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MDMA/PTSD Paper Completed and Sent for Friendly Review

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.

MDMA Data Analysis Nearly Ready for FDA Submission

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.

Canadian Study Awaits MDMA Import License

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-Sponsored MDMA/PTSD Co-Therapists will Travel to MAPS Training Seminar in Austria, June 25 July 1, 2009:

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.

Research Monitoring Team Completes Visits Around the World:

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.

Canadian MDMA/PTSD Study Gets Green Light from Health Canada:

On March 17, Health Canada issued a No Objection Letter for MAPS’ Canadian MDMA/PTSD study. This means that the Canadian protocol and the MDMA that will be used in that study (from Switzerland) have been completely approved by Health Canada. On April 2, Dr. Ingrid Pacey applied for her Section 56 exemption, equivalent to a DEA Schedule 1 license. This license will permit her to possess and handle MDMA for the study. Once she has obtained her Section 56 Exemption, probably within the next month, MAPS can proceed to acquire the necessary import/export permits for shipment of the MDMA from Switzerland to Canada. MAPS monitoring team has scheduled their first pre-study visit to discuss logistics with the team on May 9. If all goes smoothly, we anticipate starting the study within the next 2-3 months.

This study is budgeted at $250,000, all of which remains to be raised.

Harvard MDMA-Cancer/Anxiety Study Update:

A study that originated with MAPS, but that is now funded and managed independent of MAPS has had several important updates. The project offers MDMA-assisted psychotherapy and non-drug psychotherapy for advanced-stage cancer patients who are experiencing anxiety and other end-of-life issues not adequately treated by traditional means. The study had only been able to recruit from patients of the oncology service at the Lahey Clinic of Burlington, MA. Study candidates now just need to reside within a 100-mile radius of Boston and have an oncologist that the researchers can also work with. Moreover, the study now has a "Stage 2," so that 100% of participants have the opportunity to be part of the experiment employing the dose range of MDMA being evaluated as a treatment-level dose. To learn more about this study, either if you are curious or if you or someone you know may be interested in volunteering, see: http://clinicaltrials.partners.org/trials.aspx?tId=2284

Threshold Foundation Donates $8400, SAePT Donates 5000 to MDMA/PTSD Research:

Ashawna Hailey, on MAPS’ Board of Directors, presented information about our MDMA/PTSD research to a Threshold Foundation meeting. The Threshold Foundation is a group of philanthropists who meet together to pool resources and discuss their charitable giving. Ashawna made a presentation that highlighted our MDMA/PTSD research as a tool to help treat veterans of war. We wish to thank Ashawna for her speech and we extend our gratitude to the members of Threshold Foundation for their $8400 donation.

At their annual meeting on April 3, the Swiss Association for Psycholytic Therapy (SAePT) voted to donate 5000 Euros to the Swiss MDMA/PTSD study being conducted by Dr. Peter Oehen. We're grateful for this contribution and the international collaboration between MAPS and SAePT, whose members include both Dr. Oehen and Dr. Gasser.

MAPS sent a payment of $20,000 to our Swiss MDMA/PTSD study, conducted by Principal Investigator Peter Oehen, MD, and his co-therapist Verena Widmer, RN. The study has enrolled 10 subjects, with 2 subjects still in the treatment process and two more to be enrolled.

The study will cost $225,000; $60,000 is still needed.

MAPS Clinical research team members Valerie Mojeiko and Joshua Sonstroem are currently out "in the field" meeting with MAPS researchers around the world on a several week- monitoring trip. Valerie currently writes from Switzerland where they have just finished a visit with our MDMA/PTSD therapy site under the direction of psychiatrist Peter Oehen, MD and are currently working with psychiatrist Peter Gasser, MD at our LSD/end-of-life anxiety study.

"I am amazed at how many regulations there are and how difficult it is to conduct this type of research accordingly," said Valerie, "Only with careful attention to detail are we able to succeed in keeping up with the regulations--the researchers in Switzerland have put much effort into this endeavor." These visits to the research sites not only keep our research compliant with International Council on Harmonization/Good Clinical Practice (international ethical and scientific quality standard for pharmaceutical research) (ICH/GCP) guidelines, but also serve as a way to communicate between research teams and identify training or resource needs and other opportunities. "It is great to see the data firsthand and to hear stories from the researchers of the people who were helped by this therapy--Im glad to be a part of this research," said Valerie.

A bill in Congress would allow citizens to sponsor their same-sex partners to immigrate legally in the same way heterosexuals sponsor their spouses.

A bill in Congress would allow citizens to sponsor their same-sex partners to immigrate legally in the same way heterosexuals sponsor their spouses.

A bill in Congress would allow citizens to sponsor their same-sex partners to immigrate legally in the same way heterosexuals sponsor their spouses.

A bill in Congress would allow citizens to sponsor their same-sex partners to immigrate legally in the same way heterosexuals sponsor their spouses.

Click here to view the embedded video.

Alex McLean’s hack2009052204 demonstrates command-line techno with Haskell, an open source functional programming language.

Dried Diplopterys cabrerana Leaves

There seems to be a lack of curiosity about the costly frauds that flushed our economy down the toilet.

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Testing the Gakken SX-150 Analog Synthesizer, a $54.95 DIY synth kit distributed in the US by Maker Shed.

via hampush

Cuba has successfully greened its energy sector over the last few years, and is now exporting its energy revolution.

Click here to view the embedded video.

This video is a demo on how to install and use a touch screen kit with Usine.

Usine is patch oriented sound software, where you can add modules or VST plug-ins and connect them without restriction. The main goal of Usine is to provide a real time analysis of an input signal and let you interact with it and change plug-in parameters to modify the sound.

via tikitpok4Usine.