Cannabidiol and neuroimaging for stress response in young adults
Pathophysiological Mechanisms of Cannabidiol in Stress Regulation
This trial will test whether a single dose of cannabidiol (CBD) changes stress responses in 18–25-year-olds with histories of early-life adversity and elevated stress.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years to 25 Years |
| Sex | All |
| Sponsor | Icahn School of Medicine at Mount Sinai Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT07278505 on ClinicalTrials.gov |
What this trial studies
This randomized, placebo-controlled Phase 1/2 study gives cannabidiol or placebo to young adults with early-life adversity and heightened stress and uses neuroimaging, neurometabolic, endocrine, and behavioral measures to track stress responsivity. The protocol targets mesocorticolimbic network function and HPA-axis signaling to map how CBD alters brain and body stress pathways. Participants undergo standardized stress and cue-reactivity tasks while having brain imaging and biologic samples collected to link mechanism with behavioral change. Findings are intended to bridge animal and human evidence toward targeted early interventions for stress-related disorders.
Who should consider this trial
Good fit: Ideal candidates are English-speaking 18–25-year-olds with documented early-life maltreatment, moderate or higher perceived stress or high trait anxiety, intact cognition (MoCA ≥23), and willingness to undergo neuroimaging and study procedures.
Not a fit: People without a history of early-life adversity, those outside the 18–25 age range, or individuals with severe psychiatric or medical comorbidities (or who require long-term treatment rather than an acute experimental intervention) are unlikely to gain direct benefit from participation.
Why it matters
Potential benefit: If successful, the work could identify how CBD reduces stress reactivity and inform targeted early interventions for people with trauma-related vulnerability.
How similar studies have performed: Animal studies and some human trials have suggested CBD can reduce cue-induced reactivity and anxiety, but rigorous neuroimaging mechanistic studies in this high-risk human population remain limited.
Eligibility criteria
Show full inclusion / exclusion 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 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.
Where this trial is running
New York, New York
- Ichan School of Medicine at Mount Sinai — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Keren Bachi, PhD — Ichan School of Medicine
- Study coordinator: SCANS Study Team
- Email: scans@mssm.edu
- Phone: 646-984-3519
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.