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NCT06189027 · ClinicalTrials.gov registry record · Phase 3
Epigenetics and MDMA-Assisted Psychotherapy for PTSD
A Phase 3 study, sponsored by University of Southern California.
- Completed
- Registry status
- Phase 3
- Development phase
- 45
- Enrollment target
NCT06189027: Completed Phase 3 study, sponsored by University of Southern California.
NCT06189027 is a Phase 3 study that has completed, run by University of Southern California. The registered enrollment target is 45 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06189027, a Phase 3 study, has completed, sponsored by University of Southern California.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 45 participants
- Enrollment target
Study Summary
This is an add-on substudy to an already-approved clinical trial "A Multi-Site Phase 3 Study of MDMA-Assisted Psychotherapy for PTSD" (ClinicalTrials.gov Identifier: NCT03537014) which is to be a phase 3 clinical trial studying the efficacy of MDMA-Assisted Psychotherapy for Post Traumatic Stress Disorder. The parent study has been approved by Copernicus Group IRB and is being run by the MAPS Public Benefit Corporation, and is a randomized controlled trial comparing the clinical efficacy of MDMA-assisted psychotherapy to Placebo-assisted psychotherapy. The parent study will recruit participants with Post Traumatic Stress Disorder and involves 20 total study visits over the course of 18 weeks including 3 preparatory psychotherapy visits plus 3 separate treatment sessions involving psychotherapy plus the administration of MDMA vs. placebo and 3 follow up psychotherapy visits after each treatment session. This substudy adds on the collection of saliva in a salivary DNA collection kit at baseline and after treatment to the parent study clinical trail so as to assess whether the MDMA-Assisted Psychotherapy exerts influence on the epigenetic regulation of stress-associated genes as assessed in the salivary epithelial and white blood cells of the research participants. We aim to further assess whether any such changes are correlated with improvements in PTSD symptoms.
Primary Outcome
Quantify changes in methylation of glucocorticoid receptor NR3C1, the associated gene FKBP5, and Brain Derived Neurotrophic Factor (BDNF) as compared to placebo, in participants with PTSD.
Interventions
- BEHAVIORAL Psychotherapy
- DRUG MDMA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2018-11-20 |
| Est. Completion | 2024-12-31 |
| Phase | Phase 3 |
What the finished NCT06189027 record still lists
NCT06189027 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which Psychotherapy is the first listed.
NCT06189027 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06189027 about?
NCT06189027 is a clinical study titled "Epigenetics and MDMA-Assisted Psychotherapy for PTSD". This is an add-on substudy to an already-approved clinical trial "A Multi-Site Phase 3 Study of MDMA-Assisted Psychotherapy for PTSD" (ClinicalTrials.gov Identifier: NCT03537014) which is to be a phase 3 clinical trial studying the efficacy of MDMA-Assisted Psychotherapy for Post Traumatic Stress Di...
What is the current status of trial NCT06189027?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 45 participants. The study started on 2018-11-20. Estimated completion is 2024-12-31.
What interventions are being tested in trial NCT06189027?
The interventions under investigation include: Psychotherapy (BEHAVIORAL), MDMA (DRUG).
Who is sponsoring clinical trial NCT06189027?
This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06189027's enrollment target sits among peer trials
45 1870th of 2000 higher than 127 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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