2017: Together, We’re Making Medicines
Psychedelic Science 2017 will feature 175+ presenters over six days
January 12, 2017
Happy 2017 from the Multidisciplinary Association for Psychedelic Studies (MAPS)!
Last month, the U.S. Food and Drug Administration (FDA) encouraged MAPS to apply for Breakthrough Therapy Designation for MDMA-assisted psychotherapy as a treatment for posttraumatic stress disorder (PTSD). According to the FDA, a breakthrough therapy is intended “to treat a serious or life threatening disease condition,” and “may demonstrate substantial improvement over existing therapies.” If approved, Breakthrough Therapy Designation could expedite the development and review of MDMA-assisted psychotherapy for PTSD.
Meanwhile, we’re getting ready for Psychedelic Science 2017 this April 19-24 in Oakland, Calif., where we’ll explore the unprecedented progress being made in psychedelic science and medicine around the world. With three days of conference programming on five stages, from over 175 presenters, plus a Sunset Cruise, Psychedelic Comedy Banquet, 11 Full-Day Workshops, a free Marketplace, Community Forums, Film Screenings, and much more, we’ll celebrate all we’ve achieved and get a sneak peek at what lies ahead.
Don’t miss out on this historic event—register by February 15 to save 10% on Early Bird tickets!
In the January 2017 edition of the MAPS Email Newsletter, you’ll also learn:
- The first potential participant is screened in our upcoming Phase 2 trial of smoked marijuana for symptoms of PTSD in U.S. veterans
- The Institutional Review Board at Emory University approves the first protocol amendment for our upcoming Phase 1 study of the effect of MDMA on startle testing in healthy volunteers
- Our ongoing Phase 1 MDMA therapist training study enrolls two more participants
- The 14th participant is treated in our ongoing Phase 2 study of MDMA-assisted psychotherapy for anxiety associated with life-threatening illness
- Applications are now open to volunteer for the Zendo Project’s psychedelic harm reduction services in 2017
Stay connected by following MAPS on Facebook, Twitter, YouTube, reddit, Tumblr, Pinterest, Google+, LinkedIn, and Instag
ram.
As we enter 2017, we reaffirm our commitment to leveraging the donations and other support provided by you—our community—into rigorous, transparent, and efficient scientific research and public education about the benefits and risks of psychedelics and marijuana for science, therapy, spirituality, creativity, and personal growth. Together, we’re making medicines.
Always upwards,
Brad Burge
MAPS Director of Communications and Marketing
P.S. Watch and share the all-new video to learn what’s in store at Psychedelic Science 2017!
Contents
Treating PTSD with MDMA-Assisted Therapy
1. Phase 3: MAPS Prepares to Request Breakthrough Therapy Designation and Special Protocol Assessment
2. Startle Testing with MDMA: Institutional Review Board Approves First Protocol Amendment
3. Therapist Training Study: 20th and 21st Participants Enrolled in South Carolina and Colorado
MDMA-Assisted Therapy for Anxiety Associated with Life-Threatening Illness
4. Marin: 14th Participant Treated; 16th Participant Enrolled
Medical Marijuana
5. Marijuana for PTSD: In-Person Participant Screening Begins in Arizona
Ayahuasca Research
Psychedelic Harm Reduction
7. Zendo Project: Volunteer Opportunities for 2017
Support MAPS
8. December Giving Report: We’re Making a Medicine
Media
9. Stars and Stripes, Medical Daily, Mercury News, and more…
MAPS Store
10. The Ketamine Papers: Science, Therapy, and Transformation
11. LSD: My Problem Child — Signed, Original Hardcover
Events
12. Psychedelic Science 2017: April 19-24, 2017, Oakland, CA
13. “A Good Trip” Tour with Comedian Shane Mauss: January 12, 2017-February 10, 2017
15. Students for Sensible Drug Policy (SSDP) Annual Conference: March 24-26, 2017, Portland, OR
16. Global Psychedelic Dinners
More News
17. Now Hiring: MAPS Public Benefit Corporation (MPBC)
19. Newsletter Survey: Requesting Your Feedback
Register now for Psychedelic Science 2017.
Treating PTSD with MDMA-Assisted Therapy
Phase 3: MAPS Prepares to Request Breakthrough Therapy Designation and Special Protocol Assessment
On December 13, 2016, the U.S. Food and Drug Administration (FDA) participated in a teleconference with MAPS to discuss whether we should apply for Breakthrough Therapy Designation for MDMA-assisted psychotherapy as a treatment for posttraumatic stress disorder (PTSD). “It was a very helpful meeting, and we were encouraged to proceed with applying for Breakthrough Therapy Designation,” explains MAPS-sponsored researcher Michael Mithoefer, M.D.
If approved, Breakthrough Therapy Designation could expedite the development and review of MDMA-assisted psychotherapy for PTSD. According to the FDA, a breakthrough therapy is intended “to treat a serious or life threatening disease condition,” and “may demonstrate substantial improvement over existing therapies.”
In the next few weeks, we will also submit to the FDA our Phase 3 trial protocol for the Special Protocol Assessment (SPA) process. The SPA process is a rigorous review of the Phase 3 trial design that could result in FDA committing to approve MDMA-assisted psychotherapy for PTSD should the protocol as designed prove safety and efficacy.
As a non-profit with no government funding for MDMA research, we anticipate it will cost between $25-$30 million to complete these Phase 3 trials over the next five years, with over $10 million already raised or pledged. Phase 3 trials are the final stage of research needed before the FDA will decide whether to approve MDMA-assisted psychotherapy as a prescription treatment for PTSD. There is now a clear path ahead to make MDMA a legal medicine for millions of people suffering from PTSD. Learn more…
Startle Testing with MDMA: Institutional Review Board Approves First Protocol Amendment
On January 3, 2017, the Institutional Review Board (IRB) at Emory University approved the first protocol amendment for our upcoming Phase 1 study on the effect of MDMA on startle testing in healthy volunteers. Principal Investigator Barbara Rothbaum, Ph.D., a leading PTSD researcher, will conduct the study at Emory University in Atlanta, Georgia. The required safe for the study drug is installed, and we are ready for inspection by the Drug Enforcement Administration (DEA). The study will begin after DEA approval. Learn more…
Therapist Training Study: 20th and 21st Participants Enrolled in South Carolina and Colorado
On January 9, 2017, the 16th participant was enrolled at the Charleston, South Carolina study site of our ongoing Phase 1 study of the psychological effects of MDMA when used in a therapeutic setting by healthy volunteers. On December 14, 2016, the fifth participant was enrolled at the Boulder, Colorado study site. Michael Mithoefer, M.D., and Ann Mithoefer, B.S.N., are serving as Principal Investigators at the Charleston site, and Marcela Ot’alora, M.A., L.P.C., is serving as Principal Investigator of the Boulder site. Enrollment in this study is limited by invitation only to therapists in training to work on MAPS-sponsored clinical trials of MDMA-assisted psychotherapy for PTSD. This study has currently enrolled 21 out of 100 participants across the study sites in Colorado and South Carolina. Learn more…
MDMA-Assisted Therapy for Anxiety Associated with Life-Threatening Illness
Marin: 14th Participant Treated; 16th Participant Enrolled
On December 12, 2016, the 14th of 18 participants was treated in our ongoing study of MDMA-assisted psychotherapy for anxiety associated with life-threatening illness in Marin, Calif. On January 6, 2017, the 16th participant was officially enrolled in the study. Led by Principal Investigator Phil Wolfson, M.D., with Co-Therapist Julane Andries, L.M.F.T., this study is gathering preliminary data about the safety and efficacy of MDMA-assisted psychotherapy for anxiety associated with diagnosis of a life-threatening illness in 18 participants. We are currently screening additional participants for this study. Learn more…
Medical Marijuana
Marijuana for PTSD: In-Person Participant Screening Begins in Arizona
On January 2, 2017, the first in-person participant screening was conducted by researchers at the Phoenix, Ariz., site for our upcoming clinical trial of smoked marijuana for symptoms of PTSD in 76 U.S. veterans. This study is a multi-site Phase 2 drug development trial led by Coordinating Principal Investigator (PI) Marcel Bonn-Miller, Ph.D., with half of the 76 participants treated at the Johns Hopkins University site led by Site PI Ryan Vandrey, Ph.D., and the other half treated at the site in Phoenix, Ariz., led by Site PI Sue Sisley, M.D. We are currently recruiting participants across both sites. Learn more…
Ayahuasca Research
Survey: Ayahuasca for PTSD
As of January 6, 2017, we have received 239 completed responses for our new anonymous questionnaire about the potential risks and benefits associated with taking ayahuasca as a therapy for posttraumatic stress disorder (PTSD). The data collection is being sponsored by MAPS, with Jessica Nielson, Ph.D., as the Principal Investigator for this study. Take the survey…
Learn more about current and upcoming research at maps.org.
