Breakthrough for Trauma Treatment: New Research Paper Published by Frontiers in Psychiatry Journal
Zendo Project Raises $58,647, Fundraising Campaign Ends September 30
September 25, 2019
Dear friends and supporters,
A new publication from the peer-reviewed Frontiers in Psychiatry journal compares data from Phase 2 clinical trials of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD) to research on medications currently approved to treat PTSD. The results from Phase 2 trials of MDMA-assisted psychotherapy for PTSD demonstrated greater safety and efficacy measures than FDA-approved PTSD medications, leading to the U.S. Food and Drug Administration (FDA)’s decision to grant Breakthrough Therapy Designation to MDMA-assisted psychotherapy in August 2017. • Read the Paper
On September 17, 2019, all fifteen sites have officially enrolled a subject in our FDA-regulated Phase 3 clinical trial of MDMA-assisted psychotherapy for PTSD. These MAPS-sponsored Phase 3 clinical trials are taking place at various locations in the United States, Canada, and Israel. “Phase 3” means that previous studies have been completed that suggested MDMA-assisted psychotherapy is safe and effective for treating PTSD. The goal of Phase 3 clinical trials is to confirm results observed in previous Phase 2 studies. The trials are the final phase of research required by the FDA before deciding whether to approve MDMA-assisted psychotherapy as a legal prescription treatment for PTSD. If approved, MDMA will be required to be used in conjunction with psychotherapy in a clinical setting. Our new study recruitment website, mdmaptsd.org, is now accepting applications! • Learn More
The MAPS Bulletin Summer 2019: Research Edition is now available online and in subscriber mailboxes! This version of the MAPS Bulletin includes more than 5 original articles from MAPS staff members and an extensive update on MAPS-sponsored research including Phase 3 trials of MDMA-assisted psychotherapy for PTSD, medical marijuana research, ibogaine-assisted therapy for drug addiction, and ayahuasca research. • Read the Bulletin
We are excited to invite you to multiple upcoming events for MAPS supporters!
The Sleeping Octopus Assembly on Psychedelics (SOAP), in Pittsburgh, Pennsylvania, from September 27-29, 2019, an intimate conference and benefit dinner exploring the role of psychedelics in science, medicine, policy, and culture
Expanding Psychedelic Medicine, the 8th annual MAPS fundraising dinner in New York City, that coincides with the 13th annual Horizons: Perspectives on Psychedelics conference
Psychedelic Science Summit, taking place November 2-3, 2019 in Austin, Texas, a two-day educational conference featuring lectures and panels with leaders of the psychedelic renaissance
The Way of the Psychonaut by Stanislav Grof, M.D., Ph.D., is now available for purchase in the MAPS Store and on Amazon. One of the most important books ever written about the human psyche and the spiritual quest, this comprehensive work is possibly Grof’s greatest contribution. Purchase the two-book paperback set in the MAPS Store or buy eBook Volume 1 and eBook Volume 2 on Amazon.
We congratulate Johns Hopkins Medicine on the launch of the Center for Psychedelic and Consciousness Research, a dedicated study location for researchers to investigate compounds like LSD and psilocybin for mental health problems including anorexia, addiction, and depression. “It’s taken half a century since the backlash against the psychedelic ’60s, but cultural evolution takes time,” said Rick Doblin, Ph.D., MAPS Founder and Executive Director, in an interview with the New York Times. “We’re seeing a global renaissance in public and scientific interest, regulatory approvals and funding for psychedelic research.”
In this month’s edition of the MAPS Newsletter, you’ll also learn:
- A new trial location for our ongoing therapist training study in Santa Fe, New Mexico, has received regulatory approval
- The twentieth participant receives experimental treatment in our ongoing study of the effect of MDMA on startle testing
- Trainees from the MAPS MDMA Therapy Training Program and the C.G. Jung Institute of San Francisco are hosting Encountering the Numinous: Expanded States of Consciousness, Depth Psychotherapy, Analysis and Psychedelics from November 16-17
MAPS, MAPS Public Benefit Corporation (MAPS PBC), and MAPS Europe are hiring and accepting applications for new career opportunities.
- Video Systems Support Specialist (European Union)
- Regulatory Affairs and Submission Specialist (RASS)
- Clinical Study Assistant
- IMP Supply Manager (ISM) – Logistics
- CMC and Project Management Assistant (CPMA)
- Clinical Research Associate
You can support psychedelic science by referring qualified applicants to these open positions.
