Ecstasy-Assisted therapy shows promise for veterans haunted by war
NCT ID NCT05732155
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2023
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Emek medical center
RECRUITINGAfula, 1910500, Israel
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