Clinical TrialSingle-armPTSDPsilocybinRecruiting

Trauma-informed Psilocybin Assisted Psychotherapy (TiPAP) for PTSD

This Phase I, open-label, single-group pilot trial (n=13) will evaluate the safety, tolerability and preliminary clinical effects of oral psilocybin-assisted trauma-focused psychotherapy in adults aged 21–65 years with moderate or greater post-traumatic stress disorder (PTSD). Participants will receive psilocybin doses of 15 mg followed by 25 mg, alongside psychotherapy based on Acceptance and Commitment Therapy and Narrative Exposure Therapy. The intervention includes 2 preparatory psychotherapy sessions, 2 psilocybin dosing sessions separated by at least 1 week, and 3 integration sessions after each dosing session. Dosing takes place in a controlled clinical setting under physician supervision, with each session lasting approximately 6 hours, followed by integration psychotherapy beginning the next morning. The primary outcomes are treatment-emergent adverse events through 30 days after treatment completion and completion of the full intervention; change in PTSD symptom severity will also be assessed using the Clinician-Administered PTSD Scale (CAPS-5) at 30 days.

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Target Enrollment
13 participants
Study Type
Phase I interventional
Design
Non-randomized

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Compound research: PsilocybinTopic research: PTSDResearch in Israel

Detailed Description

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.

Study Protocol

Preparation

2 sessions

Dosing

sessions

Integration

sessions

Study Arms & Interventions

Psilocybin 15 mg and 25 mg + trauma-focused psychotherapy

experimental

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.

Interventions

  • Psilocybin
  • Compound

    Unmatched intervention: Trauma-Focused Psychotherapy

Participants

Ages
21 – 65
Sexes
Male & Female

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.

Study Protocol, Arms & Participants

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Study Details

  • Status
    Recruiting
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment13 participants
  • Timeline
    Start: 2025-07-22
    End: 2026-12-31
  • Compound
    Psilocybin
  • Topic
    PTSD

Study Team

Sponsors & Collaborators

Locations

Tel Aviv Sourasky Medical Center — Tel Aviv, Israel

Recent activity

  • StartedTrauma-informed Psilocybin Assisted Psychotherapy (TiPAP) for PTSD (NCT07737054, psilocybin)

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