Celebrating 33 of Years of MAPS
Open-Label Lead-In Study of MDMA-Assisted Therapy for PTSD Fully Enrolled
April 19, 2019
Dear friends and supporters,
MAPS is celebrating 33 years of psychedelic research and education! Since the creation of MAPS on April 8, 1986, our supporters have helped us conduct research on MDMA, LSD, ayahuasca, ibogaine, and marijuana. We have also hosted multiple conferences, created multiple entities including MAPS Canada, MAPS Europe, MAPS Public Benefit Corporation (MAPS PBC), and the Zendo Project. One of our proudest moments was being granted Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD). Thank you to our generous community for 33 years of support!
On April 3, 2019, our Phase 2 open-label lead-in study of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD) officially completed enrollment, and 37 study participants have now finished treatment. The purpose of this study is to provide final training and supervision for our co-therapy teams working on Phase 3 clinical trials.
On March 2, 2019, MAPS Founder and Executive Director Rick Doblin, Ph.D., spoke at Wisdom 2.0 in San Francisco, California, about the history of MAPS and MAPS-sponsored clinical trials of MDMA-assisted psychotherapy for PTSD.
In this month’s edition of the MAPS Newsletter, you’ll also learn:
- MAPS and MAPS PBC are currently hiring
- An episode of Al Jazeera America’s The Stream features MAPS researchers
- The MAPS Podcast hosts journalist, photographer, and artist James Oroc
- We’ve updated the MAPS Psychedelic Bibliography a searchable database of over 12,000 publications of psychedelic literature, scientific research, and popular culture articles
Show your support for MAPS and visionary art by purchasing a limited edition, signed and numbered print of “Visionary Origin of Language” by painter Alex Grey. This painting pays homage to Terence McKenna’s theory that psilocybin mushrooms were an evolutionary catalyst for humans. The Chapel of Sacred Mirrors (CoSM) is generously donating 10% of the proceeds to MAPS.
Today is the 76th anniversary of Dr. Albert Hofmann’s first intentional psychedelic experience with lysergic acid diethylamide (LSD) , which culminated with a historic journey on a bicycle in Basel, Switzerland. Thank you to the late Dr. Hofmann for discovering LSD and supporting MAPS-sponsored research with LSD-assisted psychotherapy!
Follow MAPS on Facebook, Twitter, Instagram, YouTube, LinkedIn, and reddit.
Thank you for supporting the expansion of psychedelic research!
With appreciation,
Amy Mastrine
MAPS Web and Email Marketing Associate
Treating PTSD with MDMA-Assisted Therapy
Phase 3 Trials of MDMA-Assisted Therapy for PTSD: 9 Sites Screening Participants
As of April 3, 2019, ten of fifteen sites are officially screening for our Phase 3 clinical trial of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD). Study participants will be administered MDMA or placebo in conjunction with psychotherapy at research sites in several locations across the United States. To learn more about currently recruiting national and international studies, visit our Participate in Research webpage. Additional Phase 3 sites will be starting in the next several months.
Our FDA-regulated Phase 3 multi-site clinical trials of MDMA-assisted psychotherapy for PTSD are continuing to open sites for screening. Taking place at 15 locations across the United States, Canada, and Israel, study volunteers will be administered MDMA or placebo in conjunction with psychotherapy at research sites in the following locations:
- Charleston, SC
- Boulder, CO
- Fort Collins, CO
- Los Angeles, CA
- New Orleans, LA
- San Francisco, CA (UCSF and private practice)
- New York, NY (NYU and private practice)
- Boston, MA
- University of Wisconsin-Madison
- Vancouver, British Columbia
- Montreal, Canada
- Be’er Ya’akov, Israel
- Tel HaShomer, Israel (Sheba Medical Center)
Phase 3 clinical trials are assessing the efficacy and safety of MDMA-assisted psychotherapy in adult participants with severe PTSD. Over a 12-week treatment period, participants will be randomized to receive twelve non-drug preparatory and integration sessions lasting 90 minutes each along with three day-long sessions about a month apart of either MDMA or placebo in conjunction with psychotherapy. The primary endpoint will be the Clinician Administered PTSD Scale (CAPS-5), as assessed by a blinded pool of independent raters.
The trials are the final phase of research required by the FDA before deciding whether to approve MDMA as a legal prescription treatment for PTSD. If approved, MDMA will be required to be used in conjunction with psychotherapy in a clinical setting.
