MAPS Email Newsletter:
FDA Approves Protocol Design for
New Study of MDMA-Assisted Therapy
for Social Anxiety in Autistic Adults
May 17, 2013
All-new clinical studies. Unprecedented media coverage. Subjects treated in legal experimental psychedelic research sessions. More opportunities to connect with the psychedelic and medical marijuana research community than ever before. The evidence is clear: we are transforming medicine.
Therapy Today explores
research into MDMA and LSD
for PTSD, social anxiety, and more
The U.S. Food and Drug Administration has approved the protocol design for our new study exploring whether MDMA-assisted therapy can improve social anxiety in adults on the autism spectrum. This is the first time MDMA-assisted therapy has been explored in clinical research for this population, and indicates a turning point for psychedelic research worldwide.
Our international research program into treating PTSD with MDMA-assisted psychotherapy is also picking up steam, with our studies in Canada, Israel, South Carolina, and Colorado all moving forward.
From upcoming events to all-new educational videos, there’s much more to discover in the May 2013 edition of the MAPS Email Newsletter. Here are a few highlights:
- The first videos from Psychedelic Science 2013 are now available online. Subscribe to our YouTube channel for new videos as they become available.
- Wired Magazine features Psychedelic Science 2013, and talks with MAPS Founder Rick Doblin, PhD, about why he’s trying to bring psychedelic research to the Pentagon
- Sofia University hosts a live discussion with psychedelic researcher James Fadiman, PhD, and Brad Burge of MAPS about psychedelics as tools for healing, growth, and discovery
Join the conversation—connect with MAPS on Facebook, Twitter, and Google+.
Public support for research into the benefical uses of psychedelics and marijuana is stronger than ever, but we still need your help to complete the research. Learn how your donation makes a difference.
MAPS Director of Communications
- FDA Approves Protocol Design for New Study
- Canada: Nine Grams of MDMA Arrive in Canada after Four-Year Delay
- Israel: First Subject Completes Experimental MDMA-Assisted Therapy Sessions
- U.S. Veterans Study: 13th Subject Completes Experimental MDMA-Assisted Therapy Sessions
- U.S. Boulder Study: DEA MDMA Order Forms Arrive at Study Site
- Help Us Change Minds and Make Medicines
- Psychedelic Medicine Course: June 3-7, Vancouver, BC, Canada
- Free Discussion: Scientific Research with Psychedelic Drugs: June 12, London, UK
- Women’s Visionary Congress: June 14-16, Petaluma, CA
- Breaking Convention: July 12-14, London, England
- Ninth International Amazon
ian Shamanism Conference: July 21-27, Iquitos, Peru
- Therapy Today, Popular Science, Wired, Alternet, and more…
- VIDEO: Psychedelic Experience: A Conversation with James Fadiman, PhD, and Brad Burge
- VIDEO: Psychedemia Documentary
- STILL AVAILABLE: Annual Subscriptions to the MAPS BULLETIN
- NOW AVAILABLE: The Healing Journey by Claudio Naranjo
- New Documentary Explores the Resurgence of Psychedelics as Medicines
- MAPS Founder Rick Doblin Speaks in Support of Alex Grey’s Entheon Fundraiser
MDMA-Assisted Therapy for Social Anxiety in Autistic Adults:
Treating PTSD with MDMA-Assisted Therapy:
Watch the Psychedelic Research Founders Discussion from Psychedelic Science 2013.
Many more videos coming soon!
MDMA-ASSISTED THERAPY FOR SOCIAL ANXIETY IN AUTISTIC ADULTS
1. FDA Approves Protocol Design for New Study
On April 30, 2013, the U.S. Food and Drug Administration approved the protocol design for our pioneering study of MDMA-assisted therapy for social anxiety in autistic adults. The Advice Letter (pdf) from the FDA requested several changes to the exclusion criteria involving subject safety, some of which we thought were not necessary based on existing scientific literature. We have prepared an amended protocol incorporating some of these changes, along with evidence for why we don’t think the other changes are necessary. Once the FDA has reviewed and approved this amendment, we will submit the protocol and study materials for review by the Institutional Review Board at Harbor-UCLA Medical Center/Los Angeles Biomedical Research Institute. Charles Grob, M.D., and Alicia Danforth, Ph.D.(c), will be co-investigators for this study. Learn more…
$256,000 estimated study cost / $256,000 still needed
Help us make psychedelics and marijuana into prescription medicines—donate today!
TREATING PTSD WITH MDMA-ASSISTED PSYCHOTHERAPY
2. Canada: Nine Grams of MDMA Arrive in Canada after Four-Year Delay
On April 16, 2013, the nine grams of MDMA to be used in our upcoming Canadian study of MDMA-assisted psychotherapy for PTSD arrived at the study pharmacy. Our efforts to start the study began in 2007, and we began seeking the import permit after Health Canada approved the protocol in March 2009. The Canadian pharmacist worked for more than 2½ years to make the security adjustments to the pharmacy required by Health Canada for the import permit. We are now preparing to submit a series of minor protocol amendments to Health Canada and to the Canadian Institutional Review Board. Once these amendments are approved, which could take several weeks to several months, we will begin screening and treating subjects. Learn more about the study or visit MAPSCanada.org.
$584,000 estimated study cost / $568,000 still needed
Learn more about MDMA-assisted psychotherapy on or at mdmaptsd.org.
3. Israel: First Subject Completes Experimental MDMA-Assisted Therapy Sessions
On April 17, 2013, the first subject was treated in our new Israeli study of MDMA-assisted psychotherapy for PTSD. This study will enroll 10 subjects with chronic, treatment-resistant PTSD, some of whom will be referred by the Israeli Defense Forces. This study is taking place at Beer Yaakov Mental Hospital, and is led by Principal Investigator Moshe Kotler, M.D. Learn more…
$468,000 required to complete this study / $428,000 still needed
4. U.S. Veterans Study: 13th Subject Completes Experimental MDMA-Assisted Therapy Sessions
On May 3, 2013, the 13th subject completed their second experimental MDMA-assi
sted psychotherapy session in our ongoing study for veterans, firefighters, and police officers with service-related PTSD. This subject is the second firefighter with chronic, treatment-resistant PTSD to be enrolled in this study, which will enroll 24 total subjects. Four subjects have now completed the study, including the long-term follow-up portion. Learn more…
$1,258,000 estimated study cost / $473,000 still needed
5. U.S. Boulder Study: DEA MDMA Order Forms Arrive at Study Site
On April 30, 2013, the DEA Schedule I Controlled Substance order forms arrived at the site for our upcoming study of MDMA-assisted psychotherapy for PTSD in Boulder, Colorado. Receiving these forms from the DEA, which took two months, marks the end of the regulatory approval process since we have now ordered the MDMA and can soon initiate the study. Learn more…
$481,000 estimated study cost / $363,000 still needed
6. Help Us Change Minds and Make Medicines
As our fiscal year comes to a close on May 31, we are filled with deep gratitude for the generosity of those who support psychedelic research and education. The last two months have been astonishing, with over $630,000 in contributions. • At Psychedelic Science 2013, we received an unexpected, anonymous gift of $20,000 from a generous woman inspired by our work with MDMA-assisted psychotherapy for PTSD, and a $5,000 contribution from Richard Wolfe. Then, on the last day of Psychedelic Science 2013, Peter Lewis contributed shares in his company valued at $302,160. • Earlier in April, we received $200,000 in general support from Joby Pritzker, $37,500 from Richard Rockefeller and $15,000 from A. Miller for our new Boulder study, and $15,500 from Board member Robert Barnhart. We also received $7,500 from Google to match Joakim Arfvidsson’s $6,000 gift for MDMA-assisted therapy, and to match Dan Cohen’s $1,000 gift and Paul Eastham’s $500 gift, both for general support. Just after we received the Google match, Dan sent an additional $1,000. We also received generous support from Sahajia Sarkisian ($1,000), an anonymous donor ($1,500), Sofia University ($2,500,) and Muster Foundation ($3,000). • In this same period, 44 people gave between $100 and $999 dollars, for a total of $10,575, and 323 gifts were received under $100 for a total of $6,577. Many of the smaller gifts were monthly donations, which over time add up to significant support. • We have a lot of work to do to raise the roughly $15 million we still need to complete our MDMA-assisted psychotherapy studies. We ask you to help us change minds and make medicines. Please consider making a gift today.
7. Psychedelic Medicine Course: June 3-7, Vancouver, BC
This advanced five-day course at the Justice Institute of British Columbia in Vancouver, BC, Canada will examine the interdisciplinary clinical context, concepts and applications behind the scientific and therapeutic uses of psychedelic or” mind manifesting” medicines for healing trauma and addiction. The course is designed for physicians, health workers, psychologists, psychiatrists, therapists, first responders and related practitioners working in the field of trauma and addictions. Contact information is available on the course website.
8. Free Discussion at Imperial College London: June 12, London, UK
The Imperial College London Centre for Neuropsychopharmacology in conjunction with the Beckley Foundation invites you to a discussion on scientific research with psychedelic drugs on June 12, 2013, from 10am-6pm at Imperial College London. View the flyer or contact Robin Carhart-Harris at firstname.lastname@example.org for more information.
9. Women’s Visionary Congress: June 14-16, Petaluma, CA
The Women’s Visionary Congress (WVC) is a gathering of healers, scholars, activists, artists, and botanists who study consciousness and altered states. WVC 2013 presenters include Brad Burge, Valerie Corral, Bruce Damer, Yalila Espinoza, Shonagh Home, Beatriz Labate, Mariavittoria Mangini, Ralph Metzner, Lakshmi Narayan, Annie Oak, Nicki Scully, Diana Slattery, Zara Snapp, and Jane Straight. Learn more…
10. Breaking Convention: July 12-14, London, England
Join MAPS Executive Director Rick Doblin, Ph.D., MDMA-assisted psychotherapy researcher Michael Mithoefer, M.D., and dozens of other international experts on psychedelic science and culture at Breaking Convention.
11. Ninth International Amazonian Shamanism Conference: July 2
1-27, 2013, Iquitos, Peru
See our Events Calendar for more!
12. Therapy Today, Popular Science, Wired, Alternet, and more…
Therapy Today: The Magical Mystery Cure | view
Richard Shrubb | May 17, 2013
Wired: Open Your Mind to the New Psychedelic Science | view
Greg Miller | April 26, 2013
Alternet: The Enormous Promise of Psychedelics for Sustaining Health, Happiness and Sanity | view
April M. Short | April 26, 2013
Popular Science: Why Doctors Can’t Give You LSD (But Maybe They Should) | view
Shaunacy Ferro | April 16, 2013
Reason: Psychedelic Science: Still Hassled by the Man | view
Brian Doherty | April 26, 2013
Wired: A Psychedelic-Science Advocate Takes His Case to the Pentagon | view
Greg Miller | May 3, 2013
Vice: Can MDMA Cure PTSD? | view
Dave Dean | April 27, 2013
Good Times Weekly: Power Plants | view
J.D. Ramey | April 16, 2013
Popular Science: Why It’s So Hard For Scientists To Study Medical Marijuana | view
Shaunacy Ferro | April 18, 2013
Courthouse News Service: Court Snuffs Professor’s Bid to Grow Pot | view
Chris Fry | April 26, 2013
Explore MAPS in the Media for even more psychedelic and medical marijuana research news.
13. VIDEO: Psychedelic Experience: A Conversation with James Fadiman, PhD, and Brad Burge
Sofia University hosts James Fadiman, PhD, and Brad Burge of MAPS
for a conversation about psychedelics for healing, growth,
On May 2, 2013, Sofia University hosted a live discussion between psychedelic researcher James Fadiman, Ph.D., and Brad Burge of MAPS about psychedelics as tools for healing, growth, and discovery. Watch the discussion…
Looking for more ways to get involved? Check out our Student Resources page!
14. VIDEO: Psychedemia Documentary
Psychedemia was the first academic conference funded by an American university to explicitly focus on the risks and benefits of psychedelic experience. This new film concisely presents the varied complexity of the emerging field of Psychedelic Studies in a way that is accessible, informative, and inspiring. Watch the film…
All proceeds from the MAPS Store support psychedelic and medical marijuana research and education!
15. STILL AVAILABLE: Annual Subscriptions to the MAPS BULLETIN
Donate $40 or more and receive a one-year subscription (3 issues), including:
From our most recent Special Edition on Psychedelics in Psychology and Psychiatry (order back issues):
“The articles contained in this volume tell a large part—but still just a part—of the story of how pioneering psychedelic studies first revealed the benefits that psychedelics could have for science, psychotherapy, and Western society. These articles also hint at the profound expansion of knowledge and healing techniques that is just now beginning, after so many have worked for so long to overcome four decades of repression and cultural stigma.”
—Rick Doblin, Ph.D., MAPS founder
16. NOW AVAILABLE: The Healing Journey by Claudio Naranjo
The Healing Journey:
by Claudio Naranjo
Published April 2013
Second Edition with a new Foreword by Rick Doblin, Ph.D.
“In this remarkable book, Chilean-American psychiatrist Claudio Naranjo takes us on a scientific adventure through his groundbreaking research into new experiential methods of psychotherapy facilitated by psychedelic substances. The Healing Journey reveals these consciousness-expanding compounds to be fascinating therapeutic tools that are now—40 years after the original publication—gaining wider recognition in Western clinical and academic circles.”
—Stanislav Grof, M.D., author of LSD Psychotherapy
$16.95 | Now available
Help us make psychedelics and marijuana into prescription medicines—donate today!
17. New Documentary Explores the Resurgence of Psychedelics as Medicines
Neurons to Nirvana: Understanding Psychedelic Medicines is a richly illustrated feature documentary about the resurgence of psychedelics as medicine. Through interviews with the world’s foremost researchers, writers, psychologists and pioneers in psychedelic psychotherapy, the film explores the history of five powerful psychedelic substances (LSD, psilocybin, MDMA, ayahuasca, and cannabis) and their previously established medicinal potential. Strictly focusing on the science and medicinal properties of these drugs, Neurons to Nirvana looks into why our society has created such a social and political bias against allowing research to continue the exploration of any possible positive effects they can present in treating some of today’s most challenging afflictions. You can help complete this important film through Kickstarter.
18. MAPS Founder Rick Doblin Speaks in Support of Alex Grey’s Entheon Fundraiser
For over 30 years, the art of Alex Grey has reached the hearts and minds of people all around the globe with its portrayals of the physical and subtle anatomy of individuals in the context of cosmic, biological and spiritual evolution. MAPS Founder Rick Doblin speaks in support of Alex Grey’s most ambitious project yet. Learn more about Entheon…
Help MAPS create safe, legal contexts for the beneficial uses of psychedelics and marijuana—check out our current volunteer opportunities!