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NCT07288151 · ClinicalTrials.gov registry record · Phase 2
MDMA-Assisted Massed Exposure Therapy for PTSD
A Phase 2 study, sponsored by Emory University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 200
- Enrollment target
NCT07288151: Recruiting Phase 2 study, sponsored by Emory University.
NCT07288151 is a Phase 2 study that is actively recruiting participants, run by Emory University. The registered enrollment target is 200 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07288151, a Phase 2 study, is actively recruiting participants, sponsored by Emory University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 200 participants
- Enrollment target
Study Summary
The goal of this clinical trial is to investigate the efficacy of 3,4-methylenedioxy-methamphetamine hydrochloride (MDMA) combined with Massed Prolonged Exposure (PE) therapy for the treatment of posttraumatic stress disorder (PTSD) in adult participants diagnosed with PTSD. This randomized, placebo-controlled trial will enroll 95 participants. The main questions it aims to answer are: * Does the combination of PE + MDMA lead to greater reduction in PTSD symptom severity from pre-treatment to one-month follow-up compared to PE + placebo? * Does PE + MDMA improve response efficiency and durability of PTSD symptom improvement compared to PE + placebo? * Does MDMA + PE enhance extinction retention and reduce amygdala threat reactivity, and are these changes associated with improved PTSD outcomes? Participants will: * Receive 10 sessions of Massed Prolonged Exposure therapy over two weeks * Be administered either 100 mg of MDMA or a placebo at Visit 2 * Undergo blinded independent evaluator assessments using the Clinician-Administered PTSD Scale for DSM-5-R (CAPS-5-R) at the one-month posttreatment follow-up
Primary Outcome
The CAPS-5-R is a structured clinical interview used to assess PTSD symptoms based on DSM-5 criteria. Each symptom is rated on frequency and intensity * Combined into a severity score per item * Total score reflects overall PTSD symptom severity
Interventions
- DRUG Placebo
- DRUG 3,4-Methylenedioxymethamphetamine (MDMA)
- BEHAVIORAL Massed Prolonged Exposure (PE)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2026-07 |
| Est. Completion | 2030-01 |
| Phase | Phase 2 |
What NCT07288151 shows while recruiting
NCT07288151 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT07288151 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07288151 about?
NCT07288151 is a clinical study titled "MDMA-Assisted Massed Exposure Therapy for PTSD". The goal of this clinical trial is to investigate the efficacy of 3,4-methylenedioxy-methamphetamine hydrochloride (MDMA) combined with Massed Prolonged Exposure (PE) therapy for the treatment of posttraumatic stress disorder (PTSD) in adult participants diagnosed with PTSD. This randomized, placebo...
What is the current status of trial NCT07288151?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 200 participants. The study started on 2026-07. Estimated completion is 2030-01.
What interventions are being tested in trial NCT07288151?
The interventions under investigation include: Placebo (DRUG), 3,4-Methylenedioxymethamphetamine (MDMA) (DRUG), Massed Prolonged Exposure (PE) (BEHAVIORAL).
Who is sponsoring clinical trial NCT07288151?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07288151's enrollment target sits among peer trials
200 304th of 2000 higher than 1,652 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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