RecruitingEarly Phase 1NCT07737054

Trauma-informed Psilocybin Assisted Psychotherapy (TiPAP) for PTSD

Trauma-informed Psilocybin Assisted Psychotherapy (TiPAP) for Post-Traumatic Stress Disorder

Sponsor

Tel-Aviv Sourasky Medical Center

Enrollment

13 participants

Start Date

Jul 22, 2025

Study Type

INTERVENTIONAL

Conditions

Post Traumatic Stress Disorder (PTSD)

Summary

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.

Eligibility

Min Age: 21 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Psilocybin (drug) and a behavioral approach called Trauma-Focused Psychotherapy for people with post traumatic stress disorder (ptsd). The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPsilocybin (drug)

Psilocybin is a naturally occurring psychedelic compound and a prodrug of psilocin, which exerts its effects primarily through serotonergic receptor activity. In this study, psilocybin is administered orally in two dosing sessions (15 mg followed by 25 mg) in a controlled clinical setting, with a minimum interval of one week between sessions. Administration is performed by a study physician, who provides medical oversight, monitors vital signs, and evaluates acute responses. Participants are prepared through preparatory psychotherapy sessions and remain in the clinic during the acute drug effects. Each session lasts approximately six hours, after which participants are discharged following physician evaluation. Integration psychotherapy sessions follow each dosing session. After each dosing session, participants are accompanied home by a designated escort or transported by taxi to their care. The first integration psychotherapy session is held the following morning.

BEHAVIORALTrauma-Focused Psychotherapy

The psychotherapy intervention is based on an integrative trauma-focused framework combining Acceptance and Commitment Therapy (ACT) and Narrative Exposure Therapy (NET). Psilocybin-assisted psychotherapy aims to facilitate emotional processing, psychological flexibility, and contextual integration of traumatic memories within a coherent autobiographical narrative. The intervention is delivered by a licensed therapist and includes two preparatory sessions, two psilocybin dosing sessions, and three integration sessions following each dosing session (six in total). Preparation focuses on therapeutic alliance and readiness for the psychedelic experience. Integration sessions support trauma processing, meaning-making, and incorporation of insights into daily functioning. The approach emphasizes flexible re-engagement with trauma-related memories while fostering a broader and more adaptive sense of self.