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

Completed · Phase 3 · Has a placebo group

Conditions studied: Posttraumatic Stress Disorder

In brief

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.

Key facts

Study ID

NCT03537014

Run by

Resilient Pharmaceuticals

People needed

100

Starts

2018-11-21

Expected to finish

2020-08-21

Last updated by the study team

2025-06-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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, meet DSM-5 criteria for current severe PTSD

You may not qualify if…

• 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 it is running

• 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 University — New York, New York, United States
• New York Private Practice — 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
• Providence Health Center — Vancouver, British Columbia, Canada
• Dr. Simon Amar, Inc. — Montreal, Quebec, Canada
• Assaf Harofeh Research Fund — Be’er Ya‘aqov, Israel
• Sheba Fund for Health Services and Research — Tel Litwinsky, Israel

Full record on ClinicalTrials.gov

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