An Open-Label, Phase 1 Study of the Safety Pharmacokinetic Profile, and Preliminary Efficacy, of Organic Whole Psilocybin-Containing Mushrooms in Patients Suffering From PTSD
Suzanne "Sue" Sisley MD
Summary
This study will examine the safety and preliminary efficacy of psilocybin mushrooms to treat adults with PTSD. Up to 24 participants will take part in this study. Each participant will ingest psilocybin from dried mushrooms in a chocolate formulation.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Individuals ≥ 18 years of age 2. Have a diagnosis of Post-Traumatic Stress Disorder (PTSD) as defined: * Meet Diagnostic and Statistical Manual-5th edition (DSM-5) criteria for current PTSD with a duration of 6 months or longer as assessed by a study psychiatrist. * Determination of at least one traumatic event as determined by the LEC-5 * A score of at least 33 on the PCL-5 3. Willing and able to provide signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.…
Interventions
- DrugPsychedelic
Organic Whole Psilocybin-Containing Mushrooms
Location
- Scottsdale Research InstituteScottsdale, Arizona