PRESS RELEASE: Three Articles Published in Psychopharmacology, Biological Psychiatry, and New England Journal of Medicine
- Major funding support announced for Phase 3 clinical trials of MDMA-assisted psychotherapy for PTSD
- Research participants share their stories in a series of new video testimonials
- Year-end fundraising drive raises 30% of $200,000 goal in first 22 days
Articles Published in Peer-Reviewed Journals
In November, three articles from MAPS staff and researchers were published in peer-reviewed scientific journals, including an update on MAPS’ MDMA drug development program in Psychopharmacology and two letters to the editor about the need for more effective post-traumatic stress disorder (PTSD) treatments in Biological Psychiatry and the New England Journal of Medicine.
• Feduccia, A. A., Holland, J., & Mithoefer, M. C. (2017). Progress and promise for the MDMA drug development program. Psychopharmacology, 1-11.
From the abstract: “Pharmacotherapy is often used to target symptoms of posttraumatic stress disorder (PTSD), but does not provide definitive treatment, and side effects of daily medication are often problematic…The most promising drug studied as a catalyst to psychotherapy for PTSD thus far is 3,4-methylenedioxymethamphetamine (MDMA).”
• Feduccia, A. A., Mithoefer, M. C., Jerome, L., Holland, J., Emerson, A., & Doblin, R. (2017). Response to the Consensus Statement of the PTSD Psychopharmacology Working Group. Biological Psychiatry.
From the abstract: “We are writing in response to the Letter to the Editor by John Krystal and colleagues…This timely research statement pointed out some of the barriers to translating a wealth of PTSD research into effective pharmacological strategies…[T]he addition of two promising candidates— cannabis and MDMA—would make this report more comprehensive.”
• Mithoefer, M. C., Jerome, L., Monson, C. (2017). Posttraumatic Stress Disorder Correspondence. New England Journal of Medicine.
From the abstract: “MDMA therapy has been shown to produce lasting improvement in symptoms of PTSD and in personality changes supportive of recovery. Proposed mechanisms of action include fear extinction, greater ease in addressing emotionally upsetting material, and strengthening of the therapeutic alliance through increased empathy and self-compassion.”
Major Support for Psychedelic Therapy Research
In 2017, MAPS has received or had pledged major support for Phase 3 clinical trials of MDMA-assisted psychotherapy for PTSD from Dr. Bronner’s ($5 million over five years), the Riverstyx Foundation ($2 million over four years), Britt Selvitelle ($1 million), and the Mental Insight Foundation ($250,000 over three years).
The initiation of Phase 3 clinical trials of MDMA-assisted psychotherapy for PTSD this spring presents MAPS with the greatest fundraising challenge in its 31-year history. These trials will cost an estimated $26 million for U.S. Food and Drug Administration (FDA) approval, and an additional estimated $10 million for European Medicines Agency (EMA) approval (negotiations with the EMA will begin in 2018). With $15.5 million received or pledged, MAPS still needs $10.5 million to obtain FDA approval for MDMA-assisted psychotherapy for PTSD.
In August, the FDA granted Breakthrough Therapy Designation to MDMA-assisted psychotherapy for PTSD, acknowledging that it “may demonstrate substantial improvement over existing therapies” and agreeing to expedite its development and review. If the trials show positive results, FDA approval for MDMA-assisted psychotherapy for PTSD is expected by 2021.
Since there is not yet government funding for psychedelic research, the completion of these clinical trials relies on individual donors, foundations, and companies who—like the FDA—see the immense potential of MDMA-assisted psychotherapy to help heal trauma on a global scale.
New Video Testimonials from Trial Participants
MAPS has released a collection of new video testimonials from clinical trial participants Roxxann, Hapi, and James as part of its year-end drive to raise $200,000 for evidence-based psychedelic and marijuana research and to develop new treatments for posttraumatic stress disorder (PTSD), anxiety, addiction, and other conditions.
Since November 15, 288 donors have already given over $60,287—30% of MAPS’ $200,000 goal—and quickly met the initial $15,000 matching grant. An additional $25,000 in matching grants have now been offered by The Sarlo Foundation ($10,000) and Justin Rosenstein ($15,000) to ensure the momentum continues.
As clinical trial participant Roxxann says, “MDMA-assisted psychotherapy illuminated dark recesses in my heart and mind and gave me the courage and compassion to heal myself. You can help make this treatment a possibility for others by making a gift to MAPS.”
MAPS is also proud to accept donations in cryptocurrency, including Bitcoin, Ethereum, and Litecoin. All contributions will support MAPS’ research into MDMA, other psychedelics, and cannabis to treat serious mental health conditions.
About MAPS and MPBC
Founded in 1986, MAPS is a 501(c)(3) non-profit research and educational organization that develops medical, legal, and cultural contexts for people to benefit from the careful uses of psychedelics and marijuana. Since its founding, MAPS has raised over $44.5 million for psychedelic therapy and medical marijuana research and education. For more information, visit maps.org.
MAPS-sponsored clinical trials are conducted by the MAPS Public Benefit Corporation (MPBC), a wholly owned subsidiary of MAPS formed in 2015 for the special purpose of balancing social benefits with income from legal sales of MDMA, other psychedelics, and marijuana. For more information, visit mapsbcorp.com.