Health Canada Gives Permission
to Import Nine Grams of MDMA:
MAPS Email Newsletter
February 14, 2013
Just yesterday, we received a very special Valentine’s Day gift from Health Canada: an official MDMA import permit for our planned Canadian study of MDMA-assisted psychotherapy for PTSD. After working 3½ years to satisfy Health Canada’s security requirements, our pharmacist finally has permission to bring nine grams of MDMA into Canada for the study.
As Phase 2 of our MDMA-assisted psychotherapy for PTSD research program takes off—with new studies also starting in Colorado and Israel—funding is a greater challenge than ever before. Now, the next challenge is to gather the data necessary to design the best possible Phase 3 trials intended to make MDMA-assisted psychotherapy a legally available treatment for PTSD.
Meanwhile, the combined forces of the U.S. Drug Enforcement Administration and National Institute on Drug Abuse/Public Health Service continue to block our FDA-reviewed study of marijuana for symptoms of PTSD in U.S. veterans. MAPS is supporting a lawsuit against the DEA for blocking medical marijuana research, and the ruling could come any day.
There’s a lot to learn in this edition of the MAPS Email Newsletter, including:
- Our new Israeli study of MDMA-assisted psychotherapy for PTSD screens its first subject
- The 12th subject is treated in our ongoing U.S. study of MDMA-assisted psychotherapy for U.S. veterans, firefighters, and police officers with PTSD
- Retired Maj. Ricky Smith speaks with ABC News Charleston about how MDMA-assisted psychotherapy has helped him move past the PTSD he developed while fighting in Kuwait and Iraq
- A dedicated Australian supporter cuts off his hair to benefit psychedelic research, and a professional couple in California “carves out” $40,000 to help us continue our work
- The American Botanical Council speaks with MAPS Executive Director Rick Doblin, Ph.D, and takes us inside Israel’s successful medical cannabis program
Are you curious what’s in store at Psychedelic Science 2013? Check out the first episode of Psychedelic Science & Me, where Beckley Foundation founder and director Amanda Feilding talks about what she’s most excited to learn and experience this April 18-23 in Oakland, California.
Valentine’s Day reminds us to celebrate the power of human connection, and to remind those closest to us how much we care for them. As we continue our work to create safe contexts for the beneficial uses of psychedelics and marijuana, it helps to remember that love always heals.
As always with love,
MAPS Director of Communications
- Israel: First Subject Completes In-Person Screening
- U.S. Veterans Study: Twelfth Subject Treated
- Canada: Health Canada Grants MDMA Import Permit
- U.S. Boulder Study: DEA Inspects Study Site for MDMA License
- MDMA Annual Report Submitted to FDA
- Raters Trained to Evaluate Therapist Competence in MDMA-Assisted Therapy
- DEA Notifies Court of Marijuana Rescheduling Case; Craker’s Legal Team Responds
- New Zealand Ibogaine Study Receives Generous Donation
- Why Give to MAPS: Personal Transformation and Public Service
- Exhibitor Space at Psychedelic Science 2013 Nearing Capacity: Reserve Your Space Soon
- Become an Official Supporter of Psychedelic Science 2013
- PSYCHEDELIC SCIENCE 2013: April 18-23, 2013, Oakland, CA
- National Medical Cannabis Unity Conference: February 22-25, Washington, D.C.
- SSDP Drug Policy Activism Boot Camp: March 2, Boston, MA
- Call for Papers: Breaking Convention: July 12-14, London, England
- Ninth International Amazonian Shamanism Conference: July 21-27, Iquitos, Peru
- VIDEO: ABC News: Mt. Pleasant Doctor Using MDMA to Treat PTSD in Veterans
- PODCAST: Living Hero Radio Show: Trips Beyond Addiction
- VIDEO: Street Interviews: Treat PTSD with MDMA?!
- HerbalGram: The Quiet Giant: Israel’s Successful Medicinal Cannabis Program
- The Atlantic: The Case for Using Drugs to Enhance Our Relationships (and Our Break-Ups)
- Salon: Take Ecstasy, Save Your Relationship
- The Globe and Mail: Why Science is Seeking a Pardon for Psychedelics
- Mirror: Can Ecstasy Help Victims of a Trauma?
- VIDEO: Berra Yazar-Klosinski, Ph.D., Shares Long-Term Research Results
- The Psychedelic Future of the Mind by Thomas B. Roberts, Ph.D.
- Distilled Spirits by Don Lattin
Treating PTSD with MDMA-Assisted Therapy:
Ibogaine Treatment for Addiction:
New in the MAPS Store:
TREATING PTSD WITH MDMA-ASSISTED PSYCHOTHERAPY
Learn more about treating PTSD with MDMA-assisted psychotherapy on or at mdmaptsd.org.
On January 17, 2013, the first subject completed in-person screening for our new Israeli study of MDMA-assisted psychotherapy for PTSD, led by Principal Investigator Moshe Kotler, M.D., and monitored by Clinical Research Associate Mimi Peleg. This study has the approval of the Israeli Ministry of Health, the Ethics Committee at Beer Yaakov Mental Health Center, and the Israeli Anti-Drug Authority. The protocol has also been approved by the U.S. Food and Drug Administration, which reviews all of the data from our Phase 2 drug development program. The Israeli Defense Forces will refer soldiers with war-related PTSD to facilitate recruitment for the study. Learn More
$468,000 estimated study cost / $436,000 still needed
ABC News Charleston interviews Dr. Mithoefer
and Ret. Maj. Ricky Smith, a veteran who
participated the study (February 4, 2013)
On January 18, 2013, the 12th subject of 24 had their first experimental session in our ongoing study of MDMA-assisted psychotherapy for veterans, firefighters, and police officers with chronic, treatment-resistant PTSD. The findings of this study in veterans with war-related trauma will be compared to the findings from our flagship pilot study of MDMA-assisted psychotherapy for PTSD, which consisted primarily of women survivors of sexual abuse and assault. This study is exploring whether the same treatment method can work for different causes of PTSD, as preliminary data suggests. As of January 30, we had received 388 inquiries about participation in the study, highlighting the extensive demand that exists for more effective treatments for PTSD. Learn more…
$1,230,000 estimated study cost / $447,000 still needed
Join Principal Investigator Michael Mithoefer, M.D., and co-therapist Annie Mithoefer, B.S.N., for a full-day workshop on Thursday, April 18 at Psychedelic Science 2013.
On February 13, 2013, our Canadian pharmacist received the corrected import permit (pdf) from Health Canada, after working for more than 2½ years to make the required security adjustments to the pharmacy for our upcoming Canadian study of MDMA-assisted psychotherapy for PTSD. The previous permit erroneously listed the manufacturer rather than the supplier on the form. Finally, after working more than three years, our Swiss MDMA supplier will now finally request an export permit. View the timeline…
$543,000 estimated study cost / $527,000 still needed
On January 10, 2013, Co-Principal Investigator Ingrid Pacey, M.D., received authorization from Health Canada to store and administer the MDMA to be used in the study. The site is now waiting to receive the MDMA import license from Health Canada, the MDMA will be imported from Switzerland, where it is currently stored. Learn more…
On February 6, 2013, field agents from the Denver, Colorado, office U.S. Drug Enforcement Administration inspected the site, safe, and alarm system that will protect the approximately eight grams of MDMA needed for our upcoming Boulder study of MDMA-assisted psychotherapy for PTSD. The agents’ report will be sent to DEA national headquarters, which will then review the report and decide whether to issue the Schedule I license to the study physician. Once the physician has received the license and the study drug, the site will begin recruiting and enrolling subjects. Learn more…
$476,000 estimated study cost / $300,000 still needed
On February 9, Principal Investigator Marcela Ot’alora, M.A., L.P.C., and MAPS Executive Director Rick Doblin, Ph.D., presented “Making MDMA-Assisted Therapy and Marijuana into Medicines for PTSD: Legal and Medical Implications,” a lecture and dessert reception at the University of Denver in Denver Law School in Denver, Colorado, sponsored by Denver Law Students for Sensible Drug Policy (SSDP).
Looking for more ways to get involved? Check out our Student Resources page!