We hope you have a lovely fall season!
MAPS Web and Email Marketing Associate
Treating PTSD with MDMA-Assisted Therapy
Phase 3 Trials of MDMA-Assisted Therapy for PTSD: All Sites Enroll a Participant
As of September 17, 2019, fifteen of fifteen sites have enrolled subjects for our FDA-regulated Phase 3 clinical trial of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD).
Taking place across the United States, Canada, and Israel, study participants 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-assisted psychotherapy as a legal prescription treatment for PTSD. If approved, MDMA will be required to be used in conjunction with psychotherapy in a clinical setting.
Phase 3 Trials of MDMA-Assisted Therapy for PTSD: Now Enrolling
We are currently seeking research volunteers for Phase 3 clinical trials of MDMA-assisted psychotherapy for PTSD. Volunteers will help contribute to scientific knowledge and will help us better understand if MDMA-assisted psychotherapy works for PTSD. MAPS conducts clinical trials under the guidance and regulations of the U.S. Food and Drug Administration (FDA) in collaboration with all federal regulators, including the Drug Enforcement Administration (DEA). To learn more about our clinical trials or apply to be a study participant, visit our new website: mdmaptsd.org.
Therapist Training Study: New Trial Location Approved for Therapist Training Study: Santa Fe, New Mexico
We are launching a third study location in Santa Fe, New Mexico, for our ongoing therapist training study, which also takes place in Boulder, Colorado, and Charleston, South Carolina. The new study site in Santa Fe has received Drug Enforcement Administration (DEA) and Institutional Review Board (IRB) approval and will be led by Principal Investigator George Greer, M.D. The study site in Boulder is led by Principal Investigator Marcela Ot’alora, M.A., L.P.C., and the study site in Charleston is led by Principal Investigator Zhenya Gelfand, M.D. Enrollment in this multi-site study is limited by invitation only to therapists in training to work on MAPS-sponsored clinical trials of MDMA-assisted psychotherapy for PTSD. To date, a total of 81 participants have enrolled in this Phase 1 study of the psychological effects of MDMA when used in a therapeutic setting by healthy volunteers. • Learn More
Startle Testing with MDMA: Twentieth Participant Receives Experimental Treatment
On September 18, 2019, the twentieth 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. If you have tried MDMA, you may be eligible to enroll in this study investigating the effects of MDMA on the startle response. For more information, please contact email@example.com. • Learn More
MDMA Therapy Training Program Update: September 2019
The MDMA Therapy Training Program has launched a series of trainings to prepare therapy providers to become eligible to work on an MDMA-assisted psychotherapy for PTSD protocol.
The Psychedelic Medicine and Cultural Trauma Community Workshop and the MDMA Therapy Training for Communities of Color events took place in Louisville, Kentucky on August 10-17, 2019. The community leaders, organizers, advocates, therapists, and healers who came together at these two powerful events truly embody the resilient strength and celebration inherent in a gathering around growth, healing, and psychedelic medicine. Inspiring workshop presentations explored community, culture, oppression, racism, traditional healing practices, ritual, earth-based wisdom, harm reduction, integration, policy, education, psychedelic medicines, clinical research, trauma therapy, intergenerational trauma, music, spirituality, and body wisdom. A total of 55 trainees learned about the therapeutic approach of MDMA-assisted psychotherapy. Of the 55 trainees, 53 were clinicians and researchers of color from across the U.S. Trainees brought wisdom and experience to conversations about delivering culturally-informed care. The week’s themes included cultivating the power of community, slowing to the pace of trust and relationship-building, and being involved in local collaborations and initiatives to deliver care and trainings with integrity. Belinda Eriacho, M.P.H., offered a presentation on the history of traditional use of plant medicines in Native populations, including the use of sassafras, which is a precursor to MDMA. This event also inspired and motivated a number of organizational insights and learnings about working cross-culturally and at the cutting edge. Many people contributed to these events in a number of different ways. Presenters during the two events included: Sara Reed, M.S., M.F.T., Camille Barton, Ismail Lourido Ali, J.D., Monnica Williams, Ph.D., A.B.P.P., Belinda Eriacho, MPH, Carl Hart, Ph.D., Marcela Ot’alora, L.P.C., Mellody Hayes, M.D., Kwasi Adusei, D.N.P., PMHNP-BC, Jamilah R. George, M.Div., Joe Tafur, M.D., Terence Ching, M.S., Marca Cassity, L.M.F.T., Rick Doblin, Ph.D., Shannon Carlin, M.A., A.M.F.T., Angella Okawa, M.A., L.M.F.T. Additional support and strength was provided by MAPS and MAPS PBC staff including Angelica Garcia, Natalie Ginsberg, Ritika Aggarwal, Sarah Scheld, as well as MAPS Public Benefit Corporation (MAPS PBC) Advisory Council Members Angella Okawa, L.M.F.T., Camille Barton, Jae Sevelius, Ph.D., Marca Cassity, M.F.T., Sara Reed, M.S. In addition, a number of community leaders rose up and demonstrated their care, insights, and leadership throughout the events. We are excited to work toward making this training and treatment modality more applicable and accessible. Thank you to all who supported these events.
