A Phase 1/2 interventional study of Psilocybin (Usona Institute) in Spinal Cord Injury, Depression - Major Depressive Disorder and Veteran, sponsored by James J. Peters Veterans Affairs Medical Center. Recruiting at 1 site in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-08-10.
Sponsored by James J. Peters Veterans Affairs Medical Center · Phase 1/2, Interventional, and Treatment
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:
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.
2,025 studies on the registry are indexed under Spinal Cord Injuries; 537 are open to participants now.
This study's planned enrollment of 30 is above the median of 24 across 1,633 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →James J. Peters Veterans Affairs Medical Center is the lead sponsor of 50 studies on the registry; 4 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 2 (25%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Psilocybin 5mg
Drug: Psilocybin (Usona Institute)
Psilocybin 10mg
Drug: Psilocybin (Usona Institute)
Psilocybin 25mg
Drug: Psilocybin (Usona Institute)
Oral capsules
Also known as: Magic Mushrooms
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.
Time frame: Screening through study completion, an average of 13 months.
Clinician rated change from baseline (V1) in the Montgomery-Asberg Depression Rating Scale (MADRS) score at 44(+/-7) days post psilocybin dose (V9).
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.
Time frame: 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).
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.
Time frame: Baseline to 44 days post psilocybin.
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).
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.
Time frame: Baseline to 7 days post psilocybin.
Self-reported change in frequency and severity of spasms using the Penn Spasm Frequency Scale (PSFS) .
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).
Time frame: Baseline to 7 days post psilocybin.
Plan to share: Undecided — If data will not be shared it is due to restrictive policies within the VA.
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Studies of the drug tested here: Psilocybin
James J. Peters Veterans Affairs Medical Center