Israel Approves Compassionate Use of MDMA-Assisted Therapy for PTSD
February 27, 2019
Dear friends and supporters,
On February 3, 2019, the Israeli Ministry of Health announced the approval of compassionate use for MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD), which will allow 50 patients to receive the therapy within a treatment protocol. Patients with PTSD will be eligible to receive treatment at four sites throughout Israel, including Rambam Medical Center in Haifa and psychiatric hospitals in Be’er Yaakov, Lev Hasharon, and Be’er Sheva.
“The ministry is taking this seriously and with appropriate caution, an in-depth investigation has been carried out. There is a considerable population in Israel of people suffering from PTSD that is resistant to other treatment,” said Bella Ben-Gershon of Israel’s Ministry of Health to Haaretz Newspaper.
MAPS clinical researchers initiated the Phase 3 study site in Beer Yaakov, Israel, on February 5, 2019. The study will involve participants with posttraumatic stress disorder (PTSD). Phase 3 trials begin in Israel mid-March 2019. This clinical trial is being led by Principal Investigator Jana Yakirevitch, M.D.
Representatives from MAPS and MAPS Public Benefit Corporation joined a discussion with the U.S. Food and Drug Administration (FDA) on February 15, 2019, focusing on the recently submitted protocol for Expanded Access for MDMA-assisted psychotherapy for PTSD. Throughout the conversation, our team answered the FDA’s questions about timelines, adverse event rates, and therapist training.
On February 8, 2019, MAPS-sponsored researchers officially completed the first-ever clinical trial of smoked marijuana (cannabis) as a treatment for PTSD symptoms, with all 76 veterans enrolled and treated. The data from the study are now being analyzed and prepared for publication later this year in a peer-reviewed biomedical journal.
“We are thrilled to finally be at the finish line of this nearly 10-year saga trying to get this crucial clinical trial completed,” said Site Principal Investigator Sue Sisley, M.D. “We are immensely grateful to all of the study’s supporters, especially the veteran service organizations who helped us with patient recruitment.” • Read the Press Release
This week, the Zendo Project will be present at Envision Festival in Costa Rica to provide psychedelic peer support services, harm reduction, and education for the seventh consecutive year. Watch our video to learn how difficult psychedelic experiences can transformed into opportunities for growth.
In this month’s edition of the MAPS Newsletter, you’ll also learn:
- The fourteenth participant is treated in our ongoing study of the effect of MDMA on startle testing in healthy volunteers
- Explore upcoming psychedelic events on the MAPS Event Calendar
- The MAPS Podcast features a discussion on sacred archetypes in a new episode with psychedelic retreat facilitator Tricia Eastman
- Browse unique items in the MAPS Store, including new Zendo Project Eco-Fleece hoodies and The Ketamine Papers
Millions of people have had a psychedelic experience at some point in their life. Without support, it can be challenging to understand and integrate these experiences. The new version of our Psychedelic Integration List is a resource of individuals and organizations in the mental health field who help people integrate past psychedelic experiences.
Follow MAPS on Facebook , Twitter , Instagram , YouTube , LinkedIn , and reddit .
Supporters like you move us forward! Thank you for being with us on our journey.
With appreciation,
Amy Mastrine
MAPS Web and Email Marketing Associate
Treating PTSD with MDMA-Assisted Therapy
Israel Approves Compassionate Use of MDMA-Assisted Therapy for PTSD
On February 3, 2019, the Israeli Ministry of Health announced the approval of compassionate use for MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD), which will allow 50 patients to receive the therapy within a treatment protocol. Patients with PTSD will be eligible to receive treatment at four sites throughout Israel, including Rambam Medical Center in Haifa and psychiatric hospitals in Be’er Yaakov, Lev Hasharon, and Be’er Sheva.
“The ministry is taking this seriously and with appropriate caution, an in-depth investigation has been carried out. There is a considerable population in Israel of people suffering from PTSD that is resistant to other treatment,” said Bella Ben-Gershon, the Ministry of Health’s Director of the Department of Treatment of Mental Trauma to Haaretz Newspaper. • Learn More
Phase 3 Trials of MDMA-Assisted Therapy for PTSD: Study Site Initiation in Tel Hashomer, Israel
On February 5, 2019, a MAPS-sponsored Phase 3 study site for MDMA-assisted psychotherapy for PTSD was initiated in Be’er Ya’akov, Israel. Led by Principal Investigator Jana Yakirevitch, M.D., this study will involve participants with PTSD. Phase 3 trials are beginning in mid-March 2019.
