MedTrace Logo

High-Intensity Inpatient MDMA-Assisted Psychotherapy for PTSD

NCT06954025 · Status: ENROLLING_BY_INVITATION · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-07-24

No results posted yet for this study

Summary

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

Conditions

  • Posttraumatic Stress Disorder (PTSD)

Interventions

DRUG

High-intensity inpatient MDMA-assisted psychotherapy

Drug: 3,4-methylenedioxymethamphetamine (MDMA) Session 1: 80 mg MDMA HCl followed by a supplemental dose of 40 mg Session 2: 120 mg MDMA HCl followed by a supplemental dose of 60 mg Psychotherapy: manualized psychotherapy

Sponsors & Collaborators

  • Leiden University Medical Center

    collaborator OTHER

  • ARQ National Psychotrauma Centre

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-16
Primary Completion
2026-12-31
Completion
2027-01-31

Countries

  • Netherlands

Study Locations

More Related Trials

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 NCT06954025 on ClinicalTrials.gov