drugset / Trial / NCT05571592
Cannabidiol as a Treatment for Social Anxiety Disorder (R61)
Phase 2
Completed
60 enrolled
NYU Langone Health
Ananda Scientific · collabNational Center for Complementary and Integrative Health (NCCIH) · collab
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2023-01-26
- Primary completion
- 2025-11-26
- Completion
- 2025-12-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cannabidiol | Other / unclassified | 200 mg | Oral |
| Subject | Cannabidiol | Other / unclassified | 400 mg | Oral |