Ecstasy-Assisted therapy shows promise for veterans haunted by war

NCT ID NCT05732155

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 08, 2026 · Last updated Jul 09, 2026 · Updated 1 time

Summary

This study explores whether MDMA (ecstasy) combined with talk therapy can help Israeli special forces veterans suffering from PTSD and moral injury. Participants receive a flexible dose of MDMA in either individual or group therapy sessions. The goal is to measure changes in PTSD symptoms and safety over the course of treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
MDMA (also known as ecstasy)
What this could lead to
If successful, this could point toward an effective therapy for PTSD and moral injury in veterans, potentially reducing symptoms and improving quality of life.
What could go wrong
This is a small, early-phase study with no placebo group, so results may not be conclusive. MDMA can cause side effects like anxiety, increased heart rate, and emotional distress during sessions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2023

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Are veterans of special forces undercover units in the Israeli army. * Are fluent in speaking and reading the predominantly used or recognized language of the study site (Hebrew). * Are able to swallow pills. * Agree to have study visits recorded, including Experimental Sessions, and non-drug psychotherapy 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. * Agree to the following lifestyle modifications : 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, remain overnight at the study site after each Experimental Session and be driven home after, and commit to medication dosing, therapy, and study procedures. * At Screening, meet DSM-5 criteria for current PTSD with a symptom duration of 6 months or longer. * At Screening, have at least moderate PTSD symptoms in the last month, based on PCL-5 total score of 36 or greater. * May have well-controlled hypertension. * May have asymptomatic Hepatitis C virus (HCV). * May have alcohol or substance use disorder. * May have a history of or current Diabetes Mellitus (Type 2). * May have hypothyroidism if taking adequate and stable thyroid replacement medication. * May have a history of, or current, glaucoma if approval for study participation is received from an ophthalmologist. Exclusion Criteria: * Are not able to give adequate informed consent. * 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-sponsored MDMA clinical trial. * Have any current problem which, in the opinion of the investigator or study physician, might interfere with participation. * Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the sponsor-investigator or study clinician, contraindicates participation in the study. * Have received Electroconvulsive Therapy (ECT) within 12 weeks of enrollment. * Have a history of or a current primary psychotic disorder. * Have a current eating disorder with active purging assessed via MINI and clinical interview. * Have current major depressive disorder with psychotic features assessed via MINI. * Have a current alcohol or substance use disorder other than caffeine or nicotine that the investigators, therapy team, and/or study physician judge to be a safety concern for enrollment in the study. * Have an active illicit (other than cannabis) or prescription drug substance use disorder at any severity within 12 months prior to enrollment. * Have current Personality Disorders. * .Any participant presenting current serious suicide risk, * Require ongoing concomitant therapy with a psychiatric medication with exceptions described in protocol section on Concomitant Medications. * 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 using the standard criteria of the American Heart Association (values of 140/90 milligrams of Mercury \[mmHg\] or higher assessed on three separate occasions). * 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 . QTc interval \> 450 milliseconds (ms) in males and \>460 ms in females corrected using 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 history of hyponatremia or hyperthermia. * Weigh less than 48 kilograms (kg). * Have engaged in ketamine-assisted therapy or used ketamine within 12 weeks of enrollment.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

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  3. A doctor treating you

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Contacts and locations

Locations

  • Emek medical center

    RECRUITING

    Afula, 1910500, Israel

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