WithdrawnPhase 2

MDMA-Assisted Psychotherapy for Treatment Resistant PTSD in Adolescents

Stopped: Under review with FDA

United States0Started 2025-07-01

Plain-language summary

The primary objective of this study is to determine the safety and feasibility of 3,4-methylenedioxymethamphetamine (MDMA) -assisted psychotherapy to treat resistant post-traumatic stress disorder (PTSD). The secondary objectives are the exploration of effectiveness for treatment-resistant PTSD, symptoms of depression, and anxiety symptoms.

Who can participate

Age range

16 Years – 17 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: * Participants must meet DSM-5 criteria for current PTSD in response to a traumatic experience. An individual is not excluded if they experience more than one traumatic event. (Traumatic Event Screening Inventory for Children given to youth and caregiver, youth given CPSS if positive screen.) * Participants must have treatment-resistant PTSD, as defined by having continued diagnosis of PTSD following at least 3-months of psychotherapy and pharmacotherapy. Psychotherapeutic treatments may include, but are not limited to, cognitive behavioral therapy (including trauma-focused cognitive behavioral therapy and exposure therapy, stress inoculation training, including anxiety management, and insight-oriented psychotherapy). Pharmacotherapies include selective serotonin reuptake inhibitors (SSRIs). * Participants may also meet criteria for a mood (except bipolar disorder) or anxiety disorder. The inclusion of adolescents with either mood or anxiety disorders is essential given frequency of co-occurring disorders. * Participants must be 16-17 years old at time of study screening. * Participants; parents/caregivers must be willing to commit to two experimental sessions, therapy sessions, follow-up sessions, and completion of assessment parameters and instruments. Adolescents must assent. * Participants must be willing to refrain from taking any psychotropic medication from the outset of the study until follow-up at 3 months. The scheduled outcome measures at 6 mon…

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

Changes in heart rhythm via Carnation Ambulatory Heart Monitor

Timeframe: Throughout the 24 hours prior to each experimental medication session, throughout the duration of each drug administration session, and the 24 hours following each experimental medication session. Up to 64 hours.

Changes in blood pressure

Timeframe: Baseline assessment and at 1-hour intervals throughout each experimental medication session. Up to 17 hours total.

Change in pulse

Timeframe: Baseline assessment and at 1-hour intervals throughout each experimental medication session. Up to 17 hours total.

Change in body temperature

Timeframe: Baseline assessment and at 1-hour intervals throughout each experimental medication session. Up to 17 hours total

Mean change in score of visual analog scale to assess potential for misuse of MDMA

Timeframe: Weekly throughout treatment and at 3-month and 6-month follow-ups. Through study completion, an average of 9 months

Trial details

NCT IDNCT06353282

SponsorUniversity of California, Los Angeles

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-01-31

View on ClinicalTrials.gov More PTSD, Post Traumatic Stress Disorder trials

Plain-language summary

Who can participate

Age range

16 Years – 17 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.

What they're measuring

Changes in heart rhythm via Carnation Ambulatory Heart Monitor

Changes in blood pressure

Timeframe: Baseline assessment and at 1-hour intervals throughout each experimental medication session. Up to 17 hours total.

Change in pulse

Timeframe: Baseline assessment and at 1-hour intervals throughout each experimental medication session. Up to 17 hours total.

Change in body temperature

Timeframe: Baseline assessment and at 1-hour intervals throughout each experimental medication session. Up to 17 hours total

Mean change in score of visual analog scale to assess potential for misuse of MDMA

Timeframe: Weekly throughout treatment and at 3-month and 6-month follow-ups. Through study completion, an average of 9 months