To learn more about currently recruiting national and international studies, visit our participate in research webpage. • Learn More
Open-Label Lead-In Study of MDMA-Assisted Therapy for PTSD: All Sites Fully Enrolled
As of April 3, 2019, all sites are officially fully enrolled in our Phase 2 open-label lead-in study of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD) at planned Phase 3 sites across the United States and Canada. The purpose of this study is to provide the final training and supervision for our co-therapy teams as they work with one study participant with PTSD. The same treatment approach will be used in Phase 3. We are currently developing long-term follow-up protocol for this multi-site open-label Phase 2 study, which will assess symptoms of PTSD in participants 12 months after completing treatment.
Expanded Access Training Update: April 2019
The MDMA Therapy Training Program has launched a series of trainings to prepare therapy providers to become eligible to work on a MAPS MDMA/PTSD protocol. In January 2019, MAPS PBC submitted an MDMA-assisted psychotherapy for PTSD protocol to the U.S. Food and Drug Administration (FDA) as part of an application to participate in the FDA Expanded Access (EA) program, which allows the which allows the wider use of an investigational treatment. The program’s purpose is to grant access to potentially beneficial investigational treatments for individuals or populations facing a serious or immediately life-threatening condition for which there is no satisfactory treatment currently available. If approved, Expanded Access for MDMA-assisted psychotherapy for PTSD would allow additional sites to meet the requirements to provide this treatment to eligible patients under a MAPS protocol.
Qualified sites in the U.S. and U.S. Territories interested in being considered to participate in an MDMA PTSD Expanded Access protocol, pending approval, may now apply with MAPS PBC to assess eligibility and obtain the prerequisite training to administer MDMA-assisted psychotherapy for PTSD under a MAPS protocol. The basic requirements of a qualified site are 1) Treatment facility conducive to MDMA-assisted psychotherapy, 2) Therapy team, qualified and able to complete MDMA Therapy Training Program, and 3) Prescribing physician who can obtain a DEA Schedule I license for MDMA.
Site and Practitioner Application procedures are posted at maps.org/training. There are two layers of application: site questionnaire and MDMA therapy training application for therapy providers. Each site must submit one site questionnaire. Additionally, each therapy provider must submit an MDMA therapy training application for therapy providers. Only applicants affiliated with a qualifying site can be considered for training at this time. MAPS PBC will review applications on an ongoing basis, as they are received.
Applications remain open for the MDMA Therapy Training for Communities of Color event, taking place August 10-17, 2019, in Louisville, Kentucky, led by Marcela Ot’alora M.A., L.P.C., and Monnica Williams, Ph.D., A.B.P.P., with support from additional trainers. More details for both events, including exact location, schedule, line-up of guest presenters, scholarship and registration fees will be available as they are updated on our website. Scholarships will be available for therapy providers and community organizers of color through the generous contributions of Open Society Foundation and several other potential donations. Details on scholarship opportunities will be posted online as soon as they are available.
Additional Expanded Access training retreats in the U.S. will be announced via the training newsletter as they are scheduled. Unregistered applicants who have already applied for the training program will automatically be considered for these events. Please sign up for the newsletter to ensure updates. • Learn More
Policy and Advocacy
U.S. Senators Schatz and Booker Formally Advocate for Expediting Approval of New Research-Grade Marijuana Manufacturers
On March 28, 2019, United States Senators Brian Schatz and Cory A. Booker of the Senate Judiciary Committee sent a formal letter to Attorney General William Barr regarding the delay of licensing new manufacturers to produce marijuana for scientific research, stating, “We believe the licensed production of marijuana for research is critically important. After two and a half years of delay, it is imperative that you advance the process for registering new manufacturers of research-grade marijuana.”
—Download and read the full letter.
U.S. Attorney General William Barr Receives Formal Letter from Six U.S. Senators Regarding the Advancement of Research-Grade Marijuana Production
On April 2, 2019, six United States Senators sent Attorney General William Barr a formal letter to follow-up about pending applications to manufacture marijuana for scientific research. “Our nation’s need for meaningful federally sanctioned research is critical. Research and medical communities should have access to research-grade materials to answer questions around marijuana’s efficacy and potential impacts, both positive and adverse. Finalizing the review of applications for marijuana manufacturing will assist in doing just that,” according to U.S. Senators Brian Schatz, Dianne Feinstein, Lisa Murkowski, Cory Gardner, Christopher A. Coons, and Tim Kaine.
—Download and read the full letter.
Support MAPS
March 2019 Giving Report: Help Fund European Studies
In March 2019, MAPS raised $224,932 in new donations and pledges from 798 supporters. Of that amount, $156,744 was for general support, $52,368 for MDMA/PTSD Phase 3, $15,000 for MDMA/end-of-life anxiety research, $11,000 for Expanded Access, and $820 for other MAPS programs.
Currently, MAPS seeks $9 million for European Medicines Agency (EMA)-regulated trials to supplement the data gathered for the FDA, with $897,735 already raised and roughly $8.1 million still needed. We have completed key negotiations with EMA, and we will have a more precise estimate of timetables and costs for Phase 3 EMA trials in mid-2019 after completion of our negotiations with each country in the EMA in which we will have a Phase 3 site.
We extend a special thanks to those who so generously supported MAPS last month:
General Support:
- Carlos Martinez ($25,000)
- Jasen Trautwein & Sagara Sanchez-Reinoso ($25,000)
- Jeffrey Breau ($16,758)
- The Eilian Family Charitable Fund ($10,000)
- Aubrey Marcus ($10,000)
- Robin Arnott ($5,000)
- Jon M. Callahan ($5,000)
- Max Kerr ($5,000)
- Nion McEvoy, Jr. ($5,000)
- Nanea Reeves ($5,000)
- Anonymous ($5,000)
- Roland Wiederaenders ($3,500)
- Cody Stross ($3,000)
- Mason Berry ($1,000)
- Jason & Amanda Crawford ($1,000)
- Nancy Davis ($1,000)
- Joshua Kappel ($1,000)
- Marc Piatkowski ($1,000)
- Phu Styles ($1,000)
- Joseph Whinney ($1,000)
MDMA/PTSD Phase 3 Research:
- Timothy Ferriss ($50,000)
MDMA/End-of-Life Anxiety Research:
- Cody Swift, RiverStyx Foundation ($15,000)
Expanded Access:
- Anonymous ($10,000)
- Lisa Schutz, One World Brewing ($1,000)
Fiscal Sponsorship:
MAPS fiscally sponsors like-minded organizations and projects. This list includes donors who have contributed to organizations we fiscally sponsor.
- Gwendolyn Grace ($15,000 – ICEERS)
- Anonymous ($1,800 – From Shock to Awe)
- Cody Swift, RiverStyx Foundation ($1,200 – Psychedelic Integration 2019)
MAPS relies on the generosity of individual donors to achieve its 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.
Help us reach our goal to make MDMA a medicine by 2021 by establishing a monthly gift of $10 or more. maps.org/donate
Learn how to include MAPS in your will or estate plans.
Learn more about hosting a Global Psychedelic Dinner to fundraise for MAPS.
Media
Featured Media: March 2019
- Nature: Oxytocin-Dependent Reopening of a Social Reward Learning Critical Period With MDMA
- Written by Romain Nardou, Eastman M. Lewis, Rebecca Rothhaas, Ran Xu, Aimei Yang, Edward Boyden and Gül Dölen on April 3, 2019
- CBS News: Veterans Urge Congress, VA to Catch Up on Expanding Access to Medical Marijuana
- Written by Anna Gunther on March 1, 2019
- Al Jazeera America’s The Stream: Are Psychedelics the New Wonder Drugs?
- Written on March 19, 2019
- Stars and Stripes: Marijuana-PTSD Study Concludes After 10 Years of Planning, Research
- Written by Nikki Wentling on March 1, 2019
- The Tim Ferriss Show: Michael Pollan — Exploring the Frontiers of Psychedelics
- Published by Tim Ferriss March 27, 2019
- CNBC: Investors are Starting to Bet Big on Psychedelic Medicine
- Written by Christina Farr on March 27, 2019
- Psychedelic Support: Can We Quantify the Placebo Effect in Psychedelic Medicine?
- Written by Alli Feduccia, Ph.D., on March 1, 2019
MAPS Podcast
MAPS Podcast: James Oroc, The New Psychedelic Revolution
In the most recent episode of the MAPS Podcast, James Oroc, journalist, photographer, and artist, offers his insights, opinions and experiences on topics ranging from 5-MEO DMT, the re-birth of LSD, Sasha Shulgin, and the culture wars present throughout the 21st century consciousness expansion movement.
Andrew Weil, M.D., is a leader and pioneer in the field of integrative medicine, a healing-oriented approach to health care which encompasses body, mind, and spirit. • Listen Now
MAPS Psychedelic Bibliography
Psychedelic Bibliography
The MAPS Psychedelic Bibliography is a searchable database of over 12,000 publications of psychedelic literature, scientific research, and popular culture articles. Each record consists of a title, author name or names, and often an abstract or notes about the piece. The bibliography allows people to learn more about where psychedelic science has been while keeping up to date on where it is going now. The Psychedelic Bibliography is an excellent resource for professional authors, university students, or MAPS fans seeking general information on the history of psychedelics. • Browse the Bibliography
For more information about the Psychedelic Bibliography, read about volunteer JB Porter’s perspective:
I started working on the Psychedelic Bibliography after running into Rick Doblin at Burning Man in 2009. I’d been using it as a resource for about two or three years and knew my way around it reasonably well – but it needed a little work. Several thousand volunteer hours have been spent the last decade to locate missing articles, add a few thousand new ones, and do a little cleanup and standardization of the records. Articles in popular culture magazines and underground newspapers have also been added to get the full breadth of the literature regarding psychedelics. This database is designed so that doctors, scientists, researchers, educators, writers, students, and laypersons anywhere on the planet can find nearly anything they’re looking for about these fascinating compounds. It’s a comprehensive, one-stop resource, and it’s definitely the coolest project I’ve ever worked on. In 2020, the Psychedelic Bibliography should have somewhere in the neighborhood of 15,000 articles, spanning from the mid-19th century to the present. And, best of all, this is a resource freely available on the internet to anybody. Psychedelics, when incorporated properly and thoughtfully, can assist both creativity and personal enlightenment. This enriches everybody and makes the world a better place. Just say know.
MAPS Store
LSD Psychotherapy by Stanislav Grof, M.D.
The sensationalism surrounding the widespread use of LSD in the late 1960s and the subsequent legislative overkill virtually ended psychotherapeutic LSD research. Much of what had been learned over thirty years of scientific medical study was so distorted or suppressed that no objective overview was available to the general reader except for this book. LSD Psychotherapy is a complete account of the controlled studies which reveal exciting and challenging data about the nature of human consciousness, perception, and reality itself. This book is also a visual feast, with numerous color drawings and paintings created by research participants. Many of these depict archetypal images from the collective human consciousness, forming a powerful addition to the text. • Buy Now
Acid Test by Tom Shroder
With an uncanny ability to reveal the mind’s remote frontiers and the unmapped areas of human consciousness, LSD and MDMA have proven extraordinarily effective in treating anxiety disorders such as post-traumatic stress–yet the drugs remain illegal for the millions of people who might benefit from them. Anchoring Tom Shroder’s Acid Test are the stories of three men: Rick Doblin, Ph.D., the founder and executive director of MAPS, who has been fighting government prohibition of psychedelics for more than thirty years; Michael Mithoefer, M.D., a former emergency-room physician, now a psychiatrist at the forefront of psychedelic therapy research; and his patient Nick Blackston, a retired Marine who has suffered unfathomable mental anguish from the effects of brutal combat experiences in Iraq. • Buy Now
Events
Browse our Event Calendar page for more opportunities.
