MDMA/PTSD U.S. Study (Veterans of War)
A Randomized Triple-Blind, Phase 2 Pilot Study Comparing 3 Different Doses of MDMA in Conjunction with Manualized Psychotherapy in 24 Veterans with Chronic Posttraumatic Stress Disorder (PTSD)
Principal Investigator: Michael Mithoefer, M.D., with co-therapist Annie Mithoefer, B.S.N.
Location: Charleston, SC (USA)
This pilot Phase 2 study is examining the safety and efficacy of MDMA-assisted psychotherapy in 24 veterans, firefighter, and police officers with service-related PTSD. We are seeking equal numbers of male and female subjects. This protocol is randomized and triple-blind. All subjects will receive weekly non-drug psychotherapy and three experimental day-long therapy sessions, scheduled three to five weeks apart. We are testing three different doses of MDMA to determine whether this design will result in a successful blind, with subjects, therapists, and the independent rater being uncertain about which subject received which dose. 12 subjects will receive a full 125 mg dose followed by a 62.5 mg supplemental dose; six subjects will receive an active dose of 75 mg followed by a supplemental 37.5 mg dose; and six subjects will receive an active placebo dose of 30 mg followed by a supplemental 15 mg dose.
Our exploratory sub-study of the mechanisms of action of MDMA-assisted psychotherapy for PTSD (which was approved by the Copernicus Institutional Review Board on December 3, 2013) will enroll subjects from this study. We will use heart rate variability (HRV) and functional magnetic resonance imaging (fMRI) to measure the physiological effects of MDMA-assisted psychotherapy and explore correlations between those effects and clinical outcomes. Our goals for this study are to contribute to the evidence base for MDMA-assisted psychotherapy, add to existing knowledge about the physiological correlates of PTSD, identify therapeutic processes within our treatment method, and gather preliminary data for a grant application to the National Institute of Mental Health (NIMH). The sub-study will be conducted in collaboration with researchers at the Medical University of South Carolina (MUSC), Smith College, and the New School for Social Research.
The findings of this study in veterans with war-related trauma will be compared to the findings from our flagship pilot study of MDMA-assisted psychotherapy for PTSD, which consisted primarily of women survivors of sexual abuse and assault. Previous studies suggest that war-related PTSD may be more prevalent and harder to cure than PTSD caused by other types of trauma, and this study may help establish the relationship between trauma etiology and treatment efficacy.
We are currently seeking research participants for this study. Please visit our participate in research page for more information.
Download the protocol for this study.
$1,376,000 estimated study cost • $1,027,000 raised • $349,000 still needed
View the timeline for this study.
December 23, 2009: We submitted our Investigational New Drug (IND) application to the FDA.
February 1, 2010: Our FDA IND application was approved with no changes required.
April 1, 2010: FDA accepted the first amendment to our Veterans of War Protocol.
August 27, 2010: The Drug Enforcement Administration (DEA) informed Clinical Investigator Michael Mithoefer, M.D., that it had approved his Schedule 1 license.
August 31, 2010: The second protocol amendment was submitted to the IRB, and approved on September 20.
September 30, 2010: The second protocol amendment was submitted to the FDA. The FDA had no objections to the amendments within the 30-day review period.
August 2, 2011: The third protocol amendment was submitted to the IRB, and approved on August 11.
August 4, 2011: The third protocol amendment was submitted to the FDA. The FDA had no objections to the amendments within the 30-day review period.
February 10, 2012: The fourth protocol amendment was submitted to the FDA. The FDA had no objections to the amendments within the 30-day review period.
February 14, 2012: The fourth protocol amendment was submitted to the IRB, and approved on February 22.
December 3, 2013: The protocol for our sub-study of the mechanisms of action of MDMA-assisted psychotherapy was approved by the Copernicus IRB
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