drugset / Trial / NCT07278505
Study of Cannabidiol and Neuroimaging on Stress
Phase 1/2
Recruiting
160 enrolled
Icahn School of Medicine at Mount Sinai
Jazz Pharmaceuticals · collabNational Institute of Mental Health (NIMH) · collab
RandomizedParallel-groupQuadruple-blindBasic science
Summary
Dysregulation in stress responsivity is a growing psychiatry-transdiagnostic fundamental phenomenon, with limited therapeutic strategies. With the legalization of medical and recreational cannabis, many people consume cannabidiol (CBD; a nonintoxicating cannabinoid) to alleviate stress response, without the benefit of scientific guidance. To address this gap, the investigators propose a rigorous translational neuroscience study in a clinical high-risk population to define the roles of CBD in stress response with mechanisms of mesocorticolimbic-network function and hierarchy, neurometabolic, endocrine, and behavior, building upon convergent evidence from animal models and human evidence from our laboratories.
Timeline
- Start
- 2025-10-28
- Primary completion
- 2030-02-28
- Completion
- 2030-02-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cannabidiol | Other / unclassified | 400 mg | Oral |
Indications
No indication recorded.