Can MDMA-Assisted therapy rewire the traumatized brain?
NCT ID NCT05790239
First seen Aug 19, 2026 · Last updated Aug 20, 2026 · Updated 1 time
Summary
This phase II trial is investigating whether MDMA-assisted therapy can reduce PTSD symptoms in veterans with moderate to severe PTSD. Participants will receive either MDMA or a low dose of d-amphetamine (as an active control) alongside psychotherapy. The study aims to compare changes in PTSD severity and functional impairment between the two groups.
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) combined with psychotherapy
- What this could lead to
- If successful, this could provide a new treatment option for veterans with PTSD, potentially reducing symptoms and improving daily functioning.
- What could go wrong
- This is a small, early-stage trial, and the results may not apply to all PTSD patients. MDMA can have side effects, and the benefits may not be greater than the control.
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 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2025
- Expected to finish
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Mar 2028
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a US federal agency other than the NIH.
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: * At Screening, meet DSM-5 criteria for current PTSD with a symptom duration of at least 6 months. * Fluent in speaking and reading the predominantly used or recognized language of the study site (English). * Must be a veteran enrolled at a VA Healthcare Center in the Greater Los Angeles area. * Able to swallow pills. * Agree to have study visits audiovisually recorded, including Experimental Sessions, IR assessments, and non-drug therapy sessions. * Able to 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 the participant becoming unwell or unreachable. * Able to identify appropriate support person(s) to stay with the participant on the evenings of Experimental Sessions if needed. * May have well-controlled hypertension that has been successfully treated with anti-hypertensive medicines, if they pass additional screening to rule out underlying cardiovascular disease. * May have asymptomatic Hepatitis C virus (HCV) that has previously undergone evaluation and treatment as needed. * Body weight of at least 45 kilograms (kg). Participants with a body weight of 45-48 kg must also have a body mass index (BMI) within the range of 18 to 30 kg/m2. BMI must be within 18 to 32 kg/m2 (inclusive). * A person able to be pregnant (PABP) must use a highly effective contraceptive method. Exclusion Criteria: * Are not able to give adequate informed consent. * Have evidence or history of significant medical or psychiatric disorders. * Are abusing illegal drugs. * Unable or unwilling to safely taper off prohibited psychiatric medication. * Current enrollment in any other clinical study involving an investigational study treatment or any other type of medical research, unless approved by the study clinician.
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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
2 sites. 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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VA Greater Los Angeles Healthcare System, Westwood campus
NOT_YET_RECRUITINGLos Angeles, California, 90073, United States
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West Los Angeles Veteran Affairs
RECRUITINGLos Angeles, California, 90095, United States
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