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Could a single dose of MDMA supercharge PTSD therapy?

NCT ID NCT07288151

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a single dose of MDMA, given alongside two weeks of daily exposure therapy, can reduce PTSD symptoms more than therapy alone. About 95 adults with PTSD will take either MDMA or a placebo during one therapy session. Researchers will check symptom changes one month later using a standard interview.

What this could mean

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

Active substance
MDMA (3,4-methylenedioxymethamphetamine)
What this could lead to
If successful, this could point toward a faster, more effective treatment for PTSD by combining a single dose of MDMA with intensive therapy.
What could go wrong
This is an early Phase 2 trial with only 95 participants, so results may not apply to everyone. MDMA can cause side effects like increased heart rate or anxiety, and the placebo group may show similar improvement.

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 200 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Jan 2030

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

21 to 70 years

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: * PTSD diagnosis as assessed by Clinician-Administered Posttraumatic Stress Scale for DSM-5 - Revised (CAPS-5-R). * Able to speak and read English (due to standardization of outcome measures). * Willing to sign a release for the investigators to communicate with their primary care or mental health providers if indicated. * Able to swallow pills. * Agree to have study visits video and/or audio recorded, including Experimental Session, assessments, and non-drug therapy sessions. * Willing to provide a contact (relative, spouse, close friend, or another support person) who is willing and able to be contacted by the investigators. * Agree to inform the investigators within 48 hours of any medical conditions and procedures. * If able to become pregnant, must have a negative pregnancy test before study entry, at study entry, and before the Medicine Session. Must agree to use adequate birth control for a month before the Medicine session and through 10 days after the Medicine Session. * Agree to the following lifestyle modifications: comply with requirements for fasting and refraining from certain medications before the Medicine Session, and not participating in any other interventional clinical trials during the duration of the study, are driven home or to a hotel after the Medicine Session, and commit to medication dosing, therapy, and study procedures Exclusion Criteria: * Are not able to give adequate informed consent. * Have previously participated in a Multidisciplinary Association for Psychedelic Studies (MAPS) sponsored MDMA clinical trial. * Have any current problem which, in the opinion of the investigator or study physician, might interfere with participation. * Have hypersensitivity to any ingredient of the Investigational Medicinal Product (IMP). * Upon review of medical or psychiatric history and psychiatric assessment, have any current or past diagnosis that would be considered a risk to participating in the study * Requires ongoing psychiatric medication use with certain exceptions. Individuals may decide to taper psychiatric medications under the guidance of their local provider. * Have a history of any medical condition that could make receiving MDMA dangerous because of increases in blood pressure and heart rate or any medical condition the study physician believes would pose a safety risk or interfere with the effects of the treatment. Any medical disorder judged by the investigator to significantly increase the risk of MDMA administration by any mechanism is exclusionary. * Have any unstable medical condition that would interfere with participation. * Have uncontrolled hypertension) documented on three separate occasions. * Have Wolff-Parkinson-White syndrome or any other accessory pathway that has not been successfully eliminated by ablation. * Have a history of ever having ventricular arrhythmia or any other abnormal heart rhythm that the study physician believes would pose a significant risk of participation. * Have an abnormal finding on electrocardiogram * Have a history of additional risk factors for Torsade de Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome). * Require the use of concomitant medications that could impact the effects or safety of MDMA during the Medicine Session. * Have symptomatic liver disease or significant liver enzyme elevations. * Have a history of hyponatremia or hyperthermia. * Weigh less than 48 kilograms (105 lbs.). * Are pregnant or nursing * 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.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

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

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

  • Contact

    Email: •••••@•••••

Locations

  • Emory Brain Health Center

    RECRUITING

    Atlanta, Georgia, 30329, United States

    Contact Email: •••••@•••••

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