Recruiting
Phase 1
Phase 2

CBD

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT07278505

Conditions

Early Life Adversity

Trauma

Stress

Eligibility Criteria

Sex: All

Age: 18 - 25

Healthy Volunteers: Accepted

Interventions

Cannabidiol

Placebo

Study Details

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

Study ID

NCT07278505

Start date

Oct 28, 2025

Status verified date

Dec, 2025

Completion date

Feb 28, 2030

Anticipated

Primary completion date

Feb 28, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 25

Healthy Volunteers: Accepted

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 Criteria:

  • 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.
  • History of impaired renal function or elevated liver enzymes at prescreening. The exclusionary lab values are: 3x normal AST/ALT, 1.5x bilirubin or <30mL/min/1.73m2 eGFR, or QTc>500.
  • 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.

Study Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Cannabidiol (CBD)

Cannabidiol - oral CBD solution 400 mg

placebo comparator: Placebo

Drug: Placebo Inactive oral solution

Interventions

Cannabidiol

400mg cannabidiol

Placebo

Inactive oral solution

Primary outcome measure

  • Neural (BOLD) functional response [ Time Frame: Day 2 ]
  • Neuronal viability indexed by GLX (combined glutamate/glutamine levels) and N-acetylaspartate (NAA) using 1H-MRS. [ Time Frame: at day 2 ]
  • Serum Cortisol level [ Time Frame: Day 2, Day 3 ]
  • Salivary Cortisol level [ Time Frame: Day 2, Day 3 ]

Central Contacts and Locations

Central contacts

SCANS Study Team

646-984-3519scans@mssm.edu

Locations

Ichan School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Contacts

Elena Silverman, MS

646-984-3519scans@mssm.edu

Ariadni Oikonomou, BA

646-984-3519scans@mssm.edu

Principal Investigator:

Keren Bachi

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

Dec 12, 2025

Last verified

Dec, 2025

Keywords

  • Cannabidiol
  • Childhood Trauma
  • Stress
  • Trauma
  • Anxiety
  • Adversity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2025-12-12.