First participant enrolled
July 10, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2026
ExpectedDecember 3, 2025
November 1, 2025
10 months
November 30, 2022
November 25, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
-180 minutes, -15 minutes, -5 minutes, +10 minutes, +20 minutes, +30 minutes
Secondary Outcomes (1)
Differences in Salivary Alpha Amylase
-180 minutes, -15 minutes, -5 minutes, +10 minutes, +20 minutes, +30 minutes
Other Outcomes (1)
Differences in fMRI BOLD Response
+45 minutes
Study Arms (2)
Cannabidiol
ACTIVE COMPARATOR300mg Cannabidiol (3mL Epidiolex), oral, single-dose
Placebo
PLACEBO COMPARATORPlacebo (3mL sesame seed oil), oral, single-dose
Interventions
Participants randomized to the cannabidiol arm will receive 3mL of Epidiolex (100mg cannabidiol/mL) in a single-dose.
Participants randomized to the placebo arm will receive 3mL of placebo (sesame seed oil) in a single dose.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Massachusetts Institute of Technology
Cambridge, Massachusetts, 02139, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John Gabrieli, PhD
Massachusetts Institute of Technology
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 30, 2022
First Posted
December 13, 2022
Study Start
July 10, 2025
Primary Completion
May 1, 2026
Study Completion (Estimated)
September 1, 2026
Last Updated
December 3, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, 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.
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.