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NCT07251491 · ClinicalTrials.gov registry record · Phase 1
Psilocybin to Treat Depression in Spinal Cord Injury
A Phase 1 study, sponsored by James J. Peters Veterans Affairs Medical Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT07251491: Recruiting Phase 1 study, sponsored by James J. Peters Veterans Affairs Medical Center.
NCT07251491 is a Phase 1 study that is actively recruiting participants, run by James J. Peters Veterans Affairs Medical Center. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07251491, a Phase 1 study, is actively recruiting participants, sponsored by James J. Peters Veterans Affairs Medical Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
The main goal of this study is to determine if psilocybin is safe for use in people with SCI. The study will measure how people with SCI respond to three psilocybin doses: low (5mg), medium (10mg), and high (25mg). The main question the study aims to answer is: does psilocybin increase the number and severity of adverse (bad) events reported by people with SCI? These may include pain, muscle spasms, symptoms of depression, and symptoms of low or high blood pressure. The investigators will also measure how well people with SCI tolerate the psychedelic experience, and compare responses between the low (5mg), medium (10mg), and high (25mg) doses. Participants will: * Agree to be enrolled in the study for up to 13 months. * Agree to complete the seven (7) visits that are included in the psilocybin-assisted therapy. * Agree to complete follow-up study visits, including in-person visits to the James J Peters VA Medical Center, located in the Bronx, New York and remote visits. * Agree to keep a log of how they are feeling and any change in the frequency or severity of adverse events.
Primary Outcome
The Adverse Events Log will be captured by the research team at screening, before and after medication taper (if needed), weekly during the taper, at each of the three preparatory and three integration sessions, at 44 days post dose, and at all remote and in-person follow-up visits; 16 assessments in total.
Interventions
- DRUG Psilocybin (Usona Institute)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2026-05-01 |
| Est. Completion | 2028-03-01 |
| Phase | Phase 1 |
What NCT07251491 shows while recruiting
NCT07251491 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 1 intervention - of which Psilocybin (Usona Institute) is the first listed.
NCT07251491 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07251491 about?
NCT07251491 is a clinical study titled "Psilocybin to Treat Depression in Spinal Cord Injury". The main goal of this study is to determine if psilocybin is safe for use in people with SCI. The study will measure how people with SCI respond to three psilocybin doses: low (5mg), medium (10mg), and high (25mg). The main question the study aims to answer is: does psilocybin increase the number a...
What is the current status of trial NCT07251491?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2026-05-01. Estimated completion is 2028-03-01.
What interventions are being tested in trial NCT07251491?
The interventions under investigation include: Psilocybin (Usona Institute) (DRUG).
Who is sponsoring clinical trial NCT07251491?
This trial is sponsored by James J. Peters Veterans Affairs Medical Center, which has 39 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07251491's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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