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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 is a Phase 2 study that is actively recruiting participants, run by Emory University. The registered enrollment target is 200 participants.
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
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07288151
The ClinicalTrials.gov registry entry for NCT07288151 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT07288151 reports 0 study locations.
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.
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