Not Yet RecruitingPhase 2psilocybin

Psilocybin-Assisted Psychotherapy for Veterans With PTSD

Sponsored by ARQ National Psychotrauma Centre

NCT ID
NCT07792538
Target Enrollment
12 participants
Start Date
2026-12
Est. Completion
2028-12

About This 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).

Conditions Studied

Posttraumatic Stress Disorder (PTSD)

Interventions

  • Psilocybin-assisted Psychotherapy

Eligibility

Age:18 Years - 70 Years
Healthy Volunteers:No
View full eligibility criteria
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.

Study Locations (1)

ARQ National Psychotrauma Centre / ARQ Centrum'45
Oegstgeest, Netherlands

Interested in this trial?

Contact the study team to learn more about eligibility and enrollment.

Annika Wirsching, MSc
CONTACT
088 330 5699a.wirsching@arq.org
View on ClinicalTrials.gov
Data Source
ClinicalTrials.gov

Last updated from source