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Psilocybin for Depression in Spinal Cord Injury

This study is looking into whether psilocybin, a substance found in certain mushrooms, can be safely used to treat depression in people with spinal cord injuries (SCI). Researchers want to see if psilocybin, given as oral capsules, causes any side effects like pain, muscle spasms, or changes in blood pressure. They will also observe how people with SCI react to different doses (5mg, 10mg, and 25mg) and if it helps improve their depression symptoms, quality of life, and overall well-being. To join, you must be at least 22 years old, have had a spinal cord injury for at least a year, and have a confirmed diagnosis of depression. The study plans to enroll 30 participants, but its current status is unclear.

Study design
This study plans to enroll 30 participants with spinal cord injury and depression, split into three groups to receive low, medium, or high doses of psilocybin. The study aims to determine the safety and response to these different doses.
What's involved
You would agree to be part of the study for up to 13 months. The study will track adverse events from screening through study completion.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for an average of 13 months, with effects tracked for a year after receiving psilocybin.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07251491

Psilocybin to Treat Depression in Spinal Cord Injury

Recruiting
PHASE1Ages 22+InterventionalTreatment
James J. Peters Veterans Affairs Medical Center
~30 participants
Updated 2026-08-10 on ClinicalTrials.gov
What's tested:Psilocybin (Usona Institute)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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.

Conditions

Spinal Cord Injury
Depression - Major Depressive Disorder
Veteran

Explore related trials

Spinal Cord InjuryUnipolar Depression

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Jill M Wecht, EdD · PRINCIPAL_INVESTIGATOR · James J Peters VA Medical Center

Who to contact

Thomas W Sutor, PhD
[email protected]
718-584-9000 · ext. 5129
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Number of Participants with Treatment-Related Adverse Events as Assessed by the Adverse Events Log.Screening through study completion, an average of 13 months.

    The Adverse Events Log will be captured by the research team at screening, before and after medication taper (if needed), weekly during the taper, at each of the three preparatory and three integration sessions, at 44 days post dose, and at all remote and in-person follow-up visits; 16 assessments in total.