1. Ethics Board Approves US MDMA/PTSD Relapse Study Protocol
On June 9, 2011, our Institutional Review Board (IRB) approved the protocol for our new "relapse study" of MDMA-assisted psychotherapy for PTSD. The Food and Drug Administration approved the protocol for this study on May 24, but the DEA must now conduct its own review before granting us the license to store and administer the MDMA. On June 14, Clinical Investigator and co-therapist Michael Mithoefer, M.D., submitted the protocol for the relapse study to the DEA. We anticipate that the DEA will approve the study soon, allowing us to schedule the study initiation and begin enrolling subjects.
This study, which will take place in Charleston, SC, is limited to up to three subjects whose PTSD symptoms returned after participating in our flagship Phase 2 clinical trial of MDMA-assisted psychotherapy for PTSD. Over 80% of the subjects in our previous study no longer met criteria for PTSD two months after treatment. These benefits tended to persist over time until our long-term follow-up, conducted an average of 41 months after treatment. However, for several subjects symptoms did eventually return. This relapse study will attempt to determine whether a single additional open-label MDMA-assisted psychotherapy session along with several non-drug psychotherapy sessions can be effective for once again enabling these subjects to be free of a diagnosis of PTSD.
2. Health Canada Reports on Inspection of Pharmacy for MDMA/PTSD Study, Requests More Information
On July 6, 2011, we received a letter from Health Canada (dated June 17, 2011) explaining the results of its May 10 inspection of the Vancouver pharmacy that will be used to store and label the MDMA capsules for our upcoming Canadian study of MDMA-assisted psychotherapy for subjects with chronic, treatment-resistant PTSD. In the letter, Health Canada requested additional information about the site and about how we proposed to transfer the MDMA from the pharmacy to the treatment facility.
Canadian regulations require that the facility used to store and label the MDMA to be used in the study is adequately secure, and that the proper accountability procedures are in place. The information requested by Health Canada included clarifications about the address of the pharmacy, the security measures available at the site, the method of transportation of the MDMA between the pharmacy and the research site, and the format of the labels to be used on the capsules. Health Canada also requires that we include an alarm system at the site. We anticipate that it will be relatively easy to address these issues. Once we do, our final hurdle is to obtain the license to import the MDMA for the study from Canada into Switzerland (where another MAPS MDMA/PTSD study was recently completed).
3. US Veterans MDMA/PTSD Study Enrolls First Five Subjects
On July 14, 2011, the second subject had their second open-label MDMA-assisted psychotherapy session in our ongoing US Phase 2 Study of MDMA-assisted psychotherapy for PTSD in veterans of war. This study is taking place in Charleston, SC, and is led by Clinical Investigators and co-therapists Michael Mithoefer, M.D., and Annie Mithoefer, B.S.N. A total of five subjects (out of 16) with chronic, treatment-resistant, combat-related PTSD have now been enrolled and a sixth has passed the initial phone screening.
While the significant number of PTSD sufferers now awaiting in-person screening for this study is encouraging (in that we will certainly have enough subjects for the study), it also highlights the pressing need for this research (since there are so many individuals for whom conventional PTSD treatments fail). Female combat veterans and either male or female veterans living near Charleston, SC, are especially encouraged to apply.
4. Researchers Debate Scientific, Ethical Implications of Harvard Ecstasy/Neurocognition Study
The July 2011 issue of the peer-reviewed scientific journal Addiction published a series of letters addressing the purpose, design, and implications of a recent study of the effects of recreational Ecstasy use on neurocognition by Harvard scientist John Halpern, M.D. The results of the study were published in the April 2011 issue of Addiction and shed new light on the risks of recreational Ecstasy use after overcoming some of the methodological flaws of previous research.
The Harvard study, for which MAPS provided both the concept and $15,000 for the initial pilot study, found no link between long-term Ecstasy use and cognitive damage. The most significant methodological issue addressed by the new study was previous studies' use of subjects who had used Ecstasy as well as other drugs, confounding the results by making it impossible for researchers to determine whether long-term changes in cognitive skills were due to Ecstasy, another drug, a combination of drugs, or some other factor entirely. The Harvard study used subjects whose drug use had been entirely or almost entirely limited to Ecstasy, and suggested that the risks of Ecstasy are significantly less than previously thought.
