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Psilocybin to Treat Depression in Spinal Cord Injury

NCT07251491 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-05-04

No results posted yet for this study

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

Interventions

DRUG

Psilocybin (Usona Institute)

Oral capsules

Sponsors & Collaborators

  • Bronx Veterans Medical Research Foundation, Inc

    collaborator OTHER

  • Usona Institute

    collaborator OTHER

  • United States Department of Defense

    collaborator FED

  • James J. Peters Veterans Affairs Medical Center

    lead FED

Principal Investigators

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

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2028-03-01
Completion
2028-03-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07251491 on ClinicalTrials.gov