Cannabidiol as a Treatment for Social Anxiety Disorder (R61)

Status Recruiting

Clinical Trial Summary

The R61 will include two CBD dose levels vs placebo (PBO) and examine potential engagement with two primary targets in a 3-week randomized controlled trial design. Willing and eligible subjects will be randomized to one of three randomized double-blind treatments (n = 20 each group): 1) CBD 800 mg (400 mg twice daily), 2) CBD 400 mg (200 mg twice daily), or 3) PBO twice daily for three weeks. Participation is estimated at approximately 1 month from end of screening to endpoint for the primary R61 study period. This includes screening, baseline, week 2 stress task, Week 3 2-day imaging paradigm, and clinical safety assessments at weeks 2 and 3.

Clinical Trial Description

In the R61 trial, two doses of a Phase 3 trial suitable hemp-derived (legal) oral CBD formulation with enhanced bioavailability will be compared against placebo (PBO) in a 3-week double-blind randomized controlled trial. Participants will undergo a standardized stress task at week 2, and a standardized 2-day fear learning and extinction protocol at week 3, with functional MRI (fMRI) brain activation accompanying fear extinction recall and fearful faces tasks on the second day. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05571592
Study type	Interventional
Source	NYU Langone Health
Contact	Liza Goodwin
Phone	646-754-4773
Email	Elizabeth.Goodwin@nyulangone.org
Status	Recruiting
Phase	Phase 2
Start date	January 26, 2023
Completion date	August 1, 2024

View Details

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