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Psilocybin-Assisted Psychotherapy for Veterans With PTSD

NCT07792538 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2026-08-28

No results posted yet for this study

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).

Conditions

  • Posttraumatic Stress Disorder (PTSD)

Interventions

DRUG

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.

Sponsors & Collaborators

  • National Healthcare System for Veterans / Landelijk Zorgsysteem voor Veteranen (LZV)

    collaborator UNKNOWN

  • Leiden University Medical Center

    collaborator OTHER

  • ARQ National Psychotrauma Centre

    lead OTHER

Principal Investigators

  • Eric Vermetten, MD, PhD · Leiden University Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-12-31
Primary Completion
2028-12-31
Completion
2028-12-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07792538 on ClinicalTrials.gov