NCT05746572
MDMA Plus Exposure Therapy for PTSD
Enrolling by Invitation
PHASE2Ages 21–70InterventionalTreatmentEmory UniversityInvestigator-initiated
~40 participants
Updated 2026-07-08 on ClinicalTrials.gov
What's tested:MDMA
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Effect of MDMA-assisted massed exposure therapy on clinician-rated PTSD symptoms
Measured over Baseline (day 1) and day 42 (+/- 2 days)
Conditions
Where it's being run
1 sites across 1 statesGeorgia1
Study leadership
- Jessica Maples-Keller, PhD · PRINCIPAL_INVESTIGATOR · Emory University
- Barbara O Rothbaum, PhD · PRINCIPAL_INVESTIGATOR · Emory University
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Meet criteria for PTSD
Willingness of the participant to sign a release for the investigators to communicate with their primary care or mental health providers if indicated
Are able to visually read and understand the English language and give written informed consent.
Are able to swallow pills.
Agree to have study visits and treatment sessions video and/or audio recorded,
Must provide a contact (relative, spouse, close friend, or another support person) who is willing and able to be reached by the investigators.
Must 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 prior to study entry, at study entry, and prior to the Medicine Session. Must agree to use adequate birth control for a month prior to 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 prior to Medicine Session, and not participate in any other interventional clinical trials during the duration of the study and are driven home or to a hotel after the Medicine Session, and commit to medication dosing, therapy, and study procedures.
Exclusion
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 assessment, have any current or past diagnosis that would be considered a risk to participating in the study
Current or past substance abuse that would be considered a risk for 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.
What this trial measures
- Effect of MDMA-assisted massed exposure therapy on clinician-rated PTSD symptomsBaseline (day 1) and day 42 (+/- 2 days)
Measured by the change in the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total severity score from baseline to 1-month post-treatment. The CAPS-5 is a structured clinician-administered measure that assesses the presence and severity of PTSD per the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria. All the DSM-5 symptoms of PTSD are assessed and rated on a scale from 0 (Absent) to 4 (Extremely Severe), with clear anchors provided to clinicians to assist with accurate ratings.