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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 is a Phase 3 study that has completed, run by University of Southern California. The registered enrollment target is 45 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06189027
The ClinicalTrials.gov registry entry for NCT06189027 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Southern California, which has 617 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Psychotherapy is the first listed.
NCT06189027 reports 0 study locations.
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.
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