NCT05571592

Cannabidiol as a Treatment for Social Anxiety Disorder (R61)

Randomized Placebo-controlled Trial to Determine the Biological Signature of Cannabidiol as a Treatment for Social Anxiety Disorder (R61)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Social Anxiety Disorder

Interventions

Type	Name	Description
DRUG	Cannabidiol	Oral Capsule Formulation of CBD dissolved in a self-emulsifying drug technology called nanodomains, encapsulated within 1-ml softgel capsules, with a CBD purity ≥98%. Imported from Ananda Scientific
DRUG	Placebo	Drug: Placebo Placebo softgel capsule formulation.

Timeline

• Start date: 2023-01-26
• Primary completion: 2025-11-26
• Completion: 2025-12-03
• First posted: 2022-10-07
• Last updated: 2026-01-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study