Psychedelic Harm Reduction
Zendo Project: Volunteer Opportunities for 2017
The Zendo Project is looking forward to continuing to build transformational communities in 2017! This year, the Zendo Project will continue to provide psychedelic peer counseling services as well as workshops and trainings in the U.S. and around the world. Zendo Project will have a presence at the following events this year:
- Envision Festival (Costa Rica, February 23-26, 2017)
- Psychedelic Science 2017 (California, USA, April 19-24, 2017)
- AfrikaBurn (South Africa, April 24-30, 2017)
- Lightning in a Bottle (California, USA, May 24-29, 2017)
- Burning Man (Nevad
a, USA, August 27-September 4, 2017)
We are currently accepting volunteer applications for multiple events. If you would like to provide psychedelic harm reduction services as a Zendo Project volunteer in 2017, please create/update a Zendo Profile and submit an application for the events that interest you. Apply to volunteer…
Learn about psychedelic harm reduction by signing up for the Zendo Project Email Newsletter, and following the Zendo Project on Facebook, Twitter, and Instagram
Support MAPS
December Giving Report: We’re Making a Medicine
In December 2016, MAPS received over $286,862 in new donations and pledges from 879 supporters.
We’re proud to say that before the New Year, MAPS exceeded our fundraising goal of $174,000 for the purchase of one kilogram of GMP MDMA to be used in our Phase 3 studies of MDMA-assisted psychotherapy for PTSD. Thanks to all of you, we raised over $252,000 total in only 43 days. The amount we raised above our goal will be used for encapsulation and labeling of the MDMA. Matching grants of $55,000 were offered during this campaign thanks to our generous supporters Justin Rosenstein ($15,000), Britt Selvitelle ($30,000), and the Sarlo Foundation ($10,000). In December, Justin Rosenstein and Pasha Thornton hosted fundraising events for MAPS, raising over $27,000 combined.
Each and every supporter helped us reach this point. In 2017 we move into our final Phase 3 studies, which marks a major milestone in MAPS’ history. Thank you for your commitment!
