Open Label Multi-Site Study of Safety and Effects of MDMA-assisted Therapy for Treatment of PTSD

Completed · Phase 2

Conditions studied: PTSD

In brief

The goal of this clinical trial is to learn if MDMA-assisted therapy is safe and effective in people diagnosed with at least severe PTSD. The main question it aims to answer is: Do three open-label sessions of MDMA-assisted therapy reduce PTSD symptoms? Participants will receive three non-drug preparatory sessions followed by three sessions of MDMA-assisted therapy. Each MDMA-assisted therapy session is followed by three non-drug integrative therapy sessions.

Key facts

Study ID

NCT03282123

Run by

Resilient Pharmaceuticals

People needed

38

Starts

2017-11-16

Expected to finish

2019-08-10

Last updated by the study team

2025-06-05

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
• 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
• Meet DSM-5 Criteria for 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] 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
• 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.
• Meet DSM-5 criteria for active substance use disorder for any substance other than caffeine or nicotine
• 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.

Where it is running

• New School Research LLC — 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
• University of Connecticut — Farmington, Connecticut, United States
• Ray Worthy Psychiatry LLC — New Orleans, Louisiana, United States
• Trauma Research Foundation — Brookline, Massachusetts, United States
• New York University — New York, New York, United States
• Affective Care — 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

Full record on ClinicalTrials.gov

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