Investigating the Effects of Cannabidiol on Social Anxiety Disorder
Recruiting · NCT05649059 · Interventional (participants receive a specific treatment) · Lead sponsor: Massachusetts Institute of Technology
View the official record on ClinicalTrials.gov →Interventions studied
CannabidiolPlacebo
What this trial is about
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).
Who can take part
Age range
18 Years to 55 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
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).
Where it is running
1 location listed across 1 US state.
- Massachusetts Institute of Technology - Cambridge, Massachusetts, United States