We extend a special thanks to those who so generously supported MAPS this past month:
MDMA/PTSD Phase 3 GMP MDMA
- Jonathan Jaffe ($25,000)
- Laney & Pasha Thornton ($10,000)
- René and Susan Ruiz ($10,000)
- The Sarlo Foundation ($10,000)
- Anonymous ($10,000)
- Anonymous ($9,331)
- Andrew Lichtenberger ($5,000)
- Anonymous ($5,000)
- Rebecca Lambert ($5,000)
- Ann F. St. Goar & Shippen L. Page ($4,968)
- Devera & Michael Witkin ($3,000)
- Mack Fuhrer ($3,000)
- Pamela & Don Lichty ($2,500)
- Robert Ackerman ($2,500)
- Annie & Michael Mithoefer ($2,000)
- Anonymous ($2,000)
- Payam Panbechi ($1,235)
- Anonymous ($1,000)
- Anonymous ($1,000)
- Anonymous ($1,000)
- Benjamin Materna ($1,000)
- Casey Knight ($1,000)
- Christopher Jay Petro ($1,000)
- Daniel Todd Cohn ($1,000)
- David Braginsky ($1,000)
- Diana & Matt Chapman ($1,000)
- Donald Mack ($1,000)
- Ed Hunsinger ($1,000)
- Fernanda Weiden ($1,000)
- Slack Technologies ($1,000)
- Jason Kats ($1,000)
- Joakim Arfvidsson ($1,000)
- Michael Cole ($1,000)
- Oleg Gorelik ($1,000)
- Peter Majerczak ($1,000)
- Peter Taubkin ($1,000)
- Robert Anton Patterson ($1,000)
- Robert Cezar Matei ($1,000)
- Sarah Renee Ayala ($1,000)
- Steven Rooke ($1,000)
General Support
- Phillip Denormandie ($25,000)
- Daniel Smith ($15,300)
- Carolyn Mary Kleefeld ($5,000)
- HeadCount ($3,233)
- Constance & H. Roemer McPhee ($3,000)
- Anonymous ($2,000)
- Lee Deaner ($1,625)
- Bill Freimuth ($1,000)
- James Ginther ($1,000)
- James S. Campbell ($1,000)
- Peggy M. Hitchcock ($1,000)
MAPS relies on the generosity of individual donors to achieve our mission. Psychedelic science is again being conducted under federal guidelines, but no funding for psychedelic psychotherapy research is yet available from governments or major foundations that aren’t family foundations. Learn how to how to include MAPS in your will or estate plans. Learn more about hosting a Global Psychedelic Dinner to bring your community together in support of psychedelic science and medicine.
Stars and Stripes, Medical Daily, Mercury News, and more….
.FEATURED.
Stars and Stripes.
Ecstasy One Step Closer to Approval as PTSD Treatment
Alex Horton | December 20, 2016.
.FEATURED.
Medical Daily.
MDMA Vs. Ecstasy: How They Differ, Risks, And Benefits You Need To Know
Joseph Palamar | December 9, 2016.
.
Mercury News.
Ayelet Waldman: How LSD Micro-Dosing Saved My Sanity a
nd MarriageMartha Ross | January 10, 2016.
.
Psychiatric Times.
Mind-Body-Spirit Interventions for Patients With PTSD
Leslie Korn, Ph.D. | December 30, 2016.
.
Huffington Post.
Psychedelic Drugs Research and Therapy Have Reached A ‘Turning Point’, Campaigners Say
George Bowden | December 30, 2016.
.
Broadly.
People Have Been Using MDMA to Treat PTSD for Decades
Suzannah Weiss | December 27, 2016.
.
Anxiety.org
MDMA: What You Need to Know About the Radical New PTSD Treatment
Samuel Henley, M.A. | December 22, 2016.
.
New.com.au
‘Researchers Are Pushing to Legalise MDMA Use for War Veterans Suffering PTSD in Australia
Samuel Henley, M.A. | December 22, 2016.
.
Here We Are Podcast
Psychotherapy + PTSD with Allison Wilens
Shane Mauss | December 4, 2016.
Explore MAPS in the Media for more psychedelic and medical marijuana research news.
MAPS Store
NEW. The Ketamine Papers: Science, Therapy, and Transformation
Edited by Phil Wolfson, M.D., and Glenn Hartelius, Ph.D.
Paperback | 448 pages | Published by MAPS (2016)
 |
“Here is an extraordinary collection of essays demonstrating that ketamine is more than just another molecule. If you are interested in the promise of ketamine as a tool of value in psychiatry, and/or you are interested in ketamine as a tool in exploring the nature of mind and the nature of what we call reality, then this book is for you!”
—David E. Presti, Ph.D., author of Foundational Concepts in Neuroscience: A Brain-Mind Odyssey
$24.95 | Buy your copy
LSD: My Problem Child — Signed, Original Hardcover
By Albert Hofmann, Ph.D.
| |
Hardcover | 209 pages | McGraw-Hill (1980)
These rare collector’s items are signed by chemist Albert Hofmann, Ph.D., and translator Jonathan Ott. Proceeds from the sale of these books will benefit MAPS’ global research projects with psychedelics. In the book, we follow Dr. Hofmann’s trek across Mexico to discover sacred plants related to LSD, and listen in as he corresponds with other notable figures about his remarkable discovery.
