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

Completed · Phase 3

Conditions studied: PTSD

In brief

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.

Key facts

Study ID

NCT04714359

Run by

Resilient Pharmaceuticals

People needed

87

Starts

2021-03-08

Expected to finish

2023-11-06

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…

• Were previously enrolled in a parent study and (meet one of the following):
• At time of unblinding, their treatment assignment was to the placebo arm; or,
• Did not begin Experimental Sessions due to the COVID-19 global pandemic or other unforeseen circumstances;
• 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.

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 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 it is running

• New School Research — Los Angeles, California, United States
• San Francisco Insight and Integration Center — San Francisco, California, United States
• UCSF — San Francisco, California, United States
• Aguazul-Blue Water Inc. — Boulder, Colorado, United States
• Wholeness Center — Fort Collins, Colorado, United States
• Ray Worthy Psychiatry — New Orleans, Louisiana, United States
• Trauma Research Foundation — Boston, Massachusetts, United States
• NYU — 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 - Madison — Madison, Wisconsin, United States
• Numinus — Vancouver, British Columbia, Canada
• Numinus — Montreal, Quebec, Canada
• Beer Yaakov Mental Health Center — Beer Yaaqov, Israel
• Tel Hashomer — Tel Aviv, Israel

Full record on ClinicalTrials.gov

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