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Recruiting Phase 1, Phase 2 NCT07278505

Study of Cannabidiol and Neuroimaging on Stress

Trial Parameters

Condition Early Life Adversity
Sponsor Icahn School of Medicine at Mount Sinai
Study Type INTERVENTIONAL
Phase Phase 1, Phase 2
Enrollment 160
Sex ALL
Min Age 18 Years
Max Age 25 Years
Start Date 2025-10-28
Completion 2030-02-28
Interventions
CannabidiolPlacebo

Brief 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 Criteria

Inclusion Criteria: * Ability to understand and give informed consent. * Individuals between 18 and 25 years old; Sex is used a biological factor (50% of individuals recruited will be females, allowing sex comparisons). * English speakers. * Cognitive performance at threshold of greater than or equal to 23 as assessed by the Montreal Cognitive Assessment (MoCA). * Presence of ELA at threshold of at least one type of maltreatment measured by the Maltreatment and Abuse Chronology of Exposure (MACE) Scale and/or one type of maltreatment scored moderate/severe as measured by the Childhood Trauma Questionnaire (CTQ) * Presence of moderate/heightened stress as measured with a score of greater than or equal to 14 on the Perceived Stress Scale and/or high trait anxiety at threshold score of greater than or equal to 40 as measured with the State-Trait Anxiety Inventory (STAI) and no greater than moderate anxiety scores (max. 14) as measured by the Generalized Anxiety Disorder-7 (GAD7) Exclusion

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