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Can a Psychedelic-Assisted therapy help veterans with PTSD?

NCT ID NCT07792538

Symptom relief Sponsor: ARQ National Psychotrauma Centre Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 28, 2026 · Last updated Aug 28, 2026

Summary

This pilot study tests whether psilocybin-assisted psychotherapy is feasible, safe, and potentially helpful for military veterans with treatment-resistant posttraumatic stress disorder (PTSD). Twelve veterans will receive two psilocybin sessions (15 mg and 25 mg) within a structured therapy framework that includes three preparatory and six integration sessions. Researchers will measure feasibility, safety, and preliminary effects on PTSD symptoms, depression, and daily functioning. The study aims to gather initial evidence for a possible new approach to a condition that often does not respond to existing treatments.

What this could mean

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

Active substance
psilocybin-assisted psychotherapy
What this could lead to
If this pilot succeeds, it could point toward a new treatment option for veterans with PTSD that has not responded to standard therapies.
What could go wrong
This is a small early-stage study with only 12 participants, so results may not apply broadly. Psilocybin can cause temporary psychological distress and changes in perception, and the trial is primarily testing feasibility, not effectiveness.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 12 people

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

Expected to start

Dec 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 to 70 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: * Are between 18 and 70 years old. * Able to provide written informed consent. * Fluent in speaking and reading Dutch. * Is a veteran of the Dutch Armed Forces. * Able to swallow pills. * Have a body mass index (kg/m2) of \>18.0. * Meet DSM-5 criteria for current PTSD. * Meet criteria for treatment-refractory PTSD. * Agree to have study visits audiovisually recorded. * Able to provide a contact (relative, spouse, close friend, or other support person) who is willing and able to be reached by the investigators in the event of the participant becoming unwell or unreachable. Exclusion Criteria: * Has a history of any medical condition that could make receiving psilocybin harmful because of temporary increases in blood pressure and heart rate. * Has a medical or psychiatric condition that could interfere with study participation or pose a risk to the participant's safety or well-being. * Has uncontrolled hypertension. * Unable or unwilling to safely taper-off prohibited psychiatric medication. * Has been exposed to electroconvulsive therapy (ECT) within 12 weeks of enrollment. * Has any current problem which, in the opinion of the investigator, might interfere with study participation.

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Conditions

The condition(s) this trial relates to.

post-traumatic stress disorder

As listed by the trial registrant

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

Posttraumatic stress disorder (PTSD)

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

  • ARQ National Psychotrauma Centre / ARQ Centrum'45

    Oegstgeest, 2342 EG, Netherlands

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