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CompletedN/A

Long-Term Safety and Effectiveness of MDMA-Assisted Therapy for PTSD

NCT05066282 · MPLONG · Resilient Pharmaceuticals

Closed to entry
Status
Not accepting participants
Not applicable
Phase
186
Target enrolment
4
Study sites
1 US states

What it is testing

Summary

The goal of this long-term follow-up study is to measure how long effects of MDMA-assisted therapy last in participants with PTSD who were treated in a prior Phase 3 clinical trial of MDMA-assisted therapy. The main question it aims to answer is: Does MDMA-assisted therapy result in lasting reductions in PTSD symptoms? Participants who have received at least one dose of MDMA-assisted therapy will take a PTSD assessment at least six months after their last MDMA-assisted therapy session in the main study.

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-V (CAPS-5) Total Severity Score (actual or imputed) from the main study Baseline and Study Termination to assessment in the current LTFU study

    Measured over LTFU IR Assessments at Least 6 Months Since Last Experimental Session in Main Study (Visit 1)

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: 1. Enrolled in a MAPS-sponsored study of MDMA-assisted therapy for the treatment of PTSD 2. Have received Investigational Medicinal Product (IMP) in at least one Experimental Session in the main study 3. Agree to be contacted by study team at least six months after the last Experimental Session in the main study to schedule and participate in LTFU visits Exclusion Criteria: 1. Are not able to give adequate informed consent 2. Have any current problem which, in the opinion of the investigator or Medical Monitor, might interfere with participation

Where

4 study sites

FacilityCityRegionCountry
USCFSan FranciscoCaliforniaUnited States
Dr. Simon Amar IncMontrealQuebecCanada
Beer Yaakov Mental Health CenterBe’er Ya‘aqovIsrael
Tel HashomerTel AvivIsrael

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.

NCT05066282 on ClinicalTrials.gov →

Last updated in the registry 2024-10-30. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits