Five Study Initiation Visits Completed for Phase 3 Trials of MDMA-Assisted Therapy
August 27, 2018
Dear friends and supporters,
On August 14 and 15, 2018, the Board of Directors for MAPS and MAPS Public Benefit Corporation gathered at the Dr. Bronner’s headquarters in Vista, California, to discuss the financials of Fiscal Year 2018 and our financial projections for Fiscal Year 2019, along with staff updates and in-depth discussion of the upcoming FDA-regulated Phase 3 trials of MDMA-assisted psychotherapy for PTSD, scheduled to begin next month at up to 16 sites in the U.S., Canada, and Israel. The 2-day discussion included a comprehensive discussion of MAPS’ drug development plans to make MDMA-assisted psychotherapy into an FDA-approved prescription medication when used in conjunction with psychotherapy as a treatment for PTSD by 2021.
MAPS-sponsored researchers have now completed study initiation visits for Phase 3 trials at five locations in the United States:
- New Orleans, Louisiana
- Fort Collins, Colorado
- Boulder, Colorado
- Private Practice, San Francisco, California
- University of California, San Francisco, California
- Los Angeles, California
The Summer 2018 Research Edition of the MAPS Bulletin is now available online and in subscribers’ mailboxes. Read through the new articles and be sure to check out the Spring 2018 Special Edition of the MAPS Bulletin.
Thanks to the incredible generosity of our international community, the Zendo Project fundraising campaign has exceeded our $100,000 fundraising stretch goal, raising a total of $101,858 from 381 donors. Our new stretch goal of $130,000 will allow the Zendo Project to expand support services, infrastructure, education, and outreach needs for the entire year of 2018. As our fundraising campaign comes to a close, limited edition perks for donors are going fast, so don’t miss this opportunity to make a gift and claim exclusive items!
This week, the Zendo Project is at Burning Man providing psychedelic peer support. The Zendo Project is prominently located at Esplanade & 5:45. We are expecting a productive and busy experience for our team of over 300 volunteers!
MAPS Founder and Executive Director Rick Doblin, Ph.D., is giving a variety of talks about psychedelic research at Burning Man 2018 including a psychedelic peer support training with the Zendo Project. For those headed to the playa, you can find Rick speaking at the following times and locations:
In the August 2018 edition of the MAPS Newsletter, you’ll also learn::
- 71 out of 76 participants have enrolled and received the study drug in our clinical trial of smoked marijuana for PTSD symptoms in U.S. veterans
- The seventh participant is treated our ongoing study of the effect of MDMA on startle testing in healthy volunteers
- The MAPS Podcast offers a peek into the psychedelic universe
The annual Horizons: Perspectives on Psychedelics conference is returning to New York City from October 5 – 7, 2018. MAPS will continue our tradition of hosting an intimate benefit dinner to support psychedelic research. Tickets are now available.
After an incredible summer, we are excited to welcome new opportunities for psychedelic research this upcoming fall!
MAPS Web and Email Marketing Associate
Treating PTSD with MDMA-Assisted Therapy
Phase 3 Trials: Study Initiation Visits for 5 Sites Completed
MAPS-sponsored researchers have completed study initiation visits for FDA-regulated Phase 3 trials of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD) at five United States locations:
- New Orleans, Louisiana
- Fort Collins, Colorado
- Boulder, Colorado
- Private Practice, San Francisco, California
- University of California, San Francisco, California
- Los Angeles, California
These Phase 3 trials are taking place at up to 16 sites in the U.S., Canada, and Israel.
