Group Psilocybin-Assisted Therapy for Post-Traumatic Stress Disorder
This study is a community-informed, pragmatic, open-label, phase 1 clinical trial of group-format psilocybin-assisted therapy (GPAT) for individuals with post-traumatic stress disorder (PTSD). The primary objectives of this phase 1 study are to assess the safety and feasibility of (GPAT) for individuals with (PTSD) and to evaluate preliminary effects on PTSD severity.
‣ General:
• T+H years of age and \<89 years of age
‣ Identify as a member of one of the cohorts to be studied:
⁃ Veteran or first responder
⁃ Female survivor of sexual violence
⁃ Indigenous person
⁃ Not pregnant, planning to become pregnant, or breastfeeding; if able to become pregnant, willing to use reliable form of birth control for the duration of the study
⁃ If needed, ability and willingness to taper and discontinue medications that may interfere with the action of psilocybin
⁃ Ability to read, speak, and understand English
⁃ Ability and willingness to consent to the terms of the study, including attending all trial visits (most of which will occur in a group setting), preparation and
⁃ follow-up sessions, and completing all trial evaluations
⁃ Ability and willingness to swallow capsules
‣ PTSD severity:
⁃ Meet criteria for PTSD, as defined in the DSM-5
⁃ At screening, symptoms of moderate to severe PTSD (PCL-5 score of 34 or greater) present for at least six months