$1000 | Available
MAPS Bulletin Winter 2016: Vol. 26 No. 3 Annual Report
Art by Michael Divine
Events
Browse our Event Calendar for more upcoming events.
Psychedelic Science 2017: April 19-24, 2017, Oakland, CA
Join us from April 19-24, 2017, in Oakland, California, for Psychedelic Science 2017, a six-day international gathering featuring three days of Conference programming, three full days of Workshops, a Sunset Cruise on the San Francisco Bay, the world’s first Psychedelic Comedy Banquet, a free and expansive Marketplace of goods and ideas, participant-led Community Sessions, and much more. Scientists, doctors, therapists, students, educators, policymakers, artists, and others from around the world will share recently completed and ongoing research into the risks and benefits of psychedelics and medical marijuana for science, medicine, spirituality, creativity, and more. Psychedelic Science 2017 is the third international Psychedelic Science conference, building on the success of Psychedelic Science in the 21st Century (2010) and Psychedelic Science 2013. Past Psychedelic Science conferences sold out early, so reserve your tickets soon. Register now for a 10% discount…
Psychedelic Science 2017 is presented by MAPS and The Beckley Foundation
“A Good Trip” Tour with Comedian Shane Mauss: JAnuary 11, 2017-February 11, 2017
Comedian Shane Mauss hosts a hilarious journey through the stigma, history, laws, and science of psychedelics in his new nationwide tour. Shane will share personal experiences and talk about the effects of psychedelics such as mushrooms, LSD, and DMT. Shane is an advocate for psychedelic studies and rights, and psychedelics are also the source of some of the most hilarious, thought-provoking, and well-received material of his career. MAPS is proud to be an honorary sponsor of “A Good Trip.” Register…
The Adventure of Self-Discovery: A Holotropic Breathwork Experience with Stan Grof and Tav Sparks: January 27-29, 2017, San Francisco, CA
Join pioneering psychedelic researcher Stanislav Grof, M.D., Ph.D., and Holotropic Breathwork facilitator Tav Sparks for a Holotropic Breathwork experience in San Francisco, Calif., from January 27-29, 2017. Through simple breathing, along with a specially designed musical journey, and a safe and supportive setting with a trained staff of facilitators, you experience a true non-ordinary state of consciousness, allowing deep self-exploration, personal transformation, and healing. Register…
Grof will also host a 2-day Holotropic Breathwork Workshop in April at Psychedelic Science 2017. Register…
Students for Sensible Drug Policy (SSDP) Annual Conference: March 24-26, 2017, Portland, OR
Hosted by Students for Sensible Drug Policy (SSDP), SSDP2017 will bring more than 400 student members, alumni, and supporters to Portland, Oregon, from March 24-26, 2017, for their annual gathering. The conference will feature educational programming, an awards ceremony, a student congress, networking opportunities, and more. Register…
Global Psychedelic Dinners
By hosting your own Global Psychedelic Dinner, you’ll join people around the world in gathering your community, having an open conversation about psychedelics, and raising funds to support MAPS. Host a dinner…
More News
Now Hiring: MAPS Public Benefit Corporation (MPBC)
MAPS Public Benefit Corporation (MPBC), a wholly owned subsidiary of MAPS, is currently hiring a Clinical Operations Associate and a Clinical Research Associate/Site Monitor to support the MPBC clinical research team in the San Francisco Bay Area. Learn more…
Global Drug Survey 2017
The Global Drug Survey is an annual anonymous survey that analyzes international drug use patterns to assist with creating resources for international drug education and harm reduction services. Learn more…
Newsletter Survey: Requesting Your Feedback
We are always striving to improve, and we would love to hear your feedback about the MAPS Email Newsletter. Take the survey…