Our FDA-regulated Phase 3 multi-site clinical trials of MDMA-assisted psychotherapy for PTSD are continuing to open sites for screening. Taking place at 15 locations across the United States, Canada, and Israel, study volunteers will be administered MDMA or placebo in conjunction with psychotherapy at research sites in the following locations:
- Charleston, SC
- Boulder, CO
- Fort Collins, CO
- Los Angeles, CA
- New Orleans, LA
- San Francisco, CA (UCSF and private practice)
- New York, NY (NYU and private practice)
- Boston, MA
- University of Wisconsin-Madison
- Vancouver, British Columbia
- Montreal, Canada
- Be’er Ya’akov, Israel
- Tel HaShomer, Israel (Sheba Medical Center)
Phase 3 clinical trials are assessing the efficacy and safety of MDMA-assisted psychotherapy in adult participants with severe PTSD. Over a 12-week treatment period, participants will be randomized to receive twelve non-drug preparatory and integration sessions lasting 90 minutes each along with three day-long sessions about a month apart of either MDMA or placebo in conjunction with psychotherapy. The primary endpoint will be the Clinician Administered PTSD Scale (CAPS-5), as assessed by a blinded pool of independent raters.
The trials are the final phase of research required by the FDA before deciding whether to approve MDMA as a legal prescription treatment for PTSD. If approved, MDMA will be required to be used in conjunction with psychotherapy in a clinical setting.
To learn more about currently recruiting national and international studies, visit our participate in research webpage. • Learn More
Open-Label Lead-In Study of MDMA-Assisted Therapy for PTSD: 29th Participant Completes Treatment
Twenty-nine 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 as they each work with one subject with PTSD using the same treatment approach to be used in Phase 3. Study sites are now enrolling and 8 sites are fully enrolled. The study is expected to be completed in mid 2019.
Startle Testing with MDMA: Fourteenth Participant Receives Experimental Treatment
On February 20, 2019, the fourteenth participant completed experimental treatment in our ongoing study of the effect of MDMA on startle testing in healthy volunteers. Led by Principal Investigator Barbara Rothbaum, Ph.D., this study is conducted at Emory University in Atlanta, Georgia. This research group is planning to conduct a subsequent study exploring the combination of MDMA with Prolonged Exposure in people with PTSD. • Learn More
Expanded Access Training Update: February 2019
The MDMA Therapy Training Program has launched a new round of trainings in the U.S., with a special focus on sites interested in offering MDMA-assisted psychotherapy for PTSD in an Expanded Access (compassionate use) protocol, which MAPS Public Benefit Corporation (MAPS PBC) submitted to the FDA in January and is awaiting approval.
Interested and qualified sites may now apply with MAPS PBC to assess eligibility and obtain the required training to administer MDMA-assisted psychotherapy for PTSD under an approved protocol. The basic requirements of a qualified site are 1) treatment facility conducive to MDMA-assisted psychotherapy, 2) therapy team, qualified and able to complete MDMA Therapy Training Program, and 3) prescribing physician who can obtain a DEA Schedule 1 license for MDMA. Only sites in the U.S. and U.S. territories may participate in a U.S. FDA Expanded Access program. Over the coming years, as Phase 2 and Phase 3 clinical trials in Europe progress, and MDMA-assisted psychotherapy clinical research develops internationally, the MDMA Therapy Training Program plans to offer more training opportunities abroad.
To support the development of compassionate use internationally, on January 27 – February 1, 2019, the MDMA Therapy Training Program delivered an MDMA-assisted psychotherapy for PTSD training to 47 therapists, doctors, and counselors in Israel. The event was hosted by the community of Neve Shalom/Wahat al-Salam, “Oasis of Peace,” an intentional village co-founded by Israelis and Palestinians. The training was led by Annie Mithoefer, B.S.N., and Michael Mithoefer, M.D., and Israeli Phase 3 clinical investigators Keren Tzarfaty, Ph.D., M.F.T., and Ido Siemion, Ph.D. This training event prepared therapy providers to work on a compassionate use protocol in Israel, with approval by the Israeli Ministry of Health to treat 50 participants.
