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Can a psychedelic drug help heal trauma? a small trial puts psilocybin to the test

NCT ID NCT07737054

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 30, 2026 · Last updated Jul 31, 2026 · Updated 1 time

Summary

This early-stage pilot study is testing whether psilocybin, a psychedelic compound, can be safely combined with trauma-focused psychotherapy for people with post-traumatic stress disorder (PTSD). Thirteen participants will receive two doses of psilocybin in a controlled setting, along with preparatory and integration therapy sessions. The main goal is to check safety and tolerability, while also measuring changes in PTSD symptoms 30 days after treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
psilocybin, a naturally occurring psychedelic compound, given orally in two doses (15 mg and 25 mg) during therapy sessions
What this could lead to
If safe and promising, this could point toward a new treatment approach for PTSD that combines therapy with a psychedelic drug.
What could go wrong
This is a very early, small pilot study with only 13 people. It is designed mainly to check safety, not to prove the treatment works. Psychedelics can cause intense psychological effects and side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 13 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Tel Aviv Sourasky Medical Center

    RECRUITING

    Tel Aviv, 6423906, Israel

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