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NCT01211405 · ClinicalTrials.gov registry record · Phase 2
Study Comparing Three Doses of MDMA Along With Therapy in Veterans With Posttraumatic Stress Disorder
A Phase 2 study, sponsored by Resilient Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 26
- Enrollment target
NCT01211405: Completed Phase 2 study, sponsored by Resilient Pharmaceuticals.
NCT01211405 is a Phase 2 study that has completed, run by Resilient Pharmaceuticals. The registered enrollment target is 26 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01211405, a Phase 2 study, has completed, sponsored by Resilient Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 26 participants
- Enrollment target
Study Summary
The goal of this clinical trial is to learn if MDMA-assisted therapy is safe and effective and reducing PTSD symptoms in veterans with chronic PTSD. The main question it aims to answer is: Do three doses of MDMA reduce PTSD symptoms? Researchers will compare 30, 75, and 125 mg of MDMA HCl with therapy to see which dose best reduces PTSD symptoms. Participants will undergo three preparatory non-drug therapy sessions with a male and female co-therapist team, then undergo three day-long MDMA-assisted therapy sessions after receiving an initial dose of 30, 75, or 125 mg MDMA HCl. After each MDMA-assisted therapy session, participants will undergo three integrative therapy sessions.
Interventions
- BEHAVIORAL Therapy
- DRUG Low dose MDMA-assisted therapy
- DRUG Medium dose MDMA-assisted therapy
- DRUG Full dose MDMA-assisted therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2010-11-10 |
| Est. Completion | 2016-08-02 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01211405
The ClinicalTrials.gov registry entry for NCT01211405 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Resilient Pharmaceuticals, which has 17 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Therapy is the first listed.
NCT01211405 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01211405 about?
NCT01211405 is a clinical study titled "Study Comparing Three Doses of MDMA Along With Therapy in Veterans With Posttraumatic Stress Disorder". The goal of this clinical trial is to learn if MDMA-assisted therapy is safe and effective and reducing PTSD symptoms in veterans with chronic PTSD. The main question it aims to answer is: Do three doses of MDMA reduce PTSD symptoms? Researchers will compare 30, 75, and 125 mg of MDMA HCl with ther...
What is the current status of trial NCT01211405?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 26 participants. The study started on 2010-11-10. Estimated completion is 2016-08-02.
What interventions are being tested in trial NCT01211405?
The interventions under investigation include: Therapy (BEHAVIORAL), Low dose MDMA-assisted therapy (DRUG), Medium dose MDMA-assisted therapy (DRUG), Full dose MDMA-assisted therapy (DRUG).
Who is sponsoring clinical trial NCT01211405?
This trial is sponsored by Resilient Pharmaceuticals, which has 17 total clinical trials registered on ClinicalTrials.gov.
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