Study of Cannabidiol and Neuroimaging on Stress

Part of paid clinical trials in New York, New York.

Sponsor
Icahn School of Medicine at Mount Sinai
Study ID
NCT07278505
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Early Life Adversity
  • Stress
  • Trauma

Eligibility Criteria

Sex
ALL
Age
18 Years - 25 Years
Healthy Volunteers
Accepted

Interventions

  • Cannabidiol — DRUG
    400mg cannabidiol
  • Placebo — DRUG
    Inactive oral solution

Study Details

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.

Key Dates

Start date
Oct 28, 2025
Status verified
Dec 2025
Primary completion
Feb 28, 2030
Completion
Feb 28, 2030

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Cannabidiol (CBD)
    Cannabidiol - oral CBD solution 400 mg
  • Placebo Comparator: Placebo
    Drug: Placebo Inactive oral solution

Primary Outcome Measure

Neural (BOLD) functional response [ Time Frame: Day 2 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Ichan School of Medicine at Mount SinaiNew YorkNew York10029
Elena Silverman, MS
[email protected]
646-984-3519
Ariadni Oikonomou, BA
[email protected]
646-984-3519
Keren Bachi (PRINCIPAL_INVESTIGATOR)

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