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CompletedPhase 3Results posted

A Multi-Site Phase 3 Study of MDMA-Assisted Psychotherapy for PTSD (MAPP2)

NCT04077437 · Resilient Pharmaceuticals

Closed to entry
Status
Not accepting participants
Phase 3
Phase
121
Target enrolment
14
Study sites
8 US states

What it is testing

Summary

The goal of this clinical trial is to learn if MDMA-assisted therapy is safe and effective in people with at least moderate PTSD. The main question it aims to answer is: Do three sessions of MDMA-assisted therapy reduce PTSD symptoms? Researchers will compare three sessions of MDMA-assisted therapy with an initial dose of 80 to 120 mg to three sessions of placebo with therapy. Participants will undergo three preparatory sessions without any study drug, followed by three MDMA-assisted therapy or placebo with therapy sessions. Each medication session will be followed by three integrative therapy sessions without study drug.

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 Primary Endpoint in Clinician Administered PTSD Scale for DSM-V (CAPS-5)

    Measured over Baseline to 18 weeks post baseline post enrollment confirmation

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: * 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 * 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 * At baseline, have moderate PTSD diagnosis 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 Bazett's 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 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 use disorder * Have used Ecstasy (material represented as containing MDMA) more than 10 times within the last 10 years or at least once within 6 months of the first Experimental Session; or have previously participated in a MAPS-sponsored MDMA clinical trial

Where

14 study sites

FacilityCityRegionCountry
New School ResearchLos AngelesCaliforniaUnited States
San Francisco Insight and Integration CenterSan FranciscoCaliforniaUnited States
UCSFSan FranciscoCaliforniaUnited States
Aguazul Bluewater, Inc.BoulderColoradoUnited States
Wholeness CenterFort CollinsColoradoUnited States
University of ConnecticutFarmingtonConnecticutUnited States
Ray Worthy Psychiatry LLCNew OrleansLouisianaUnited States
Trauma Research FoundationBostonMassachusettsUnited States
New York UniversityNew YorkNew YorkUnited States
Nautilus Psychiatric ServicesNew YorkNew YorkUnited States
Zen Therapeutic Solutions, LLCMt. PleasantSouth CarolinaUnited States
University of Wisconsin - MadisonMadisonWisconsinUnited States
Assaf Harofeh Research FundBeer YaaqovIsrael
Sheba Fund for Health Services and ResearchTel LitwinskyIsrael

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.

NCT04077437 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