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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07251491
The ClinicalTrials.gov registry entry for NCT07251491 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is James J. Peters Veterans Affairs Medical Center, which has 39 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Psilocybin (Usona Institute) is the first listed.
NCT07251491 reports 0 study locations.
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.
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