More information on therapy training requirements and application procedures for Expanded Access sites and therapy providers can be found on the MDMA Therapy Training Program webpage. Each site must submit one site questionnaire. Additionally, each therapy provider must submit an MDMA Therapy Training Program Application for Therapy Providers. Only applicants affiliated with a qualifying site can be considered for training at this time. MAPS PBC will review applications on an ongoing basis, as they are received. Applicants can expect a response 3-6 weeks after submitting a complete application. Interested applicants should be familiar with the Treatment Manual, which describes the MDMA-assisted psychotherapy modality, before submitting an application.
Throughout this year and the coming years, the MDMA Therapy Training Program will host training retreats at various locations across the US. On May 4–11, 2019, Marcela Ota’lora, M.A., L.P.C., and Bruce Poulter, R.N., will lead a training event outside Fort Collins, Colorado. Additionally, the MDMA Therapy Training for Communities of Color, led by Marcela Ot’alora MA, L.P.C., and Monnica Williams, Ph.D., A.B.P.P., with support from additional trainers, will take place August 10-17 in Louisville, Kentucky. Additional training retreats, once scheduled, will be announced via the MDMA Therapy Training Newsletter. Please sign up online to receive updates. • 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.
Medical Marijuana
Researchers Complete First Clinical Trial of Marijuana for PTSD in Veterans
On February 8, 2019, MAPS-sponsored researchers officially completed the first-ever clinical trial of smoked marijuana (cannabis) as a treatment for PTSD symptoms, with all 76 veterans enrolled and treated. The data from the study are now being analyzed and prepared for publication later this year in a peer-reviewed biomedical journal.
“We are thrilled to finally be at the finish line of this nearly 10-year saga trying to get this crucial clinical trial completed,” said Site Principal Investigator Sue Sisley, M.D. “We are immensely grateful to all of the study’s supporters, especially the veteran service organizations who helped us with patient recruitment.” • Read the Press Release | Learn More
Psychedelic Peer Support
Zendo Project: Psychedelic Peer Support at Envision Festival 2019 and Chapel of Sacred Mirrors Event
For the seventh consecutive year, the Zendo Project is providing psychedelic harm reduction services at Envision Festival 2019 in Costa Rica this month. Last year at Envision Festival, Zendo Project volunteers provided compassionate support for hundreds of guests, and dozens more used the Zendo Project facilities as a space to rest and rehydrate.
From June 29 – 30 at the Chapel of Sacred Mirrors (COSM) in Wappinger, New York, the Zendo Project will host a psychedelic peer support 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. • Buy Tickets | Learn More
Support MAPS
January 2019 Giving Report: MAPS Seeks Funding for European Studies
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 January 2019, MAPS raised $293,078 in new donations and pledges from 814 supporters. Of that amount, $222,197 was for general support, $38,648 for a conflict resolution study in Israel, $20,110 for therapist training, $10,200 for Ibogaine research, $1,752 for Phase 3, and $170 for other projects.
We extend a special thanks to those who so generously supported MAPS last month:
General Support:
- Moshe Tov Kreps ($121,351)
- Vinny Smith ($40,000)
- Frank & Susan Kavanaugh ($25,000)
- Joseph Salazar ($2,206)
- Cody L. Stone ($2,000)
- Roddy Gibbs ($1,000)
- Timothy Jassmann ($1,000)
- Brandon Nolte ($1,000)
- Rose Marsh Boyle ($1,000)
- Thomas Terry ($1,000)
Therapist Training in Israel:
- Moshe Tov Kreps ($20,000)
Conflict Resolution Study in Israel:
- Moshe Tov Kreps ($38,649)
Ibogaine Research:
- Michael Sinyard ($10,000)
Fiscal Sponsorship:
- MAPS fiscally sponsors like-minded organizations and projects. This list includes donors who have contributed to organizations we fiscally sponsor.
- Moshe Tov Kreps ($20,000 – ICEERS)
- Frank & Susan Kavanaugh ($15,000 – Mission Within)
- Tas Dienes ($1,000 – Better Living Through Chemistry)
- Jessica Nielson ($1,000 – Chacruna)
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
- PRESS RELEASE: Researchers Announce Completion of First Clinical Trial of Marijuana for PTSD in Veterans
- Written by Brad Burge on February 20, 2019
- Haaretz: Party Drug or Breakthrough Treatment? Israel Approves Compassionate Use of MDMA to Treat PTSD
- Written by Ido Efrati on February 10, 2019
- Newsweek: MDMA To Be Used in Trauma Treatment in Israel and U.S. May Not Be Far Behind
- Written by Callum Paton on February 11, 2019
- Business Insider: A Top Psychedelic Scientist Says ‘The Climate’s Looking Good’ for Magic Mushrooms and MDMA to Turn Into Medicines at a Gathering of the World’s Billionaires
- Written by Erin Brodwin and Alyson Shontell on January 25, 2019
- Forbes: Trump Attorney General Pick Puts Marijuana Enforcement Pledge In Writing
- Written by Tom Angell on January 28, 2019
- Santa Cruz Good Times: Can Santa Cruz MDMA Research Change Mental Health?
