MAPS Schedules Meeting with European Medicines Agency (EMA)
May 31, 2018
Dear friends and supporters,
This month, The Lancet Psychiatry published results of our pioneering U.S. Food and Drug Administration (FDA)-regulated clinical trial of MDMA-assisted psychotherapy for the treatment of posttraumatic stress disorder (PTSD) in veterans, firefighters, and police officers. The double-blind, placebo-controlled, Phase 2 pilot study in 26 participants found that one month after their second day-long experimental session, 68% in the full-dose MDMA group did not qualify for a diagnosis of PTSD, compared to 29% in the low-dose MDMA (active placebo) control group.
“At least one in two PTSD patients cannot tolerate or do not respond adequately to existing treatments, so there is an urgent need for better treatments for the millions of military veterans and others with PTSD,” said Principal Investigator Michael Mithoefer, M.D. “These results are further evidence that MDMA, used just two times at monthly intervals, can make psychotherapy much more effective and better tolerated. I’m excited that Phase 3 trials will soon confirm whether this therapy can be approved for widespread use in a few years.”
On June 12, 2018, MAPS will meet with the European Medicines Agency (EMA) in London, United Kingdom, to discuss scientific advice for the Phase 3 clinical development of MDMA-assisted psychotherapy for treatment of posttraumatic stress disorder (PTSD). Data gathered in European trials would provide support for a planned Marketing Authorization Application for EMA.
On May 29, 2018, MAPS Executive Director Rick Doblin, Ph.D., spoke at the Oslo Freedom Forum about MDMA-assisted psychotherapy for PTSD in human rights activists and others. Rick’s presentation begins at 06h:48m:00s. Watch Jason Silva advocate for psychedelic research at the same conference at 22m:42s.
Last weekend, MAPS and the Zendo Project attended Lightning in a Bottle festival in Bradley, California, where MAPS provided psychedelic education and the Zendo Project provided 24/7 psychedelic peer support for attendees having difficult experiences.
How to Change Your Mind: What the New Science of Psychedelics Teaches Us About Consciousness, Dying, Addiction, Depression, a new book from renowned author Michael Pollan, was released on May 15, 2018. The first 100 orders of this new book from the MAPS Store will include a limited edition version of Dr. Bronner’s soap that highlights the company’s support for psychedelic research.
In the May 2018 edition of the MAPS Newsletter, you’ll also learn::
- Our ongoing therapist training study enrolls the 60th participant
- The Zendo Project is hosting a workshop with Alex Grey and Allyson Grey at the Chapel of Sacred Mirrors (COSM)
- 60 out of 76 participants have enrolled and received study drug in our clinical trial of smoked marijuana for PTSD in U.S. veterans
We are grateful for your support as we reach new heights!
MAPS Web and Email Marketing Associate
Table of Contents
Treating PTSD with MDMA-Assisted Therapy
- European Medicines Agency (EMA) to Host Meeting with MAPS
- Therapist Training Study: 60th Participant Enrolls
- Cognitive Behavioral Conjoint Therapy for PTSD: Sixth Dyad Completes Long-Term Follow-Up Interview
- MDMA Therapy Training Program: Expanded Access Update
- Participate in Research
MDMA-Assisted Therapy for Anxiety Associated with Life-Threatening Illness
- 60th Participant Enrolls in Smoked Marijuana Trial for Chronic PTSD in Veterans
- Are You a U.S. Military Veteran with PTSD?
Policy and Advocacy
Psychedelic Peer Counseling
- The Mushroom Cure with Adam Strauss: Now – June 16, 2018, Berkeley, California
- American Society of Clinical Psychopharmacology Annual Meeting: May 29 – June 1, 2018, Miami, Florida
- How To Change Your Mind with Michael Pollan, June 1 – 6, 2018, Boulder, Colorado, Santa Cruz, California, and San Francisco, California
- Rick Doblin and Ingmar Gorman speaking at Beyond Psychedelics: June 21 – 24, 2018, Prague, Czech Republic
- Los Angeles Psychedelic Science Psymposium (LAPSS): June 22 – 23, 2018, Los Angeles, California
- SAND18 Italy: July 3 – 9, 2018, Orvieto, Italy
- 126th Annual APA Convention: August 9 – 12, 2018, San Francisco, California
- Cultural and Political Perspectives on Psychedelic Science: August 18 – 19, 2018, San Francisco, California
- Horizons: Perspectives on Psychedelics: October 5 – 7, 2018, New York, New York
- Psychedelic Psychotherapy Forum 2018: October 11 – 14, 2018, Victoria, BC, Canada
- Colloquium on Psychedelic Psychiatry 2018: October 13 – 14, 2018, Nacka, Sweden
- Science and Nonduality (SAND) 2018: October 24 – 28, 2018, San Jose, California
- New Surveys Launched by Psychedelic Research Group (PRG) at Imperial College
- MAPS at Plantas Sagradas en las Américas
- MAPS Public Benefit Corporation (MPBC) is Hiring
- DMT Survey
Treating PTSD with MDMA-Assisted Therapy
European Medicines Agency (EMA) to Host Meeting with MAPS
On June 12, 2018, MAPS will meet with the European Medicines Agency (EMA) in London, United Kingdom, to discuss scientific advice for the clinical for the clinical development of MDMA-assisted psychotherapy for treatment of posttraumatic stress disorder (PTSD). Data gathered in European trials would provide support for a planned Marketing Authorization Application for EMA.
On May 24, 2018, Clinical Research Associate, Gabrielle Fortier, M.P.H., of the MAPS Public Benefit Corporation (MPBC), conducted a Study Initiation Visit for a Phase 3 study of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD) at the planned Phase 3 site in Fort Collins, Colorado. A Study Initiation Visit for the Boulder, Colorado study site is scheduled for June 13, 2018.
The Phase 3 trials starting in the summer of 2018 will assess the efficacy and safety of MDMA-assisted psychotherapy in adult participants with PTSD at sites in the U.S., Canada, and Israel. Over a 12-week treatment period, participants will be randomized to receive 12 associated 90-minute non-drug preparatory and integration sessions along with three day-long sessions of either MDMA or placebo in conjunction with psychotherapy about a month apart. 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 U.S. Food and Drug Administration (FDA) before deciding whether to approve MDMA as a legal prescription treatment for PTSD, required to be used in conjunction with psychotherapy in an outpatient setting with a residential stay. Learn more…
Therapist Training Study: 60th Participant Enrolls
On May 8, 2018, the 60th participant 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: Sixth Dyad Completes Long-Term Follow-Up Interview
On May 28, 2018, the sixth dyad completed their long-term follow-up interview in our ongoing 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. Long-term follow-up data will provide additional information to guide the design of future trials.
The study enrolled dyads comprised of one participant diagnosed with PTSD and one concerned significant other who does not have PTSD but does experience psychosocial distress. MDMA was administered to both participants to help facilitate communication and connection between participants and therapists. The primary goal of this study is to develop a combined method of MDMA with CBCT for PTSD. This is the first MAPS-sponsored MDMA study conducted with VA-affiliated researchers and the first to employ measures developed for the DSM-5. Learn more…
MDMA Therapy Training Program: Expanded Access Update
The MDMA Therapy Training Program is currently preparing researchers to work on Phase 3 clinical trials researching MDMA-assisted psychotherapy for Posttraumatic Stress Disorder (PTSD). These 82 therapists are in the midst of our supervision program, which will be an integral part of our training program going forward. Phase 3 trials are starting Summer 2018 in the United States, Canada, and Israel. The results of the Phase 3 studies will support 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.
Later this 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’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. Learn more about Expanded Access on the FDA’s website.
If Expanded Access is approved, new sites meeting the requirements below can seek approval to be part of MPBC’s multi-center Expanded Access protocol, which will allow them to administer open-label MDMA-assisted psychotherapy for PTSD. Qualified therapist applicants will have a team of therapy providers, a physician, and a facility suitable to conduct MDMA-assisted psychotherapy, with approval by regulatory agencies.
An online application for potential Expanded Access sites and their therapy providers will be posted in late 2018. Since Expanded Access is a US FDA program, only sites in the US and US territories may participate. 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.
MDMA-Assisted Therapy for Anxiety Associated with Life-Threatening Illness
Marin: Study Closeout Visit Scheduled for June 7 – 8, 2018
A monitoring visit of the study of MDMA-assisted psychotherapy for anxiety associated with life-threatening illness in Marin, Calif., is scheduled to take place from June 7- 8, 2018. Clinical Operations Manager Rebecca Matthews and Clinical Research Associate Alia Lilienstein of MAPS will conduct the closeout visits. Led by Principal Investigator Phil Wolfson, M.D., with Co-Therapist Julane Andries, L.M.F.T., this study is gathering preliminary data about the safety and efficacy of MDMA-assisted psychotherapy for anxiety associated with a diagnosis of a life-threatening illness. Learn more…
60th Participant Enrolls in Smoked Marijuana Trial for Chronic PTSD in Veterans
On May 16, 2018, the 60th 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. On March 26 – 29, Gabby Fortier, Clinical Research Associate, monitored the clinical research site. 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
Policy and Advocacy
MAPS at Semana Psicoactiva in Bogota, Columbia
On April 20, 2018, MAPS Policy and Advocacy Counsel Ismail Ali spoke at Semana Psicoactiva in Bogota, Colombia, regarding innovative uses for presently-illegal substances. Ali spoke amongst Colombian researchers and therapists MAPS is working with to conceptualize an MDMA-assisted psychotherapy for PTSD study in Colombia.
