Psilocybin to Treat Depression in Spinal Cord Injury

NCT07251491 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: 1872390SC240097
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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; Veteran; Depression - Major Depressive Disorder

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Treatment-Related Adverse Events as Assessed by the Adverse Events Log.

  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 Outcomes (2)

• Clinician rated change from baseline (V1) in the Montgomery-Asberg Depression Rating Scale (MADRS) score at 44(+/-7) days post psilocybin dose (V9).

  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).

  Baseline to 44 days post psilocybin.

Other Outcomes (2)

• 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).

  Baseline to 7 days post psilocybin.

• Self-reported change in frequency and severity of spasms using the Penn Spasm Frequency Scale (PSFS) .

  Baseline to 7 days post psilocybin.

Study Arms (3)

Psilocybin Low Dose

EXPERIMENTAL

Psilocybin 5mg

Drug: Psilocybin (Usona Institute)

Psilocybin Medium Dose

EXPERIMENTAL

Psilocybin 10mg

Drug: Psilocybin (Usona Institute)

Psilocybin High Dose

EXPERIMENTAL

Psilocybin 25mg

Drug: Psilocybin (Usona Institute)

Interventions

Psilocybin (Usona Institute) DRUG

Oral capsules

Also known as: Magic Mushrooms

Psilocybin High Dose; Psilocybin Low Dose; Psilocybin Medium Dose

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bronx Veterans Medical Research Foundation, Inc: collaborator
• Usona Institute: collaborator
• United States Department of Defense: collaborator
• James J. Peters Veterans Affairs Medical Center: lead

Study Sites (1)

James J. Peters Department of Veterans Affairs Medical Center

The Bronx, New York, 10468, United States

RECRUITING

Related Publications (9)

• Lyes M, Yang KH, Castellanos J, Furnish T. Microdosing psilocybin for chronic pain: a case series. Pain. 2023 Apr 1;164(4):698-702. doi: 10.1097/j.pain.0000000000002778. Epub 2022 Sep 5.

  PMID: 36066961 BACKGROUND

• Abrams SK, Rabinovitch BS, Zafar R, Aziz AS, Cherup NP, McMillan DW, Nielson JL, Lewis EC. Persons With Spinal Cord Injury Report Peripherally Dominant Serotonin-Like Syndrome After Use of Serotonergic Psychedelics. Neurotrauma Rep. 2023 Aug 22;4(1):543-550. doi: 10.1089/neur.2023.0022. eCollection 2023.

  PMID: 37636336 BACKGROUND

• Liu Y, Collins C, Wang K, Xie X, Bie R. The prevalence and trend of depression among veterans in the United States. J Affect Disord. 2019 Feb 15;245:724-727. doi: 10.1016/j.jad.2018.11.031. Epub 2018 Nov 5.

  PMID: 30699861 BACKGROUND

• Smith BM, Weaver FM, Ullrich PM. Prevalence of depression diagnoses and use of antidepressant medications by veterans with spinal cord injury. Am J Phys Med Rehabil. 2007 Aug;86(8):662-71. doi: 10.1097/PHM.0b013e318114cb6d.

  PMID: 17667197 BACKGROUND

• Sloshower J, Skosnik PD, Safi-Aghdam H, Pathania S, Syed S, Pittman B, D'Souza DC. Psilocybin-assisted therapy for major depressive disorder: An exploratory placebo-controlled, fixed-order trial. J Psychopharmacol. 2023 Jul;37(7):698-706. doi: 10.1177/02698811231154852. Epub 2023 Mar 20.

  PMID: 36938991 BACKGROUND

• Goodwin GM, Aaronson ST, Alvarez O, Atli M, Bennett JC, Croal M, DeBattista C, Dunlop BW, Feifel D, Hellerstein DJ, Husain MI, Kelly JR, Lennard-Jones MR, Licht RW, Marwood L, Mistry S, Palenicek T, Redjep O, Repantis D, Schoevers RA, Septimus B, Simmons HJ, Soares JC, Somers M, Stansfield SC, Stuart JR, Tadley HH, Thiara NK, Tsai J, Wahba M, Williams S, Winzer RI, Young AH, Young MB, Zisook S, Malievskaia E. Single-dose psilocybin for a treatment-resistant episode of major depression: Impact on patient-reported depression severity, anxiety, function, and quality of life. J Affect Disord. 2023 Apr 14;327:120-127. doi: 10.1016/j.jad.2023.01.108. Epub 2023 Feb 4.

  PMID: 36740140 BACKGROUND

• Goodwin GM, Aaronson ST, Alvarez O, Arden PC, Baker A, Bennett JC, Bird C, Blom RE, Brennan C, Brusch D, Burke L, Campbell-Coker K, Carhart-Harris R, Cattell J, Daniel A, DeBattista C, Dunlop BW, Eisen K, Feifel D, Forbes M, Haumann HM, Hellerstein DJ, Hoppe AI, Husain MI, Jelen LA, Kamphuis J, Kawasaki J, Kelly JR, Key RE, Kishon R, Knatz Peck S, Knight G, Koolen MHB, Lean M, Licht RW, Maples-Keller JL, Mars J, Marwood L, McElhiney MC, Miller TL, Mirow A, Mistry S, Mletzko-Crowe T, Modlin LN, Nielsen RE, Nielson EM, Offerhaus SR, O'Keane V, Palenicek T, Printz D, Rademaker MC, van Reemst A, Reinholdt F, Repantis D, Rucker J, Rudow S, Ruffell S, Rush AJ, Schoevers RA, Seynaeve M, Shao S, Soares JC, Somers M, Stansfield SC, Sterling D, Strockis A, Tsai J, Visser L, Wahba M, Williams S, Young AH, Ywema P, Zisook S, Malievskaia E. Single-Dose Psilocybin for a Treatment-Resistant Episode of Major Depression. N Engl J Med. 2022 Nov 3;387(18):1637-1648. doi: 10.1056/NEJMoa2206443.

  PMID: 36322843 BACKGROUND

• Khazaeipour Z, Taheri-Otaghsara SM, Naghdi M. Depression Following Spinal Cord Injury: Its Relationship to Demographic and Socioeconomic Indicators. Top Spinal Cord Inj Rehabil. 2015 Spring;21(2):149-55. doi: 10.1310/sci2102-149. Epub 2015 Apr 12.

  PMID: 26364284 BACKGROUND

• Krause JS, Kemp B, Coker J. Depression after spinal cord injury: relation to gender, ethnicity, aging, and socioeconomic indicators. Arch Phys Med Rehabil. 2000 Aug;81(8):1099-109. doi: 10.1053/apmr.2000.7167.

  PMID: 10943762 BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries; Quadriplegia; Paraplegia; Depression; Neuralgia

Interventions

Psilocybin

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Peripheral Nervous System Diseases; Neuromuscular Diseases; Pain

Intervention Hierarchy (Ancestors)

Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tryptamines; Indolizidines; Indolizines

Study Officials

• Jill M Wecht, EdD

  James J Peters VA Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas W Sutor, PhD

CONTACT

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

Dylan C Arnero, MS

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: psilocybin 5mg psilocybin 10mg psilocybin 25mg

Study Record Dates

• First Submitted: September 30, 2025
• First Posted: November 26, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

US (1)