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Not yet recruitingPhase 2

Psilocybin-Assisted Psychotherapy for Veterans With PTSD

NCT07792538 · PsiVet · ARQ National Psychotrauma Centre

Closed to entry
Status
Not accepting participants
Phase 2
Phase
12
Target enrolment
1
Study sites
Outside the US

What it is testing

Summary

This study will evaluate the feasibility, safety and preliminary efficacy of psilocybin-assisted psychotherapy in military veterans with treatment-refractory posttraumatic stress disorder (PTSD).

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

  • Clinician-Administered PTSD Scale for DSM-5 Revised (CAPS-5-R)

    Measured over From Baseline to 1 month after final integrative psychotherapy session

  • Semi-structured interview

    Measured over One month after final integrative psychotherapy session

  • Treatment Acceptability/Adherence Scale Modified (TAAS-M)

    Measured over One month after final integrative psychotherapy session

  • Feasibility of participant screening and study retention

    Measured over From screening until one month after the final integrative psychotherapy session.

  • Concomitant medication use

    Measured over From screening until one month after the final integrative psychotherapy session.

  • Columbia Suicide Severity Rating Scale (C-SSRS)

    Measured over Measured at several timepoints from screening to one month after the final integrative psychotherapy session.

  • Adverse events

    Measured over From screening until one month after the final integrative psychotherapy session.

  • Blood pressure

    Measured over At several timepoints between screening and one month after the final integrative psychotherapy session, including during psilocybin administration.

  • Heart rate

    Measured over At several timepoints between screening and one month after the final integrative psychotherapy session, including during psilocybin administration.

  • Body temperature

    Measured over At several timepoints between screening and one month after the final integrative psychotherapy session, including during psilocybin administration.

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

18 Years to 70 Years
Ages
All
Sex
Not accepted
Healthy volunteers
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.

Where

1 study site

FacilityCityRegionCountry
ARQ National Psychotrauma Centre / ARQ Centrum'45Oegstgeest—Netherlands

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.

NCT07792538 on ClinicalTrials.gov →

Last updated in the registry 2026-08-28. Registry records change; this page reflects the data build of 2026-09-24.

Related

Where this trial sits

Substance

All 2 trials from ARQ National Psychotrauma Centre →