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RecruitingPhase 1 / Phase 2

Psilocybin to Treat Depression in Spinal Cord Injury

NCT07251491 · STOP · James J. Peters Veterans Affairs Medical Center

Recruiting
Status
Accepting participants
Phase 1 / Phase 2
Phase
30
Target enrolment
1
Study sites
1 US states

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Number of Participants with Treatment-Related Adverse Events as Assessed by the Adverse Events Log.

    Measured over Screening through study completion, an average of 13 months.

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

22 Years
Ages
All
Sex
Not accepted
Healthy volunteers
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

1 study site

FacilityCityRegionCountry
James J. Peters Department of Veterans Affairs Medical CenterThe BronxNew YorkUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT07251491 on ClinicalTrials.gov →

Last updated in the registry 2026-08-10. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance

Recruiting in