Clinical trial NCT05649059: Investigating the Effects of Cannabidiol on Social Anxiety Disorder
Official title: Investigating the Effects of Cannabidiol on Social Anxiety Disorder
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Phobia, Social
Keywords: Social Anxiety Disorder
Cannabidiol
fMRI
Lead sponsor: Massachusetts Institute of Technology
Sponsor class: OTHER
Collaborators: name: Massachusetts General Hospital
First posted: 2022-12-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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).

Primary outcomes:
measure: Change in Acute Subjective Anxiety
timeFrame: -180 minutes, -15 minutes, -5 minutes, +10 minutes, +20 minutes, +30 minutes
Secondary outcomes:
measure: Differences in Salivary Alpha Amylase
timeFrame: -180 minutes, -15 minutes, -5 minutes, +10 minutes, +20 minutes, +30 minutes
Other outcomes:
measure: Differences in fMRI BOLD Response
timeFrame: +45 minutes
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Cambridge
country: United States
facility: Massachusetts Institute of Technology
state: Massachusetts
Study officials:
affiliation: Massachusetts Institute of Technology
name: John Gabrieli, PhD
role: PRINCIPAL_INVESTIGATOR
References: