A Tilt Toward Hope
FDA clears the way for Phase 3 trials of MDMA-assisted psychotherapy for PTSD
December 9, 2016
Dear friends and supporters,
This month, I’m especially excited to bring you the latest news from the Multidisciplinary Association for Psychedelic Studies (MAPS).
On November 29, 2016, we met with the U.S. Food and Drug Administration (FDA) to plan our upcoming Phase 3 clinical trials of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD). The outcome was as encouraging as we’d hoped: the FDA is ready for MAPS to move forward with the final stage of research necessary to make MDMA-assisted psychotherapy a legal treatment option for PTSD. We expect formal approval of the Phase 3 trials in early 2017, and starting Phase 3 in June 2017.
Right after the meeting, The New York Times announced the outcome, with the wave of international news coverage that followed bringing unprecedented public attention to our work. Mashable reported that “psychedelic therapy is making a comeback”; New York Magazine called it “a tilt toward hope.”
“It changed my life,” explains Ed, a former firefighter and study participant, to the Times. “It allowed me to see my trauma without fear or hesitation and finally process things and move forward.” U.S. Marine veteran C.J. Hardin recalls: “The MDMA sessions showed me a light I could move toward. Now I’m out of the darkness and the world is all around me.”
Also in the December 2016 edition of the MAPS Email Newsletter:
- The protocol for our upcoming study of the effects of MDMA on startle testing is cleared by the FDA
- The 13th participant is treated in our ongoing study of MDMA-assisted psychotherapy for anxiety associated with life-threatening illness
- The MAPS Store Winter Sale continues until January 7 with discounts on books, clothing, and more
- Tickets for the Sunset Cruise and Psychedelic Comedy Banquet at Psychedelic Science 2017 are selling fast—register before February 15 to save 10% on Early Bird tickets!
Stay connected by following MAPS on Facebook, Twitter, YouTube, reddit, Tumblr, Pinterest, Google+, LinkedIn, and Instagram.
There is a clear path ahead for the prescription approval of MDMA-assisted psychotherapy for PTSD. Over the next four years, funding this research and educating people about its promise will be our greatest challenges—challenges we will meet together.
Always upwards,
Brad Burge
MAPS Director of Communications and Marketing
P.S. Your $50 gift pays for one full dose of pharmaceutical-grade MDMA for Phase 3 clinical trials. Just like MDMA-assisted psychotherapy, a little bit goes a long way: Help make MDMA a medicine.
Contents
Treating PTSD with MDMA-Assisted Therapy
1FDA Agrees to Phase 3 Trials of MDMA-Assisted Therapy for PTSD
2 Startle Testing with MDMA: FDA Clears Study to Proceed
3 Canada: Study Officially Completed
4 Boulder: 21st Participant Completes 12-Month Follow-Up
5 Israel: Two Participants Complete 12-Month Follow-Up
6 Therapist Training Study: 19th Participant Enrolled
MDMA-Assisted Therapy for Anxiety Associated with Life-Threatening Illness
7 Marin: 13th Participant Treated
Ayahuasca Research
Psychedelic Harm Reduction
9 Zendo Project: Volunteer at Envision Festival in Costa Rica
Support MAPS
10 Donate to Make MDMA a Legal Medicine
11 November Giving Report: Moving Forward to Phase 3
Media
12 The New York Times: FDA Agrees to New Trials for MDMA as Relief for PTSD Patients
13 The Guardian, Rolling Stone, Fox News, and more…
MAPS Store
14 Winter Sale: New Products and Low Prices
Events
15 Psychedelic Science 2017: April 19-24, 2017, Oakland, CA
16 “A Good Trip” Tour with Comedian Shane Mauss: December 8, 2016-February 10, 2017
18 Students for Sensible Drug Policy Annual Conference: March 24-26, 2017, Portland, OR
More News
20 MAPS Bulletin Winter 2016 Annual Report
21 Recap: Catharsis on the Mall 2016
22 MAPS Public Benefit Corporation (MPBC) is Hiring
23 MAPS Volunteer Opportunity: SharePoint Developer and Clinical Management System Integrator
On November 30, 2016, The New York Times published a feature article about the outcome of MAPS’ End of Phase 2 Meeting with the FDA.
Treating PTSD with MDMA-Assisted Therapy
FDA Agrees to Phase 3 Trials of MDMA-Assisted Therapy for PTSD
On November 29, 2016, the U.S. Food and Drug Administration (FDA) hosted staff and researchers at MAPS and the MAPS Public Benefit Corporation (MPBC) for a formal End of Phase 2 Meeting to discuss clinical trials of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD). During the 90-minute meeting at the FDA’s White Oak Campus in Silver Spring, Maryland, the FDA stated they are now ready for MAPS to move forward with Phase 3 clinical trials of MDMA-assisted psychotherapy for PTSD. The formal approval of the Phase 3 trial protocol is expected by mid-April 2017.
On November 30, 2016, The New York Times published a feature article announcing the outcome of our End of Phase 2 meeting with the FDA. Trial participants Ed Thompson and CJ Hardin spoke with the NYTimes about how MDMA-assisted psychotherapy helped them overcome treatment-resistant PTSD. “It changed my life,” explains Ed. “It allowed me to see my trauma without fear or hesitation and finally process things and move forward.” CJ speaks about the results from his treatment, stating, “The MDMA sessions showed me a light I could move toward. Now I’m out of the darkness and the world is all around me.”
We expect to initiate our first Phase 3 clinical trial in June 2017, which will last 2-3 years and enroll at least 230 participants. We are working with the FDA’s guidance on determining the final form of the Phase 3 trials, including selection of appropriate control group and sample size.
We need to raise approximately $25-30 million (of which we’ve already raised more than $10 million) to complete Phase 3 trials and all associated toxicity and pharmacology studies over the next 5 years. 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: FDA Clears Study to Proceed
On November 30, 2016, the FDA cleared the upcoming MAPS-sponsored 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 original protocol was approved by the Institutional Review Board (IRB) on July 26, 2016. The DEA is currently reviewing the protocol, with the study expected to begin in 2017. Learn more…
Canada: Study Officially Completed
On November 27, 2016, investigators gathered for the formal closeout of our Phase 2 pilot study of MDMA-assisted psychotherapy for PTSD in Vancouver, Canada. Conducted by Clinical Trial Leader Alli Feduccia, Ph.D., the closeout included a thorough review of the study’s documentation, database, files, and adherence to regulations. All treatment sessions and long-term follow-up interviews for this study have now been completed. Led by Principal Investigator Ingrid Pacey, M.D., this small pilot study gave Canadian therapists experience delivering MDMA-assisted psychotherapy for PTSD, with data collected from three women and three men. The final results are being prepared for publication as a part of a global meta-analysis of MDMA-assisted psychotherapy results. Learn more…
| $479,000estimated study cost | $48,000raised$69,000raised by partners | $353,000still needed |
Donate Nowhelp fund more research |
Boulder: 21st Participant Completes 12-Month Follow-Up
On November 28, 2016, the 21st participant out of 23 completed their 12-month follow-up interview in our Phase 2 study of MDMA-assisted psychotherapy in 23 subjects with chronic PTSD in Boulder, Colorado, led by Principal Investigator Marcela Ot’alora, M.A., L.P.C. These data will provide additional information to guide the design of our upcoming Phase 3 trials. The final results are being prepared for publication, which is expected in 2017. Learn more…
| $802,000estimated study cost | $802,000raised | Funding Complete |
Donate Nowhelp fund more research |
Israel: Two Participants Complete 12-Month Follow-Up
On November 10 and November 28, 2016, the fifth and sixth of 10 participants completed their 12-month follow-up interviews in our Israeli Phase 2 study of MDMA-assisted psychotherapy for PTSD. Led by Principal Investigator Moshe Kotler, M.D., this Phase 2 study has treated 10 subjects with chronic, treatment-resistant PTSD from any cause. Learn more…
| $509,000estimated study cost | $509,000raised | Funding Complete |
Donate Nowhelp fund more research |
Therapist Training Study: 19th Participant Enrolled
On November 30, 2016, the fourth participant was enrolled at the recently initiated Boulder, Colorado study site in our ongoing Phase 1 study of the psychological effects of MDMA when used in a therapeutic setting by healthy volunteers. 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 19 out of 100
participants across the study sites in Boulder, Colorado, and Charleston, South Carolina. Learn more…
| $429,000estimated study cost | $35,000raised | $394,000still needed |
Donate Nowhelp fund more research |
MDMA-Assisted Therapy for Anxiety Associated with Life-Threatening Illness
Marin: 13th Participant Treated
On On November 17, 2016, the 13th participant was treated in our ongoing study of MDMA-assisted psychotherapy for anxiety associated with life-threatening illness in Marin, Calif. 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 in 18 subjects diagnosed with a life-threatening illness. We are currently screening additional participants for this study. Learn more…
| $627,000estimated study cost | $218,000raised | $409,000still needed |
Donate Nowhelp fund more research |
Ayahuasca Research
Survey: Ayahuasca for PTSD
As of December 1, 2016, we have received 202 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. “Results show a promising trend towards self-reported reductions in PTSD symptoms, depression, and suicidal thoughts and decreased alcohol and prescription drug use, with increases in the use of other psychedelics and MDMA after trying ayahuasca,” explains Nielson. “There are a few reports of the ayahuasca experience itself being traumatizing when done in settings without an experienced facilitator or appropriate after-care.” Take the survey…
Learn more about current and upcoming research at maps.org.
