Psilocybin to Treat Depression in Spinal Cord Injury (NCT07251491) | Clinical Trial Compass
RecruitingPhase 1/2
Psilocybin to Treat Depression in Spinal Cord Injury
United States30 participantsStarted 2026-05-01
Plain-language 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.
Who can participate
Age range
22 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants with Treatment-Related Adverse Events as Assessed by the Adverse Events Log.
Timeframe: Screening through study completion, an average of 13 months.
Trial details
NCT IDNCT07251491
SponsorJames J. Peters Veterans Affairs Medical Center