NCT07251491 · James J. Peters Veterans Affairs Medical Center
Psilocybin to Treat Depression in Spinal Cord Injury
(STOP)
What this study is about
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).
View original scientific description
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
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- The Bronx, New York
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 4, 2026 · Source of record for eligibility and locations