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RecruitingEarly Phase 1

Trauma-informed Psilocybin Assisted Psychotherapy (TiPAP) for PTSD

NCT07737054 · TiPAP-PTSD · Tel-Aviv Sourasky Medical Center

Recruiting
Status
Accepting participants
Early Phase 1
Phase
13
Target enrolment
1
Study sites
Outside the US

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Number of Participants With One or More Treatment-Emergent Adverse Events

    Measured over From the first psilocybin administration session through 30 days after completion of the therapeutic intervention.

  • Number of Participants Completing the Full Therapeutic Intervention

    Measured over From enrollment through completion of the 30-day follow-up assessment.

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

21 Years to 65 Years
Ages
All
Sex
Not accepted
Healthy volunteers
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

1 study site

FacilityCityRegionCountry
Tel Aviv Sourasky Medical CenterTel AvivIsrael

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT07737054 on ClinicalTrials.gov →

Last updated in the registry 2026-07-30. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits