Psilocybin to Treat Depression in Spinal Cord Injury

Part of paid clinical trials in The Bronx, New York.

Sponsor
James J. Peters Veterans Affairs Medical Center
Study ID
NCT07251491
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Depression - Major Depressive Disorder
  • Spinal Cord Injury
  • Veteran

Eligibility Criteria

Sex
ALL
Age
22 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Psilocybin (Usona Institute) — DRUG
    Oral capsules

Study Details

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 Dates

Start date
May 1, 2026
Status verified
Apr 2026
Primary completion
Mar 1, 2028
Completion
Mar 1, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Psilocybin Low Dose
    Psilocybin 5mg
  • Experimental: Psilocybin Medium Dose
    Psilocybin 10mg
  • Experimental: Psilocybin High Dose
    Psilocybin 25mg

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
James J. Peters Department of Veterans Affairs Medical CenterThe BronxNew York10468
Thomas W Sutor, PhD
[email protected]
718-584-9000
Dylan C Arnero, MS
[email protected]
718-584-9000

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By research site
James J. Peters Department of Veterans Affairs Medical Center· The Bronx, NY

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