Safety, Tolerability, Outcomes of Psilocybin for Depression (STOP Depression) in Veterans With Spinal Cord Injury
James J. Peters Veterans Affairs Medical Center
Summary
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.
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 ca…
Eligibility
- Age range
- 22+ years
- Sex
- All
- Healthy volunteers
- No
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 contracep…
Interventions
- DrugPsilocybin (Usona Institute)
Oral capsules
Location
- James J. Peters Department of Veterans Affairs Medical CenterThe Bronx, New York