About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Psilocybin (Usona Institute)
Treatment groups
Sponsors and collaborators
James J. Peters Veterans Affairs Medical Center
Lead sponsor
Bronx Veterans Medical Research Foundation, Inc
Collaborator
Usona Institute
Collaborator
United States Department of Defense
Collaborator