Actively Recruiting
Study of Cannabidiol and Neuroimaging on Stress
Led by Icahn School of Medicine at Mount Sinai · Updated on 2025-12-12
160
Participants Needed
1
Research Sites
226 weeks
Total Duration
On this page
Sponsors
I
Icahn School of Medicine at Mount Sinai
Lead Sponsor
J
Jazz Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Study of Cannabidiol and Neuroimaging on Stress
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand and give informed consent
- Age between 18 and 25 years
- Biological sex used as a factor; 50% of participants will be female to allow sex comparisons
- English speaking
- Cognitive performance with a Montreal Cognitive Assessment (MoCA) score of 23 or higher
- Presence of early life adversity (ELA) with at least one type of maltreatment on the Maltreatment and Abuse Chronology of Exposure (MACE) Scale and/or moderate/severe maltreatment on the Childhood Trauma Questionnaire (CTQ)
- Moderate or heightened stress indicated by a score of 14 or higher on the Perceived Stress Scale and/or a score of 40 or higher on the State-Trait Anxiety Inventory (STAI), with no more than moderate anxiety (maximum 14) on the Generalized Anxiety Disorder-7 (GAD7) scale
You will not qualify if you...
- Medical conditions that make participation unsafe or prevent treatment compliance, including cardiac disease, arrhythmias, central neurological disease, head trauma, or seizures
- Current psychiatric diagnosis according to DSM-5 assessed by the Mini International Neuropsychiatric Interview (M.I.N.I.)
- Use of psychoactive drugs (except nicotine or alcohol) within the past 7 days
- Positive urine drug screen for substances including THC, cocaine, opiates, benzodiazepines, barbiturates, amphetamines, and others
- Use of cannabis products, including CBD, within the past 3 weeks
- Use of medications affecting brain imaging or endocrine function, including psychotropic drugs, in the past 3 months
- Participation in non-medication treatments for anxiety or stress in the past 3 months
- Medical or psychiatric contraindications to CBD or its ingredients (e.g., sesame oil allergy)
- Pregnancy or breastfeeding
- Not using effective contraception methods such as hormonal contraception, IUD, sterilization, or double barrier methods
- Participation in another drug trial in the past 3 months
- History of impaired kidney function or elevated liver enzymes beyond specified lab value limits
- Use of medications or supplements that interact with CBD metabolism within 14 days before and during the study
- Any condition deemed unsafe or preventing adherence to the study procedures by the clinician or principal investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Ichan School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
Research Team
S
SCANS Study Team
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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