Clinical trials are starting in September 2018, and will assess the efficacy and safety of MDMA-assisted psychotherapy in adult participants with 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 an outpatient setting. Learn more…
Startle Testing with MDMA: Seventh Participant Receives Experimental Treatment
On August 24, 2018, the seventh participant completed experimental treatment in our ongoing study of the effect of MDMA on startle testing in healthy volunteers. Led by Principal Investigator Barbara Rothbaum, Ph.D., this study is conducted at Emory University in Atlanta, Georgia. This study will be followed by another study exploring the combination of MDMA with Prolonged Exposure in PTSD patients. Learn more…
MDMA Therapy Training Program: August 2018 Update
From July 16 – 19, 2018, MAPS-sponsored researchers Dr. Michael Mithoefer and Annie Mithoefer, BSN, Marcela Ot’alora, LPC, and Bruce Poulter, RN, together with MAPS Executive Director Rick Doblin, Ph.D., MPBC Executive Director Amy Emerson and MPBC Associate Director of Training and Supervision Shannon Carlin, M.A., participated in a four-day meeting in Boulder, CO., to further develop the training program for MAPS-sponsored MDMA researchers and potential Expanded Access sites. Work included adapting the program for a larger audience, planning refinements to the Treatment Manual, conducting a revision of the online training module (Part A), and building a standard format for in-person therapy trainings. The purpose of these adaptations is to prepare for the upcoming FDA Expanded Access program in 2019, which will involve a massive expansion of the number of people participating in these trainings.
MAPS and MPBC are excited to support the development of MDMA-assisted psychotherapy for PTSD research in Europe and South America. Approximately 60 therapists and researchers will attend a training in the Netherlands from September 27 – October 3, led by Annie Mithoefer, B.S.N. and Michael Mithoefer, M.D. to prepare potential sites to conduct Phase 3 trials in Europe. Another training in Colombia, South America is being planned for early November, led by Marcela Ot’alora, LPC to prepare researchers in Colombia and Chile.
In the coming year, MAPS will apply for a special FDA program called Expanded Access. The program’s purpose is to grant access to potentially beneficial investigational treatments for people facing a serious or immediately life-threatening condition for which there is no satisfactory treatment currently available.
If Expanded Access for MDMA-assisted psychotherapy for PTSD is approved, which both FDA and DEA have indicated is almost certain, new sites in the U.S. may obtain approval and undergo training to administer open-label MDMA-assisted psychotherapy to eligible patients with treatment-resistant PTSD, under a MAPS protocol. Qualified applicants will have a team of therapy providers, a physician, and a facility suitable to conduct MDMA-assisted psychotherapy with approval by regulatory agencies. In the coming years, MAPS may be able to apply for similar programs abroad. The FDA’s website has more information on its Expanded Access program.
Currently MPBC is updating its website, including web pages for the Therapy Training Program. We intend to have an online training application for eligible sites and providers later this year. Complete applications for potential sites to work on a U.S. FDA Expanded Access protocol for MDMA-assisted psychotherapy will be reviewed on an ongoing basis, starting late 2018 and continuing through the duration of the protocol, pending approval. Registration for the first training cohort will take place early 2019. Training events will take place starting March 2019, in locations across the U.S.
If you would like to receive updates about the MDMA Therapy Training Program and Expanded Access plans, as well as learn about upcoming requirements for Expanded Access sites and providers, please sign up online for our training newsletter. Learn more…
Participate in Research
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 will open in the coming months. Please bookmark our Participate in Research page and check it frequently for updates. Learn more…
71st Participant Enrolls in Smoked Marijuana Trial for Chronic PTSD in Veterans
As of Thursday, August 9, 2018, 71 of 76 participants enrolled and received study drug in the first-ever clinical trial of smoked marijuana (cannabis) for treatment of symptoms of posttraumatic stress disorder (PTSD) in U.S. veterans. Taking place at the Scottsdale Research Institute (SRI) in Phoenix, Arizona, this clinical trial will evaluate the safety and efficacy of four different potencies of marijuana for symptoms of PTSD in 76 U.S. veterans. Gabrielle Fortier, M.P.H., Clinical Research Associate of the MAPS Public Benefit Corporation (MPBC), will monitor the site September 4 – 7, 2018. Our recruitment website can be visited here. Learn more…
Are You a U.S. Military Veteran with PTSD?
