Psilocybin to Treat Depression in Spinal Cord Injury
Recruiting now · Phase 1/Phase 2
Conditions studied: Spinal Cord Injury, Depression - Major Depressive Disorder, Veteran
In brief
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.
Key facts
- Study ID
- NCT07251491
- Run by
- James J. Peters Veterans Affairs Medical Center
- People needed
- 30
- Starts
- 2026-08-06
- Expected to finish
- 2028-03-01
- Last updated by the study team
- 2026-08-10
Who can join
Age: 22 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 it is running
- James J. Peters Department of Veterans Affairs Medical Center — The Bronx, New York, United States (enrolling)
Full record on ClinicalTrials.gov
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