MDMA-AT for PTSD in Young Adults With Childhood Trauma (NCT07765693) | Clinical Trial Compass
Not Yet RecruitingPhase 2
MDMA-AT for PTSD in Young Adults With Childhood Trauma
United States15 participantsStarted 2026-10-31
Plain-language summary
This study is testing a new, emerging treatment for young adults (ages 18-26) with Posttraumatic Stress Disorder (PTSD). The treatment is combining the substance, MDMA, with up to three psychotherapy sessions, also known as MDMA-Assisted Therapy (MDMA-AT).
The main questions it aims to answer are:
* Is the treatment safe and feasible to administer?
* Does the treatment improve PTSD symptoms?
Participants will be asked to:
* Complete screening procedures, including a medical and psychiatric evaluation to ensure safe participation
* Attend up to three preparatory talk therapy sessions prior to the first MDMA-AT dosing session
* Attend three integration talk therapy sessions after each MDMA-AT dosing session
* Attend up to three total MDMA-AT dosing sessions
* Complete assessments from baseline to 38-weeks post-baseline
* Complete a fMRI scan at baseline and at 18-weeks post-treatment
* Complete self-report measures and ecological momentary assessments (EMAs) across the study period
Who can participate
Age range
18 Years – 26 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Demographic and Participant Information
* Between the ages of 18-26 years old upon signing the written consent form
* Proficient in speaking and reading English.
* Capable of providing informed consent.
* Is able to swallow pills.
* Willing and able to be contacted by phone throughout the study
* Resides in the United States
* Meets DSM-5 criteria for PTSD with sufficient severity assessed at study screening
* History of index Criterion A trauma that occurred in childhood
* Must agree to inform the research team within 48 hours of any emerging or new medical conditions and/or procedures
* Must provide an emergency contact
* Has someone to drive them home after each MDMA-AT session (or agrees to take a taxi/rideshare while accompanied by a close other)
* Agree not to drive for 24 hours after each MDMA-AT session
* Agree to return to place of residence immediately after each MDMA-AT session, and stay there until the next morning
* Has a trusted close other who is at least 18 years of age that agrees to stay with them throughout the night until the morning after each MDMA-AT session, and is willing to attend the ICF meeting and co-sign the ICF
* Agree to not participate in any other interventional clinical trials from baseline to the primary study endpoint
* Is willing and able to refrain from taking any psychiatric medications during the study period.
* Agrees to abstain from other medications (e.g., over the counter, PRN medications, etc) unless approval …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Adverse Events, Serious Adverse Events, and Adverse Events of Special Interest
Timeframe: Assessed from baseline to 18-weeks post baseline, and again at two follow-up timepoints (26- and 38-weeks post-baseline).
2
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
Timeframe: From baseline to 18-weeks post-baseline.