Recruiting
Phase 1
Phase 2

Psilocybin

Sponsor:

James J. Peters Veterans Affairs Medical Center

Code:

NCT07251491

Conditions

Spinal Cord Injury

Depression - Major Depressive Disorder

Veteran

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Interventions

Psilocybin (Usona Institute)

Study Details

Brief 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.

Conditions

Spinal Cord Injury

Depression - Major Depressive Disorder

Veteran

Study ID

NCT07251491

Start date

Aug 6, 2026

Status verified date

Aug, 2026

Completion date

Mar 1, 2028

Anticipated

Primary completion date

Mar 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Psilocybin Low Dose

Psilocybin 5mg

experimental: Psilocybin Medium Dose

Psilocybin 10mg

experimental: Psilocybin High Dose

Psilocybin 25mg

Interventions

Psilocybin (Usona Institute)

Oral capsules

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 and Locations

Central contacts

Thomas W Sutor, PhD

718-584-9000Thomas.Sutor@mountsinai.org

Dylan C Arnero, MS

718-584-9000Dylan.Arnero@va.gov

Locations

James J. Peters Department of Veterans Affairs Medical Center

Recruiting

The Bronx, New York, United States, 10468

Contacts

Thomas W Sutor, PhD

718-584-9000thomas.sutor@mountsinai.org

Dylan C Arnero, MS

718-584-9000Dylan.Arnero@va.gov

More Information

Sponsor

James J. Peters Veterans Affairs Medical Center

Last update posted

Aug 10, 2026

Last verified

Aug, 2026

Keywords

  • Tetraplegia
  • Paraplegia
  • Psychosocial Wellbeing
  • Depression
  • Neuropathic Pain
  • Psychedelics

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by James J. Peters Veterans Affairs Medical Center on 2026-08-10.