NCT07792538

Brief 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).

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_2

Timeline
24mo left

Started Dec 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 23, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 28, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2026

Expected
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

August 28, 2026

Status Verified

August 1, 2026

Enrollment Period

2 years

First QC Date

July 23, 2026

Last Update Submit

August 25, 2026

Conditions

Posttraumatic Stress Disorder (PTSD)

Keywords

PsilocybinPTSDVeteransPsilocybin-assisted psychotherapyPosttraumatic stress disorderPsychotherapy

Outcome Measures

Primary Outcomes (10)

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

    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

    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)

    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

    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

    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)

    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

    Severity, incidence and frequency of AEs and serious adverse events (SAEs).

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

  • Blood pressure

    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

    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

    Body temperature (°C) will be monitored.

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

Secondary Outcomes (2)

  • Sheehan Disability Scale

    Change from Baseline to one month after final integrative psychotherapy session

  • Beck Depression Inventory-II (BDI-II)

    Change from baseline to one month after final integrative psychotherapy session

Study Arms (1)

Psilocybin-assisted psychotherapy

EXPERIMENTAL

Psilocybin-assisted psychotherapy

Drug: Psilocybin-assisted Psychotherapy

Interventions

Psilocybin-assisted PsychotherapyDRUG

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.

Psilocybin-assisted psychotherapy

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ARQ National Psychotrauma Centre / ARQ Centrum'45

Oegstgeest, 2342 EG, Netherlands

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Eric Vermetten, MD, PhD

    Leiden University Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Annika Wirsching, MSc

CONTACT

088 330 5699a.wirsching@arq.org

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2026

First Posted

August 28, 2026

Study Start (Estimated)

December 1, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

August 28, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)