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Open Label Study of MDMA-assisted Psychotherapy for Treatment of PTSD With Optional fMRI Sub-Study

NCT04030169 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2025-01-28

Study results available
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Summary

The goal of this clinical trial is to learn if MDMA-assisted therapy is safe and effective in people diagnosed with at least severe PTSD.

The main question it aims to answer is: Do two open-label sessions of MDMA-assisted therapy reduce PTSD symptoms?

Participants will receive three non-drug preparatory sessions followed by two sessions of MDMA-assisted therapy. Each MDMA-assisted therapy session is followed by three non-drug integrative therapy sessions.

Conditions

Interventions

DRUG

Midomafetamine HCl

Non-directive psychotherapy conducted during MDMA-assisted psychotherapy session

Sponsors & Collaborators

  • Multidisciplinary Association for Psychedelic Studies

    collaborator OTHER

  • MAPS Europe B.V.

    lead INDUSTRY

Principal Investigators

  • Prof. Dr. Eric Vermetten, MD · Leiden University Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-24
Primary Completion
2023-12-14
Completion
2023-12-15
FDA Drug
Yes

Countries

  • Czechia
  • Germany
  • Netherlands
  • Norway
  • United Kingdom

Study Locations

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Entities

Diseases

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 NCT04030169 on ClinicalTrials.gov