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New treatment option for Phobia, Social
Official title Investigating the Effects of Cannabidiol on Social Anxiety Disorder
ClinicalTrials.gov ID: NCT05649059
What this study is testing
What is Cannabidiol?
Cannabidiol is an investigational medicine, being studied as a potential treatment for phobia, social.
Also referred to as Epidiolex.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55
You may be able to join if
- 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).
You likely can't join if
- 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).
See the full eligibility 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).
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Cambridge, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 55 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cambridge, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.