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  1. Terrapinzflyer
    The FDA Approves Another MAPS Study!

    The good news just keeps on pouring in! On February 1, the FDA sent us a “may proceed” letter for our study of MDMA-assisted psychotherapy for the treatment of posttraumatic stress disorder (PTSD) in veterans of war. The design of this study is our most sophisticated and complicated to date. This may become the design for the large-scale, multi-site MDMA/PTSD Phase 3 studies that FDA requires to prove safety and efficacy prior to approval for use as a prescription medication.

    This study will evaluate whether veterans with war-related PTSD respond similarly to subjects in our initial MDMA/PTSD study. Those subjects were primarily women with PTSD as a result of sexual abuse, rape, or violent crime (although two subjects were male veterans with war-related PTSD). We will enroll sixteen veterans, roughly equal numbers of men and women. We will test three different doses of MDMA to evaluate which doses can be used to effectively produce a double-blind study in which the subjects and therapists make a substantial number of incorrect guesses about which dose was randomly administered. In our pilot study, the therapists always guessed correctly, and the subjects almost always guessed correctly, as to whether an inactive placebo or a full-dose of MDMA was administered. This new protocol also allows enrollment of subjects with Hepatitis C and controlled hypertension – subjects with either condition were excluded in the pilot study. You can read more about the study on our MDMA page, where all the pertinent documents are available for view.

    In a reflection of how skilled the MAPS clinical research team has become at designing scientific protocols, the FDA approved the new protocol without asking for any changes. This is a remarkable accomplishment and a first for MAPS.

    We are now seeking approval for our MDMA/PTSD study in veterans from the Institutional Review Board (IRB), which we anticipate will take about 1 month. If all goes well, the study can begin enrolling subjects this spring.

    This newest study is projected to cost MAPS approximately $500,000. We are working diligently to secure funding from large foundations, which due to the controversial nature of MDMA have not yet funded any of our research. For the time being, we are counting on your support to fund our groundbreaking studies.
    Sincerely,


    Randolph Hencken, M.A.
    Director of Communication and Marketing, MAPS
    Conference Organizer

    From an email so no link- should be up soon at:
    http://www.maps.org/news

Comments

  1. Terrapinzflyer
    and eight months later they finally cleared the last regulatory step- winning DEA approval:

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