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Psilocybin to Treat Depression in Spinal Cord Injury

Study acronym: STOP
StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Start date changed from estimate of May 1, 2026 to Aug 6, 2026v6
  2. Recruitment opened
    • Start date: Jan 1, 2026 to May 1, 2026
    • Site details revised
    v5
  3. Trial status: Recruiting to Not Yet Recruiting
    • Site details revised
    v4
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v3
  5. Secondary endpoints: details revised at 2 of 2 entriesv2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07251491
Lead Sponsor James J. Peters Veterans Affairs Medical Center
Collaborators: Bronx Veterans Medical Research Foundation, Inc, Usona Institute, United States Department of Defense
Conditions
(from sponsor)		 Spinal Cord Injury, Depression - Major Depressive Disorder, Veteran
Related terms Depression, Neuralgia, Paraplegia, Quadriplegia, Spinal Cord Injuries
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov