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Investigating the Effects of Cannabidiol on Social Anxiety Disorder (CAN-SAD)

Primary Purpose

Phobia, Social

Status
Not yet recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Cannabidiol
Placebo
Sponsored by
Massachusetts Institute of Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Phobia, Social focused on measuring Social Anxiety Disorder, Cannabidiol, fMRI

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Massachusetts General Hospital
  • Massachusetts Institute of Technology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Cannabidiol

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).

Full Information

First Posted
November 30, 2022
Last Updated
September 26, 2023
Sponsor
Massachusetts Institute of Technology
Collaborators
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05649059
Brief Title
Investigating the Effects of Cannabidiol on Social Anxiety Disorder
Acronym
CAN-SAD
Official Title
Investigating the Effects of Cannabidiol on Social Anxiety Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2023 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
May 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Massachusetts Institute of Technology
Collaborators
Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Phobia, Social
Keywords
Social Anxiety Disorder, Cannabidiol, fMRI

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cannabidiol
Arm Type
Active Comparator
Arm Description
300mg Cannabidiol (3mL Epidiolex), oral, single-dose
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo (3mL sesame seed oil), oral, single-dose
Intervention Type
Drug
Intervention Name(s)
Cannabidiol
Other Intervention Name(s)
Epidiolex
Intervention Description
Participants randomized to the cannabidiol arm will receive 3mL of Epidiolex (100mg cannabidiol/mL) in a single-dose.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants randomized to the placebo arm will receive 3mL of placebo (sesame seed oil) in a single dose.
Primary Outcome Measure Information:
Title
Change in Acute Subjective Anxiety
Description
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).
Time Frame
-180 minutes, -15 minutes, -5 minutes, +10 minutes, +20 minutes, +30 minutes
Secondary Outcome Measure Information:
Title
Differences in Salivary Alpha Amylase
Description
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
Other Pre-specified Outcome Measures:
Title
Differences in fMRI BOLD Response
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Omar Rutledge, MS
Phone
617-324-2898
Email
orutledge@mit.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Gabrieli, PhD
Organizational Affiliation
Massachusetts Institute of Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
A. Eden Evins, MD, MPH
Email
aeevins@mgh.harvard.edu
First Name & Middle Initial & Last Name & Degree
A. Eden Evins, MD, MPH
Facility Name
Massachusetts Institute of Technology
City
Cambridge
State/Province
Massachusetts
ZIP/Postal Code
02139
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Omar Rutledge, MS
Phone
617-324-2898
Email
orutledge@mit.edu
First Name & Middle Initial & Last Name & Degree
John Gabrieli, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
Data will become available beginning one year after publication of the results.
IPD Sharing 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.

Learn more about this trial

Investigating the Effects of Cannabidiol on Social Anxiety Disorder

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