Although MDMA is not the same as Ecstasy (illegal Ecstasy pills often contain substances other than MDMA, and MAPS' clinical studies use only pure MDMA), these results will encourage additional research into the possible therapeutic benefits of MDMA. According to commentary published in the April 2011 issue of Addiction by Bond University psychologist Michael Lyvers:
"Given that MDMA is being administered to human patients to assess its efficacy as a treatment for post-traumatic stress disorder, ethical arguments against an experimental within-subjects approach to detecting possible long-term brain, cognitive and memory effects of MDMA in human volunteers may now be less relevant. Once such research has been replicated consistently across a range of typical dosing regimens, the chimera of MDMA-induced neurotoxicity in human ecstasy users may finally be put to rest."
Read the rest of Lyvers' commentary. The July 2011 issue of Addiction also included letters about the Harvard study from Andrew C. Parrott of Swansea University, John E. Fisk and colleagues of the University of Central Lancashire, and Jacqui Rodgers of Newcastle University, as well as a reply from Dr. Halpern.
5. European Symposium Opens the Door for International Ayahuasca Research
On June 17, 2011, an international group of scholars and scientists met in Amsterdam for the European Ayahuasca Research Symposium, a one-day lecture series to which MAPS donated around $1450. MAPS' funds went to bringing researchers who started MAPS Hungary (Ede Frecska and Petra Bokor) to Amsterdam to be in direct contact with other scientists in order to refine their thinking about the design of a planned ayahuasca study. The symposium explored the current state of research into the medical, therapeutic, and spiritual uses of ayahuasca. Simon Powell, author of the new bookThe Psilocybin Solution (soon to be available in the MAPS store), wrote a thorough review of the presentations and summarized their likely impact on the field of psychedelic research. "So, the gauntlet has been laid down," Powell writes. "There is a definite way ahead for science to explore ayahuasca's widely attested healing potential." MAPS and the author would like to thank Bill Linton for sponsoring the conference report. The symposium was presented by the OPEN Foundation and co-sponsored by MAPS, COGnITO, and the Núcleo de Estudios Interdisciplinares sobre Psicoactivos (NEIP).
6. MAPS Members' Generosity Makes Psychedelic Research Possible
In 1992, MAPS had $897.45 available to sponsor research projects and distribute honest information about the risks and benefits of psychedelics and marijuana. Since then, MAPS has distributed over $12 million to developing psychedelics and marijuana into prescription medicines for pain, anxiety, trauma, and other hard-to-treat conditions. Thanks to the generous contributions from members of the MAPS community over the past 25 years, MAPS has grown from a one-man project into a fast-growing non-profit research organization coordinating clinical research in six countries and on four continents.
In the past several months, we have received numerous substantial donations that have enabled us to dramatically expand our research program and set our sights on obtaining regulatory approval for MDMA-assisted psychotherapy for PTSD. We would especially like to thank David Bronner (of Dr. Bronner's Magic Soaps) for his $5,000 contribution to the Shulgin Legacy Project and his generous gift of $100,000 for our research projects, as well as an anonymous donor for another $100,000 gift. We also received $35,000 from The Libra Foundation for our US study of MDMA-assisted psychotherapy for PTSD in veterans of war, $11,000 from Larry Hagman, and $10,000 in unrestricted funds to the ayahuasca Yawanawa Project.
Thank you also to all of those who have contributed what you could, whether time or money or speaking with your friends about the importance of MAPS' research. We couldn't do it without you.
7. CARTOGRAPHIE PSYCHEDELICA: December 8-12, Oakland, CA
: the science or art of making maps
Including lectures, workshops, a benefit auction, a tribute dinner for transpersonal pioneers Stanislav & Christina Grof, a late-night celebration, a brunch cruise on the San Francisco Bay, unique vendors, and visual and performance art.
The KALEIDOSCOPE VAULT
Psychedelic Adventure Auction
The MEDICINE BALL
Late-Night Celebration & Menagerie of Curiosities
The FLOATING WORLD
Brunch Cruise on the San Francisco Bay
All proceeds from CARTOGRAPHIE PSYCHEDELICA will support the next stage of research into MDMA-assisted psychotherapy for PTSD.