- Written by Wallace Baine on January 8, 2019
- New Atlas: New Study Suggests Mild, Long-Term MDMA Use Doesn’t Damage Normal Social Functioning
- Written by Rich Haridy on February 10, 2019
MAPS Podcast
MAPS Podcast: Episode 34 – Tricia Eastman – Sacred Archetypes in Modern Psychedelics
Tricia Eastman is a pioneer in the psychedelic renaissance. Eastman’s holistic approach incorporates eastern philosophy, biohacking, soul retrieval, archetypal mapping, meditation, somatic therapy, and shamanism. As a medicine woman, she curates retreats in countries where use is legal working with 5-MeO-DMT from the Sonoran Desert Toad and iboga. She has been initiated into Bwiti traditions of Mboumba Eyano and trained in the Missoko, as well as facilitated the psychospiritual iboga program for Crossroads Treatment Center in Mexico. • Listen Now
MAPS Store
Zendo Project Eco-Fleece Hoodie
Stay warm and cozy while supporting the Zendo Project with these Eco-Fleece hoodies! Each hoodie is made with recycled and organic materials and low-impact dyes by Alternative Apparel, whose facilities are WRAP-certified and adhere to Fair Labor Association guidelines. Proceeds from these shirts support the Zendo Project’s mission to provide psychedelic peer support for difficult psychedelic experiences at multiple large-scale events every year. Screen printed locally by The Print Gallery. • Buy Now
The Ketamine Papers
The Ketamine Papers opens the door to a broad understanding of this medicine’s growing use in psychiatry and its decades of history providing transformative personal experiences. Now gaining increasing recognition as a promising approach to the treatment of depression, posttraumatic stress disorder (PTSD), and other psychological conditions, ketamine therapies offer new hope for patients and clinicians alike. With multiple routes of administration and practices ranging from anesthesia to psychotherapy, ketamine medicine is a diverse and rapidly growing field. The Ketamine Papers clarifies the issues and is an inspiring introduction to this powerful tool for healing and transformation—from its early use in the 1960s to its emerging role in the treatment of depression, suicidality, and other conditions. This comprehensive volume is the ideal introduction for patients and clinicians alike, and for anyone interested in the therapeutic and transformative healing power of this revolutionary medicine. • Buy Now
Events
Browse our Event Calendar page for more opportunities.
Wisdom 2.0: March 1-3, 2019, San Francisco, California
Join us for the premier event exploring living wisely in the digital age! Speakers this year include MAPS Founder and Executive Director Rick Doblin, Ph.D., and author of How to Change Your Mind Michael Pollan. Wisdom 2.0 addresses the great challenge of our age: to not only live connected to one another through technology, but to do so in ways that are beneficial to our own well-being, effective in our work, and useful to the world. • Learn More
Introduction to Therapeutic Ketamine, March 8, 2019, New York, New York
Ketamine is medicine that is primarily used as a surgical anesthetic, but which also has rapid-acting antidepressant effects and visionary properties. Dr. Bennett will describe different ways of working with ketamine for depression, including low-dose infusions, ketamine-facilitated psychotherapy, and psychedelic ketamine journeys. She will also talk about which psychiatric patients are appropriate for ketamine treatment and which patients would not be a good fit for this approach, according to the most current medical literature. This program will include live Q&A and discussion. This content is geared toward medical and mental health professionals, but it is open to everyone. • 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, Ph.D., MAPS Founder and Executive Director, will offer the keynote speech. • Learn More
International Conference on Novel Psychoactive Substances, April 8-9, 2019, Maastricht, Netherlands
The VI International Conference on Novel Psychoactive Substances (NPS) aims to share knowledge and strengthen collaboration on NPS among multidisciplinary professionals at the international level. The conference is jointly organised by the United Nations Office on Drugs and Crime (UNODC), the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA), the World Anti-Doping Agency (WADA), University of Hertfordshire, University of Maastricht. • 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.” We warmly invite you to join us in the historic celebration at the beautiful Asilomar Conference Grounds, overlooking the Pacific Ocean. MAPS Executive Director Rick Doblin, Ph.D., will be giving an address. • Learn More
Integrative Mental Health Conference, April 15-17, 2019, San Francisco, California