February 5, 2013: David Bronner joins the MAPS
Board of Directors (pictured). Left to right: David Bronner,
John Gilmore, Rick Doblin, and Robert Barnhart
On January 15, 2013, MAPS submitted our MDMA Annual Report to the U.S. Food and Drug Administration. Annual reports give the FDA an overview of completed, ongoing, and planned studies for specific Investigational New Drug (IND) Applications. This report covers the period from October 2, 2011 through October 1, 2012, and provides a cumulative listing of all studies using MDMA under our U.S. IND #63,384, including a comprehensive analysis of MDMA’s risk/benefit profile when used in psychotherapy for PTSD. Download the MDMA Annual Report…
Our MDMA Investigator’s Brochure, which provides risk and benefit data and other information for researchers and regulators engaged in clinical trials using MDMA, is also available online. Download the MDMA Investigator’s Brochure…
On January 23, 2013, MAPS coordinated an all-day training in San Francisco, Calif., for new adherence raters for our MDMA-assisted psychotherapy for PTSD research program. Adherence raters establish and assess therapist adherence to the Treatment Manual in conducting MDMA-assisted psychotherapy, in order to help assure data quality and standardization. Adherence raters are either licensed therapists or are in school or training to be licensed therapists. The training was led by lead adherence rater Evan Sola, M.A., MAPS Executive and Clinical Research Assistant Linnae Ponté, and MAPS Clinical Research Assistant Colin Hennigan. Download the Therapist Adherence and Competence Rating Manual… | Learn more…
On January 22, 2013, the U.S. Drug Enforcement Administration filed a Notice of Supplemental Authority (pdf) with the First Circuit Court of Appeals in Boston, Mass., in Prof. Lyle Craker’s ongoing federal lawsuit against the DEA for denying him a license to grow marijuana under contract to MAPS exclusively for federally regulated medical research. The Notice informed the Court of an unsuccessful Americans for Safe Access lawsuit against the DEA to reschedule marijuana. On January 30, 2013, Craker’s legal team filed a response (pdf) to inform the Court that the ASA case is not legally relevant to Craker’s lawsuit. The First Circuit Court’s decision in Lyle E. Craker v. Drug Enforcement Administration is still pending. Learn more…
On February 7, the Center for Law and the Biosciences and the Stanford Interdisciplinary Group in Neuroscience and the Law (SIGNAL) hosted MAPS Founder and Executive Director Rick Doblin, Ph.D., and ACLU attorney Allen Hopper at the Stanford Law School to discuss the scientific research and legal challenges surrounding developing psychedelics and marijuana into prescription medicines.
IBOGAINE TREATMENT FOR ADDICTION
On January 11, 2013, Principal Investigator Geoff Noller, Ph.D., reported that our ongoing observational study of ibogaine treatment for opioid dependence in New Zealand had received an additional donation of about $10,000 from Matt and Kristi Bowden’s Stargate International Trust. The grant, which follows the Bowdens’ earlier $25,000 donation to MAPS-sponsored ibogaine projects in New Zealand and Mexico, could not have come at a better time, says Dr. Noller. “With the study gaining momentum, we’re beginning to draw participants and interest in general, from around the country. While this is great news for ibogaine research in New Zealand, it also means extra resources are required, as each participant must be introduced to the study and then followed up on a monthly basis.” Learn more…
Download the Winter 2012 MAPS Bulletin,
containing our 2012 Annual Report.
Philanthropy, or “love of humanity,” means generously taking action to make a better world. Every gift you make to MAPS connects you to a larger community whose collective power can create change. Two recent gifts from people on opposite sides of the world show the visionary spirit of our supporters.
Australian pathologist Shaunus Brousek recently wrote to us: “Just forwarding you some images of when I cut my hair off for research about two weeks ago, raised $1,178 AUD. Hope this helps your work with MDMA-assisted PTSD treatment.” He sent along the photographs below. We are grateful for Shaunus’ humor, and his ability to connect his personal transformation with public service.
Another message came from a professional couple in California who wrote, “It took me a while to sort out our charitable donations this year. Not as big as I was hoping but we’ve carved out $40,000 this year for MAPS.”
Most of the other 190 gifts we received in January were for general support. The Josh Mailman Foundation gave $10,000, and Board member John Gilmore gave $25,000. In addition, Carolyn Kleefeld donated a print of her breathtaking painting “Vapor Reef” for the new Israeli treatment room, and $5,000 to support our Israeli study. Support for Psychedelic Science 2013 was received from Dr. Bronner’s Magic Soaps ($5,000) and Hydrosouls ($1,250).
