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Trauma-informed Psilocybin Assisted Psychotherapy (TiPAP) for PTSD (TiPAP-PTSD)

26 luglio 2026 aggiornato da: Tel-Aviv Sourasky Medical Center

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

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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

This study is an open-label pilot clinical trial evaluating the safety, tolerability, and preliminary clinical effects of psilocybin-enhanced trauma-focused psychotherapy for the treatment of post-traumatic stress disorder (PTSD).

PTSD is a chronic and disabling condition characterized by intrusive symptoms, avoidance, negative alterations in cognition and mood, and hyperarousal. Despite the availability of evidence-based psychotherapies and pharmacological treatments, a substantial proportion of patients do not achieve sufficient symptom relief, highlighting the need for novel and rapid-acting interventions.

Psilocybin, a serotonergic psychedelic compound, has demonstrated potential therapeutic effects in a range of psychiatric conditions, including depression, anxiety, and trauma-related disorders. When administered in a controlled therapeutic setting, psilocybin may facilitate emotional processing, cognitive flexibility, and adaptive reorganization of trauma-related memories.

In this study, psilocybin administration is combined with an integrative trauma-focused psychotherapeutic framework based on principles of Acceptance and Commitment Therapy (ACT) and Narrative Exposure Therapy (NET). ACT emphasizes psychological flexibility, acceptance, self-as-context, and values-based action, supporting individuals in changing their relationship with trauma-related internal experiences. NET complements this approach by facilitating the structured integration of traumatic memories within a coherent autobiographical narrative, embedding the traumatic experience within the broader context of the individual's life story. Together, this framework is designed to support the processing of traumatic experiences within an expanded and flexible cognitive-emotional context, promoting adaptive meaning-making and reconnection with a broader sense of self.

Participants will undergo a structured treatment protocol consisting of preparatory sessions, two psilocybin administration sessions (15 mg for the first session and 25 mg for the second session), and post-session integration sessions.

The study physician retains clinical authority to discontinue a dosing session or withdraw a participant at any time, including in the event of sustained cardiovascular distress, severe psychological distress unresponsive to support, or acute psychiatric decompensation.

The primary objective of the study is to evaluate the safety and tolerability of psilocybin administration in individuals with PTSD. Safety will be assessed through monitoring of adverse events and clinical observations throughout the study.

Secondary objectives include assessing changes in PTSD symptom severity using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) at 30 days following the intervention.

This pilot study will enroll 13 participants and is intended to provide preliminary data on feasibility, safety, and potential clinical effects to inform the design of a future randomized controlled trial.

Tipo di studio

Interventistico

Iscrizione (Stimato)

13

Fase

  • Prima fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Israele
      • Tel Aviv, Israele, 6423906
        • Reclutamento
        • Tel Aviv Sourasky Medical Center

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  • 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).
  • Ability to provide written informed consent.
  • Ability to read, write, speak, and understand Hebrew.
  • Prior trauma-focused psychotherapy.

  • Medically healthy at screening, as determined by a study physician, including:

    • No exclusionary medical conditions.
    • Resting blood pressure between 90/60 and 150/90 mmHg and heart rate between 45-100 bpm.
    • Normal laboratory results (including liver function, renal function, and electrolytes).

Exclusion Criteria:

  • 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.
  • Significant suicidal risk as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS), including active suicidal ideation with intent or plan, or suicidal behavior within the past 6 months.
  • Substance use disorder (excluding nicotine and caffeine); mild-to-moderate alcohol or cannabis use may be permitted under monitoring and PI approval.
  • Use of psychedelic substances within 3 months before enrollment
  • Participation in a clinical trial involving administration of a psychedelic substance within the past 12 months.
  • History of adverse psychological reaction to psychedelics requiring hospitalization.
  • Significant cardiovascular disease, including ischemic heart disease, uncontrolled hypertension, arrhythmia, or heart failure (NYHA class ≥3).
  • Dementia or suspected cognitive impairment.
  • Traumatic brain injury with loss of consciousness >24 hours or post-traumatic amnesia >7 days (unless cleared by neurological evaluation).
  • Pregnancy, breastfeeding, or positive pregnancy/drug test (excluding cannabis) on the day of dosing.
  • BMI <18 or >33
  • Abnormal liver or renal function tests.
  • Use of medications contraindicated with psilocybin.
  • Changes in psychiatric medication (dose or type) within one month before enrollment.
  • Needle phobia or inability to undergo blood testing.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Psilocybin-Assisted Trauma-Focused Psychotherapy
Participants receive a structured clinical intervention combining preparatory psychotherapy sessions, two psilocybin dosing sessions (15 mg and 25 mg), and integration psychotherapy sessions within a trauma-focused therapeutic framework.
Droga: Psilocybin (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.

Comportamentale: Trauma-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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Participants With One or More Treatment-Emergent Adverse Events
Lasso di tempo: From the first psilocybin administration session through 30 days after completion of the therapeutic intervention.

Treatment-emergent adverse events (TEAEs) are defined as any medical or psychological adverse event that begins or worsens after the first psilocybin administration. The reported outcome will be the number of participants experiencing at least one TEAE from the first dosing session through the 30-day follow-up period.

Treatment-emergent adverse events (TEAEs) will be identified through clinical assessments conducted by the study physician and psychologist, monitoring of vital signs (blood pressure and heart rate), participant self-reports, administration of the Columbia-Suicide Severity Rating Scale (C-SSRS) to assess suicidal ideation and behavior, and the Swiss Psychedelic Side Effects Inventory (SPSI) to systematically assess psychedelic-related side effects. Serious adverse events (SAEs) will be monitored, documented, and reported in accordance with the study safety reporting procedures.
From the first psilocybin administration session through 30 days after completion of the therapeutic intervention.
Number of Participants Completing the Full Therapeutic Intervention
Lasso di tempo: From enrollment through completion of the 30-day follow-up assessment.
Feasibility and tolerability will be assessed by the number of participants who successfully complete the full therapeutic intervention, defined as completion of both psilocybin administration sessions and all protocol-required preparatory and integration psychotherapy sessions. Successful completion of the intervention reflects the feasibility of implementing the study protocol as planned and the tolerability of the intervention.
From enrollment through completion of the 30-day follow-up assessment.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in PTSD Symptom Severity as Measured by CAPS-5
Lasso di tempo: Baseline to 30 days after completion of the therapeutic intervention
PTSD symptom severity will be assessed using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). The outcome measure will reflect the change in CAPS-5 total score from baseline to 30 days after completion of the therapeutic intervention.
Baseline to 30 days after completion of the therapeutic intervention

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Tel-Aviv Sourasky Medical Center

Collaboratori

Tel Aviv University Sagol School of Neuroscience

Investigatori

  • Investigatore principale: Talma Hendler, Prof., Tel Aviv University and Tel Aviv Sourasky Medical Center

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

22 luglio 2025

Completamento primario (Stimato)

1 dicembre 2026

Completamento dello studio (Stimato)

31 dicembre 2026

Date di iscrizione allo studio

Primo inviato

14 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

26 luglio 2026

Primo Inserito (Effettivo)

30 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

30 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

26 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 0101-24-PILOT
  • Internal Study ID (Altro identificatore: Tel Aviv Sourasky Medical Center)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Descrizione del piano IPD

Data sharing plans are currently under consideration. Given the pilot nature of the study, small sample size, and the sensitive nature of the data, individual participant data may be shared in a de-identified form upon reasonable request, subject to ethical approval and institutional policies.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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