What this phase means
Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are psilocybin, Supportive Therapy, or Prolonged Exposure Therapy. The registry lists allocation as randomized. This pilot study will examine the safety, tolerability, acceptability, and how well it works of combination psilocybin + psychotherapy to decrease PTSD symptoms.
They plan to enroll about 150 people at Atlanta. Taking part typically means taking a study drug (or dummy pill), following a program (exercise, therapy, diet, or an app) plus check-ins.
Official title (unrewritten)
The Safety and Acceptability of Psilocybin With Support and With Massed Prolonged Exposure Therapy for PTSD
Interventions: psilocybin, Supportive Therapy, Prolonged Exposure Therapy
Primary outcome (registry wording): Change in PTSD symptoms based on CAPS-5-R total severity score