Dear MAPS Members and Supporters,
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. Please donate today to ensure that this study can be completed. To sweeten the offer we have a great gift of the month from Ram Dass and Ralph Metzner below.
Randolph Hencken, M.A.
P.S. We have recently announced all the presenters at Psychedelic Science in the 21st century on the conference webpage. The conference has limited capacity and we are working hard to make it sell out. So register while you still can, ideally before our late registration rates (an additional $50) go into effect on March 15.
P.P.S. We just changed email systems here at MAPS, please double-check and update your user information online today.
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What’s happening this month at MAPS:
- Journal of the American Botanical Council published an article that details the DEAs obstruction of medical marijuana research and its refusal to license Prof. Lyle Craker to start a MAPS-funded marijuana production facility
- Obama nominates medical marijuana obstructionist Michelle Leonhart to become Administrator of the DEA
- Change.org: Ask the Senate to Block Anti-Medical Marijuana DEA Leader
- MDMA/PTSD documents submitted to Jordanian IRB
- Board of Directors has biannual meeting: Ashawna Hailey donates $200,000!
- MAPS, Drug War, and Psychedelic Medicine are central characters in new book by Charles Shaw
- Unheard Voices project seeks healing stories of psychedelic medicine
- Beckley Foundation releases Cannabis Policy: Moving Beyond Stalemate, a book researched and written by leading drug policy analysts
MAPS Gift of the month
This month we are pleased to offer the brand new book Birth of A Psychedelic Culture by Ram Dass and Ralph Metzner (retail $29.95) to any new member who makes a donation of $40 or more or to any current member who makes a donation of $25 or more. To retrieve your gift go to our donation page and type in MAPS in the coupon field (note: must be CAPITALIZED).
Birth of A Psychedelic Culture:
Birth of a Psychedelic Culture, an extraordinary new book, shines a bright light on the emergence of the sixties culture and the experiments with mind-altering substances undertaken by Professors Timothy Leary, Richard Alpert (Ram Dass) and then-Harvard graduate student Ralph Metzner. Based on a series of conversations between Metzner and Ram Dass and recorded by psychiatrist and author Gary Bravo, this book describes their initial experiments at Harvard, the experiments after they were dismissed from Harvard, their journeys to India and their reflections on that transformative era.
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