Awakened Futures Summit 2019, May 18-19, 2019, San Francisco, California
From May 18-19, 2019, the first annual 2-day Awakened Futures Summit will discuss the intersection of psychedelics, technology and meditation. Attendees will explore how the renaissance of psychedelic science and the mainstreaming of contemplative practices might combine with the latest transformative technologies to create the next paradigm of healing and awakening. MAPS Development Officer Liana Sananda Gillooly will be a featured speaker at this event. • Learn More
Canna West Summit 2019, May 29-31, 2019, Los Angeles, California
Now in its 6th chapter, Infocast’s Canna WEST Summit returns with its unique cross-section of policy, health, and technical regulators from dozens of states. These regulators will engage with cannabis operators, testing and quality professionals, and solution providers. This is the place where innovators, advocates, and compliance consultants can sit down with policy leaders and compliance enforcers, understand their priorities, and in turn educate them on the unique needs and issues of the highly innovative cannabis culture and medical eco-system. • MAPS supporters receive 10% off registration with this coupon code: 192231
World Ayahuasca Conference 2019, Girona, Spain, May 31 – June 2, 2019
Join us in Girona, in the beautiful region of Catalonia (Spain), to celebrate the diversity of ayahuasca cultures, practices, art, film, and research. AYA2019 will be more than a conference. It will be the largest event ever held about ayahuasca, one where we inspire each other to work together for a more connected, meaningful, and sustainable life on earth. • Learn More
Queering Psychedelics, June 1-2, 2019, San Francisco, California
This 2-day conference is part of Chacruna’s Women, Gender Diversity, and Sexual Minorities speaker series. It highlights the voices of queer visionaries within the psychedelic community as well as examines the history of psychedelics from queer and non-binary perspectives. As the so-called psychedelic renaissance reaches a pivotal moment of mainstream interest and regulatory legitimacy, it is vital that traditionally underrepresented communities share a seat at the table and have their voices heard so as to ensure access to all the benefits that psychedelics and plant medicine offer. • Learn More
Breaking Convention 2019, August 16-18, 2019, London, United Kingdom
Breaking Convention is a biennial multidisciplinary conference on psychedelic consciousness, featuring more than 150 presenters from around the world. Europe’s largest conference on psychedelic consciousness, Breaking Convention is now approaching its eighth year. Breaking Convention is a truly multi-faceted festival selling nearly a thousand tickets in forty countries and offering the latest ground-breaking research and insights across human and social sciences, law, politics, art, history and philosophy. Spanning three full days, Breaking Convention features numerous workshops, awards, an art exhibition, and films. • Learn More
Horizons: Perspectives on Psychedelics 2019, October 11-13, 2019, New York, New York
Horizons: Perspectives on Psychedelics is an annual forum in New York City that examines the role of psychedelic drugs and plant medicines in science, medicine, culture and spirituality. In recent years, a growing community of scientists, doctors, scholars, and activists have orchestrated a renaissance in psychedelic research and practice. Horizons brings together the brightest minds and the boldest voices of this movement to share their knowledge, insights, and dreams for the future. Now in its twelfth year, Horizons is the largest and longest-running annual gathering of the psychedelic community in the world. • Learn More
International Drug Policy Reform Conference, November 6-9, 2019, St. Louis, Missouri
The International Drug Policy Reform Conference is a biennial event that brings together people from around the world who believe that the war on drugs must end. Reform attendees have the opportunity to spend three days interacting with people committed to finding alternatives to the war on drugs while participating in sessions given by leading experts from around the world. • Learn More
Participate in Psychedelic Reseearch
MDMA Studies Supported by MAPS
MAPS sponsors clinical trials around the world that require human participants. Our studies have strict enrollment criteria based on the goal of the study and the condition the study is investigating.
Phase 3 trial participant enrollment is now open. Please bookmark our Participate in Research page and check it frequently for updates.
Psychedelic Use, Compassion, and Life Satisfaction Study
Arizona State University is gathering information on psychedelic drug use and overall life satisfaction. We are currently looking for individuals who have had psychedelic experiences, and those who are lifelong abstainers. To participate, you must be at least 18 years old. This study will consist of two parts. Upon completion, you will be entered into a drawing to win 1 of several gift cards worth up to $99. • Take the Survey
Cannabis Survey
The aim of this study is to help to develop a model for the sale of cannabis in the United Kingdom. The study aims to address many questions regarding the sale of cannabis for both medical and recreational use in the UK. The survey should take about 20 minutes to complete.• Take the Survey
Military and Veteran Perceptions of Psychedelics Survey
Austin Peay State University researchers Roxanne Hallisey and Dr. Emily Pica are conducting a study about military and veteran perceptions of psychedelics. The survey takes about 40 minutes to complete and asks for the voluntary participation of United States military members and veterans. • Take the Survey
Psychedelic Culture Survey
The Limina Foundation is conducting an anonymous survey about today’s psychedelic culture. • Take the Survey
More News
Source Research Foundation Grants for Students
Source Research Foundation is offering up to $10,000 in grants for students with research proposals to expand the field of psychedelic science. • Learn More
Limited Edition Art Prints by Chor Boogie
House Of Roulx is selling limited edition, hand embellished art prints by visionary artist Chor Boogie, and 10% of all sales will be donated to MAPS! • Shop Now
We’re Hiring!
MAPS and MAPS Public Benefit Corporation (MAPS PBC) are currently hiring! MAPS is hiring a Chief Operations Officer (COO). MAPS PBC is hiring a Drug Development Assistant, and Training Coordinator. You can support MAPS by referring qualified applicants to our open positions. Application instructions vary by position, so please read carefully.