Phobia, Social Clinical Trial
— CAN-SADOfficial title:
Investigating the Effects of Cannabidiol on Social Anxiety Disorder
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).
Status | Not yet recruiting |
Enrollment | 50 |
Est. completion date | May 2025 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility | 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. - Current diagnosis of social anxiety disorder (QuickSCID-5). - 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 beta-blockers or benzodiazepines in past 2 weeks. - 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 CYP3A4 or CYP2C19 (as assessed through Lexicomp). - History of liver disease. - History of hypersensitivity to cannabinoids. - History of hypersensitivity to sesame seed oil. - Currently breastfeeding (if female). |
Country | Name | City | State |
---|---|---|---|
United States | Massachusetts General Hospital | Boston | Massachusetts |
United States | Massachusetts Institute of Technology | Cambridge | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Massachusetts Institute of Technology | Massachusetts General Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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). | +45 minutes | |
Primary | 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 bottom 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 | 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). | -180 minutes, -15 minutes, -5 minutes, +10 minutes, +20 minutes, +30 minutes |
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