Patients are increasingly looking for mental health care options that go beyond medications and conventional therapy, they are more often now turning to alternative and complementary medicine. You will walk away from this conference with a new or strengthened understanding of how integrative modalities play a role in maintaining, improving, and helping to heal mental health issues and diseases. Join the premier integrative mental health summit organized by the world’s leader in training physicians and other health professionals in a new model of medicine. • Learn More
American Psychiatric Association Annual Meeting, May 18-22, 2019, San Francisco, California
APA’s Annual Meeting is the premier psychiatry event of the year. This year marks the 175th Anniversary of the founding of the American Psychiatric Association. With 650+ educational sessions, 38 courses, 8 tracks, 40 AMA PRA Category 1 Credits™ available, and 15,000+ attendees, there’s no better event to learn, discover and experience the best educational content in psychiatry. • Learn More
Psychedelics 101 & 102 for Clinicians, May 18-19, 2019, New York, New York
This 2-day training offered by psychologists Ingmar Gorman, Ph.D., 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
World Ayahuasca Conference 2019, Girona, Spain, May 31 – June 2, 2019
Join us in Girona, in the beautiful region of Catalonia (Spain), to celebrate the diversity of ayahuasca cultures, practices, art, film, and research. AYA2019 will be more than a conference. It will be the largest event ever held about ayahuasca, one where we inspire each other to work together for a more connected, meaningful, and sustainable life on earth. • 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
Breaking Convention 2019, August 16-18, 2019, London, United Kingdom
Breaking Convention is a biennial multidisciplinary conference on psychedelic consciousness, featuring more than 150 presenters from around the world. Europe’s largest conference on psychedelic consciousness, Breaking Convention is now approaching its eighth year. Breaking Convention is a truly multi-faceted festival selling nearly a thousand tickets in forty countries and offering the latest ground-breaking research and insights across human and social sciences, law, politics, art, history and philosophy. Spanning three full days, Breaking Convention features numerous workshops, awards, an art exhibition, and films. • Learn More
Zendo Project Workshop at the Chapel of Sacred Mirrors: Peer Support Training 2019, June 29-30, 2019, Wappinger, New York
What can you do to help someone having a difficult psychedelic experience? What techniques are available for helping transform a potentially traumatic situation into a positive or even therapeutic one? Journey to the Chapel of Sacred Mirrors (CoSM) for a special weekend workshop focused on psychedelic peer support led by the Zendo Project. Introduce yourself to tools and information on reducing potential risks of drug use and how to work with challenging experiences to create a platform for honest and responsible conversations about substance use. This training is designed for those who are interested in learning how to assist in difficult psychedelic experiences. We demonstrate that safe, productive psychedelic experiences are possible without the need for law enforcement-based prohibitionist policies. This is also an opportunity to connect with your community in an immersive workshop complete with role-playing, exercises for grounding and connection, and the opportunity to meet and develop relationships with your local community. Developed for peer counselors, educators, mental health clinicians, event producers, and individuals who are interested in volunteering for harm reduction organizations like the Zendo Project, creating their own grassroot peer support, or helping others experiencing psychedelic challenges. • Learn More
Horizons: Perspectives on Psychedelics 2019, October 11-13, 2019, New York, New York
Horizons: Perspectives on Psychedelics is an annual forum in New York City that examines the role of psychedelic drugs and plant medicines in science, medicine, culture and spirituality. In recent years, a growing community of scientists, doctors, scholars, and activists have orchestrated a renaissance in psychedelic research and practice. Horizons brings together the brightest minds and the boldest voices of this movement to share their knowledge, insights, and dreams for the future. Now in its twelfth year, Horizons is the largest and longest-running annual gathering of the psychedelic community in the world. • Learn More
More News
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
Psychedelic Integration List
Without support, it can be challenging to understand and integrate some psychedelic experiences. The Psychedelic Integration List is a resource of individuals and organizations in the mental health field who help people integrate past psychedelic experiences. • Learn More