8. Out of Mind: September 13, Victoria, BC, Canada
9. Vanguard Science: September 18, Vancouver, BC, Canada
10. MAPS 25th Anniversary Pacific Northwest Tour: September 20, Portland, OR
11. Horizons Psychedelics Conference: October 14-16, NYC
MAPS is proud to be an official partner of Horizons: Perspectives on Psychedelics, an interdisciplinary conference taking place on October 14-16, 2011, at Judson Memorial Church in the heart of Greenwich Village in New York City. "Horizons" is an annual conference (now in its fifth year) the goal of which is to open a fresh dialogue on the role of psychedelics in medicine, culture, history, spirituality, and creativity. Speakers will include ethnopharmacologist Dennis McKenna, Ph.D., MAPS Lead Clinical Research Associate Berra Yazar-Klosinski, Ph.D., Institute of Transpersonal Psychology co-founder James Fadiman, Ph.D., and more.
12. MAPS to Speak at Women's Visionary Congress: July 29-31, Petaluma, CA
13. Next Week: IONS Presents Noetic 2.0: Tools & Technologies for a World Transforming
We hope you'll join us next week in San Francisco for Noetic 2.0: Tools and Technologies for a World Transforming, hosted by the Institute of Noetic Sciences (IONS). MAPS is an official co-sponsor of Noetic 2.0, and we encourage you to visit the conference website and participate in this perspective-changing event. The conference features both a special post-conference institute with Deepak Chopra and a post-conference retreat at the IONS EarthRise Retreat Center. Also, don't forget to visit the MAPS table and learn what else MAPS is doing to support responsible innovation in science, consciousness, and medicine.
14. Special MAPS Discount for Science & Nonduality Conference: October 19-23, San Rafael, CA
On October 19-23, 2011, the Science and Nonduality Conference will take place at the Embassy Suites and Marin Center in San Rafael, CA. SAND 2011 will gather together over 60 of the world's leading scientists, spiritual leaders, authors, and teachers to explore the concept of "time" through the integrated perspectives of modern science, ancient tradition, art, philosophy, and experience. MAPS will be sponsoring a panel at the conference where scientists and other members of the MAPS community will discuss the conference theme from the perspective of psychedelic research. Speakers will include Stanislav Grof, John Hagelin, Richard Rohr, Gangaji, David Peat, Zoketsu Norman Fischer, Michael Harner, Rabbi David A. Cooper, Fred Alan Wolf, and many others.
MAPS supporters can also take advantage of a special offer: Receive $45 off registration simply by entering the coupon code MAPS when ordering your tickets. To learn more, visit the Science and Nonduality website.
15. MAPS Celebrates the Marriage of Valerie and Josh Mojeiko, Long-Time Staff Members
On June 18, 2011, a small group of friends, family, and members of the MAPS community gathered in the desert dusk to celebrate the marriage of Josh and Valerie Mojeiko. The ceremony was held at the breathtaking City of Rocks State Park in southern New Mexico. As Director of Finance and Information Technology, Josh has helped bring MAPS into the 21st century by managing the endless flows of data and resources that fuel MAPS' work. As Deputy Director, over the last 10 years Valerie has used her natural management expertise and strategic vision to help build MAPS into the international research organization it is today. Like the depth of their commitment to each other, their contribution to MAPS, and to psychedelic research worldwide, is immeasurable.
16. Leyla Marjorie Klosinski Takes First Breaths
At 12:15 PM on June 19, 2011, Leyla Marjorie Klosinski emerged into the arms of her father, Clinton Klosinski, and her mother, MAPS Lead Clinical Research Associate Berra Yazar-Klosinski, Ph.D. Weighing in at a respectable 7 lbs 13.5 oz (3550 g), Leyla is the latest addition to the fast-growing MAPS community. Berra is recuperating well with her husband, her mother, and the Santa Cruz summer sun. While Leyla has yet to contribute any volunteer hours, she owes her mother a good deal of labor and will be asked to contribute to the next MAPS Bulletin.