PRESS RELEASE: MDMA-Assisted Therapy Shows Promise for Veterans with Chronic, Treatment-Resistant PTSD
• Results published in The Lancet Psychiatry
Brad Burge, Director of Strategic Communications, MAPS
Today, the results of a pioneering U.S. Food and Drug Administration (FDA)-regulated clinical trial of MDMA-assisted psychotherapy for the treatment of posttraumatic stress disorder (PTSD) in veterans, firefighters, and police officers were published in the peer-reviewed journal The Lancet Psychiatry.
Sponsored by the non-profit Multidisciplinary Association for Psychedelic Studies (MAPS), the double-blind, placebo-controlled, Phase 2 pilot study in 26 participants found that one month after their second day-long experimental session, 68% in the full-dose MDMA group did not qualify for a diagnosis of PTSD, compared to 29% in the low-dose MDMA (active placebo) control group. The course of double-blind treatment included 13.5 hours of non-drug psychotherapy and 16 hours (two day-long experimental sessions) of either full-dose or low-dose MDMA-assisted psychotherapy. On average, the positive results were sustained one year later.
Led by Michael Mithoefer, M.D., and Ann Mithoefer, B.S.N., in Charleston, South Carolina, the trial was one of MAPS’ six completed Phase 2 pilot studies of MDMA-assisted psychotherapy for PTSD. Trial participants included veterans (22), firefighters (3), and police officers (1), all with service-related PTSD.
“At least one in two PTSD patients cannot tolerate or do not respond adequately to existing treatments, so there is an urgent need for better treatments for the millions of military veterans and others with PTSD,” said Dr. Mithoefer. “These results are further evidence that MDMA, used just two times at monthly intervals, can make psychotherapy much more effective and better tolerated. I’m excited that Phase 3 trials will soon confirm whether this therapy can be approved for widespread use in a few years.”
The study replicated previous research showing an acceptable risk profile for MDMA, with the most frequently reported adverse reactions during experimental sessions being anxiety, headache, fatigue, and muscle tension. Adverse reactions one week following treatment included anxiety, fatigue, and insomnia. Temporary elevations in pulse, blood pressure, and temperature were also recorded during MDMA sessions, and did not require medical intervention.
In August 2017, based on the results of MAPS’ Phase 2 trials, 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.
Phase 3 clinical trials of MDMA-assisted psychotherapy for PTSD will begin in the summer of 2018, and will enroll 200-300 participants across 16 sites in the U.S., Canada, and Israel. If the Phase 3 trials demonstrate significant efficacy and an acceptable safety profile, FDA approval is expected by 2021.
With an average of 20 veterans committing suicide every day, there is an urgent need for more effective treatments for PTSD. As of June 30, 2016, over 868,000 veterans were receiving disability payments from the U.S. Department of Veterans Affairs for PTSD, with an estimated cost of over $17 billion per year.
The Lancet Psychiatry article was authored by Michael Mithoefer, M.D., Ann Mithoefer, B.S.N., Allison Feduccia, Ph.D., Lisa Jerome, Ph.D., Mark Wagner, Ph.D., Joy Wymer, Ph.D., Julie Holland, M.D., Scott Hamilton, Ph.D., Berra Yazar-Klosinski, Ph.D., Amy Emerson, B.A.., and Rick Doblin, Ph.D.
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 $47 million for psychedelic therapy and medical marijuana research and education. As a non-profit with no government funding for psychedelic research, MAPS relies on contributions from individuals, businesses, and foundations. For more information, visit maps.org.
MAPS has raised $26.2 million of the $26.7 million needed for its FDA Phase 3 trials of MDMA-assisted psychotherapy for PTSD. MAPS is currently seeking an additional $5 million for European Medicines Agency (EMA) trials.
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.