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WithdrawnPhase 2

Study of Safety and Effects of MDMA-assisted Therapy for Treatment of PTSD

NCT04968938 · NUMCAP1 · Resilient Pharmaceuticals

Closed to entry
Status
Not accepting participants
Phase 2
Phase
Target enrolment
Study sites

What it is testing

Summary

The purpose of this clinical trial is to learn if MDMA-assisted therapy is safe and effective in people with PTSD. The main question it aims to answer is: Do two open-label sessions of MDMA-assisted therapy reduce PTSD symptoms? Participants will undergo three non-drug preparatory therapy sessions followed by two open-label MDMA-assisted therapy sessions. After, participants will undergo three non-drug integrative therapy sessions.

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 in PTSD Checklist (adapted PCL-5) total score

    Measured over 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 a recognized language of the study site. * Are able to swallow pills. * Agree to have study visits recorded, including Study Drug Sessions and non-drug therapy sessions. * Must provide a contact (relative, spouse, close friend, or other support person) 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, 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 Friderica'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. * Have current alcohol or substance use disorders.

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.

NCT04968938 on ClinicalTrials.gov →

Last updated in the registry 2024-11-01. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits