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Study of MDMA hydrochloride therapy in adolescents aged 16‑18 with treatment‑resistant post‑traumatic stress disorder

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on adolescents aged 16 to 18 who have Post‑traumatic stress disorder that has not improved with usual treatments. Participants will receive an oral capsule containing MDMA hydrochloride (code name MIDOMAFETAMINE HYDROCHLORIDE) as part of a structured therapy program.

The main goal is to find out whether this approach can be carried out safely and whether participants can complete the treatment plan. Each participant will attend three sessions in which the medication is taken, and each session will be followed by a counseling period called an integration session to help process the experience. A final assessment will be performed about a week after the last integration session.

“Feasibility” means checking if the whole process can be done as planned, while “safety” means watching for any unwanted medical problems, known as adverse events. Integration sessions are meetings with a therapist to discuss thoughts and feelings that arise after taking the medication, helping to make sense of the experience. Throughout the study, health professionals will monitor participants for any side effects and will record whether anyone stops the treatment early.

The research process

The trial runs in 10 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and baseline assessment

    After joining the study you will provide informed consent and undergo screening to confirm eligibility for the trial.

    Baseline measurements will be taken, including questionnaires that evaluate post‑traumatic stress disorder symptoms, anxiety, depression, and overall health.

  2. Step 2

    Pre‑therapy preparation sessions

    You will attend several non‑drug therapy sessions with a trained therapist to prepare for the upcoming mdma-assisted sessions.

    These meetings aim to build trust, explain the process, and teach coping strategies.

  3. Step 3

    First mdma‑assisted therapy session

    On the day of the first session you will receive one oral mdma capsule containing 120 mg of the medication.

    The capsule is taken under medical supervision, and the therapy session lasts several hours while you are monitored for safety.

    After the medication effects subside you will have a brief post‑session discussion with the therapist.

  4. Step 4

    First integration session

    Within a few days after the first mdma session you will meet the therapist for an integration session.

    The purpose is to discuss experiences, process emotions, and reinforce coping skills learned during therapy.

  5. Step 5

    Second mdma‑assisted therapy session

    A second oral mdma capsule of 120 mg will be administered in the same supervised setting as the first session.

    The therapy proceeds in the same manner, with continuous monitoring and a short debrief afterward.

  6. Step 6

    Second integration session

    An integration meeting with the therapist follows the second mdma session, focusing on reflecting on the experience and applying insights to daily life.

  7. Step 7

    Third mdma‑assisted therapy session

    A third oral mdma capsule containing 120 mg is given under the same conditions as the previous sessions.

    The session includes the same safety monitoring and therapeutic support.

  8. Step 8

    Third integration session

    The final integration session takes place after the third mdma dose, allowing you to consolidate the overall therapeutic experience.

  9. Step 9

    Final assessment

    Within one week after the last integration session you will complete the same questionnaires used at baseline, such as the CAPS‑CA‑5 interview, to evaluate changes in post‑traumatic stress disorder symptoms.

    Safety will be reviewed by recording any adverse events that occurred during the study.

  10. Step 10

    Study completion

    Treatment completion is defined as having attended all three mdma-assisted sessions and the final assessment within the specified time frame.

    The study ends after the final safety review and data collection are finished.

Who can join the trial?

8 criteria

  • Age 16 through 18 years old – you must be a teenager between 16 and 18 years of age.
  • Diagnosis of PTSD using the CAPS-CA-5 interview – a structured questionnaire that doctors use to confirm post‑traumatic stress disorder.
  • Tried at least one evidence‑based treatment without enough improvement – you have already completed a therapy or medication that is proven to work for PTSD, but it did not reduce your symptoms significantly.
  • Social support system in place – you need a parent, foster parent, or mentor who is willing and able to help you during the study.
  • Safe and stable living situation – you must have a stable place to live and no ongoing threats such as stalking.
  • Willingness to create a post‑treatment care plan with your current referrer – you agree to work with the professional who referred you to set up follow‑up care after the study.
  • Written informed consent – you must sign a document showing that you understand the study and agree to take part.
  • Both male and female participants are allowed to join the trial.

Who cannot join the trial?

11 criteria

  • Cannot speak or write in Dutch.
  • Known hypersensitivity (allergy) to MDMA or any of the inactive ingredients (excipients) in the study drug.
  • Used recreational MDMA (taken for fun, not as a medicine) within three months before the first study session.
  • Sexually active females who are not using an effective method of birth control, and any pregnant females.
  • History or evidence of serious disease affecting blood (hematological), hormones (endocrine), brain blood vessels (cerebrovascular), heart (cardiovascular), coronary arteries, lungs (pulmonary), kidneys (renal), digestive system (gastrointestinal), immune system (immunocompromising), or nervous system (neurological), including seizure disorder.
  • Current severe suicidal thoughts (acute suicidality), psychotic problems, bipolar disorder, or any substance use disorder.
  • Any of the following heart conditions: high blood pressure (hypertension), coronary artery disease, peripheral vascular disease, congenital long QT syndrome, enlarged heart muscle (cardiac hypertrophy), reduced heart blood flow (cardiac ischemia), congestive heart failure, fast heart rate (tachycardia), artificial heart valve, or any other serious heart problem.
  • Intellectual disability with an IQ (intelligence quotient) less than 70.
  • Ongoing trauma caused by a parent who is part of the adolescent’s current primary‑care system.
  • Any current problem that the investigator or medical staff believes could interfere with participation.
  • Pregnant, breastfeeding, or a positive urine pregnancy test at screening for participants who could become pregnant.
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Verified sites

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  • Amsterdam UMC

    Responsive

    The NetherlandsAmsterdam, The Netherlands

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Investigated drugs

MDMA hydrochloride is a medication that produces feelings of empathy, openness, and reduced fear. In this study it is given in a capsule that the participant swallows. The drug is used to help the young people feel safer and more able to talk about their traumatic experiences during therapy sessions. MDMA‑assisted therapy combines the medication with structured psychotherapy. Participants meet with trained therapists for several sessions before, during, and after taking the medication. The therapy provides a supportive, calm environment where the adolescent can explore memories of trauma, learn new coping skills, and work toward reducing PTSD symptoms. The goal is to see if this combined approach is safe and feasible for teens whose PTSD has not improved with other treatments.

What is already known about the treatment

MDMA hydrochloride - This medication is taken as an oral capsule, usually 120 mg, and is swallowed with water. It is not an approved drug but is being studied in clinical trials for safety and usefulness, especially for people with PTSD that does not improve with other treatments. It is mainly looked at for helping adolescents with severe PTSD by making them feel more relaxed and able to talk about their memories. MDMA works by raising the levels of natural chemicals like serotonin, dopamine and norepinephrine in the brain, which can lower fear and increase feelings of trust, and it belongs to the empathogen‑entactogen class of drugs.

Investigated diseases

Post‑traumatic stress disorder - It is a mental health condition that can develop after a person experiences or witnesses a traumatic event. Symptoms often include vivid recollections, avoidance of reminders, heightened alertness, and negative changes in mood or thoughts. The condition may start soon after the trauma or appear months later. Over time, symptoms can become more persistent and begin to interfere with daily activities, relationships, and school performance. Stress responses may intensify, leading to increased avoidance and emotional numbness. The disorder can fluctuate, with worsening during stressful periods or when reminders of the trauma arise.
Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase IITrial ID2024-515184-65-01Estimated enrolment12 patientsSponsorAmsterdam UMC Stichting

sourced from the EU Clinical Trials Register and site verification

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