RecruitingPhase 1Phase 2NCT07278505

Study of Cannabidiol and Neuroimaging on Stress

Pathophysiological Mechanisms of Cannabidiol in Stress Regulation

Sponsor

Icahn School of Medicine at Mount Sinai

Enrollment

160 participants

Start Date

Oct 28, 2025

Study Type

INTERVENTIONAL

Conditions

Stress Trauma Early Life Adversity

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.

Eligibility

Min Age: 18 YearsMax Age: 25 Years

Plain Language Summary

Simplified for easier understanding

This study is examining whether cannabidiol (CBD) affects how the brain responds to stress in young adults who experienced childhood trauma. Brain imaging (MRI and spectroscopy) will be used before and after taking CBD to look for changes in stress responses. **You may be eligible if...** - You are 18–25 years old - You experienced childhood trauma or maltreatment - You currently have moderate-to-high stress or anxiety, but not a clinical anxiety disorder - You speak English - You have not used cannabis or CBD products in the past 3 weeks - You are not currently taking any psychiatric or mood medications **You may NOT be eligible if...** - You currently meet criteria for a psychiatric disorder (like depression, anxiety disorder, PTSD, etc.) - You have used psychoactive drugs (other than nicotine or alcohol) in the past 7 days - You have a history of heart disease, neurological conditions, head trauma, or seizures - You are currently in therapy for anxiety or stress - You have a history of hypersensitivity to cannabinoids Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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