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Recruiting NCT05649059

Investigating the Effects of Cannabidiol on Social Anxiety Disorder

Phase IV Interventional Phobia, Social

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cannabidiol, Placebo.
Who it may be relevant to
Registry conditions: Phobia, Social. Basic parameters: 18 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • Drug Cannabidiol
    Participants randomized to the cannabidiol arm will receive 3mL of Epidiolex (100mg cannabidiol/mL) in a single-dose.
  • Drug Placebo
    Participants randomized to the placebo arm will receive 3mL of placebo (sesame seed oil) in a single dose.

Primary outcome measures

  • Change in Acute Subjective Anxiety [Time frame: -180 minutes, -15 minutes, -5 minutes, +10 minutes, +20 minutes, +30 minutes]
Secondary outcome measures (1)
  • Differences in Salivary Alpha Amylase [Time frame: -180 minutes, -15 minutes, -5 minutes, +10 minutes, +20 minutes, +30 minutes]

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.
  • 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 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Other

Study locations

United States · 1 center
  • Massachusetts Institute of Technology — Cambridge

Identifiers

NCT: NCT05649059 · 2206000688

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