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CompletedPhase 3Results posted

A Multi-Site Open-Label Extension Study of MDMA-Assisted Psychotherapy for PTSD

NCT04714359 · MAPPUSX · Resilient Pharmaceuticals

Closed to entry
Status
Not accepting participants
Phase 3
Phase
87
Target enrolment
15
Study sites
7 US states

What it is testing

Summary

The goal of this clinical trial is to learn if MDMA-assisted therapy is safe and effective at reducing PTSD symptoms in people with PTSD who received placebo in a prior MDMA-assisted therapy study. The main question it aims to answer is: Do PTSD symptoms decrease in people who receive a flexible dose of MDMA (120 or 180 mg MDMA HCl) with therapy in three sessions? Participants will undergo three preparatory therapy sessions without any study drug, then three MDMA-assisted therapy sessions with a flexible dose of 80 or 120 mg, followed by three integrative therapy sessions without study drug after each MDMA-assisted therapy session.

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

  • Change From Baseline to Visit 16 in PCL-5 Total Score

    Measured over Baseline enrollment to approximately 18 weeks later (Visit 16 occurs 24 to 32 days after Experimental Session 3)

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: * Were previously enrolled in a parent study and (meet one of the following): 1. At time of unblinding, their treatment assignment was to the placebo arm; or, 2. Did not begin Experimental Sessions due to the COVID-19 global pandemic or other unforeseen circumstances; 3. Completed fewer than three Experimental Sessions prior to Study Termination due to the COVID-19 global pandemic or other unforeseen circumstances. * Are considered in good standing with the study site at which they enrolled in a parent study; if, in the opinion of the investigator, therapy team, and Medical Monitor, the participant was compliant with protocol requirements, even if they were unable to complete all study visits. * Are at least 18 years old * Are fluent in speaking and reading the predominantly used or recognized language of the study site * Are able to swallow pills * Agree to have study visits recorded, including Experimental Sessions, Independent Rater assessments, and non-drug psychotherapy sessions * Must provide a contact (relative, spouse, close friend or other caregiver) who is willing and able to be reached by the investigators in the event of a participant becoming suicidal or unreachable. * Must agree to inform the investigators within 48 hours of any medical conditions and procedures * If of childbearing potential, must have a negative pregnancy test at study entry and prior to each Experimental Session, and must agree to use adequate birth control through 10 days after the last Experimental Session. * Must not participate in any other interventional clinical trials during the duration of the study * Agree to the following lifestyle modifications: comply with requirements for fasting and refraining from certain medications prior to Experimental Sessions. * Must be willing to remain overnight at the study site after each Experimental Session and be driven home after, and commit to medication dosing, therapy, and study procedures. Exclusion Criteria: * Are not able to give adequate informed consent Have uncontrolled hypertension * Have a marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval \>450 milliseconds \[ms\] in males and \>460 ms in females corrected by Fridericia formula) * Have a history of additional risk factors for Torsade de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome) * Have evidence or history of significant medical disorders, such as myocardial infarction, cerebrovascular accident, or aneurysm * Have symptomatic liver disease * Have recent history of hyponatremia or hyperthermia * Weigh less than 48 kilograms (kg) * Are pregnant or nursing, or are of childbearing potential and are not practicing an effective means of birth control * Have an active illicit or prescription drug substance use disorder within 12 months

Where

15 study sites

FacilityCityRegionCountry
New School ResearchLos AngelesCaliforniaUnited States
San Francisco Insight and Integration CenterSan FranciscoCaliforniaUnited States
UCSFSan FranciscoCaliforniaUnited States
Aguazul-Blue Water Inc.BoulderColoradoUnited States
Wholeness CenterFort CollinsColoradoUnited States
Ray Worthy PsychiatryNew OrleansLouisianaUnited States
Trauma Research FoundationBostonMassachusettsUnited States
NYUNew YorkNew YorkUnited States
New York Private PracticeNew YorkNew YorkUnited States
Zen Therapeutic Solutions, LLCMt. PleasantSouth CarolinaUnited States
University of Wisconsin - MadisonMadisonWisconsinUnited States
NuminusVancouverBritish ColumbiaCanada
NuminusMontrealQuebecCanada
Beer Yaakov Mental Health CenterBeer YaaqovIsrael
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.

NCT04714359 on ClinicalTrials.gov →

Last updated in the registry 2025-06-06. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits