On September 30, we submitted our draft protocol, informed consent, and Case Report Forms for our Jordanian MDMA/PTSD research to Principal Investigator Nasser Shuriquie, M.D. and his Jordanian research team, and to Clinquest JO, a Jordanian Contract Research Organization (CRO). We have decided to hire Clinquest JO to monitor the study in order to limit the amount of travel and resources that our U.S. monitoring team would have to expend to travel frequently to Jordan. Furthermore, Clinquest JO helped to establish the Jordanian FDA, are culturally situated to Jordan, and speak Arabic. We are impressed with their quality of work and will be pleased to work with them. Dr. Shuriquie introduced Kamila Novak, Ph.D. of Clinquest JO to MAPS Executive Director Rick Doblin Ph.D. when Rick was in Jordan on August 13, 2009.

On October 20, Rick and Michael Mithoefer, M.D. will go to Amman, Jordan to make a presentation about the research agenda to representatives of the Jordanian FDA, Dr. Shuriquie, Shuriquies co-therapist and others who may be involved in the study. Clinquest JO will bring several clinical research staff from Egypt to hear the presentation. MAPS is excited to be venturing through the doorway to the Arabic research world.

From October 18-23, Michael and Rick will attend the conference "Future Directions in PTSD: Prevention, Diagnosis and Treatment," put on by the Institute for Advanced Studies at the Hebrew University of Jerusalem. Michael will present a poster on MAPS MDMA/PTSD pilot study at the conference. Michael and Rick will also meet with Efrat Yasur, founder of Transcom Global, an Israeli CRO. MAPS is hiring Transcom Global to monitor our Israeli MDMA/PTSD study.

In light of the results from our US MDMA/PTSD pilot study and preliminary results from our Swiss and Israeli pilot studies, we have completed an overall review of our methodology and study documents used in our studies. We have incorporated what we have learned in revised versions of our MDMA/PTSD protocols and Case Report Forms (CRFs). The revised protocols are designed to be more efficient. We have narrowed down our research focus and have eliminated some redundant outcome measures from the protocols. Weve also added a measure of suicidality required by the FDA for all studies using drugs that have psychological effects.

One of the strengths of MAPS drug development approach is our willingness to do the extra work required to incorporate lessons learned in our protocols as they are in process. This fine-tuning is the essence of what Phase 2 pilot studies are all about. They are learning opportunities for the development and design of Phase 3 multi-site studies. The Phase 3 studies will evaluate in a large number of subjects the safety and efficacy of MDMA-assisted psychotherapy for the treatment of PTSD. The outcome of these Phase 3 studies will determine if the FDA and other regulatory agencies eventually approve MDMA for prescription use.

Were close to completing the protocol design for our upcoming U.S. MDMA/PTSD study exclusively for veterans of war. We plan to submit this protocol to the FDA in November 2009. A crucial protocol design meeting with Rick Doblin, Ph.D., Michael Mithoefer, M.D. and Ilsa Jerome, Ph.D. took place several weeks ago at Ricks home office. We will be using the Phase 2 study in veterans to test a possible design for our Phase 3 multi-site studies -- our most sophisticated protocol design to date. We will provide more information about details of the protocol in an upcoming email newsletter.

This scientific, peer-reviewed paper has a section on MDMA. The authors quote an article from Rick Doblin, Ph.D. published in 2002 which was about MAPS' MDMA/PTSD Clinical Plan. They also quote Andy Parrott about MDMA's therapeutic potential, even though he has mostly written about the risks of MDMA.