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Psilocybin-Assisted Psychotherapy for Veterans With PTSD (PsiVet)

25 augustus 2026 bijgewerkt door: ARQ National Psychotrauma Centre

Psilocybin-Assisted Psychotherapy for Posttraumatic Stress Disorder in Military Veterans: A Pilot Feasibility Study

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

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Posttraumatic stress disorder (PTSD) is a severe and debilitating mental health condition that significantly impacts patients' lives, leading to functional impairments, strained relationships, and high healthcare costs. About half of the patients with PTSD do not benefit from current evidence-based psychotherapy and available pharmacological treatments offer only limited benefits. Therefore, there is a high need for novel therapeutic approaches in the treatment of PTSD.

Psilocybin-assisted psychotherapy is a promising approach combining the pharmacological effects of psilocybin, a serotonergic psychedelic, with psychotherapy. Psilocybin-assisted psychotherapy has shown promising effects in several phase 2 studies in the treatment of mental health conditions such as depression and end-of-life anxiety, with two phase 3 studies underway for treatment-resistant depression. Building on these initial promising results, psilocybin-assisted psychotherapy is increasingly being studied for other psychiatric indications, including PTSD.

Many of psilocybin's potential therapeutic mechanisms appear to be transdiagnostic in nature. For example, studies suggest that psilocybin can enhance introspection, emotional processing, and psychological flexibility, all of which could facilitate psychotherapeutic processes. Psilocybin has also been shown to reduce avoidance and promote neural plasticity and cognitive reappraisal, which could be particularly relevant for addressing core symptoms of PTSD, such as persistent avoidance and rigid negative thought patterns. Furthermore, its ability to foster a sense of connectedness aligns well with the therapeutic need of individuals with PTSD who face challenges related to social isolation.

Preliminary findings from an initial Phase 2 trial suggest that psilocybin-assisted psychotherapy may be safe and associated with clinically meaningful improvements in PTSD symptoms. However, this study differed from the present study in several important aspects. Participants were not required to have had previous unsuccessful evidence-based psychotherapies for PTSD, and psilocybin administration was not embedded within psychotherapeutic treatment. The current open-label pilot study will focus on veterans with treatment-refractory PTSD, a patient population that frequently shows partial or no response to standard evidence-based PTSD treatment. In addition, psilocybin administration will be part of an extensive psychotherapeutic treatment protocol. This study aims to collect data on the feasibility, preliminary efficacy and safety of psilocybin-assisted psychotherapy in this population, to inform a potential future randomized controlled trial.

Studietype

Ingrijpend

Inschrijving (Geschat)

12

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Nederland
      • Oegstgeest, Nederland, 2342 EG
        • ARQ National Psychotrauma Centre / ARQ Centrum'45

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Psilocybin-assisted psychotherapy
Geneesmiddel: Psilocybin-assisted Psychotherapy
Two psilocybin sessions (15 mg psilocybin in the first session; 25 mg psilocybin in the second session) embedded in a psychotherapeutic framework with three preparatory sessions and six integrative sessions.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Clinician-Administered PTSD Scale for DSM-5 Revised (CAPS-5-R)
Tijdsspanne: From Baseline to 1 month after final integrative psychotherapy session
The last month CAPS-5-R is a semi-structured interview that assesses index history of DSM-5-defined traumatic event exposure, including the most distressing event and time since exposure, and rates intrusion symptoms (intrusive thoughts or memories), avoidance, cognitive and mood symptoms, arousal and reactivity symptoms, duration and degree of distress and dissociation. The CAPS-5-R will be administered by a study independent CAPS-5-R rater.
From Baseline to 1 month after final integrative psychotherapy session
Semi-structured interview
Tijdsspanne: One month after final integrative psychotherapy session
Comprehensive qualitative information about participants' evaluation of the feasibility, acceptability and efficacy of psilocybin-assisted psychotherapy for PTSD will be collected through a semi-structured interview.
One month after final integrative psychotherapy session
Treatment Acceptability/Adherence Scale Modified (TAAS-M)
Tijdsspanne: One month after final integrative psychotherapy session
A modified 10-item version of the Treatment Acceptability and Adherence Scale (TAAS-M) will be used to describe acceptability and adherence to psilocybin-assisted psychotherapy.
One month after final integrative psychotherapy session
Feasibility of participant screening and study retention
Tijdsspanne: From screening until one month after the final integrative psychotherapy session.
The feasibility of participant screening and study retention will be assessed by documenting the number and proportion of participants who fail screening, the number and proportion of enrolled participants who discontinue the intervention, and the reasons for screen failure and discontinuation. All measures will be summarized descriptively.
From screening until one month after the final integrative psychotherapy session.
Concomitant medication use
Tijdsspanne: From screening until one month after the final integrative psychotherapy session.
Concomitant medication use during study participation will be recorded.
From screening until one month after the final integrative psychotherapy session.
Columbia Suicide Severity Rating Scale (C-SSRS)
Tijdsspanne: Measured at several timepoints from screening to one month after the final integrative psychotherapy session.
The C-SSRS is a clinician-administered measure of suicidal behavior devised to detect potential suicidal thoughts or behaviors during a clinical trial.
Measured at several timepoints from screening to one month after the final integrative psychotherapy session.
Adverse events
Tijdsspanne: From screening until one month after the final integrative psychotherapy session.
Severity, incidence and frequency of AEs and serious adverse events (SAEs).
From screening until one month after the final integrative psychotherapy session.
Blood pressure
Tijdsspanne: At several timepoints between screening and one month after the final integrative psychotherapy session, including during psilocybin administration.
Systiloc and diastolic blood pressure (mmHg) will be monitored.
At several timepoints between screening and one month after the final integrative psychotherapy session, including during psilocybin administration.
Heart rate
Tijdsspanne: At several timepoints between screening and one month after the final integrative psychotherapy session, including during psilocybin administration.
Heart rate (beats per minute) will be monitored.
At several timepoints between screening and one month after the final integrative psychotherapy session, including during psilocybin administration.
Body temperature
Tijdsspanne: At several timepoints between screening and one month after the final integrative psychotherapy session, including during psilocybin administration.
Body temperature (°C) will be monitored.
At several timepoints between screening and one month after the final integrative psychotherapy session, including during psilocybin administration.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Sheehan Disability Scale
Tijdsspanne: Change from Baseline to one month after final integrative psychotherapy session
The Sheehan Disability Scale is a 3-item assessment of functional impairment.
Change from Baseline to one month after final integrative psychotherapy session
Beck Depression Inventory-II (BDI-II)
Tijdsspanne: Change from baseline to one month after final integrative psychotherapy session
The BDI-II is a 21-item self-report measure for depression symptom severity.
Change from baseline to one month after final integrative psychotherapy session

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

ARQ National Psychotrauma Centre

Medewerkers

Leiden University Medical Center
National Healthcare System for Veterans / Landelijk Zorgsysteem voor Veteranen (LZV)

Onderzoekers

  • Hoofdonderzoeker: Eric Vermetten, MD, PhD, Leiden University Medical Center

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 december 2026

Primaire voltooiing (Geschat)

1 december 2028

Studie voltooiing (Geschat)

1 december 2028

Studieregistratiedata

Eerst ingediend

23 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

25 augustus 2026

Eerst geplaatst (Werkelijk)

28 augustus 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

28 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

25 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 2025-521488-11-00
  • 2025 (Subsidie/contract van de Amerikaanse NIH: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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