“There’s a lot of interest of bringing MDMA for PTSD in Colombia in the context of the country’s ongoing post-conflict/post-civil war efforts,” explains Ali.
U.S. Army SGT(R) Jonathan M. Lubecky Joins MAPS
U.S. Army SGT(R) Jonathan M. Lubecky has joined the MAPS Policy and Advocacy team as Veterans’ and Government Affairs Liaison to engage with veterans and to support our efforts to end the Department of Justice-enforced National Institute on Drug Abuse (NIDA) monopoly on marijuana. On April 26, 2018, Rick Doblin and Lubecky attended a Veterans Medical Cannabis roundtable in Washington, D.C., at the invitation of Congressmen Earl Blumenauer and J. Luis Correa.
U.S. Army SGT(R) Jonathan M. Lubecky and Rick Doblin, Ph.D., attend the Veterans Medical Cannabis roundtable in Washington, D.C.
Psychedelic Peer Counseling
Zendo Project Workshop at Chapel of Sacred Mirrors (COSM)
From June 22 – 23, 2018, at the Chapel of Sacred Mirrors (COSM) in Wappinger, New York, the Zendo Project will host a training about how to help someone having a difficult psychedelic experience with artists Alex Grey and Allyson Grey. Techniques for transforming a potentially traumatic situation into a positive or even therapeutic one will be discussed. Learn more…
April 2018 Giving Report: MAPS Seeks Funding for European Studies
Considerable funding is needed to complete clinical research, before submitting a New Drug Application to the U.S. Food & Drug Administration. MAPS’ primary goal is to complete funding for our Phase 3 trials of MDMA-assisted psychotherapy for the treatment of PTSD. We have now raised $26.7 million of the $26.7 million needed for our upcoming Phase 3 clinical trials to make MDMA-assisted psychotherapy a legal prescription treatment for PTSD in the U.S. The final $500,000 was pledged by Dr. Richard Rockefeller’s two children, Clay and Rebecca, and 7 of their cousins.
MAPS is currently seeking $5 million for European Medicines Agency (EMA) trials to supplement the data gathered for the FDA, with $420,000 already raised and $4.6 million still to go. MAPS will have a clearer estimate of costs for Phase 3 EMA trials after we complete our negotiations with EMA. 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:
- Hilary Silver ($10,000)
- Bequest of Tim Butcher ($2,701)
- Adam Growald ($1,000)
- Shawn Joyce ($1,000)
- Shawn Wylie ($1,000)
- Thomas Shanks ($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: May 2018
- PRESS RELEASE: MDMA-Assisted Therapy Shows Promise for Veterans with Chronic, Treatment-Resistant PTSD
- Written by Brad Burge on May 1, 2018
- The New York Times: Treating PTSD With MDMA? You Might Have Some Questions.
- Written by Dave Philipps on May 2, 2018
- Fox News: Gutfeld On Using Ecstasy To Cure PTSD
- Published on May 2, 2018
- Forces Network: Class A Ecstasy Drug Can Help PTSD, Says Study
- Written on May 2, 2018
- Business Insider: Psychedelic Drugs Appear to Fundamentally Reorganize the Brain — and They’re Starting to Turn Into Approved Treatments
- Written by Erin Brodwin on May 6, 2018.
- Wired: Ketamine Stirs Up Hope – and Controversy – as a Depression Drug
- Written by Moises Velasquez-Manoff on May 8, 2018.
- Bitcoin Insider: Bitcoin’s Anonymous $55 Million Pineapple Fund Gives Final Donation
- Written by C. Edward Kelso on May 12, 2018
How to Change Your Mind by Michael Pollan
The first 100 orders will receive an additional gift of a bottle of Dr. Bronner’s pure castile peppermint soap and a copy of the MAPS Bulletin!