Military veterans with PTSD are invited to participate in a confidential and federally‐authorized clinical research study of the impact of cannabis on PTSD symptoms. Volunteers must be local to the Phoenix, AZ area. Compensation for time and travel is provided. If you are interested in learning more about this confidential research study, or would like to see if you qualify to participate, please contact Scottsdale Research Institute, LLC: wecanstudy.org
Psychedelic Peer Counseling
Zendo Project Fundraising Campaign and Burning Man 2018
Thanks to an incredible outpouring of generosity from our community, the Zendo Project has raised $101,858 from 381 international donors in under 6 weeks! Your support carried our campaign beyond our initial $70,000 goal as well as our $100,000 stretch goal. Our new $130,000 stretch goal will fully fund the Zendo Project’s services, infrastructure, education, and outreach needs for the entire year of 2018. We are running low on limited edition perks for donors, so don’t miss this opportunity to donate and claim your unique perk!
Starting on Monday, August 27 and ending Monday, September 3, the Zendo Project will provide 24/7 psychedelic peer support services in Black Rock City for anyone having a difficult psychedelic experience. The Zendo Project will be located at 5:45 and Esplanade. We are proud to offer a safe space for our seventh consecutive year.
Here is our full schedule for Burning Man 2018:
Psychedelic Peer Support Services
- When: 24/7 service starting 8PM on Monday, August 27, 2018 and ending 8AM Monday, September 3rd, 2018
- Where: Esplanade & 5:45
- Details: Visit the Zendo Project if you or anyone you know is having a difficult psychedelic experience, or would like support with integrating a prior experience. Please note that in order to keep the space private, the Zendo Project is not open for visitors, only guests and volunteers.
Training, Orientation, and Education
- When: Tuesday, August 28, 2018 • 11:00 AM – 2:00 PM
- Where: 2:30 & Gort (FOAM Against the Machine, Foam Dome)
- Details: The Zendo Project team is hosting a 3-hour educational training focused on principles and procedures for providing psychedelic peer support. Volunteer applications are closed, but this event is open to the public.
Talk: Psychedelic Support and Integration
- When: Friday, August 31, 2018 • 1:00 PM – 2:00 PM
- Where: 8:15 & Cylon (Camp Soft Landing, Palenque Norte)
- Details: Zendo Project Manager Ryan Beauregard is providing education about harm reduction and psychedelic integration.
Harm Reduction Principles and Practices
- When: Wednesday, August 29, 2018 • 1:00 PM – 2:00 PM
- Where: Esplanade & 3:45 (EntheosRising)
- Details: Explore the current state of harm reduction during a panel discussion featuring Zendo Project Director Sara Gael, Mitchell Gomez of DanceSafe, and Meagan Coral of Harmonia.
Psychedelic Integration Circle
- When: Sunday, September 2, 2018 • 4:00 PM – 5:15 PM
- Where: 2:30 & Gort (FOAM Against the Machine, Sanctuary Space)
- Details: Zendo Project team members Shannon Clare Carlin and Linnae Ponté invite you to this supportive space for grounding, respite, and to reconnect with your inner grace.
July 2018 Giving Report: Fundraising for Zendo Project Psychedelic Peer Support Services
MAPS is currently seeking $8.6 million for European Medicines Agency (EMA) trials to supplement the data gathered for the FDA, with $397,735 already raised and roughly $8.2 million still to go. MAPS will have a clearer estimate of costs for Phase 3 EMA trials after we complete our negotiations with EMA and each individual European country, probably by early to mid-2019.
In July 2018, MAPS raised $378,000 in new donations and pledges from 917 supporters.
On July 16, MAPS began fundraising for the Zendo Project, a harm reduction program of MAPS, which provides peer support services at festivals and events around the world. We’ve raised over $100,000 including an $8,000 matching grant from the Riverstyx Foundation which has been entirely matched. Our new stretch goal is $130,000. Find out more here.
