Psilocybin to Treat Depression in Spinal Cord Injury (STOP)

James J. Peters Veterans Affairs Medical Center

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Veteran; Spinal Cord Injury; Depression - Major Depressive Disorder

Treatments: Drug: Psilocybin (Usona Institute)

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT07251491

1872390

SC240097 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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30 participants in 3 patient groups

Psilocybin Low Dose

Experimental group

Description:

Psilocybin 5mg

Treatment:

Drug: Psilocybin (Usona Institute)

Psilocybin Medium Dose

Experimental group

Description:

Psilocybin 10mg

Treatment:

Drug: Psilocybin (Usona Institute)

Psilocybin High Dose

Experimental group

Description:

Psilocybin 25mg

Treatment:

Drug: Psilocybin (Usona Institute)