Psychedelic Harm Reduction
Zendo Project: Fundraising Success, Event Updates, and More
For the fifth consecutive year, the Zendo Project will provide psychedelic harm reduction services at Envision Festival in Costa Rica, an event taking place in February 2017. Last year at Envision Festival, Zendo Project volunteers provided compassionate support for 116 guests, and dozens more used the Zendo Project facilities as a space to rest and/or rehydrate. Volunteer applications for this event are being accepted until December 12, 2016 Apply to volunteer…
Zendo Project volunteers at Envision Festival in Costa Rica
Learn about psychedelic harm reduction by signing up for the Zendo Project Email Newsletter, and following the Zendo Project on Facebook, Twitter, and Instagram
MAPS Founder Rick Doblin, Ph.D., and Asana Co-Founder Justin Rosenstein at a fundraising event in San Francisco, California, on December 3, 2016.
Support MAPS
Donate to Make MDMA a Legal Medicine
You can help heal people suffering from PTSD by making a gift toward the production of MDMA needed for U.S. Food and Drug Administration (FDA) Phase 3 clinical trials of MDMA-assisted psychotherapy. To complete these trials, MAPS needs your help to raise the last $174,000 (now just a bit less than $50,000) of the $400,000 needed for one kilogram of pharmaceutical-grade MDMA, made under current Good Manufacturing Practices (cGMP) in a certified laboratory.
327 donors have already brought us 71% of the way to our goal with less than 23 days left!
Every gift helps make a difference in the lives of people suffering from PTSD. Learn more | Make a gift today…
November Giving Report: Moving Forward to Phase 3
In November 2016, MAPS received $210,000 in new donations and pledges from 465 supporters.
November marked the start of what we anticipate will be our final fundraising campaign to raise the remaining $170,000 of the $400,000 required for the purchase of one kilogram of GMP MDMA to be used in our Phase 3 studies of MDMA-assisted psychotherapy for PTSD. We’ve received three generous matches for this campaign so far: $15,000 from Justin Rosenstein, $30,000 from Britt Selvitelle, and $10,000 from the Sarlo Foundation. We’ve already raised over $124,105, 61% of our $174,000 goal. With the help of generous supporters like you, we hope to reach our goal by December 31, 2016.
“Compassion demands that we not deny medicine to the sick,” explains Rosenstein. “I support psychedelic research in the hopes that it will help bring that compassionate care to those who need it most.”
We extend a special thanks to those who so generously supported MAPS this past month:
General Support
- Nathan Cummings Foundation ($20,000)
- Audra Foster ($3,000)
- Douglas & Christine Gehrman Family Foundation ($1,000)
- Andrew Ryan ($1,000)
- Flavio Rump ($1,000)
- Louis B. Bjostad ($1,000)
- Sahajia Sarkisian ($1,000)
- Shaun Sutton ($1,000)
MDMA/PTSD Phase 3 GMP MDMA:
- Ben Warner ($1,000)
- Hans Petter Sveen ($1,000)
- Lucy Khoury ($1,000)
Marijuana for PTSD:
- Julie Holland ($1,202)
Zendo Project:
- Naval Ravikant ($1,000)
- Ben Halper ($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.
