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

This study is exploring MDMA-assisted therapy for healthcare workers and first responders who are experiencing symptoms of post-traumatic stress disorder (PTSD) or adjustment disorders due to their work. The goal is to see if this therapy is safe and effective in reducing these symptoms. Researchers will measure changes in PTSD symptoms using a specific checklist (PCL-5) at the end of the treatment period. To join, you must be an adult (18 or older) who has experienced work-related stress in a healthcare or emergency response setting, can speak and read English, and can swallow pills. The study is currently unclear on its recruitment status and plans to enroll 30 participants.

Study design: This is an interventional study with a planned enrollment of 30 participants. The study does not specify a phase.
What's involved: You would go through screening visits (3-7 weeks), including two preparatory sessions. If eligible, you would have three all-day MDMA dosing sessions, each followed by three 90-minute integration (non-drug) therapy sessions. The active treatment phase lasts between 6 and 16 weeks.
Compensation: Not stated in the trial record.
Follow-up: Your PTSD symptoms will be measured at the end of treatment, up to 17 weeks after you enroll.

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

Not Yet Recruiting

PHASE2Ages 18+InterventionalTreatment

Nautilus Sanctuary

~30 participants

Updated 2026-05-05 on ClinicalTrials.gov

What's tested:MDMA

At a glance

Recruiting sites

0 of 3 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

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)

Conditions

Post-Traumatic Stress Disorder

Adjustment Disorders

Where it's being run

3 sites across 3 states

Colorado1

New York1

North Carolina1

Study leadership

Willa Hall, Ph.D. · STUDY_DIRECTOR · Nautilus Sanctuary
Casey Paleos, M.D. · PRINCIPAL_INVESTIGATOR · InnerMost PBC

Who to contact

Willa Hall, Ph.D.

[email protected]

9175091497

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

Change from Baseline on symptoms of Post-Traumatic Stress based on the PTSD Checklist for DSM-5 (PCL-5) at Treatment TerminationUp to 17 weeks post-enrollment (Baseline)
The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD and is widely used by researchers and clinicians to monitor change during and after a treatment intervention. Participants indicate how much distress they have experienced due to symptoms such as "Repeated, disturbing memories, thoughts, or images of a stressful experience from the past," "Trouble remembering important parts of a stressful experience from the past," and "Feeling irritable or having angry outbursts" using a Likert scale ranging from 0 (Not at all) to 4 (Extremely). Items are summed to provide a total severity score (range = 0-80). It takes 5-10 minutes to complete.

Trialytics