Cannabidiol for Stress

(SCANS Trial)

Overseen By SCANS Study Team

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Icahn School of Medicine at Mount Sinai

Compensation: Varies

Number of Visits: Unknown

160 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Keren Bachi, PhD

Principal Investigator

Ichan School of Medicine

Are You a Good Fit for This Trial?

This trial is for individuals with anxiety disorders, nerve injury, trauma, or stress from early life adversity. Participants should be interested in how Cannabidiol (CBD) might help manage stress. Specific inclusion and exclusion criteria are not listed but typically involve age ranges, health status, and other factors relevant to the study.

Inclusion Criteria

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)

English speakers

Cognitive performance at threshold of greater than or equal to 23 as assessed by the Montreal Cognitive Assessment (MoCA)

Exclusion Criteria

Being pregnant or breastfeeding

Participating in another pharmacotherapeutic trial in the past three months

I have used cannabis or CBD products in the last three weeks.

What Are the Treatments Tested in This Trial?

Interventions

• Cannabidiol

Trial Overview The study is testing whether CBD can help regulate stress response compared to a placebo. It involves neuroimaging to observe brain function and will measure changes in neurometabolic activity, hormone levels, and behavior.

How Is the Trial Designed?

Group I: Cannabidiol (CBD) Experimental Treatment 1 Intervention

Cannabidiol - oral CBD solution 400 mg

Group II: Placebo Placebo Group 1 Intervention

Drug: Placebo Inactive oral solution

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Jazz Pharmaceuticals

Industry Sponsor

Trials

252

Recruited

35,100+

Bruce C. Cozadd

Jazz Pharmaceuticals

Chief Executive Officer since 2009

BA in Economics from Yale University, MBA from Stanford University

Dr. Austin

Jazz Pharmaceuticals

Chief Medical Officer since 2023

MD from the Royal College of Surgeons in Ireland