Study of Cannabidiol and Neuroimaging on Stress

NCT07278505 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: STUDY-25-003371R01MH139940
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Early Life Adversity; Trauma; Stress

Keywords

Cannabidiol; Childhood Trauma; Stress; Trauma; Anxiety; Adversity

Outcome Measures

Primary Outcomes (4)

• Neural (BOLD) functional response

  Measurement of brain activity using the Blood Oxygenation Level Dependent (BOLD) signal Neural (BOLD) functional response to acute stress and network hierarchy in resting state functional connectivity. BOLD response will measure neural activity during stress conditions as compared to rest and control conditions

  Day 2

• Neuronal viability indexed by GLX (combined glutamate/glutamine levels) and N-acetylaspartate (NAA) using 1H-MRS.

  Concentration of brain chemicals (N-acetylaspartate, Glutamate/Glutamine Levels) as an indicator of brain health measured using non-invasive imaging of magnetic resonance spectroscopy.

  at day 2

• Serum Cortisol level

  The cortisol blood test measures the level of cortisol in the blood. Cortisol is a steroid (glucocorticoid or corticosteroid) hormone produced by the adrenal gland.

  Day 2, Day 3

• Salivary Cortisol level

  The cortisol saliva test measures the level of cortisol in the saliva. Cortisol is a steroid (glucocorticoid or corticosteroid) hormone produced by the adrenal gland.

  Day 2, Day 3

Secondary Outcomes (4)

• Visual analog scale for stress (VASStress)

  Day 2, Day 3

• Visual analog scale for anxiety (VASAnxiety)

  Day 2, Day 3

• Adrenocorticotropic hormone (ACTH) level

  Day 2, Day 3

• Serum noradrenaline level

  Day 2, Day 3

Study Arms (2)

Cannabidiol (CBD)

EXPERIMENTAL

Cannabidiol - oral CBD solution 400 mg

Drug: Cannabidiol

Placebo

PLACEBO COMPARATOR

Drug: Placebo Inactive oral solution

Drug: Placebo

Interventions

Cannabidiol DRUG

400mg cannabidiol

Also known as: CBD, Epidiolex

Cannabidiol (CBD)

Placebo DRUG

Inactive oral solution

Placebo

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• Have a medical condition that would make study participation unsafe, and/or which would make treatment compliance difficult, and/or would prevent adherence to study procedure. This includes but is not limited to the following criteria: history of cardiac disease, arrhythmias, neurological disease of central origin, head trauma, and seizures.
• Meet criteria for any current psychiatric diagnosis as per DSM-5 \[determined with the Mini International Neuropsychiatric Interview for DSM-5 (M.I.N.I. version 7.2)\].
• Using any psychoactive drug (other than nicotine and/or alcohol) in the past seven days (determined by lack of acute withdrawal symptoms, the negative result of a urine drug screen, timeline follow back, and alcohol breathalyzer to detect alcohol intoxication).
• Positive urine drug screen (tetrahydrocannabinol, cocaine, opiates, benzodiazepines, barbiturates, amphetamines, morphine, methadone, methamphetamines, oxycodone, phencyclidine, tricyclic antidepressant, buprenorphine, methylenedioxymethamphetamine)
• Use of cannabis products, including CBD, during the past three weeks (determined with urine screen and self-report). Urine drug screen will be performed at each encounter. (Note: Epidiolex is known to sometimes cause a false positive for THC on urine toxicology; drug screen in visit after first CBD administration will not include THC as not to diminish the study blind. Stored urine will be tested for THC after study blind is opened).
• Use of medication altering BOLD response, neurometabolic/glutamatergic levels, and endocrine function, including psychotropic medications (e.g., SSRIs), during the past three months.
• Participation in non-medication-based treatments for anxiety or heightened stress, including cognitive behavioral therapy or other evidence-based treatments, in the past three months.
• Medical or psychiatric contraindications for CBD administration (e.g., history of hypersensitivity to cannabinoids) or any of the ingredients in the product (sesame oil).
• Being pregnant or breastfeeding.
• Not using an appropriate method of contraception such as hormonal contraception (oral hormonal contraceptives, Depo-Provera, Nuva-Ring), intrauterine device (IUD), sterilization, or double barrier method (combination of any two barrier methods used simultaneously, i.e., condom, spermicide, diaphragm).
• Participating in another pharmacotherapeutic trial in the past three months.
• Participants who have used any medication, dietary supplements (and/or grapefruit juice), or combination of medications and supplements known to alter the metabolism of, or interact with CBD (bupropion, rifampin, barbiturates, phenothiazines, cimetidine, etc.) 14 days prior to and during the duration of the study.
• Any condition that would make study participation unsafe and/or which would prevent adherence to study procedure (e.g., suicidal or homicidal ideation requiring immediate attention, severe inadequately treated mental health condition) as determined by the study clinician and/or PI.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• Jazz Pharmaceuticals: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Ichan School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

Related Links

• Prescreen Survey

MeSH Terms

Conditions

Wounds and Injuries; Anxiety Disorders

Interventions

Cannabidiol

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Keren Bachi, PhD

  Ichan School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

SCANS Study Team

CONTACT

646-984-3519; scans@mssm.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: December 12, 2025
• Study Start: October 28, 2025
• Primary Completion (Estimated): February 28, 2030
• Study Completion (Estimated): February 28, 2030
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)