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Zendo Project Beanies
Stay warm while showing your support for the Zendo Project with one of these soft beanies.
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MAPS Podcast: Episode 27 – Dieter Hagenbach, Albert Hofmann, and His LSD
April 2018 marks the 75th anniversary of the first experiences with LSD that Dr. Hofmann embarked on in Basel, Switzerland. It’s the perfect occasion to revisit this talk by Dieter which relies heavily on this fantastic book, “Mystic Chemist: The life of Albert Hofmann and His LSD”. Taken from the 2013 Psychedelic Science conference, Dieter Hagenbach gives an oral account of the life of Albert Hofmann and his discovery of LSD. Listen now…
The Mushroom Cure with Adam Strauss: Now – June 16, 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…
American Society of Clinical Psychopharmacology Annual Meeting: May 29 – June 1, 2018, Miami, Florida
The 2018 ASCP Annual Meeting will bring together academic investigators, industry scientists, U.S. and international regulators from FDA and EMA, National Institutes of Health components including NIMH, NIDA, NIAAA and many other professionals working in drug development and clinical trials. It provides the opportunity to present and hear new findings in the treatment of psychiatric illness. and with over 1,000 attendees, it is the place for networking, planning and the training of young investigators. MAPS Clinical Data Scientist Allison Feduccia, Ph.D., will give a 10-minute talk in the Pharmaceutical Pipeline Presentations entitled MDMA-Assisted Therapy for Treatment of Chronic Posttraumatic Stress Disorder (PTSD): Findings from Phase 2 Clinical Research Trials, co-authored by Feduccia, Lisa Jerome, Ph.D., Michael Mithoefer, M.D., Berra Yazar-Klosinski, Ph.D., Amy Emerson, B.S., and Rick Doblin, Ph.D. Learn more…
Rick Doblin and Ingmar Gorman speaking at Beyond Psychedelics: June 21 – 24, 2018, Prague, Czech Republic
Beyond Psychedelics is the global multidisciplinary forum on psychedelics in the Czech Republic, the country with a longstanding history of psychedelic research. Conference organizers intend to discuss the potential of psychedelics, alternative states of consciousness and technologies in the current social climate. Conference presentations will review current challenges and risks, explore the basis of safe use and sensible integration, and create new synergies. Learn more…
How to Change Your Mind with Michael Pollan: June 1 – 6 2018, Boulder, Colorado, Santa Cruz, California, and San Francisco, California
Michael Pollan, author of five New York Times best sellers, will discuss his latest book, How to Change Your Mind: What the New Science of Psychedelics Teaches Us About Consciousness, Dying, Addiction, Depression, and Transcendence, in Boulder, Colorado, Santa Cruz, California, and San Francisco, California from June 1 – 6, 2018. Learn more…
Los Angeles Psychedelic Science Psymposium (LAPSS): June 22 – 23, 2018, Los Angeles, California
MAPS is proud to be a fiscal sponsor of the Los Angeles Psychedelic Science Symposium (LAPSS), an educational conference taking place from June 22 – 23, 2018, at the University of California, Los Angeles, in the Ackerman Grand Ballroom. The goal of LAPSS is to provide opportunities for leading psychedelic science experts to share their evidence-based research about the potential medicinal and therapeutic applications for psychedelics. Learn more…
SAND18 Italy: July 3 – 9, 2018, Orvieto, Italy
Join the Science and Nonduality (SAND) gathering in Italy for six inspiring days with scientists, philosophers, spiritual teachers and artists, in an openhearted exploration to expand and embody our interconnectedness and further our individual and collective evolution. Our tools are many and diverse: experiential workshops, talks, conversations, meditation, movement, music and more. 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…
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…
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 at Plantas Sagradas en las Américas
The Sacred Plants in the Americas conference was held from February 23 – 25, 2018 in Ajijic, Jalisco, Mexico. The conference had the purpose of building a bridge between indigenous and traditional psychoactive practices, psychedelic science, and drug policy through multidisciplinary and intercultural dialogue. Watch the presentations from MAPS staff in the playlist below.
Free Book Giveaway from Dr. Bronner’s: How to Change Your Mind by Michael Pollan
Dr. Bronner’s is giving away 1,000 free copies of How to Change Your Mind, author Michael Pollan’s new book about psychedelics! Subscribe to email newsletters from Dr. Bronner’s and MAPS for your chance to win. Learn More…
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…
Johns Hopkins School of Medicine researchers are conducting an anonymous, internet-based survey study about DMT experiences. Learn More…