Trauma-informed Psilocybin-assisted psychotherapy for PTSD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label pilot study combines psilocybin administration with a trauma-focused psychotherapeutic framework to treat PTSD in adults. Participants receive preparatory sessions, two psilocybin doses (15 mg then 25 mg), and integration work based on Acceptance and Commitment Therapy and Narrative Exposure Therapy. Primary goals are to assess safety and tolerability, with secondary aims to observe changes in PTSD symptoms using CAPS-5 at 30 days post-treatment. The study enrolled 13 participants and aims to inform the design of a future randomized trial. Conducted at Tel-Aviv Sourasky Medical Center with collaboration from Tel Aviv University, the study emphasizes feasibility and preliminary clinical signals in this innovative approach.

Why it matters

Who can join: the full rules

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.

Where it's running

• Tel Aviv Sourasky Medical Center
  Tel Aviv, Israel Recruiting

Study contacts

• Principal investigator: Talma Hendler, Prof. — Tel Aviv University and Tel Aviv Sourasky Medical Center
• Study coordinator: Ayelet Or-Borichev, PhD
• Email: ayeletorb@gmail.com
• Phone: +972507941243

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.