MAPS is pleased to share that after months of work, our research team has completed a scientific paper that reports the remarkable results from our US MDMA/PTSD pilot study. Dr Michael Mithoefer, Annie Mithoefer, BSN, Ilsa Jerome, PhD, Mark Wagner, PhD, and MAPS President Rick Doblin, PhD, with assistance from statistician Yvonne Michel PhD, spent tremendous effort preparing the paper for submission to a peer-reviewed journal. We have now sent out the paper to several friendly reviewers for informal critique. We will incorporate the feedback we get from these reviewers and then submit the paper to a peer-reviewed scientific journal. This is a major milestone for MAPS and the legitimacy of psychedelic psychotherapy. When the paper is published in a peer-reviewed journal, MDMA-assisted psychotherapy will gain credibility among the scientific community and subsequently the general population. We have not yet released the paper to our readership, but keep checking back on our monthly email update to read about the results of this historic study.

On May 29, 2009, we will submit a preliminary dataset to FDA containing basic safety information from our US MDMA-assisted psychotherapy pilot study. Over the past several months MAPS Clinical Research Associate Valerie Mojeiko has been working diligently with a team of consultants from the pharmaceutical industry to prepare this preliminary data set, and to develop a streamlined collection of standard operating procedures to use in future data sets. This submission to FDA is the first of several data reports from our first pilot study and will provide the scientific justification for future protocols that we will submit to FDA.]]>

IRB Services, the Canadian IRB that we are working with, has approved the changes to our MDMA/PTSD protocol that were made by Health Canada. MAPS Canadian MDMA-assisted psychotherapy PTSD study is now at the stage of seeking to import the research-grade MDMA into Canada. MDMA has never been legally imported to Canada before, so the process is a little slow. MAPS is working with a pharmacist who has applied for the license to import and we hope the approval will take place swiftly but we have no idea how long this process will actually take. When the license to import has been obtained, we can go forward with obtaining the specific import/export permits to ship the MDMA from the manufacturer in Switzerland to the pharmacist in Canada. Once the MDMA arrives in Canada, we can start enrolling subjects.

On Friday May 8, Valerie Mojeiko and Josh Sonstroem of MAPS Clinical Research Team, went to Vancouver to conduct a pre-study site visit. They met with co-therapists Ingrid Pacey, MD and Andrew Feldmar, PhD along with other site staff. This visit was necessary to ensure that data will be collected in manners compliant with FDA and Health Canada guidelines and that procedures will follow the protocol and IRB rules.

We are seeking a research assistant to help with this study 10-20 hours per week who lives in Vancouver and has prior research experience. Please view our job posting for more information. ]]>

MAPS has finalized plans and chosen a time and location for our first five-day MDMA/PTSD therapist training retreat for MAPS-sponsored researchers. The event will take place at the end of June in the Austrian mountains, where its off-season, reasonably priced, and more-or-less centrally located for therapist teams and MAPS staff coming together from the US, Canada, Switzerland, Spain, Israel, and Jordan.

Michael Mithoefer, MD and Annie Mithoefer, BSN, the co-therapist team from MAPS successfully completed U.S. MDMA/PTSD pilot study, will share techniques and results with the other therapists. June May Ruse, PhD, will present the principles in our treatment manual, which she is developing with feedback from our research teams.

The therapeutic outcomes in our US study were remarkable. In order to increase the chances that other co-therapist teams can replicate these results in MAPS other studies, Michael and Annie will present videotapes of their sessions and lead discussions about lessons theyve learned. The Swiss and Israeli co-therapist teams, who have treated some subjects but havent completed their studies yet, will also lead presentations about their results and methods. We will also discuss cultural differences, research methodology, and other treatments for PTSD and their similarities and differences from MDMA-assisted psychotherapy. We will have time for a breathwork session and opportunities for informal sharing. MAPS staff will be creating podcasts and writing blogs from the training seminar to keep our members and other interested parties informed of the valuable information that comes from it.

This private retreat will also serve to inform MAPS 2010 conference, which is open to medical professionals, MAPS members and the general public. If you are interested in learning more about MDMA/PTSD therapy, please write to Valerie@maps.org and she will put you on a list to receive information about future training opportunities.

This therapist training program, the first of its kind, will cost about $20,000. Were currently looking for one or more donors willing to underwrite this historic gathering. ]]>

Over the past several weeks, MAPS clinical research team members Valerie Mojeiko, Director of Operations and Clinical Research Associate, and Joshua Sonstroem, Information and Technology Specialist and Accountant, visited MAPS research sites around the globe. Visits such as these are conducted periodically to ensure that each research team is conducting their research in accordance with US Food and Drug Administration (FDA) guidelines so that the data can ultimately be presented to the FDA as well as to national regulatory agencies and the European Medicines Agency (EMEA).

Valerie and Josh made visits to our Swiss LSD/end-of-life anxiety study and Swiss MDMA/PTSD study. Rick Doblin, PhD joined Valerie and Josh at our Israeli MDMA/PTSD study, and at our proposed Jordanian MDMA/PTSD Study.

The Israeli study is budgeted at $90,000, $60,000 remains to be raised.]]>