Investigating the Effects of Cannabidiol on Social Anxiety Disorder

Phase 4

Not yet recruiting

• Conditions: Phobia, Social

• Registration Number: NCT05649059
• Lead Sponsor: Massachusetts Institute of Technology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-30
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Inclusion Criteria:<br><br> - Ability and willingness to provide written informed consent.<br><br> - Sufficiently fluent in English to participate in the trial.<br><br> - Between 18-55 years of age (inclusive).<br><br> - Right-hand dominant.<br><br> - Current medications are stable for past 30 days (no changes to dose or frequency).<br><br> - Negative result on pregnancy test (if female).<br><br> - Negative result on urine drug screening.<br><br> - Current diagnosis of social anxiety disorder (QuickSCID-5).<br><br> - Liebowitz Social Anxiety Scale (LSAS = 60).<br><br>Exclusion Criteria:<br><br> - History of bipolar disorder, schizophrenia, psychosis, delusional disorders.<br><br> - History of eating disorder within past 6 months.<br><br> - History of any traumatic brain injury.<br><br> - Currently diagnosed with diabetes mellitus.<br><br> - Presence of severe medical illness that would prevent completion of study<br> procedures.<br><br> - Presence of significant neurological illness or cognitive dysfunction (e.g.;<br> seizures, dementia).<br><br> - History of substance use disorder within past 6 months (other than nicotine and<br> caffeine).<br><br> - Use of any cannabis-containing products in past 30 days (CBD or THC).<br><br> - Use of beta-blockers or benzodiazepines in past 2 weeks.<br><br> - History of claustrophobia.<br><br> - Contraindications for MRI (e.g.; shrapnel).<br><br> - Presence of any other medical condition that, in the investigator's opinion, may<br> interfere with the study procedures.<br><br> - Use of concomitant medication that has a strong interaction with CYP3A4 or CYP2C19<br> (as assessed through Lexicomp).<br><br> - History of liver disease.<br><br> - History of hypersensitivity to cannabinoids.<br><br> - History of hypersensitivity to sesame seed oil.<br><br> - Currently breastfeeding (if female).

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Acute Subjective Anxiety

Secondary Outcome Measures

Name	Time	Method
Differences in Salivary Alpha Amylase