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    PRESS RELEASE: MDMA-Assisted Psychotherapy Shows Promise for Veterans with PTSD 
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    Results Published: MDMA-Assisted Psychotherapy for Veterans with Chronic, Treatment-Resistant PTSD



    The Lancet Psychiatry publishes MDMA research results


    May 2, 2018

    Yesterday, 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.

    The publication has already received widespread international media attention in The New York Times, CNN, Reuters, Fox News, Agence France Presse, British Forces News, Stars & Stripes, and much more.


    "The MDMA alone or the therapy alone don't appear to be as effective," explains Mithoefer. "The MDMA seems to act as a catalyst that allows the healing to happen."

    "I was actually able to forgive myself," explains McCourry. "There are also still some challenges I have to face from time to time related to the PTSD. But now I am able to work through them without getting stuck."

    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.

    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.

    MAPS has raised $26.2 million of the $26.7 million needed for its U.S. Phase 3 trials of MDMA-assisted psychotherapy for PTSD. MAPS is currently seeking an additional $5 million for European Medicines Agency (EMA) trials.
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    #2
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    Sounds like a big step forward in psychiatry. I hope the FDA keeps opening their mind up.
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