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Taking people in United StatesPhase 2

Dose Optimization of MDMA-Assisted Therapy for PTSD

Key facts

Who runs it
Bronx VA Medical Center
Where
The Bronx, United StatesSee the site
Trial code
Status
Recruiting
Phase
Phase 2
People taking part
60 people, planned
Started
3 Jun 2025
Expected to end
Oct 2029
Type of study
Interventional
Treatments tested
  • Midomafetamine
  • Psychotherapy
Record updated
8 October 2026

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 20 criteriaShow less

Who can take part

  • Are a U.S. military veteran at least 18 years old
  • Are able to provide written, informed consent
  • Are able to swallow pills
  • Agree to have study visits recorded, including Experimental Sessions, psychological assessments, and non-drug therapy sessions
  • Must provide a contact who is willing and able to be reached by the investigators in the event of a participant becoming unwell or unreachable
  • 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 contraceptive methods
  • Must have a current PTSD diagnosis at screening and baseline
  • Must not participate in any other interventional clinical trials for the duration of the study
  • Must commit to medication dosing, therapy, and all study procedures

Who cannot take part

  • Have a history of any medical condition, or any significant clinical finding on screening tests, that could make receiving a sympathomimetic drug harmful
  • Abusing illegal drugs or alcohol
  • Have received Electroconvulsive Therapy (ECT) or ketamine therapy within 12 weeks of enrollment
  • Have uncontrolled hypertension
  • Have evidence or history of significant medical or psychiatric disorders
  • Have symptomatic liver disease
  • Have history of hyponatremia or hyperthermia
  • Unable or unwilling to safely taper off prohibited psychiatric medication
  • Are not able to give adequate informed consent
  • Weigh less than 48 kilograms (kg)
  • Are pregnant or nursing or are able to become pregnant and are not practicing an effective means of contraception

Where in United States

  • James J Peters VA Medical CenterThe Bronx, United StatesContact: Lesley LuTaking people

About the trial

What the trial wants to find out

This open label, within-subjects dose optimization trial will investigate the optimal number of MDMA-Assisted Therapy treatment cycles (i.e., one MDMA session and three integration sessions) in a sample of U.S. veterans with PTSD. Participants will complete from one to five cycles of MDMA-AT.

The group in the trial

  • Treatment ArmTreatment being tested

    Open label, within-subjects treatment arm. Participants receive 120mg + optional 60mg supplement. There will be from one to five dosing sessions that occur three to five weeks apart. Each dosing session is followed by three integration psychotherapy sessions.

    Treatment: Midomafetamine and Psychotherapy

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Dose Optimization Study of MDMA-Assisted Therapy for PTSD in U.S. Veterans
Record updated
8 October 2026