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NCT07278505 · ClinicalTrials.gov registry record · Phase 1

Study of Cannabidiol and Neuroimaging on Stress

A Phase 1 study of Stress and Trauma, sponsored by Icahn School of Medicine at Mount Sinai.

Recruiting
Registry status
Phase 1
Development phase
160
Enrollment target
1
Study location

NCT07278505: Recruiting Phase 1 study of Stress and Trauma, sponsored by Icahn School of Medicine at Mount Sinai.

NCT07278505 is a Phase 1 study of Stress and Trauma that is actively recruiting participants, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 160 participants, below the 785-participant average among 152 other Stress trials with a reported enrollment target (80% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07278505, a Phase 1 study of Stress and Trauma, is actively recruiting participants, sponsored by Icahn School of Medicine at Mount Sinai.

RECRUITING
Registry status
Phase 1
Development phase
160 participants
Enrollment target
1
Study location

Study 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.

Primary Outcome

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

Interventions

  • DRUG Placebo
  • DRUG Cannabidiol

Study Locations (1)

New York

  • Ichan School of Medicine at Mount Sinai - New York

Trial Details

FieldValue
Enrollment Target 160 participants
Start Date 2025-10-28
Est. Completion 2030-02-28
Phase Phase 1

What NCT07278505 shows while recruiting

NCT07278505 is an interventional study that assigns participants to a tested intervention. The registered 160 participants enrollment target is mid-sized for trials with a published cap, below the 785-participant average among 152 other Stress trials with a reported enrollment target (80% lower).

The record links to 3 conditions, with Stress appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT07278505 reports a single indexed study location in New York.

Frequently Asked Questions

What is clinical trial NCT07278505 about?

NCT07278505 is a clinical study titled "Study of Cannabidiol and Neuroimaging on Stress". 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, wit...

What is the current status of trial NCT07278505?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 160 participants. The study started on 2025-10-28. Estimated completion is 2030-02-28.

What conditions does trial NCT07278505 study?

This clinical trial studies the following conditions: Stress, Trauma, Early Life Adversity.

What interventions are being tested in trial NCT07278505?

The interventions under investigation include: Placebo (DRUG), Cannabidiol (DRUG).

Who is sponsoring clinical trial NCT07278505?

This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07278505 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Stress

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT07278505's enrollment target sits among peer trials

160 40th of 152 higher than 111 of 152 other Stress trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Stress trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT07278505, the US trial registry maintained by the National Library of Medicine. NCT07278505 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.