Generate year round interest for your company, product, or organization by signing up as an exhibitor at Psychedelic Science 2013. Spaces are limited and we are rapidly reaching capacity so act now. This will be an opportunity to network with the greater psychedelic science community while showcasing your business on a historically bustling weekend in the San Francisco Bay. See our Supporter Brochure for full details, or contact Brian Brown at email@example.com for more information.
Thank you to all who are making Psychedelic Science 2013 possible by becoming an official Supporter. To find out how you can get your company or organization name in front of like-minded people while supporting your favorite part of the conference, contact Virginia Wright at firstname.lastname@example.org.
Psychedelic Science 2013 Supporters
Workshop: Psychedelic Horizons
Psychedelic Science 2010 sold out, and tickets are selling much faster in 2013. We have added additional hotel rooms at the discount rate, but space is limited.
- Over 80 confirmed speakers from over 13 countries
- 60 presentations qualify for Continuing Education for psychologists, social workers, MFTs, and nurses
- Up to 8.5 AMA PRA Category 1 Credits™ are available for physicians in Continuing Medical Education (CME) presentations
- Sunset Cruise on the San Francisco Bay
- Saturday Night Dinner, Address by Wade Davis, and Performance by Phadroid
- The Marketplace of Goods and Ideas (free and open to the public), featuring the Evening Moonlight Café, Tea House, MAPS Art Gallery, Silent Auction, book signings, poster sessions, and over 30 exhibitors
|Register soon—don’t miss out!||RSVP on|
Join Students for Sensible Drug Policy (SSDP) for a day of training, workshops, discussion, networking, and expert presentations aimed to help refine your skills as an advocate for ending the war on drugs. Sessions will be led by Aaron Houston, Stacia Cosner, Drew Stromberg, and Devon Tackels of the SSDP national staff. Featuring a keynote address from MAPS Executive Director Rick Doblin, Ph.D.
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. The Call for Papers is now open; abstracts must be received by February 28.
See our Events Calendar for more!
17. VIDEO: ABC News: Mt. Pleasant Doctor Using MDMA to Treat PTSD in Veterans | view
ABC News Charleston | February 4, 2013
18. PODCAST: Living Hero Radio Show: Trips Beyond Addiction | listen
Jari Chevalier | January 14, 2013
19. VIDEO: Street Interviews: Treat PTSD with MDMA?! | view
The Lip TV | January 11, 2013
20. HerbalGram: Israel’s Successful Medicinal Cannabis Program | view
American Botanical Council | February 11, 2013
21. The Atlantic: The Case for Using Drugs to Enhance Our Relationships (and Our Break-Ups) | view
interview with Brian Earp | January 31, 2013
23. The Globe and Mail: Why Science is Seeking a Pardon for Psychedelics | view
Taras Grescoe | January 18, 2013
Berra Yazar-Klosinski, Ph.D., of MAPS presents the exciting findings from our long-term follow-up study of MDMA-assisted psychotherapy for treating PTSD on December 7, 2012, as a part of the First Friday Art Tour in Santa Cruz, CA.
Explore MAPS in the Media for even more psychedelic and medical marijuana research news.
NEW IN THE MAPS STORE
All proceeds from the MAPS Store support psychedelic and medical marijuana research and education!
by Thomas B. Roberts, Ph.D.
Thomas B. Roberts, Ph.D., reveals how new uses for psychedelics (or entheogens) will enrich individuals as well as society as a whole. With contributions from Charles Grob, M.D., and Roger N. Walsh, M.D., Ph.D., the book explains how psychedelics can raise individual and business attitudes away from self-centeredness, improve daily life with strengthened feelings of meaningfulness and spirituality, and help us understand and redesign the human mind.
$12.95 / Now available
by Don Lattin
Veteran journalist Don Lattin, author of the bestselling The Harvard Psychedelic Club, brings together the life stories of three men—celebrated author Aldous Huxley, New Age movement leader Gerald Heard, and Alcoholics Anonymous co-founder Bill Wilson—who transformed the landscape of Western religion and spirituality in the 20th century. Weaving an intimate account of his own recovery with the lives of the central characters, Lattin shows us the redemptive power of storytelling, the strength of fellowship, and the power of living more compassionately.
$21.95 / Now available