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Enrolling by invitationPhase 2

High-Intensity Inpatient MDMA-Assisted Psychotherapy for PTSD

NCT06954025 · HI-MAP · ARQ National Psychotrauma Centre

Closed to entry
Status
Not accepting participants
Phase 2
Phase
20
Target enrolment
1
Study sites
Outside the US

What it is testing

Summary

This study will evaluate the feasibility, safety and efficacy of high-intensity inpatient MDMA-assisted psychotherapy for treatment-refractory posttraumatic stress disorder.

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

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
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: * At least 18 years old. * Able to provide written informed consent. * Fluent in speaking and reading Dutch. * Able to swallow pills. * Body weight of at least 48 kg. * Meet DSM-5 criteria for current PTSD. * Meet criteria for treatment-refractory PTSD. * Currently in treatment at ARQ Centre'45. * 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 a sympathomimetic drug harmful because of increases in blood pressure and heart rate. * Has uncontrolled hypertension. * Has a recent history of clinically significant hyponatremia or hyperthermia. * Has current unstable liver or biliary disease. * Unable or unwilling to safely taper-off prohibited psychiatric medication. * Has engaged in a new form of psychiatric or mental health care within 12 weeks of enrollment, including Electroconvulsive Therapy (ECT). * 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 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'45OegstgeestNetherlands

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.

NCT06954025 on ClinicalTrials.gov →

Last updated in the registry 2025-07-24. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits