This is an open-label pilot study designed to evaluate the safety, tolerability, and preliminary clinical effects of psilocybin-enhanced trauma-focused psychotherapy in individuals with post-traumatic stress disorder (PTSD).
Participants will receive a structured therapeutic protocol that includes preparatory sessions, two psilocybin administration sessions (15 mg followed by 25 mg), and integration sessions based on a trauma-focused therapeutic approach.
The primary objective of the study is to assess the safety and tolerability of psilocybin administration in this clinical population. Secondary objectives include evaluating changes in PTSD symptom severity, as measured by the Clinician-Administered PTSD Scale (CAPS-5), at 30 days following treatment.
This pilot study will include 13 participants and is intended to inform the feasibility and design of a subsequent randomized controlled trial.
Age 21-65 years.
Diagnosis of post-traumatic stress disorder (PTSD) according to DSM-5 criteria, as assessed by CAPS-5.
At least 1 year since the traumatic event.
Moderate or greater PTSD severity (CAPS-5 score ≥ 25).
Current or past diagnosis of psychotic disorders, bipolar disorder, schizoaffective disorder, dissociative identity disorder, or borderline personality disorder (as assessed by MINI or SCID-5-SPQ).
Current psychotic features.
First-degree relative with a history of a psychotic disorder.
History of antidepressant-induced mania or hypomania.
Tel-Aviv Sourasky Medical Center
Lead sponsor
Tel Aviv University Sagol School of Neuroscience
Collaborator