Our next MDMA Therapy Training Program retreat will take place from October 1-8, 2019, in Asheville, North Carolina, and will be led by Annie Mithoefer, B.S.N., and Michael Mithoefer, M.D. Registration for the October training is now full. Future training retreats will be announced through the training newsletter as they are scheduled.
In January 2019, MAPS Public Benefit Corporation (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. We’ve received and responded to several rounds of comments from FDA regarding our protocol submission for Expanded Access, and we will likely hear from the FDA next month. The Expanded Access 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, MAPS PBC will start with a limited number of qualified sites to provide MDMA-assisted psychotherapy for participants with treatment-resistant PTSD under a MAPS PBC protocol.
Sites in the U.S. and U.S. territories interested in being considered to participate in an MDMA/PTSD protocol may now apply with MAPS PBC to assess eligibility and obtain the prerequisite training to administer MDMA-assisted psychotherapy. 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.
Additional site and practitioner requirements are posted on our website. Each site must submit one site questionnaire and all applicants interested in training need to complete a therapy training application for 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.
Zendo Project: Burning Man 2019 and Fundraising Campaign
In late August, the Zendo Project provided psychedelic peer support services and education to 546 guests at Burning Man 2019 in Black Rock City, Nevada. MAPS and the Zendo Project hosted a psychedelic speaker series, EntheoGeneration, which brought in over 30 speakers across various disciplines. The four-day series focused on topics including Major Projects and Research, Mysticism and Spirit, and Plant Medicines; Indigenous and Marginalized Perspectives. Recordings of the presentations will be made available via the MAPS Newsletter and on YouTube soon.
There is still time to donate to the annual Zendo Project fundraising campaign! We still need $41,352 to reach our $100,000 fundraising goal. Donate to the Zendo Project today and receive perks exclusively available for contributors to this campaign! • Donate Now • Learn More
August 2019 Giving Report: MAPS Raises $113,333, Zendo Project Fundraising Campaign Raises $58,647
In August 2019, MAPS raised $113,333 in new donations and pledges from 863 supporters. Of that amount, $82,954 was for general support and $13,357 was for the Zendo Project.
On August 16, MAPS launched our annual crowdfunding campaign for the Zendo Project, a psychedelic peer support program that provides training and services for challenging psychedelic experiences. The Zendo Project is working towards a fully sustainable model where program expenses are entirely covered by event venues and producers or recovered through training fees. Until the Zendo Project achieves full sustainability, we rely on support from individual donors to bring psychedelic harm reduction to the places where it is needed most. This year, $55,000 is available in matching grants from three generous supporters ($30,000 from the Riverstyx Foundation, $15,000 from Connor Hill, and $10,000 from Dan McMurtrie). The first $55,000 in donations to the campaign will be matched dollar for dollar, effectively doubling the impact of these gifts!
Currently, MAPS estimates $9-$10 million is needed for European Medicines Agency (EMA) trials to supplement the data gathered for the FDA. In May 2019, MAPS reached our initial goal of $2 million raised for this program, facilitating the continuation of critical start up activities for the planned trials in multiple European countries.
We extend a special thanks to those who so generously supported MAPS last month:
- Ryan Zurrer ($19,990)
- Craig Comstock ($9,274)
- Robert Tod Chubrich ($5,179)
- Ariel Poler ($5,000)
- Karl Richard ($5,000)
- AmazonSmile Foundation ($3,109)
- Andrew Ryan ($2,500)
- Sahajia Sarkisian ($1,500)
- Tyler Borland ($1,000)
- Adam Goetsch ($1,000)
- Jeffrey Guss ($1,000)
- Chad Hollingsworth ($1,000)
- Frederick Schilling ($1,000)
- Audra Foster ($12,577)
- Candra Docherty ($1,500)
- Shibani Malhotra ($1,000)
Therapists of Color Team Training:
- Tyler Norris ($1,000)
MAPS fiscally sponsors like-minded organizations and projects. This list includes donors who have contributed $1,000+ to organizations we fiscally sponsor.
- Robin Wechkin and Bill Bolosky ($49,687) – AIMS Institute
- Anonymous ($30,000) – From Shock to Awe
- Harry A. Morton ($5,000) – The Mission Within
- Louis Schwartzberg ($5,000) – Prescription X
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
MAPS, MAPS Public Benefit Corporation (MAPS PBC), and MAPS Europe are currently hiring! MAPS is hiring a Outreach and Sales Coordinator and a Community Engagement Associate. MAPS Public Benefit Corporation (MAPS PBC) is currently hiring! MAPS PBC is hiring a Video Systems Support Specialist (European Union), Regulatory Affairs and Submission Specialist (RASS), Clinical Study Assistant,IMP Supply Manager (ISM) – Logistics, CMC and Project Management Assistant (CPMA), and Clinical Research Associate. MAPS Europe is hiring a Clinical Research Associate, a Video Systems Support Specialist, and an Independent Rater. You can support psychedelic science by referring qualified applicants to these open positions.
Featured Media: September 2019
- Breakthrough for Trauma Treatment: Safety and Efficacy of MDMA-Assisted Therapy Compared to Paroxetine and Sertraline
- September 12, 2019
- Boston Magazine: The Interview: MDMA-Therapy Expert Dr. Rick Doblin
- September 10, 2019
- New York Times: Johns Hopkins Opens New Center for Psychedelic Research
- September 4, 2019
- New York Times: Tim Ferriss, the Man Who Put His Money Behind Psychedelic Medicine
- September 6, 2019
- IndieBio: Arvind Gupta & Rick Doblin, Ph.D.
- September 4, 2019
The Way of the Psychonaut: Encyclopedia for Inner Journeys by Stanislav Grof, M.D., Ph.D. (Two-Volume Book Set and eBook)
The Way of the Psychonaut is one of the most important books ever written about the human psyche and the spiritual quest. The new understandings were made possible thanks to Albert Hofmann’s discovery of LSD–the microscope and telescope of the human psyche–as well as other psychedelic substances. This comprehensive work is a tour de force through the worlds of psychology and psychotherapy, Holotropic Breathwork, maps of the psyche, birth, sex, and death, psychospiritual rebirth, the roots of trauma, spiritual emergency and transpersonal experiences, karma and reincarnation, higher creativity, great art, and archetypes. • Two-Volume Book Set: Volumes 1 and 2 • eBook (Volume 1) • eBook (Volume 2)
Browse our Event Calendar page for more opportunities.
Sleeping Octopus Assembly on Psychedelics, Pittsburgh, Pennsylvania, September 27-29, 2019
Hosted at a historic mansion in Pittsburgh, Pennsylvania, SOAP is a yearly conference exploring the role of psychedelics in science, medicine, policy, and culture. In partnership with the Multidisciplinary Association for Psychedelic Studies (MAPS) and the Pittsburgh Psychedelic Society, this year’s event will feature conversations with experts from various realms of the psychedelic renaissance, to broaden horizons and inspire guests with the power of these substances to heal lives and communities. • Learn More
MAPS Fundraising Dinner, September 28, 2019, Pittsburgh, Pennsylvania
On Saturday, September 28, 2019, you’re invited to join MAPS for an intimate benefit dinner in a historic mansion with MAPS Founder Rick Doblin, Ph.D., and Shannon Clare Carlin, M.A., A.M.F.T., Director of Training and Supervision for MAPS’ MDMA Therapy Training Program. The dinner will feature special guest, neuroscientist Dr. Gül Dölen, M.D., Ph.D., of Johns Hopkins Medicine. Space is very limited, so reserve your seat at the table today! This gathering takes place during the second annual Sleeping Octopus Assembly on Psychedelics (SOAP) conference, happening in Pittsburgh, Pennsylvania, from September 27-29. SOAP is hosted in partnership with MAPS and the Pittsburgh Psychedelic Society. • 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
MAPS Benefit Dinner, October 12, 2019, New York, New York
On Saturday, October 12, 2019, you’re invited to join MAPS for our 8th annual benefit dinner in New York City at a private home in Soho, Manhattan. We are thrilled to host special guests Hamilton Morris from VICE TV’s “Hamilton’s Pharmacopeia,” Dr. Rachel Yehuda from Icahn School of Medicine at Mount Sinai, MAPS-sponsored Phase 2 MDMA therapist Will Van Derveer, M.D., and MAPS Founder Rick Doblin, Ph.D. Space is very limited, so reserve your seat at the table today! • Learn More
The Ayahuasca Religions: The Sacrament, the Traditions and the Science, Montreal, Canada, October 19, 2019
The Ayahuasca Religions, The Sacrament, the Traditions and the Science is Canada’s first conference on the religious and scientific aspects of Ayahuasca. • Learn More
The Future of Psychedelic-Assisted Therapy, Montreal, Canada, November 1, 2019
A new wave of clinical research involving psychedelic compounds shows promising results for mental health conditions. MDMA is at the forefront of this psychiatric research; a multinational clinical trial of MDMA-assisted treatment for PTSD is currently underway in Canada, the U.S., and Israel. Sponsored by MAPS, this research holds the potential to make MDMA available to the public as a medicine for use in conjunction with psychotherapy by 2023, revolutionizing treatment for one of humanity’s most debilitating forms of suffering. This evening talk for the general public will include MDMA research therapists introducing and exploring this exciting new frontier in mental health care, including discussing drug effects, the accompanying psychotherapy protocol, and the MAPS research program. • Learn More
Psychedelic Science Summit, November 2-3, 2019, Austin, Texas
Join MAPS and the psychedelic community at Fair Market in Austin, Texas for the first Psychedelic Science Summit! This two-day conference will feature lectures and panels from leaders of the psychedelic renaissance. You’ll have a chance to connect with the fast-growing international psychedelic community and explore the opportunities and challenges that lay ahead for the expanding fields of psychedelic science, medicine, and spirituality. Featuring keynote talks from MAPS Founder Rick Doblin, Ph.D., and mycologist Paul Stamets. Full schedule and speaker lineup to be announced soon. • Learn More
Psychedelics for Clinicians 101 & 102, November 2-3, 2019, Montreal, Canada
This 2-day training offered by psychologists Ingmar Gorman and Elizabeth Nielson is designed for clinicians and healthcare providers who want to learn more about current psychedelic research and clinical practice, including how to work with patients who have a history of psychedelic use or have expressed an interest in using psychedelics. This interactive training includes experiential learning and role-play exercises. It is the first time a program of this kind has been offered in Montreal. • 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
Encountering the Numinous: Expanded States of Consciousness, Depth Psychotherapy, Analysis and Psychedelics, San Francisco, California, November 16-17, 2019
The “psychedelic renaissance” has opened up new vistas of possibility for healthy individuals engaging with the ordinary challenges of daily life yet longing for greater spiritual depth and meaning. What has emerged is the recognition that the healing potential comes not from the drug alone, but from the powerful numinous experiences that often emerge from these expanded states of consciousness — occurring within the context of a secure relationship with a therapist/guide in a contained setting. We will be exploring how a depth psychological perspective has been incorporated into current FDA-approved clinical trials targeting those struggling with hard-to-treat conditions.• Learn More
Participate in Psychedelic Research
MDMA Studies Sponsored by MAPS
MAPS sponsors clinical trials around the world that offer volunteers the opportunity to participate in our research studies. Our studies have strict enrollment criteria based on the goal of the study and the condition the study is investigating.
Ayahuasca Ceremony and Retreat Participant Survey
This is an anonymous survey gathering preliminary data about the safety and ethics of ayahuasca ceremonies in various settings. The data collection is a part of the doctoral dissertation work of the principal investigator, Jessica Brown, M.A., L.M.F.T. • Learn More
Thank you to Dr. Bronner’s for their company’s support of the MAPS Newsletter!