Psilocybin to Treat Depression in Spinal Cord Injury (STOP)

August 6, 2026 updated by: Jill M. Wecht, Ed.D., James J. Peters Veterans Affairs Medical Center

Safety, Tolerability, Outcomes of Psilocybin for Depression (STOP Depression) in Veterans With Spinal Cord Injury

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Background: Depression may be explained partly by decreased signaling of serotonin in the nervous system. Psilocybin, the active component of 'magic mushrooms', is a drug that activates serotonin pathways in the nervous system. Some scientists think psilocybin could help people with major depression, but it is not currently approved as a medicine in the United States. People with spinal cord injuries (SCI) often feel depressed, even more commonly than people without injuries. People with SCI have not been included in psilocybin studies. The goals of this study are first to see if psilocybin can be safely administered, and to determine if psilocybin can help improve symptoms of depression in people with SCI. Study Goals: The investigators will look at how safe psilocybin is for people with SCI, how people with SCI respond to different doses, and whether it helps reduce the severity of depression and other problems, like pain or muscle spasms. The study team will also check to see if psilocybin improves quality of life and wellbeing. The study will track these effects for a year after participants receive psilocybin. Study Plan: Thirty people with chronic SCI with a depressive disorder will be asked to join-15 with paraplegia and 15 with tetraplegia. They will be split into three groups to try different psilocybin doses: low (5mg), medium (10mg), and high (25mg). The study will take a stepwise approach to safety, but participants will not know the dose of psilocybin they receive. There will be at least 16 study visits, including medical and mental health check-ups, psilocybin assisted therapy, primary study endpoint and follow-up visits. What Will Be Measured: The study focus is to see if psilocybin is safe and tolerable in people with SCI. The study will track side effects, how people feel, and any changes in mood, pain, medication use, or body reactions. Doctors will check for problems like chest pain, high blood pressure, and changes in suicidal thoughts. The study team will also measure satisfaction with the therapy, experiences during the psilocybin sessions, and changes in depression. Why It Matters: Some people wrongly believe depression is just a normal part of living with SCI, so their depression may not be adequately treated. Also, people with SCI often can't join trials of new treatments because they have other health problems. Psilocybin could help treat depression and may improve many body functions affected by SCI if it is shown to be safe and effective.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New York
      • The Bronx, New York, United States, 10468
        • Recruiting
        • James J. Peters Department of Veterans Affairs Medical Center
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Psilocybin Low Dose
Psilocybin 5mg
Drug: Psilocybin (Usona Institute)
Oral capsules
Other Names:
  • Magic Mushrooms
Experimental: Psilocybin Medium Dose
Psilocybin 10mg
Drug: Psilocybin (Usona Institute)
Oral capsules
Other Names:
  • Magic Mushrooms
Experimental: Psilocybin High Dose
Psilocybin 25mg
Drug: Psilocybin (Usona Institute)
Oral capsules
Other Names:
  • Magic Mushrooms

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
Screening through study completion, an average of 13 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinician rated change from baseline (V1) in the Montgomery-Asberg Depression Rating Scale (MADRS) score at 44(+/-7) days post psilocybin dose (V9).
Time Frame: Baseline to 44 days post psilocybin.
The MADRS is a ten-item diagnostic questionnaire that includes questions related to symptoms of (1) apparent sadness; (2) reported sadness; (3) inner tension; (4) reduced sleep; (5) reduced appetite; (6) concentration difficulties; (7) lassitude; (8) inability to feel; (9) pessimistic thoughts; and (10) suicidal thoughts. Each item yields a score of 0 to 6, with higher scores reflecting more severe depression. MADRS scores correspond to 0-6 (normal or no depression), 7-19 (mild depression), 20-30 (moderate depression), 31-39 (severe depression), and 40-60 (extremely severe depression). Higher scores are indicative of higher levels of depression, range of scores 0-60.
Baseline to 44 days post psilocybin.
Self reported change in depression severity score on the Beck Depression Inventory (BDI-II) from baseline (V1) to 44(+/-7) days post psilocybin (V9).
Time Frame: Baseline to 44 days post psilocybin.
The BDI-II consists of four answer choices that are scored from 0 (no symptom) to 3 (severe symptom). Total BDI scores correspond to 0-9 (minimal depression), 10-18 (mild depression), 19-29 (moderate depression) and 30-63 (severe depression). Higher scores are indicative of higher levels of depression, range of scores 0-63.
Baseline to 44 days post psilocybin.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in self-reported levels of pain interference in daily life, overall mood, and sleep quality from baseline (V1) to 7 days post psilocybin (V7) using the International Spinal Cord Injury Pain Basic Data Set (iSCI-PBD).
Time Frame: Baseline to 7 days post psilocybin.
The iSCI-PBD detects change in the number of painful condition types, the severity of pain, location of painful conditions, and pain interference in daily life, overall mood, and sleep quality. The outcome will include change in pain interference in daily life, overall mood, and sleep quality from baseline (V1) to 7 days post psilocybin (V7) using the iSCI-PBD with scores ranging from 0 (no interference) to 10 (extreme interference). Higher scores are indicative of higher levels of pain interference, range of scores 0-10.
Baseline to 7 days post psilocybin.
Self-reported change in frequency and severity of spasms using the Penn Spasm Frequency Scale (PSFS) .
Time Frame: Baseline to 7 days post psilocybin.
The PSFS is a self-report measure used to assess the perception (over a one-week time frame) of spasticity frequency on a 0 ("no spasm") to 4 ("spasms occurring more than 10 times per hour) scale, and severity on a 1 ("mild") to 3 ("severe") following SCI. The investigators will track change changes in spasms from baseline (V1) to 7 days post psilocybin (V7). Higher scores are indicative of higher levels of spasm frequency (score range 0-4) and spasm severity (score range 0-3).
Baseline to 7 days post psilocybin.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

James J. Peters Veterans Affairs Medical Center

Collaborators

United States Department of Defense
Bronx Veterans Medical Research Foundation, Inc
Usona Institute

Investigators

  • Principal Investigator: Jill M Wecht, EdD, James J Peters VA Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 6, 2026

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2028

Study Registration Dates

First Submitted

September 30, 2025

First Submitted That Met QC Criteria

November 18, 2025

First Posted (Actual)

November 26, 2025

Study Record Updates

Last Update Posted (Actual)

August 10, 2026

Last Update Submitted That Met QC Criteria

August 6, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1872390
  • SC240097 (Other Grant/Funding Number: CDMRP Department of Defense)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

If data will not be shared it is due to restrictive policies within the VA.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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