Clinical trialNCT03537014CompletedPhase 3Interventional

A Multi-Site Phase 3 Study of MDMA-Assisted Psychotherapy for PTSD (MAPP1)

SponsorResilient PharmaceuticalsEnrollment100Posttraumatic Stress Disorder

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Bessel van der Kolk, MD
Trauma Research Foundation
Principal Investigator
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Casey Paleos, MD
Affective Care
Principal Investigator
clinicaltrials.gov ↗
Cole Marta, MD
New School Research, LLC
Principal Investigator
clinicaltrials.gov ↗
Emma Hapke, MD
Dr. Simon Amar, Inc.
Principal Investigator
clinicaltrials.gov ↗
Josh Woolley, MD, PhD
University of California, San Francisco
Principal Investigator
clinicaltrials.gov ↗
Michael Bogenschutz, MD
New York University/Langone Medical Center/Bellevue Hospital
Principal InvestigatorKOL profile →
clinicaltrials.gov ↗
Randall Brown, MD, PhD
University of Wisconsin, Madison
Principal Investigator
clinicaltrials.gov ↗
Ray Worthy, MD
Ray Worthy Psychiatry, LLC
Principal Investigator
clinicaltrials.gov ↗
Revital Amiaz, MD
The Chaim Sheba Medical Center, Tel Hashomer Hospital
Principal Investigator
clinicaltrials.gov ↗
Scott Shannon, MD
Wholeness Center
Principal Investigator
clinicaltrials.gov ↗
Sylvestre Quevedo, MD
San Francisco Insight and Integration Center
Principal Investigator
clinicaltrials.gov ↗
Wael Garas, MD
Aguazul-Bluewater, Inc.
Principal Investigator
clinicaltrials.gov ↗
Yevgeniy Gelfand, MD
Zen Therapeutics Solutions, LLC
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

15 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Canada

Providence Health Center
Vancouver, British Columbia, Canada
Dr. Simon Amar, Inc.
Montreal, Quebec, Canada

Israel

Assaf Harofeh Research Fund
Be’er Ya‘aqov, Israel
Sheba Fund for Health Services and Research
Tel Litwinsky, Israel

United States

New School Research Llt
North Hollywood, California, United States
San Francisco Insight and Integration Center
San Francisco, California, United States
University of California San Francisco
San Francisco, California, United States
Aguazul-Blue Water Inc.
Boulder, Colorado, United States
Wholeness Center
Fort Collins, Colorado, United States
Ray Worthy Psychiatry Llc
New Orleans, Louisiana, United States
Trauma Research Foundation
Boston, Massachusetts, United States
New York Private Practice
New York, New York, United States
New York University
New York, New York, United States
Zen Therapeutic Solutions, Llc
Mt. Pleasant, South Carolina, United States
University of Wisconsin at Madison
Madison, Wisconsin, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

PlaceboMidomafetamine HCl

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 21 Nov 2018
Primary completion: 11 Aug 2020
Completion: 21 Aug 2020
Last update posted: 6 Jun 2025
Registered enrollment: 100
Registry id: NCT03537014

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.