European Medicines Agency (EMA) Hosts Scientific Advice Meeting with MAPS
June 22, 2018
Dear friends and supporters,
This month in London, United Kingdom, MAPS had a successful meeting with the European Medicines Agency (EMA) to obtain scientific advice for European clinical trials of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD) licensure. The discussion with the Scientific Advice Working Party (SAWP) of EMA focused on scientific advice for the clinical development of MDMA-assisted psychotherapy for treatment of PTSD in Europe. Data gathered in European Phase 3 trials would provide support for a planned Marketing Authorization Application for EMA.
In other global news, researchers in Brazil recently conducted the first MDMA-assisted psychotherapy session for a Brazilian investigator-sponsored open-label therapist training study, supported by collaboration with MAPS. The purpose of smaller investigator-sponsored studies in countries around the globe is to supplement FDA and EMA data to support licensure in other countries.
The most recent newsletter from the National Center for PTSD highlights the results of MAPS’ Phase 2 trial of MDMA-assisted psychotherapy for the treatment of posttraumatic stress disorder (PTSD) in veterans, firefighters, and police offers. “Findings from this study suggest that MDMA-assisted psychotherapy is a potential strategy for enhancing treatment outcome in PTSD.” Read the newsletterhere.
We are excited to share the newest edition of the MAPS Bulletin, now available online and in subscribers’ mailboxes! The theme for our Spring 2018 Special Edition is “Breakthrough,” which features 17 new articles about the growing field of psychedelic science from authors including Amanda Feilding, Michael Mithoefer, M.D., and Allison Feduccia, Ph.D., along with an article by John Densmore, drummer for The Doors.
You are invited to join MAPS and our community in Pittsburgh, Pennsylvania this July for the Sleeping Octopus Assembly on Psychedelics (SOAP), a 3-day conference featuring leaders of the psychedelic research renaissance. This intimate gathering takes place from July 13-15, and features two days of psychedelic education, a MAPS benefit dinner, a comedy show, live music, and much more. Tickets are currently on sale, and we hope to see you there!
In the June 2018 edition of the MAPS Newsletter, you’ll also learn::
- Our ongoing therapist training study enrolls the 65th participant
- 64 out of 76 participants have enrolled and received study drug in our clinical trial of smoked marijuana for PTSD in U.S. veterans
- The Zendo Project hosted a sold-out workshop with Alex Grey and Allyson Grey at the Chapel of Sacred Mirrors (COSM)
The MAPS Summer Sale is continuing through the end of June, so don’t miss your chance to support MAPS and receive up to 40% off in discounts on books, apparel, and other select items in the MAPS Store.
Thank you for supporting our efforts to heal and uplift others.
MAPS Web and Email Marketing Associate
Treating PTSD with MDMA-Assisted Therapy
Phase 3 Trials: MAPS Meets with European Medicines Agency (EMA)
On June 12, 2018, MAPS had a successful meeting in London, United Kingdom, with the Scientific Advice Working Party (SAWP) of the European Medicines Agency (EMA). The discussion focused on scientific advice for the clinical development of MDMA-assisted psychotherapy for the treatment of posttraumatic stress disorder (PTSD). Data gathered in European trials would provide support for a planned Marketing Authorization Application for EMA.
- MAPS’ efforts to work with the EMA are moving forward well
- MAPS will likely to be able to move to Phase 3 MDMA research in Europe
- We will need increase the number of subjects and countries for Phase 3 research in the EU
- EMA research is more complex that FDA research
- MAPS will host a training for European therapists from September 27 – October 3, 2018.
- EMA Phase 3 is scheduled to start late in the summer of 2019
The U.S. FDA-regulated Phase 3 trials starting in August 2018 will assess the efficacy and safety of MDMA-assisted psychotherapy in adult participants with PTSD at up to 16 sites in the U.S., Canada, and Israel. 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 with a residential stay. Learn more…
Therapist Training Study: 65th Participant Enrolls
On June 5, 2018, the 65th 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 Investigator, Marcela Ot’alora, M.A., L.P.C. Michael Mithoefer, M.D., is serving as Principal Investigator at the site in Charleston, South Carolina with Sub-Investigator Ann Mithoefer, B.S.N. Learn more…
Cognitive Behavioral Conjoint Therapy for PTSD: Study Closeout in July
In May 2018, the sixth dyad completed their long-term follow-up interview in our study of MDMA combined with Cognitive Behavioral Conjoint Therapy (CBCT) for posttraumatic stress disorder (PTSD) at our Charleston, South Carolina site led by Principal Investigator, Michael Mithoefer, M.D., and Sub-Investigator, Candice Monson, Ph.D.. The study close-out will be conducted in July 2018. Learn more…
MDMA Therapy Training Program: June 2018 Update
In preparation for Phase 3 trials starting Summer 2018, the MDMA Therapy Training Program is currently supporting 82 researchers in their final stage of training through our supervision program, a process of mentorship that will be an integral part of therapy training going forward. These Phase 3 therapy teams will provide MDMA-assisted psychotherapy for severe posttraumatic stress disorder (PTSD) at sites in the United States, Canada, and Israel. With the results from Phase 3 trials, MAPS will apply for a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA), to make MDMA-assisted psychotherapy into a legal prescription medicine, anticipated to take place in 2021.
This month, Annie Mithofer, BSN, and Michael Mithoefer, M.D., led a weeklong in-person training in Northern California focused on MDMA-assisted psychotherapy, as part of the California Institute of Integral Studies (CIIS)’s Certificate for Psychedelic Therapies and Research Program. This fall, as MAPS prepares for a multi-site study of MDMA-assisted psychotherapy for PTSD in Europe, the MDMA Therapy Training Program will host a training in the Netherlands to prepare European Phase 3 researchers for this endeavor. In early November, Marcela Otalora will lead a training in Colombia for South American therapists.
In the coming year, MAPS plans to apply for a special FDA program called Expanded Access which allows the use of an investigational treatment outside of a clinical trial. The program is designed to address urgent and life-threatening conditions in patients who don’t currently have promising treatment options. You can learn more about Expanded Access on the FDA’s website.
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 subjects. 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…
64th Participant Enrolls in Smoked Marijuana Trial for Chronic PTSD in Veterans
As of Wednesday, June 13, 2018, the 64th of 76 participants enrolled and received study drug in the first-ever clinical trial of smoked marijuana (cannabis) for 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. A new 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 Workshop at Chapel of Sacred Mirrors (COSM)
From June 22 – 23, 2018, at the Chapel of Sacred Mirrors (COSM) with artists Alex Grey and Allyson Grey in Wappinger, New York, the Zendo Project hosted a training about how to help someone having a difficult psychedelic experience. Techniques for transforming a potentially traumatic situation into a positive or even therapeutic one will be discussed. Learn more…
May 2018 Giving Report: MAPS Seeks Funding for European Studies
In May 2018, MAPS raised nearly $583,000 in new donations and pledges from 385 supporters.
Last month, Clay and Rebecca Rockefeller, the son and daughter of Richard Rockefeller, raised the remaining $500,000 needed for MAPS’ Phase 3 MDMA/PTSD studies in the U.S. to support FDA approval. Clay and Rebecca raised the funds within the Rockefeller family from themselves and their cousins in honor of their father’s philanthropic efforts and dedication to finding better treatments for PTSD in the last years of his life. With these gifts, MAPS has now raised the $26.7 million needed for its upcoming Phase 3 clinical trials for FDA approval.
MAPS is currently seeking $8 million for European Medicines Agency (EMA) trials to supplement the data gathered for the FDA, with $420,000 already raised and roughly $7.6 million still to go. MAPS will have a clearer estimate of costs for Phase 3 EMA trials after it completes its negotiations with EMA around the end of the Summer or Fall 2018. Supporters of MAPS’ European research have a special opportunity to have their gifts matched since MAPS has received a $500,000 matching grant for EMA with $210,000 already raised (and $210,000 matched) and $290,000 still to be matched.
We extend a special thanks to those who so generously supported MAPS last month:
- Adam Wiggins ($50,000)
- Shane Leather ($2,000)
- Michael Hamann ($1,000)
Phase 3 MDMA/PTSD:
- Clay & Rebecca Rockefeller & Cousins ($500,000)
- Patricia & Richard Simon ($10,000)
- Daniel Uvanovic ($1,000)
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: June 2018
- The San Francisco Chronicle: Michael Pollan Takes a Trip in His Latest Book, “How to Change Your Mind”
- Written by Jessica Zack on May 21, 2018.
