Eight Sites Officially Screening in Phase 3 Clinical Trials
January 28, 2019
Dear friends and supporters,
We are excited to announce that eight sites are officially screening for our Phase 3 clinical trial of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD). Study volunteers 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. Seven additional Phase 3 sites will be starting in the next several months.
We are thankful to our generous donors for the outpouring of support to our year-end fundraising campaign. In seven weeks, a total of 1,949 donors from 43 countries contributed $429,289, reaching 143% of our initial $300,000 goal. We also fulfilled the $40,000 matching grant provided by Ed Littlefield and the $50,000 matching grant provided by Justin Rosenstein in support of MAPS’ mission. Thank you to our contributors to psychedelic research and education!
In a new video from Inc., MAPS Founder and Executive Director Rick Doblin, Ph.D., speaks about MAPS’ progress towards the goal of legalizing MDMA-assisted psychotherapy for the treatment of PTSD and other mental health conditions. Study participant Jonathan Lubecky, U.S. Army SGT(R), is interviewed about his participation in MAPS-sponsored Phase 2 clinical trials of MDMA-assisted psychotherapy for PTSD.
In the January 2019 edition of the MAPS Newsletter, you’ll also learn:
- Our ongoing therapist training study enrolls the 73rd participant
- The Students for Sensible Drug Policy International Conference takes place March 29-31, 2019 in Rosemont, Illinois, with a keynote from Rick Doblin, MAPS Founder and Executive Director
- The MAPS Podcast features a discussion with Matthew Baggott, Ph.D., on MDMA and emotions
MAPS is a proud partner of the Arizona Psychedelics Conference in Tempe, Arizona, from February 8-10, 2019. This three-day event is the first psychedelic conference to take place in Arizona and is an opportunity to learn from MAPS staff and researchers including Brad Burge, M.A., Bia Labate, Ph.D., Sue Sisley, M.D., Veronika Gold, M.A., M.F.T., Eric Sienknecht, Psy.D., and a Zendo Project workshop facilitated by Sara Gael, M.A., and Ryan Beauregard, B.A.
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Thank you for helping MAPS to reach new milestones. We are more excited than ever to advance our mission!
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: 8 Sites Screening Participants
This month, our Phase 3 multi-site study of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD) is continuing to open sites for screening. Eight sites are open for screening at this time. Study volunteers 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.
Our FDA-regulated Phase 3 clinical trials of MDMA-assisted psychotherapy for PTSD are taking place at 15 locations across the United States, Canada, and Israel. Eight study sites are currently recruiting participants.
Our Phase 3 researchers have completed a total of eleven study site initiation visits for Phase 3 within the United States, and we are scheduling three study site initiation visits for additional study sites in the United States, Canada, and Israel in the coming months.
The 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 an outpatient setting. • Learn More
Open-Label Lead-In Study of MDMA-Assisted Therapy for PTSD: 26th Participant Completes Treatment
Twenty-six participants have completed treatment 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 provide supervision for our co-therapy teams. Study sites are now enrolling and 7 sites are fully enrolled. The study is expected to be completed in early 2019.
Therapist Training Study: 73rd Participant Enrolls
On January 15, 2019, the 73rd participant officially enrolled in our ongoing Phase 1 study of the psychological effects of MDMA when used in a therapeutic setting by healthy volunteers. 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. The Boulder, Colorado, study site is led by Principal Investigators, Marcela Ot’alora, M.A., L.P.C., and Wael Garas, M.D. Michael Mithoefer, M.D., is serving as Principal Investigator at the site in Charleston, South Carolina with Sub-Investigator Annie Mithoefer, B.S.N. • Learn More
Expanded Access Training Update
The MDMA Therapy Training Program is preparing to launch a series of trainings for therapy providers who will provide MDMA-assisted psychotherapy for PTSD under a MAPS-sponsored Expanded Access protocol, pending protocol approval. As of this week, Multidisciplinary Association for Psychedelic Studies (MAPS) has now submitted the Expanded Access protocol to the FDA for review. Expanded Access is a special FDA program which allows the use of an investigational treatment outside of a clinical trial. 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. The FDA’s website has more information on its Expanded Access program.
Pending approval, Expanded Access for MDMA-assisted psychotherapy for PTSD would allow additional qualified sites in the US to provide this treatment to eligible patients under a MAPS treatment protocol. The basic requirements of a qualified site are: 1) facility conducive to this treatment, 2) qualified and trained therapy team, 3) Medical Doctor who can obtain a DEA Schedule 1 license for MDMA. Sites must also gain Drug Enforcement Administration (DEA) approval to manage, store, and administer MDMA, a controlled substance.
An online application for sites in the US and US Territories that are interested in the MDMA PTSD Expanded Access protocol will be published within the next two weeks on maps.org and will be distributed through the training newsletter. For sites and therapists interested in working under a MAPS protocol (Expanded Access or otherwise), there are two layers of application: 1) Site Questionnaire, and 2) MDMA Therapy Training Application for Providers. Each site must submit one Site Questionnaire. Additionally, each therapy provider must submit an MDMA Therapy Training Application for Providers. Only applicants affiliated with a qualifying site can be considered for training to be eligible to work on Expanded Access or another MAPS protocol. Applications will be reviewed on a rolling basis, and several training cohorts of 60 trainees are anticipated to be enrolled in 2019, with training events at various locations in the US.
Since Expanded Access is a US FDA program, only sites in the US and US territories may participate. International programs may become available in the future. As one example, the MDMA Therapy Training Program will host a training event in Israel in January, as a collaboration with the Israeli Ministry of Health, to prepare Israeli therapists to work on an Open Access protocol.
One Expanded Access training event, scheduled in August 2019, will be an MDMA Therapy Training event for Communities of Color led by Marcela Ot’alora G, LPC, and Monnica Williams, PhD, with support from additional trainers. The purpose of this training is to ensure that MDMA therapy will be available to communities of color by training therapy providers of color in this modality, to expand thinking about PTSD to include racial trauma, and to inform the ongoing development of culturally-informed curriculum within the MDMA Therapy Training Program. The Multidisciplinary Association for Psychedelic Studies (MAPS) recently received a grant from Open Society Foundation (OSF) to support this training, and MAPS will continue to fundraise for this specific event, and to provide training opportunities for therapy providers who come from or work with marginalized communities. If you would like to support MDMA Therapy Training opportunities for people of color, please consider making a donation.
The MDMA Therapy Training program has also created an online portal for therapy providers and sites to network with each other, to connect in the hopes of building a site, or growing staff, to work on an Expanded Access MDMA PTSD protocol, pending FDA approval. This portal will be sent via the training newsletter within the next two weeks. If you are looking for more staff, an MD, or other needs, we hope that this platform will support you. Please sign up for the training newsletter to ensure updates. making a donation. • 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 is now open. Please bookmark our Participate in Research page and check it frequently for updates.
Support MAPS
December Giving Report: Breakthrough for Psychedelic Medicine
Currently, MAPS seeks $9 million for European Medicines Agency (EMA) trials to supplement the data gathered for the FDA, with $897,735 already raised and roughly $8.1 million still to go. We have completed key negotiations with EMA, and we will have an ever 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, and with each site.
In December 2018, MAPS raised $743,855 in new donations and pledges from 1,671 supporters. Of that amount, $508,215 was for general support, $131,290 for Phase 3, $64,250 for therapist training, $40,000 for Expanded Access, and $100 for other projects.
We extend a special thanks to those who so generously supported MAPS last month:
General Support:
- Justin Rosenstein ($50,000)
- The Entheogen Fund ($30,000)
- Dale Okuno ($25,000)
- Ron Beller ($25,000)
- Sami Inkinen ($25,000)
- Ranch Santa Fe Foundation ($17,000)
- Hull Family Foundation ($15,000)
- Poore Foundation ($15,000)
- Peter H. and E. Lucille Gaass Kuyper Foundation ($15,000)
- Chris Freund ($10,000)
- René Ruiz ($10,000)
- Samuel Friedman ($10,000)
- Anne F. St. Goar & Shippen Page ($9,882)
- Aubrey Marcus ($6,621)
- William JJ Gordon Foundation ($6,000)
- Andrew Kirk Gradison ($5,000)
- Ashley Gordon ($5,000)
- Carter Thomas ($5,000)
- David Roth ($5,000)
- Gale Hayman ($5,000)
- Jennifer Abele ($5,000)
- Pamela & Don Lichty ($5,000)
- Paul & Kristina Eklund ($5,000)
- Yavanna Foundation ($5,000)
- Anonymous ($5,000)
- Elliot Godzich ($3,250)
- Colin Wilson ($3,000)
- Gopal & Ann Reddy ($3,000)
- Harris and Eliza Kempner Fund ($3,000)
- Michael McPhee ($3,000)
- Rachel Hamilton ($3,000)
- Anonymous ($2,500)
- Emily Swanson ($2,500)
- Justin Boseant ($2,500)
- Michael Mithoefer ($2,500)
- Shwartz Family Foundation ($2,500)
- Andrea Snetsinger ($2,000)
- Andrew Koraleski ($2,000)
- Anonymous ($2,000)
- Cameron Cheever ($2,000)
- Anonymous ($2,000)
- Mack Fuhrer ($2,000)
- Mark S. Smith ($2,000)
- Piper Mavis ($1,500)
- Grant Leonard ($1,100)
- Adrian B Pichurko ($1,000)
- Alisa Cohn ($1,000)
- Bill Freimuth ($1,000)
- Bonnie Brunet & Martin Rist ($1,000)
- Brian Reily ($1,000)
- Caleb Whitten ($1,000)
- Chris & Monica Graff ($1,000)
- Christian & Christine Morgan ($1,000)
- Daniel Ross ($1,000)
- Anonymous ($1,000)
- David Golob ($1,000)
- Dawn McCollough ($1,000)
- Anonymous ($1,000)
- Doug Hutchinson ($1,000)
- Doug Robinson ($1,000)
- Duke DeLoache ($1,000)
- Erik Bouchard ($1,000)
- Fernanda Giroleti Weiden ($1,000)
- Herman A. Watson ($1,000)
- Ingrid & Anthony Lombardino ($1,000)
- Jacob Sablosky ($1,000)
- James D. Northrup ($1,000)
- James Stewart Campbell ($1,000)
- Jason Brett ($1,000)
- Jerry Greenfield ($1,000)
- Jeya Aerenson ($1,000)
- Jo Kurth Jagoda ($1,000)
- John & Barbara Crary ($1,000)
- John Green ($1,000)
- Anonymous ($1,000)
- Kevin S. Feldman ($1,000)
- Laney & Pasha Thornton ($1,000)
- Leigh Marz & Michael Ziegler ($1,000)
- Les Szabo ($1,000)
- Martha Stampfer ($1,000)
- Mason F. Lord, Jr. ($1,000)
- Michael Pollan & Judith Belzer ($1,000)
- Michelle Glass ($1,000)
- Peggy Hitchcock ($1,000)
- Robert & Nancy Ley ($1,000)
- Robert Ackerman ($1,000)
- Rosemarie Rotella ($1,000)
- Sam Hummel, Jr. ($1,000)
- Stephen & Jerri Harrison ($1,000)
- Steve Zenone ($1,000)
- Tobias Bruns ($1,000)
- Anonymous ($1,000)
Phase 3 MDMA/PTSD U.S.:
- PSFC ($125,000)
- Elliot Godzich ($3,250)
Therapists of Color Training:
- Jonathan Daining ($4,000)
Expanded Access (Colorado):
- Telluray Foundation ($40,000)
Therapist Training Study:
- Telluray Foundation ($60,000)
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: January 2019
- Inc: This Entrepreneur Is About To Legalize Ecstasy
- Published on January 14, 2019
- CBC Radio: The Big Trip: How Psychedelic Drugs Are Changing Lives and Transforming Psychiatry
- Written by Deanne Bender on December 28, 2018
- Stat News: What Will 2019 Bring for Science and Medicine? We Asked the Experts
- Written by Stat Staff on December 31, 2018
- Quartz: These Are The Science Concepts You Need to Know To Understand Political Life in 2019
- Written by Elijah Wolfson, Akshat Rathi, Olivia Goldhill, Zoë Schlanger, Chase Purdy and Katherine Ellen Foley on December 30, 2018
- Vice: The Steady Rise of the Trippy Festival
- Written by Kevin Franciotti on December 19, 2018
- Motherboard: The Decline of American Peyote
- Written by Daniel Oberhaus on December 14, 2018
MAPS Podcast
MAPS Podcast: Episode 33 – Matthew Baggott – Beyond Fear – MDMA and Emotion
This episode of the MAPS Podcast features a discussion from Matthew Baggott, Ph.D., on how MDMA and related drugs alter emotions and social functioning in people.
Matthew Baggott, Ph.D., is a neuroscientist who has been studying the perceptual and emotional effects of drugs like MDMA in healthy human volunteers for over 13 years. He was part of the first team to receive federal funding to administer MDMA to healthy people and he co-authored the first successful application to administer MDMA to people with posttraumatic stress disorder (PTSD). He earned his Ph.D. in neuroscience from the University of California, Berkeley and is currently a postdoctoral fellow at University of Chicago. • Listen Now
MAPS Store
The Fellowship of the River: A Medical Doctor’s Exploration into Traditional Amazonian Plant Medicine by Joseph Tafur, M.D.
Western medicine has not been particularly successful at relieving people from conditions like depression, chronic pain, migraine headaches, addiction, and PTSD. Dr. Tafur helps us to understand why. Too often, the Western medical approach fails to address the emotional dimension of illness. This is where traditional plant medicines, with their ability to alter consciousness and open channels of communication to our emotions, offer so much promise. The stories shared here demonstrate the astonishing—mystical, colorful, metaphysical—effects of ayahuasca and Traditional Amazonian Plant Medicine. Follow Dr. Tafur through the Amazon jungle as he develops a breakthrough understanding of how psychoactive plants interact with the complex network that connects our minds and hearts to our physical anatomy. • Buy Now
PiHKAL: A Chemical Love Story tells the tale of a psychopharmacologist and his wife/research partner and their decades devoted to the creation and investigation of psychedelic drugs as tools for the study of the human mind. Altered state experiences are explored in the context of intimacy. In TiHKAL: The Continuation, the authors continue their exploration of the chemistry and transformative power of psychedelic drugs, devoting this volume to tryptamines, β-carbolines and LSD analogues. • Buy Now
Events
Browse our Event Calendar page for more opportunities.
Free 90-Minute Live-Session Online Breathwork Workshop For Friends of MAPS
A large percentage of people who experience Dr. Stan Grof’s Holotropic Breathwork feel they access the same range of experiences that they do during psychedelic sessions. In this special offer for MAPS supporters, we’re offering you a free workshop to try this powerful modality for yourself. • Claim Your Code • Learn More
Arizona Psychedelics Conference: February 8-10, 2019 Tempe, Arizona
The first psychedelic conference of Arizona is a three-day event seeking to examine the therapeutic potential of psychedelics like psilocybin, ayahuasca, peyote, MDMA, DMT, ibogaine, ketamine, cannabis, and more. Join us to examine the role of psychedelic drugs and plant medicines in science, medicine, culture, and spirituality. Over the course of the weekend, we will explore these topics through a series of presentations, workshops, panel discussions, and a marketplace. • Learn More
Psychedelics 101 & 102 for Clinicians: February 9-10, 2019, New York, New York
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. • Learn More
Psychedelic Harm Reduction and Integration Clinical Consultation Group: February 14 – May 2, 2019, New York, New York
The Psychedelic Education and Continuing Care Program provides education and training for clinicians who are interested in learning about psychedelic clinical research and providing harm reduction and integration psychotherapy for people who use, or are thinking about using psychedelics. Our Psychedelic Harm Reduction and Integration Psychotherapy (PHRIP) Consultation group is a 12-session weekly group meeting for clinicians who have taken our Psychedelics 101 & 102 for Clinicians intensive training or have similar background knowledge. • Learn More
The Students for Sensible Drug Policy International Conference, March 29-31, 2019, Rosemont, Illinois
SSDP2019: The Global Students for Sensible Drug Policy Conference will bring more than 400 student members, alumni, and supporters to the Chicago area from March 29-31 for our annual gathering. Rick Doblin, MAPS Founder and Executive Director, will offer the keynote speech. • Learn More
The Association for Transpersonal Psychology (ATP) International Transpersonal Conference, April 12-14, 2019, Pacific Grove, California
The Association for Transpersonal Psychology (ATP) will be celebrating its 50th anniversary in 2019 with an exciting conference. The theme of the conference is “The Future of Transpersonal Psychology: Acknowledging the Past, Honoring the Present, and Envisioning the Future.” In 1969 the transpersonal psychology field came into existence when ATP being granted non-profit status and published its first issue of the Journal of Transpersonal Psychology. We warmly invite you to join us in the historic celebration at the beautiful Asilomar Conference Grounds, overlooking the Pacific Ocean, where many previous ATP conferences were held. • 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
More News
Now Hiring: MAPS Public Benefit Corporation
MAPS Public Benefit Corporation is seeking an enthusiastic, focused, and organized person to join our Training and Supervision team. The Admissions Coordinator plays a major role in the interactions between the MDMA Therapy Training Program and the public through close tracking of communications and applicants using online systems. This outward-facing position requires someone excited to engage with people and adept at database management. • Learn More
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. • Learn More
In Memory of Tom Taussig: A Eulogy
We mourn the passing of Tom Taussig with this beautiful eulogy written by Patricie Anzari and translated from Czech into English by Nathan Cutler:
Tom died on December 7, 2018 in the cozy, welcoming home he built with his own hands in Point Richmond, on the banks of San Francisco Bay. He was born on February 17, 1933 in Prague, Czechoslovakia. Faced with Nazi persecution, his family fled to the United States when he was seven years old. Though he became an American, throughout his life he maintained fluency in his native Czech language, enriching it from time to time with endearing neologisms.
In his first profession as a computer science professor at Berkeley, Tom was an expert on the Internet. Later, he switched to experiential, transpersonal psychotherapy. He accompanied hundreds of people from many countries of the world as they explored the inner depths, both of their own souls and of the universe itself. Everywhere he went, he sowed hope and opened hearts. Never domineering or even dominant, he was always friendly and unassuming. He never drew attention to himself – he had his assistants lead his workshops, for example – yet somehow he was always the prime mover. His method was one of loving, selfless service. He enjoyed connecting his friends from various corners of the world, and by the end of his 85-year life he had created an informal, planet-spanning network of people not on the egocentric materialism bandwagon – a network of mutual assistance and support.
For me personally Tom was a teacher, a steadfast friend, and a liberator from the bonds of totalitarianism. We met in 1984, at an underground seminar in what was then Czechoslovakia. For me it was a turning point: my first realization that the psychology I had studied in college had another side – a different and wonderful version of itself that spontaneously grew in me, in spite of being roundly rejected by the uptight rules of “conventional science.” There, at that secret seminar, for the first time in my life I witnessed the miracle of emotional engagement, worked by a caring therapist not embarrassed to hug his clients and share his personal life story with them.
Tom drew aside the Iron Curtain for me, helping me to leave the country in 1986 to spend three transformative months in the USA. There, he introduced me to my principal teachers: John Weir Perry, Stanislav Grof, Ram Dass, and Chunliang Al Huang, among others. In 1990, two months after the Velvet Revolution in Czechoslovakia, I embarked on an independent path, opening a private transpersonal psychotherapy practice and, over time, developing my own method called Active Egolysis. Tom came to visit every year and collaborated with me at my workshops. Later, he helped me equip a center for multi-day programs. Re-reading this incomplete listing of his influences on me, I could easily succumb to a feeling that I was an important figure in his life. But I know better: I am but one of many, many friends from around the world whom he gifted in a similarly generous manner.
Tom was a man of modest means: making others happy was the only thing that made sense to him. An excellent and innovative cook, he loved to invite groups of friends over for dinner. Every Sunday evening when he was in California, his home was open to one and all. He loved socializing and getting to know new people and cultures. He was transpersonal in the true sense of the word: he transcended his own person, and his Ego demanded the wellbeing of others. Having left his worldly body behind, Tom continues to accompany and encourage us. The flame of his soul is inextinguishable.