MAPS is sponsoring a Phase 2, open-label randomized controlled comparative study on the effectiveness of MDMA-assisted therapy in U.S. Veterans with chronic PTSD. Led by esteemed PTSD researcher Rachel Yehuda, Ph.D., Director at the Mental Health Patient Care Center, James J. Peters VA Medical Center, and Professor of Psychiatry and Neuroscience at the Icahn School of Medicine at Mount Sinai Hospital, the study is moving through the investigator-initiated research program of the U.S. Department of Veterans Affairs (VA).
The study is enrolling 60 veterans and will collect further information on whether there is a difference in two versus three sessions of MDMA-assisted therapy in terms of safety and efficacy in reducing PTSD symptoms. This study will also act as a training ground for VA clinicians and therapists on the MAPS MDMA-assisted therapy modality, and will include blood collection samples for later analysis of hormones, molecules, and other biological markers that may be related to having or recovering from PTSD.
- Current Status: Active
- ClinicalTrials.gov Record
- Study Protocol
- Study Timeline
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Enrolling: Phase 2 Study at the Bronx, New York Veterans Affairs Medical Center
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Five Participants Enrolled in Phase 2 Study at the Bronx, New York Veterans Affairs Medical Center
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First Participant Completes Treatment in Phase 2 Study at the Bronx, New York Veterans Affairs Medical Center
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One Subject Treated, Four Subjects Evaluated in Phase 2, Open-Label, Randomized Comparative Effectiveness Study for MDMA-Assisted Therapy in U.S. Military Veterans with Chronic PTSD
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Participant Enrolled in Phase 2, Open-Label, Randomized Comparative Effectiveness Study for MDMA-Assisted Therapy in U.S. Military Veterans with Chronic PTSD
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First Participant Treated in A Phase 2, Open-Label, Randomized Comparative Effectiveness Study for MDMA-Assisted Therapy in U.S. Military Veterans with Chronic PTSD
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First Participant Will Enroll in A Phase 2, Open-Label, Randomized Comparative Effectiveness Study for MDMA-Assisted Therapy in U.S. Military Veterans with Chronic PTSD
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First Participant Screening in A Phase 2, Open-Label, Randomized Comparative Effectiveness Study for MDMA-Assisted Therapy in U.S. Military Veterans with Chronic PTSD
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First Participant Consented to Participation in A Phase 2, Open-Label, Randomized Comparative Effectiveness Study for MDMA-Assisted Psychotherapy in U.S. Military Veterans with Chronic PTSD
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Site Initiation Visit Takes Place for Phase 2 Study at the Veterans Affairs Medical Center in Bronx, New York
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Phase 2 Study at the Bronx, New York Veterans Affairs Medical Center
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A Phase 2, Open-Label, Randomized Comparative Effectiveness Study for MDMA-Assisted Therapy in U.S. Military Veterans with Chronic PTSD