- Psychiatry Advisor: MDMA-Assisted Therapy Effective for Treating PTSD in Veterans, First Responders
- Written by Laurel Ranger on May 21, 2018.
- Oslo Freedom Forum 2018: Rick Doblin, Ph.D.
- Published on May 29, 2018.
- The Huffington Post: A Drug Researcher Talks Michael Pollan’s Book, PTSD Treatment And Trump On LSD
- Written by Erin Shumaker on May 24, 2018.
- Medium: MDMA Helped Me Recover from War
- Written by Jonathan Lubecky on May 29, 2018.
- Time: Ending America’s War on Drugs Would Finally Unleash the Therapeutic Potential of Psychedelics
- Written by Rick Doblin on May 30, 2018.
- Yahoo News: Ecstasy-Assisted Therapy is Bringing Peace to People with PTSD
- Written by Michael Walsh on June 19, 2018.
MAPS Podcast: Episode 29 – Michael Pollan Interview
Michael Pollan discusses his new book How to Change Your Mind: What the New Science of Psychedelics Teaches Us About Consciousness, Dying, Addiction, Depression and Transcendence.
Michael beams into the MAPS Podcast for an all-new episode of the show. His iconic books on the nature and ethics of food have become staples within the zeitgeist of the modern diet and sustainable agriculture. Now, as evidenced in his new book and this podcast, he’s taken on the world of psychedelic science and research with as much insight and objectivity as you would expect from him.
Zach Leary’s conversation with Michael dives into the importance of the research he studied while writing the book, the origins of his interest on the topic, and his own personal experiences with psychedelic medicines. Listen now…
MAPS Summer Sale: Discounts until June 30
The MAPS Summer Sale continues until June 30! Don’t miss your chance to support MAPS and receive up to 40% off in discounts on books, apparel, and other select items in the MAPS Store. Shop Now…
MAPS Laptop Sleeve
Proudly support MAPS’ research and keep your laptop safe with a MAPS Laptop Sleeve! This neoprene case features a zippered front pocket for your accessories as well as a zippered main pocket to safely carry any laptop up to 15 inches. Each laptop sleeve is screen printed with the MAPS logo.
$35.00 | Buy Now…
The Mushroom Cure with Adam Strauss: Now – July 7, 2018, Berkeley, California
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…
126th Annual APA Convention: August 9 – 12, 2018, San Francisco, California
MAPS will have a table at this event and there will be a series of talks about psychedelics at the annual American Psychological Association conference from August 9 – 12, 2018, in San Francisco, California. Learn more…
2018 Detroit Psychedelic Conference: August 10 – 12, 2018, Detroit, Michigan
This year’s conference will explore new trends and technologies in the psychedelic community. This year’s conference will be bringing together diverse speakers from around the world to share there expertise in the Entheogenic world. This year’s theme is Entheogenics in Urban Environments. Learn more…
Cultural and Political Perspectives on Psychedelic Science: August 18 – 19, 2018, San Francisco, California
This symposium at the California Institute for Integral Studies will launch the book Plant Medicines, Healing and Psychedelic Science: Cultural Perspectives, co-edited by Beatriz Labate and Clancy Cavnar (Springer, 2018). The event explores both cutting edge and enduring issues related to psychedelics, culture, and politics. Speakers offer a meta-reflexive approach to central aspects of the so-called “psychedelic renaissance” that are often not addressed in psychedelic conferences or publications. 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…
A Conversation with Documentary Filmmakers Caleb Hellerman and Micha Peled: MDMA-Assisted Therapy for PTSD
Independent filmmakers Caleb Hellerman and Micha Peled are co-directing a documentary that will feature PTSD patients who are going through clinical trials of MDMA-assisted psychotherapy. They are currently filming people being treated by the therapy teams conducting MAPS’ multi-site Phase 3 trial. Here’s a recent conversation about their project. 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 Adherence Raters, a Clinical Intern, a Clinical Medical Writer, and a Clinical Research Associate 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…
Johns Hopkins School of Medicine researchers are conducting an anonymous, internet-based survey study about DMT experiences. Learn More…