We extend a special thanks to those who so generously supported MAPS last month:
- Ullmann Family Foundation ($20,000)
- Garrett Greenburg ($2,500)
- Mack Fuhrer ($2,500)
- Nathan Markovich ($2,500)
- John H. Buchanan ($2,000)
- Bo Zhao ($1,000)
- James Stewart Campbell ($1,000)
- John B. Stuppin ($1,000)
- Marya Hecht ($1,000)
- Nicholas Chubrich ($1,000)
- Paul Stamets ($1,000)
- Sahajia Sarkisian ($1,000)
- Steven Charles Schlansker ($1,000)
Phase 3 MDMA/PTSD U.S.:
- Rebecca Lambert ($50,000)
- Rockefeller Family Fund ($40,000)
- Michael A. Lambert ($20,000)
Phase 3 MDMA/PTSD Europe:
- Abby Rockefeller ($100,000)
- Anonymous ($30,000)
Phase 2 MDMA/End of Life Anxiety:
- Anonymous ($10,000)
- Tim Ferriss ($24,000)
- Anonymous ($15,000)
- Anonymous ($4,193)
- Lucas Jushinski ($2,700)
- Adele Getty & Michael Williams ($2,000)
- Nick Sullivan ($1,547)
- Ethan Devine ($1,000)
- Sir Ivan Wilzig with the Peaceman Foundation ($1,000)
- Tyler Norris ($1,000)
- Nick Sullivan ($1,000)
- Ben Williamson ($1,000)
- Joel Dietz ($1,000)
- Ben & Coy Halper ($1,000)
- Anthony Greenberg ($1,000)
- Bill Fell ($1,000)
- Christoph Schoenfleisch ($1,000)
- Kirsten Kairos ($1,000)
- Ronald A. Mis ($1,000)
- DanceSafe ($700)
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 non-family 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
Featured Media: August 2018
- PRESS RELEASE: First Clinical Trial of Marijuana for PTSD in Veterans Nearly Completes Enrollment
- Written by Brad Burge on August 9, 2018
- Playboy: How the Least Religious City in America Became a Psychedelic Mecca
- Written by Deanna DeBara on June 26, 2018
- Leafly: Healing With the Psychonauts: Psychedelic Medicine Goes Mainstream
- Written by Erika Schickel on July 23, 2018.
- East Bay Express: Can Cannabis Be Considered a Psychedelic?
- Written by Kathleen Richards on July 11, 2018.
- Playboy: The Proof Is in the Trip: Alternative Psychedelic-Laced Therapy Is Changing Lives
- Written by Michelle Janikian on July 10, 2018.
- Psychedelic Times: A Psychedelic Study In Connecticut Aims to Bridge the Racial Gap in MDMA Psychotherapy
- Written by Alexander Lekhtman on July 17, 2018.
- Cosmic Sister: Psychedelic Feminism Grants Hand Talking Stick to Women
- Written by Cosmic Sister on July 10, 2018.
MAPS Podcast: Subscribe for New Episodes
Tune in to the MAPS Podcast, hosted by Zach Leary, for the most up-to-date content from the psychedelic universe! The MAPS Podcast features talks from scientists, cultural luminaries, members of the MAPS team, psychedelic comedians, and other unique individuals who contribute to the ever-growing MAPS community. Subscribe or listen using your favorite podcast portal: iTunes, Stitcher, or Google Play. Listen now…
MAPS Dichroic Glass Pendant
Made with care by the team at Dichroic Alchemy in Ashland, Oregon, each handmade pendant features a shimmering, blue-green dichroic MAPS logo which changes color depending on the angle from which it is viewed. The back of the pendant frames the logo in black. Show your support of psychedelic science with these beautifully subtle pieces. One black satin-nylon cord included with purchase.
$35.00 | Get Your Pendant Today!
LSD Psychotherapy by Stanislav Grof, M.D.
LSD Psychotherapy is a complete account of a remarkable chapter in the ever-continuing inquiry into our transpersonal nature and origins. The controlled studies described in this book reveal exciting and challenging data about the nature of human consciousness, perception, and reality itself. Drawing on this work, Stanislav Grof outlines a new cartography of the human mind, one which accounts for experiences such as shamanic trances, near-death experiences and altered states of consciousness. This vision is also the foundation for Dr. Grof’s revolutionary Holotropic Breathwork techniques.
$19.95 | Buy Now…
The Mushroom Cure: July 20, 2018 – September 7, 2018, New York, New York
They say that laughter is the best medicine, but for one comedian suffering from obsessive compulsive disorder, it just might be psychedelic mushrooms. The Mushroom Cure is the hilarious, harrowing, and heartrending tale of how, inspired by a scientific study, Adam Strauss tried to treat his severe OCD with psychedelics. The Mushroom Cure is written and performed by Adam Strauss, and directed by Jonathan Libman. Learn more…
SAND18 Italy: July 3 – 9, 2018, Orvieto, Italy
Join our friends from the Science and Nonduality (SAND) Conference at the beautiful Castello di Titignano, in Umbria, Italy for a week-long festival designed to expand your mind and heart while celebrating the mystery and beauty of life. The retreat will include talks, experiential workshops, round-tables, music, dance, good food, and an amazing international community of explorers. Incredible natural landscapes surround the castle and allow us to immerse fully and wholeheartedly into this collective exploration. Learn more…
Paul Stamets: Psilocybin Mushrooms and the Mycology of Consciousness: Immersion into the MycoVerse: September 20, 2018, Portland, Oregon
Psychedelic science is making a comeback! Come be a part of the mushrooming psychedelic renaissance on 920 Psilocybin Day with famed mycologist Paul Stamets at Portland’s Newmark Theater. This event is presented by the Portland Psychedelic Society and PSI-2020. Stamets will present his talk, “Psilocybin Mushrooms and the Mycology of Consciousness: Immersion into the MycoVerse.” Learn more…
Psycherence: September 21, 2018, Tallinn, Estonia
Psycherence is the Baltic’s biggest consciousness and psychedelics conference. This is an opportunity to meet the planet’s four leading experts in the field as they present their greatest ideas from their lifelong work. Psycherence offers a vision — a complementary approach to what science has already given us in understanding this intriguing and interesting spectrum of ideas. Learn more…
Horizons: Perspectives on Psychedelics: October 5 – 7, 2018, 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…
Psychedelic Psychotherapy Forum 2018: October 11 – 14, 2018, Victoria, BC, Canada
The Psychedelic Psychotherapy Forum engages mental health professionals and all others interested in advancing the ethical and legal use of psychedelic medicine for healing and growth. Highlight topics at the Forum include psychedelics and the “entropic” brain, Ketamine-assisted psychotherapy, activist therapists who are taking initiatives to change laws, and the training of psychedelic psychotherapists. Learn more…
Colloquium on Psychedelic Psychiatry 2018: October 13 – 14, 2018, Nacka, Sweden
A high quality, 2-day international academic seminar on psychedelic science, with a special focus on the use of psychedelics in psychiatry. “Colloquium” is a latin term with three interpretations, the most common of which refers to an academic seminar. The Colloquium on Psychedelic Psychiatry 2018 will be a high quality, 2-day international academic seminar on psychedelic science, with a special focus on the use of psychedelics in psychiatry. Learn more…
Science and Nonduality (SAND) 2018: October 24 – 28, 2018, San Jose, California
This year, the Science and Nonduality conference will bring together some of the brightest minds in science, along with spiritual teachers from various traditions, to expand and deepen our understanding and experience of what it means to be human. Learn more…
Portland Psychedelic Society Conference: October 27, 2018, Portland, Oregon
Portland Psychedelic Conference is a day-long conference with CEs for mental health professionals, naturopaths, and the public. The Portland Psychedelic Society is community of people who come together to foster evolutionary work on ourselves and help others integrate their experiences and foster their self-work. We emphasize creating an atmosphere of safety and mutual guidance and support, honor, trust, and integrity. Learn more…
Spirit Plant Medicine Conference: November 2 – 4, 2018, Vancouver, British Columbia
Our intention with this eighth annual Spirit Plant Medicine Conference is to offer accurate, respectful, and most of all beneficial information and inspiration on the use of and larger context around such plant medicines. This is an intention arising from a vision and a prayer carried in the hearts of many. To that end, we have assembled an exceptional group of knowledgeable, engaging, and heartfelt speakers to share their wisdom. You’re warmly invited to join us for a remarkable weekend of insight, inspiration, compassion, and yes, humour. Learn more…
KRIYA Ketamine Conference – November 3 – 4, 2018, Hillsborough, California
KRIYA Conference is devoted to the use of ketamine in psychiatry and psychotherapy. Ketamine has been shown in numerous studies to be helpful in the treatment of severe depression and a variety of psychiatric disorders. Ketamine is emerging as a useful adjunct to psychotherapy or as a tool for psycho-spiritual exploration. Learn more…
New Surveys Launched by Psychedelic Research Group (PRG) at Imperial College
The Psychedelic Research Group (PRG) at Imperial College has three large-scale psychedelic survey studies. All surveys are reaching out to people who intend to take a classical psychedelic, but with different focuses:
1.) Psychedelic Survey – a broad survey for users who plan to have a psychedelic experience in the future in any kind of setting except from a ceremony/retreat
2.) Microdosing Survey – a survey for users intending to microdose
3.) Ceremony Survey – a survey for users who will have a psychedelic experience within the frame of a psychedelic drug retreat/ceremony
MAPS Public Benefit Corporation is Hiring
The MAPS Public Benefit Corporation, a wholly owned subsidiary of MAPS, is hiring an Adherence Program Coordinator for upcoming clinical trials. Learn More…
Ayahuasca Global Survey
If you have consumed ayahuasca, you are invited to join over 4,000 people from more than 50 countries in the first global survey of ayahuasca drinking. The research is based at the University of Melbourne and involves an international team of collaborators and partners including MAPS. Take the survey…
Set and Setting Study: Psychedelics and Flow States
Conducted by the Flow Genome Project of Imperial College London, the overarching mission of this study is to improve our understanding of how mental, physical and environmental variables impact peak-experiences. Take the survey…
Johns Hopkins School of Medicine researchers are conducting an anonymous, internet-based survey study about DMT experiences. Learn More…
Huxley’s Last Trip: A Psychedelic Opera
“Huxley’s Last Trip” is a psychedelic performance based on “LSD: The Opera,” which unveils astonishing relationships among literary, scientific, academic, and political leaders in the early period of psychedelic experimentation. Learn more…
Usona Institute: Psilocybin as a Treatment for Depression
The Usona Institute, a psychedelic research organization, is conducting research into the therapeutic potential of psilocybin as a treatment for depression. To learn more and apply as a participant, visit the Usona Institute website.
Now Hiring: The Beckley Foundation (United Kingdom)
The Beckley Foundation is hiring a full-time Communications Officer to join their thriving communications team in Oxford for August. Applicants must have excellent writing and administrative skills, a background in media and communications, and experience working with an NGO or similar organisation, in addition to a right to work in the United Kingdom. Learn More….
Support Psilocybin Research in the United Kingdom
The Psychedelic Society UK’s new video reviews scientific research into the therapeutic potential of psilocybin as a treatment for mental health disorders, highlighting efforts to expedite research in the United Kingdom through government reclassification of psilocybin. Watch the video…
New Documentary: Microdose Me
MAPS Founder Rick Doblin, Ph.D., will be featured in Microdose Me, an upcoming documentary about the effects of psychedelics on depression, anxiety, PTSD, and addiction. Support the completion of this film by contributing to their Indiegogo campaign. Learn more…
Johns Hopkins Survey: Psychedelic Experiences and Psychological Insights
Support psychedelic research by taking a new survey about psychedelic experiences, conducted by researchers from Johns Hopkins University’s Psychedelic Research Team. Take the survey…
MDMA The Movie: 21 Minutes of Footage
Documentary filmmakers producing MDMA: The Movie have released 21 minutes of edited footage, along with the full treatment of the upcoming educational film. This film features interviews with multiple study participants who received MDMA-assisted psychotherapy as a treatment for PTSD in MAPS-sponsored clinical trials. Learn more…