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NCT04264026 · ClinicalTrials.gov registry record · Phase 2
MDMA-Assisted Psychotherapy in Veterans With Combat-Related, Refractory PTSD
A Phase 2 study, sponsored by VA Loma Linda Health Care System.
- Completed
- Registry status
- Phase 2
- Development phase
- 5
- Enrollment target
NCT04264026 is a Phase 2 study that has completed, run by VA Loma Linda Health Care System. The registered enrollment target is 5 participants.
The verdict
NCT04264026, a Phase 2 study, has completed, sponsored by VA Loma Linda Health Care System.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 5 participants
- Enrollment target
Study Summary
This will be a single-site, open-label phase 2 study designed to test the feasibility of administering MDMA in conjunction with psychotherapy for combat-related treatment-resistant PTSD in US military veterans currently enrolled in VA. MDMA will be given in conjunction with structured psychotherapy in three single-dose psychotherapy sessions in a hospital setting over the course of 12 weeks, along with preparatory and integration psychotherapy sessions in-between each active-dose session. The overall objective of this study is to evaluate the risks, benefits, and feasibility of MDMA used in conjunction with manualized psychotherapy, on reduction of symptoms, or remission of PTSD, as evaluated by standard clinical measures, in a VA Healthcare System. The primary outcome measure for the study is the Clinician-Administered PTSD Scale (CAPS-5), a semi-structured interview used in the majority of clinical trials for PTSD, which will be assessed at baseline, primary endpoint, and at the long-term 12-month follow-up visit. Secondary safety and efficacy measures will also be collected. The planned duration of this study is 1-3 years, with each active treatment period lasting approximately 12 weeks, along with a long-term follow-up 12 months after the last active-drug session.
Interventions
- DRUG 3,4-methylenedioxymethamphetamine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2021-07-29 |
| Est. Completion | 2025-05-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04264026
The ClinicalTrials.gov registry entry for NCT04264026 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VA Loma Linda Health Care System, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which 3,4-methylenedioxymethamphetamine is the first listed.
NCT04264026 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04264026 about?
NCT04264026 is a clinical study titled "MDMA-Assisted Psychotherapy in Veterans With Combat-Related, Refractory PTSD". This will be a single-site, open-label phase 2 study designed to test the feasibility of administering MDMA in conjunction with psychotherapy for combat-related treatment-resistant PTSD in US military veterans currently enrolled in VA. MDMA will be given in conjunction with structured psychotherapy ...
What is the current status of trial NCT04264026?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 5 participants. The study started on 2021-07-29. Estimated completion is 2025-05-01.
What interventions are being tested in trial NCT04264026?
The interventions under investigation include: 3,4-methylenedioxymethamphetamine (DRUG).
Who is sponsoring clinical trial NCT04264026?
This trial is sponsored by VA Loma Linda Health Care System, which has 5 total clinical trials registered on ClinicalTrials.gov.
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