NCT07251491 Psilocybin to Treat Depression in Spinal Cord Injury
| NCT ID | NCT07251491 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | James J. Peters Veterans Affairs Medical Center |
| Condition | Spinal Cord Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2026-08-06 |
| Primary Completion | 2028-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2026-08-06 with a primary completion date of 2028-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Able and willing to provide informed consent * Spinal cord injury for at least 1 year * Confirmed diagnosis of depression * At least 22 years of age at time of consent * At least 50 kg (110 lbs.) body weight * Fully independent from ventilatory support (ventilator or diaphragm pacer) * Fluent in speaking and reading English * Able to swallow pills * Agree to have study visits recorded with audio and video * Agree to release outside medical and psychiatric records * Able and willing to taper off antidepressant, under clinician supervision * Agree to use adequate contraceptive methods Exclusion Criteria: * Are not able to give adequate informed consent * Have used psilocybin or another psychedelic within 6 months * Have received Electroconvulsive Therapy (ECT) within 12 weeks * Have used ketamine within 12 weeks * Have a history of Bipolar I Disorder * Have a current eating disorder * Have a current severe alcohol or cannabis use disorder within the 6 months * Have an illicit drug or prescription drug substance use disorder within 12 months * Current serious suicide risk * History of heart attack, aneurysm, or stroke * Uncontrolled hypertension * Are pregnant or nursing
Contact & Investigator
Jill M Wecht, EdD
PRINCIPAL INVESTIGATOR
James J Peters VA Medical Center
Frequently Asked Questions
Who can join the NCT07251491 clinical trial?
This trial is open to participants of all sexes, aged 22 Years or older, studying Spinal Cord Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07251491 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07251491 currently recruiting?
Yes, NCT07251491 is actively recruiting participants. Contact the research team at Thomas.Sutor@mountsinai.org for enrollment information.
Where is the NCT07251491 trial being conducted?
This trial is being conducted at The Bronx, United States.
Who is sponsoring the NCT07251491 clinical trial?
NCT07251491 is sponsored by James J. Peters Veterans Affairs Medical Center. The principal investigator is Jill M Wecht, EdD at James J Peters VA Medical Center. The trial plans to enroll 30 participants.