Media
FEATURED
PBS Radio
Using Ecstasy to Treat PTSD: ‘I Felt Like My Soul Snapped Back into Place’
Caleb Hellerman | December 1, 2016
FEATURED
The Guardian
MDMA Approved for Final Trials to Treat PTSD Before Possible Legalization
Olivia Salon | December 1, 2016
FEATURED
Popular Science
MDMA Could be on the Market Legally by 2021
Knvul Sheikh | November 30, 2016
Red State
The Cure for PTSD? How a Rave Drug Can Be a Treatment
Jonathan Lubecky | November 16, 2016
Rolling Stone
How MDMA Treats PTSD: Everything You Need to Know
Annamarya Scaccia | December 1, 2016
Fox News
Ecstasy Trials Approved by FDA for PTSD Patients
November 30, 2016
CBC Radio
‘I Have No Doubt it Saved My Life’: MDMA Drug Helps Former Firefighter with PTSD
Anna Marie Tremonti | December 5, 2016
- 30-40% off select books
- Reduced prices on signed books by Albert Hofmann and Alexander “Sasha” Shulgin, including PiHKAL, TiHKAL, and LSD: My Problem Child
- Rare signed glass from Sasha Shulgin’s laboratory
The New York Times: F.D.A. Agrees to New Trials for MDMA as Relief for PTSD Patients
Dave Philipps | November 30, 2016
On November 30, 2016, The New York Times announced that the U.S. Food and Drug Administration (FDA) is ready for the Multidisciplinary Association for Psychedelic Studies (MAPS) to move forward with Phase 3 clinical trials of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD). Dave Philipps of The New York Times speaks with trial participants C.J. Hardin and Ed Thompson about how MDMA-assisted psychotherapy helped them overcome treatment-resistant PTSD. “It changed my life,” explains Thompson. “It allowed me to see my trauma without fear or hesitation and finally process things and move forward.” Hardin speaks about the results from his treatment, stating, “The MDMA sessions showed me a light I could move toward. Now I’m out of the darkness and the world is all around me.” Read the article…
The Guardian, Rolling Stone, Fox News, and more…
Mashable
‘I Saw My Fear’: How Psychedelic Therapy is Making a Comeback
Maria Gallucci | December 5, 2016
Pharmacy Times
Is Ecstasy Becoming a Legitimate Medical Treatment?
Eric Roath, PharmD | December 6, 2016
Explore MAPS in the Media for more psychedelic and medical marijuana research news.
MAPS Store
Winter Sale: New Products and Low Prices
The MAPS Store Winter Sale features rare artifacts, signed books, new jewelry, 30-40% off select books, 10% off select MAPS apparel. Get a gift for a friend, expand your psychedelic research library, or acquire a rare historic artifact for your collection.
Featuring:
All sales support MAPS’ work to expand the scientific, medical, and spiritual uses of psychedelics and marijuana. Discounts from the Winter Sale will be available until January 7, 2017, while supplies last. Shop now…
Signed glassware from Sasha Shulgin’s laboratory
The Ketamine Papers: Science, Therapy, and Transformation
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: December 8, 2016-February 10, 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…
Students for Sensible Drug Policy 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…
MAPS Bulletin Winter 2016: Vol. 26 No. 3 Annual Report
Art by Michael Divine
More News
MAPS Bulletin Winter 2016 Annual Report
The Winter 2016 edition of the MAPS Bulletin is now available online and arrives soon in subscriber mailboxes! In addition to our detailed 2016 Annual Financial Report, this issue includes over a dozen original articles from researchers, advocates, MAPS staff, and others. The triannual MAPS Bulletin is a key part of our work to educate the public and encourage scientific research into the safest and most beneficial ways to use psychedelics and marijuana for science, healing, spirituality, and personal growth. Learn more…
Recap: Catharsis on the Mall 2016
From November 11-13, 2016, starting on Veterans Day and immediately following the U.S. presidential election, more than 2,000 people gathered on the National Mall in Washington, D.C., for the second annual Catharsis on the Mall: A Vigil for Healing, a 48-hour event focusing on healing from trauma. The event featured presentations, visionary art, dancing, conversations, and harm reduction services provided by the Zendo Project. MAPS co-created Catharsis with DC community activists, and serves as its fiscal sponsor. We are looking forward to hosting this event again in 2017. Learn more…
MAPS Public Benefit Corporation (MPBC) is Hiring
MAPS Public Benefit Corporation (MPBC), a wholly owned subsidiary of MAPS, is currently hiring a Clinical Operations Associate (COA) to work from our office in Santa Cruz, Calif., and support the MPBC clinical research team. The candidate should be comfortable working in a small but fast paced environment while maintaining a positive outlook and attention to detail. The successful candidate will have strong analytical competencies, as well as knowledge in clinical development. The COA is responsible for supporting the Clinical Teams and Clinical Research Sites interactions with Accounting. Learn more….
MAPS Volunteer Opportunity: SharePoint Developer and Clinical Management System Integrator
MAPS is currently seeking a volunteer who has experience with Microsoft SharePoint, program management, process improvement, and operations. Learn more…