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Not yet recruitingPhase 2

MDMA-Assisted Therapy for Stress Disorders in Healthcare Workers and First Responders

NCT05455996 · Nautilus Sanctuary

Closed to entry
Status
Not accepting participants
Phase 2
Phase
30
Target enrolment
3
Study sites
3 US states

What it is testing

Summary

The purpose of this study is to assess the safety and efficacy of MDMA-Assisted Therapy on Frontline Health Care Workers and First Responders suffering from symptoms of Post-Traumatic Stress.

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 on symptoms of Post-Traumatic Stress based on the PTSD Checklist for DSM-5 (PCL-5) at Treatment Termination

    Measured over Up to 17 weeks post-enrollment (Baseline)

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: * Were exposed to stressors related to their work in a health care setting or emergency response system * Are fluent in speaking and reading English. * Are able to swallow pills. * Agree to have study visits recorded, including Experimental Sessions, and non-drug therapy sessions. * Have a contact (relative, spouse, close friend or other Support Person) who is willing and able to be reached by the Sponsor-Investigators in the event of a participant becoming suicidal or unreachable. * Agree to inform the Sponsor-Investigators within 48 hours of any medical conditions and procedures. * If able to become pregnant, 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. * Comply with requirements for fasting and refraining from certain medications prior to Experimental Sessions, not participate in any other interventional clinical trials during the duration of the study, be driven home after Experimental Sessions, and commit to medication dosing, therapy, and study procedures. Exclusion Criteria: * Have previously participated in a clinical treatment trial using MDMA. * Have a past diagnosis of PTSD unrelated to their work in the healthcare or emergency response systems. * Have received Electroconvulsive Therapy (ECT) within 12 weeks of enrollment. * Have a history of or a current primary psychotic disorder or bipolar I disorder * Have a current eating disorder with active purging * Have current major depressive disorder with psychotic features * Have a history of any medical condition that could make receiving a sympathomimetic drug harmful because of increases in blood pressure and heart rate * Have uncontrolled essential hypertension * Have a history of ventricular arrhythmia at any time, other than premature ventricular contractions (PVCs) in the absence of ischemic heart disease. * Have Wolff-Parkinson-White syndrome or any other accessory pathway that has not been successfully eliminated by ablation. * Have a history of arrhythmia, other than premature atrial contractions (PACs) or occasional PVCs in the absence of ischemic heart disease, within 12 months of screening. * 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's formula). * Have a history of additional risk factors for Torsade de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome). * Require use of concomitant medications that prolong the QT/QTc interval during Experimental Sessions. * Have symptomatic liver disease or have significant liver enzyme elevations. * Have a history of hyponatremia or hyperthermia. * Weigh less than 48 kilograms (kg). * Are pregnant or nursing, or able to become pregnant and are not practicing an effective means of birth control.

Where

3 study sites

FacilityCityRegionCountry
MemoruBoulderColoradoUnited States
InnerMost, PBCNew YorkNew YorkUnited States
The Pearl InstituteWaynesvilleNorth CarolinaUnited States

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.

NCT05455996 on ClinicalTrials.gov →

Last updated in the registry 2026-05-05. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits