High-Intensity Inpatient MDMA-Assisted Psychotherapy for PTSD (HI-MAP)

This open-label Phase II trial (n=20) will evaluate the feasibility, safety, and effectiveness of high-intensity inpatient MDMA-assisted psychotherapy for treatment-refractory posttraumatic stress disorder (PTSD). Participants will receive two MDMA sessions—first 80 mg plus 40 mg, then 120 mg plus 60 mg—integrated into a four-week inpatient therapy programme that includes manualised psychotherapy and non-drug preparatory and integrative sessions.

Conducted at ARQ Centrum’45 in the Netherlands, this pilot study is sponsored by the ARQ National Psychotrauma Centre and aims to explore whether delivering MDMA-assisted therapy in an intensive inpatient setting can benefit patients with moderate to severe PTSD who have not improved after at least two standard trauma-focused therapies.

The study will assess not only PTSD symptom severity, using the Clinician-Administered PTSD Scale (CAPS-5-R), but also functional impairment via the Sheehan Disability Scale. The researchers hope this model will increase safety, reduce dropout rates, and broaden access for patients who have complex comorbidities, including substance use disorders or suicidality, that typically exclude them from outpatient psychedelic research.

Topic PTSD Safety
Compound MDMA
Country Netherlands
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Trial Details



Trial Number

Sponsors & Collaborators

Leiden University
Leiden University Medical Center is doing several studies into psychedelics. They do this in cooperation with other universities (e.g. Utrecht University) and companies (e.g. COMPASS).

Data attribution

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