Bronx VA starts a psilocybin safety trial for depression after spinal cord injury

What the study is testing

This is a phase 1/2 study whose main goal is safety. It plans to enroll 30 people with chronic spinal cord injury and a depressive disorder, 15 with paraplegia and 15 with tetraplegia, split into three groups. Per the registry, the groups receive psilocybin 5 mg, 10 mg or 25 mg in oral capsules. Assignment isn't random: the team takes a stepwise approach to safety, but participants, care providers and outcome assessors don't know which amount a participant got.¹

The primary outcome is the number of participants with treatment-related adverse events, logged at 16 points from screening through the end of the study, an average of 13 months. The registry names pain, muscle spasms, depression symptoms and symptoms of low or high blood pressure among the events it is watching for. Secondary outcomes are changes on two depression scales, the clinician-rated MADRS and the self-reported Beck Depression Inventory, 44 days after the psilocybin session. The team also tracks pain and spasms a week after.¹

The study's description says people with spinal cord injury "have not been included in psilocybin studies," and that "some people wrongly believe depression is just a normal part of living with SCI."¹

Who can take part

The posted criteria call for a spinal cord injury at least a year old, a confirmed diagnosis of depression, an age of 22 or older, independence from a ventilator or diaphragm pacer, fluency in English, and willingness to taper off antidepressants under a clinician's supervision. Exclusions include psilocybin or another psychedelic within six months, ketamine or electroconvulsive therapy within 12 weeks, bipolar I disorder, a current eating disorder, recent substance use disorders, serious suicide risk, a history of heart attack, aneurysm or stroke, uncontrolled hypertension, and pregnancy or nursing.¹

The official title names veterans, but the posted inclusion criteria don't list veteran status as a requirement, so anyone interested should ask the study team. Participants commit to seven visits for the psilocybin-assisted therapy, at least 16 study visits in all, and up to 13 months of follow-up, some in person at the Bronx hospital and some remote.¹

Who runs and funds it

The Bronx VA is the lead sponsor and Jill M. Wecht, EdD, is the principal investigator. The collaborators are the Bronx Veterans Medical Research Foundation, the Usona Institute and the U.S. Department of Defense; the registry lists a Defense Department grant, SC240097, and names the study drug as psilocybin from the Usona Institute.¹ We found no VA announcement of the study's start as of November 2.

The Bronx VA's other psychedelic studies

By our count of the registry, 2 psilocybin studies have listed a site at the James J. Peters VA. The hospital was also a site for Usona's phase 3 depression trial, NCT06308653, which enrolled 238 people across its sites and is now active but not recruiting.² The hospital also sponsors an MDMA-assisted therapy study for PTSD, NCT06418178, which is recruiting.³ Our New York trials list tracks every psilocybin study with a site in the state.

Psilocybin remains a Schedule I drug under federal law, so it can't be prescribed outside approved research.⁴ For what's legal in New York today, see psilocybin therapy in NYC; for crisis lines, see safety and help.