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CompletedPhase 2Results posted

Study of Safety and Effects of MDMA-assisted Psychotherapy for Treatment of PTSD (Canada)

NCT03485287 · Resilient Pharmaceuticals

Closed to entry
Status
Not accepting participants
Phase 2
Phase
4
Target enrolment
2
Study sites
Outside the US

What it is testing

Summary

The goal of this clinical trial is to learn if MDMA-assisted therapy is safe and effective at reducing PTSD symptoms in people 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.

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 to Primary Endpoint in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Severity Score

    Measured over Baseline (Visit 3) to Primary Endpoint (Visit 19,18 weeks post enrollment)

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 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 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 \[ms\] 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; or have previously participated in a MAPS or Lykos-sponsored MDMA clinical trial.

Where

2 study sites

FacilityCityRegionCountry
British Columbia Centre on Substance AbuseVancouverBritish ColumbiaCanada
Dr. Simon Amar, LLCMontrealQuebecCanada

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.

NCT03485287 on ClinicalTrials.gov →

Last updated in the registry 2025-06-10. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits