Medical-Grade MDMA Arrives at Multiple Phase 3 Clinical Trial Sites
Just Five Days Left to Donate to Our Annual Year-End Fundraiser
December 26, 2018
Dear friends and supporters,
We are amazed by the overwhelming support we have recently received from MAPS supporters. In just six weeks, 1,354 donors have raised $301,645 in support of legal psychedelic research, exceeding our initial $300,000 year-end fundraising goal. We are now working toward our $400,000 stretch goal, and all additional donations support the continued expansion of our work. As we approach the new year, we are extremely thankful to those who are supporting our fundraising campaign.
There are still five days left to make a tax-deductible donation in 2018, which will help us fund the development of psychedelic medicine.
Stretch Goal: $400,000
$301,645 raised by 1,354 generous donors
The first shipment of pharmaceutical-grade MDMA for Phase 3 clinical trials has arrived at study sites in New Orleans, Louisiana, Charleston, South Carolina, Fort Collins, and Boulder, Colorado. Made under Good Manufacturing Practices (GMP) in a certified laboratory, this study drug will be administered in conjunction with psychotherapy to study participants. Eight study sites across the United States are currently screening participants.
The Zendo Project is celebrating their sixth consecutive year of providing psychedelic peer support services and education. Throughout 2018, over 900 guests were supported by compassionate volunteers. • Learn More
In the December 2018 edition of the MAPS Newsletter, you’ll also learn:
- MAPS Public Benefit Corporation is hiring an Admissions Coordinator
- Our ongoing therapist training study enrolls the 71st participant
- Explore participation opportunities for 2019 on the MAPS Event Calendar
- The MAPS Podcast features the State of the Psychedelic Union panel, presented by Shannon Clare Carlin, M.A., and Cole Marta, M.D.
The MAPS Store Winter Sale continues until January 11, 2019. Don’t miss this opportunity to receive discounts up to 30% off on a variety of unique items! • Shop and Receive Discounts
We are excited to welcome opportunities for psychedelic research in the new year.
MAPS Web and Email Marketing Associate
Treating PTSD with MDMA-Assisted Therapy
Medical-Grade MDMA Arrives at Multiple Phase 3 Clinical Trial Sites
This month, MAPS study sites in New Orleans, Louisiana, Charleston, South Carolina, Fort Collins, and Boulder, Colorado received a shipment of pharmaceutical-grade MDMA, made under current Good Manufacturing Practices (GMP) in a certified laboratory, to be administered in conjunction with psychotherapy to study participants.
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.
Our Phase 3 researchers have completed a total of eight study site initiation visits for Phase 3 within the United States, and we are scheduling seven study site initiation visits for remaining study sites in the United States, Canada, and Israel in early 2019.
Do you have PTSD? You may qualify for a study of an investigational drug (MDMA) used in combination with psychotherapy. • Learn More
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: 25th Participant Completes Treatment
Twenty-five 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: 71st Participant Enrolls
On December 20, 2018, the 71st 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
MDMA Therapy Training Program: November 2018 Update
Currently, the MDMA Therapy Training Program is preparing for the launch of a series of Expanded Access training events in the US next year. In the coming weeks, the Multidisciplinary Association for Psychedelic Studies (MAPS) will apply for a special U.S. FDA program called Expanded Access (EA), which allows the use of an investigational treatment outside of a clinical trial. If the FDA agrees with the protocol, Expanded Access for MDMA-assisted psychotherapy for PTSD would allow additional qualified sites in the U.S. 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. Since Expanded Access is a U.S. FDA program, only sites in the U.S. and U.S. territories may participate. International programs may become available in the future.
An online application for sites in the U.S. and U.S. territories that are interested in the MDMA PTSD Expanded Access protocol will be published early in the new year at maps.org. The MPBC Training and Supervision Department will review applications on an ongoing basis. The training department is developing a platform for therapists and sites to connect online in the interest of establishing clinics for Expanded Access.
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 and stay tuned for website updates and application material in the new year.
In January 2019, the MDMA Therapy Training Program will host a training event in Israel to prepare Israeli therapists to work on an Open Access protocol. Over the next year or two, as Phase 2 and 3 trials in Europe progress and additional protocols are developed and approved internationally, the MDMA Therapy Training Program will offer more training opportunities for international providers.
The MDMA Therapy Training Program is currently drafting a Code of Ethics for MDMA therapy providers, focusing on the professional guidelines for ethical therapeutic relationship. We are committed to reflecting internally on ethical care, to incorporating ethics as a foundation for our training curriculum, and collaborating with a growing network of psychedelic psychotherapy providers. When the Code of Ethics is finalized, it will be published online. Given the special ethical considerations of MDMA-assisted psychotherapy, as a psychedelic organization, we take seriously our commitment to safety.
MAPS recently received a grant from Open Society Foundation (OSF) to support an MDMA Therapy Training event for Communities of Color in August 2019 led by Marcela Ot’alora G, L.P.C., and Monnica Williams, Ph.D., 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 enrollment of subjects to those with PTSD from racial trauma, and to inform the ongoing development of culturally-informed curriculum within the MDMA Therapy Training Program. 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. More information on this event, including date, time, and application information will be posted online in the coming weeks. If you would like to support MDMA Therapy Training opportunities for people of color, please consider 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. • Learn More
Psychedelic Peer Support
Zendo Project Celebrates Sixth Year of Psychedelic Peer Support Services
As the year comes to a close, the Zendo Project is celebrating our sixth year of providing psychedelic peer support services and education. In 2018, we assisted over 900 guests and offered over a dozen public trainings. We thank our volunteers, donors, and supporters for helping us continue to expand psychedelic harm reduction. The Zendo Project looks forward to another year of co-creating a community of compassionate care. • Learn More
November Giving Report: MAPS Seeks Funding for European Studies
Your support helps makes psychedelics into legal medicines. By making a tax-deductible donation to MAPS, you can help heal posttraumatic stress disorder (PTSD), anxiety, addiction, and other conditions.
Currently, MAPS is also seeking $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 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, and with each site.
In November 2018, MAPS raised $390,444 in new donations and pledges from 1,072 supporters.
We extend a special thanks to those who so generously supported MAPS last month:
- Mai Family Foundation ($50,000)
- Michael Pollack ($25,000)
- Anonymous ($15,000)
- John B. Gunn, Jr. ($10,000)
- David Morhovich ($5,000)
- John and Carole Garand ($5,000)
- Regina Cannon ($3,826)
- Patricia and Richard Simon ($3,600)
- Judith Posner ($1,000)
- Anonymous ($1,000)
- Anonymous ($1,000)
- Anonymous ($1,000)
- Anonymous ($1,000)
- Laura Wiginton ($1,000)
- Magaly Mauer ($1,000)
- Anonymous ($1,000)
- Matthew Jamerson ($1,000)
- McIover Steiner ($1,000)
- Molly Kovite ($1,000)
- Peter Taubkin ($1,000)
- Robert Gansser ($1,000)
- Anonymous ($1,000)
Phase 3 MDMA/PTSD U.S.:
- Frank Kienast ($20,000)
- Jamie Snider ($10,000 for Emory site)
- Sarena Snider ($10,000 for Emory site)
Therapists of Color Training:
- Open Society Foundation ($70,000)
- Anonymous ($100,000)
Marijuana for PTSD:
- Julie Holland ($2,568)
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 $15 or more. maps.org/donate
Featured Media: November 2018
- Independent: MDMA is now proven to help those with trauma – so let’s decriminalise it and put it back in the medicine cabinet
- Written by David Nutt on November 20, 2018
- Psychedelic Times: Let’s Talk About Compass And Psychedelic Capitalism: Interview with Rick Doblin
- Written by Wesley Thoricatha on November 21, 2018
- Wired: MDMA Makes People Cooperative and Helps Build Trust After Betrayal
- Written by Sanjana Varghese on November 23, 2018
- Inverse: MDMA Clinical Trials Are Now Open for Enrollment at Five Sites in the US
- Written by Peter Hess on November 29, 2018
- Psych Congress Network: Phase 3 Trials to Test MDMA-Assisted Therapy for PTSD
- Written by Jolynn Tumolo on December 7, 2018
- Life is a Festival Podcast: Just Say Know: The State of Psychedelics in 2018 with Brad Burge
- Written by Eamon Armstrong on December 11, 2018
MAPS Podcast: Episode 32 – Dr. Cole Marta and Shannon Clare Carlin, M.A.
This episode of the MAPS Podcast is the State of the Psychedelic Union panel recorded live at PsyFire festival in Los Angeles, California, featuring Dr. Cole Marta and Shannon Clare Carlin, M.A., and moderated by Zach Leary. The discussion covers the current state of psychedelic research as it relates to Phase 3 clinical trials of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD), antidepressant treatments with ketamine, the Zendo Project, and cognitive liberty for all of us. • Listen Now
MAPS Store Winter Sale
The MAPS Store Winter Sale continues until January 11, 2019! Take this special opportunity to receive discounts up to 30% off when expanding your psychedelic library, purchasing a gift for a friend, or acquiring a historic artifact for your collection. All sales contribute to MAPS’ mission to make psychedelic-assisted therapy a legal treatment. • Shop and Receive Discounts
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
The Mushroom Cure: January 3, 2019, 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 hallucinogenic mushrooms. The Mushroom Cure is the true story of how Adam Strauss tried to cure his severe OCD with psychedelics. 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. • 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
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
Iboga/Ibogaine Community Engagement Initiative
The International Center for Ethnobotanical Education, Research & Service (ICEERS) is leading working on engaging the global iboga/ibogaine community in a process of inquiry that captures key strengths and assets, identifies promising strategies and best practices, and builds the foundation for a shared vision. ICEERS is now launching a survey about iboga and ibogaine, and you are invited to participate. The survey takes between 10 to 25 minutes to fill out, depending on your profile and on how many ideas and opinions you have on various issues. Your participation is completely voluntary and anonymous; all information will be treated with the strictest confidentiality. No identifying information from any of the participants will be recorded or disclosed under any circumstances. Survey responses will be stored on a private, secure server. • Take the Survey