Study of Cannabidiol and Neuroimaging on Stress
NCT07278505 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 160
Last updated 2025-12-12
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.
Conditions
- Early Life Adversity
- Trauma
- Stress
Interventions
- DRUG
-
Cannabidiol
400mg cannabidiol
- DRUG
-
Inactive oral solution
Sponsors & Collaborators
- collaborator INDUSTRY
-
National Institute of Mental Health (NIMH)
collaborator NIH -
Icahn School of Medicine at Mount Sinai
lead OTHER
Principal Investigators
-
Keren Bachi, PhD · Ichan School of Medicine
Study Design
- Allocation
- RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 25 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-10-28
- Primary Completion
- 2030-02-28
- Completion
- 2030-02-28
- FDA Drug
- Yes
Countries
- United States
Study Locations
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