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New treatment option for Spinal Cord Injury
Official title Psilocybin to Treat Depression in Spinal Cord Injury
ClinicalTrials.gov ID: NCT07251491
What this study is testing
What is Psilocybin (Usona Institute)?
Psilocybin (Usona Institute) is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for spinal cord injury.
Also referred to as Magic Mushrooms.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- Time commitment: about 13 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 and older
You may be able to join 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
You likely can't join 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- The Bronx, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 13 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include The Bronx, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.