Study Initiation Visits Begin for Phase 3 Trials of MDMA-Assisted Therapy
July 31, 2018
Dear friends and supporters,
Starting in August and September 2018, MAPS will begin the process of screening applications and enrolling participants for our FDA-regulated Phase 3 trials of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD), taking place at up to 16 sites in the U.S., Canada, and Israel. It has taken MAPS more than 32 years to reach the start of Phase 3 research, and we are proud of this historic milestone.
MAPS-sponsored researchers have now completed study initiation visits for Phase 3 trials at five locations in the United States:
- New Orleans, Louisiana
- Fort Collins, Colorado
- Boulder, Colorado
- Private Practice, San Francisco, California
- University of California, San Francisco, California
On July 16, 2018, the Zendo Project launched a crowdfunding campaign to expand psychedelic peer support services at festivals and events around the world. Just 15 days after launch, 248 donors have already contributed $72,397 — exceeding our initial $70,000 goal. We have fulfilled the $22,200 matching grant provided by several generous donors. We were quickly able to meet our goal, thanks in large part to Tim Ferriss, a New York Times best-selling author who donated $24,000 to help us expand psychedelic peer support services and education. We are announcing a $100,000 stretch goal, which will allow us to further develop our outreach and education initiatives. Thank you to everyone who made a gift and claimed exclusive perks.
We had a great time with the psychedelic community in Pittsburgh, Pennsylvania from July 13 – 15, 2018, at the Sleeping Octopus Assembly on Psychedelics (SOAP). More than half of all participants traveled from areas outside of Pittsburgh. The 3-day conference featured leaders of the psychedelic research renaissance. The intimate gathering featured two days of psychedelic education presentations, a MAPS benefit dinner, a workshop with the Zendo Project, a comedy show, live music, and much more. Thank you to all who attended! We appreciate your participation.
Psychedelic comedy is coming to Los Angeles on August 13! Join comedians Moshe Kasher, Eric Andre, Shane Mauss, and Duncan Trussell for a benefit event to support psychedelic research conducted by MAPS. Tickets are available via The Largo.
In the July 2018 edition of the MAPS Newsletter, you’ll also learn::
- Our ongoing therapist training study enrolls the 66th participant
- 69 out of 76 participants have enrolled and received study drug in our clinical trial of smoked marijuana for PTSD in U.S. veterans
- MAPS work is featured in mainstream media
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Your support fuels our success! Thank you for helping to make our work a reality.
With appreciation,
Amy Mastrine
MAPS Web and Email Marketing Associate
Treating PTSD with MDMA-Assisted Therapy
Phase 3 Trials: Participant Enrollment Begins This Summer
As summer comes to a close, we will begin the process of screening applications and enrolling participants for FDA-regulated Phase 3 trials of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD), taking place at up to 16 sites in the U.S., Canada, and Israel.
These Phase 3 trials are starting in September 2018, and will assess the efficacy and safety of MDMA-assisted psychotherapy in adult participants with 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 with a residential stay. Learn more…
Phase 2 Trials: Finalized Data in Review
Researchers involved with international MAPS-sponsored studies of MDMA-assisted psychotherapy have completed the process of collecting scientific data for several Phase 2 trials.
MDMA-Assisted Therapy for PTSD:
- Charleston, South Carolina
- Boulder, Colorado
- Vancouver, BC, Canada
- Tel Aviv, Israel
MDMA-Assisted Therapy for Social Anxiety in Autistic Adults:
- Los Angeles, California
We are currently preparing the data for submission to various scientific journal publications. Learn more…
Therapist Training Study: 66th Participant Enrolls
On July 10, 2018, the 66th 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…
MDMA Therapy Training Program: July 2018 Update
From June 24-30, 2018, Annie Mithoefer, B.S.N. and Michael Mithoefer, M.D., led a weeklong in-person training in Northern California focused on MDMA-assisted psychotherapy in the treatment of posttraumatic stress disorder (PTSD), as part of the California Institute of Integral Studies’ (CIIS) Certificate for Psychedelic Therapies and Research Program (CPTR). Over 90 trainees with a wide range of professional backgrounds learned about the foundation of MAPS’ approach to MDMA-assisted psychotherapy, which involves a non-directive therapeutic orientation that supports participants’ inner healing ability to guide the treatment process.
In the coming year, MAPS plans to apply for a special U.S. Food and Drug Administration (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 people facing a serious or immediately life-threatening condition for which there is no satisfactory treatment currently available. MAPS has had positive preliminary discussions about Expanded Access with both FDA and DEA. If Expanded Access for MDMA-assisted psychotherapy for PTSD is approved as anticipated, new sites may obtain approval and undergo training to administer MDMA-assisted psychotherapy to eligible patients with treatment-resistant PTSD, under a MAPS protocol. The FDA’s website has more information on its Expanded Access program. Since Expanded Access is a U.S. FDA program, only sites in the U.S. and U.S. territories may participate. In the coming years, MAPS may be able to apply for similar programs abroad.
The MDMA Therapy Training Program, operated by the MAPS Public Benefit Corporation (MPBC), is currently updating our training website and creating an online application for potential Expanded Access sites and therapy providers, to be posted in late 2018. We do not yet have trainings scheduled. 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.
The MDMA Therapy Training Program is also currently supporting researchers in their final phase of training to work on Phase 3 clinical trials researching MDMA-assisted psychotherapy for 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 planned to start in the coming months, 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.
MAPS and MPBC are also excited to support the development of MDMA-assisted psychotherapy for PTSD research in Europe and South America. Several European countries will host Phase 3 sites; MPBC is hosting an invitation-only MDMA therapy training this fall to prepare European researchers for this endeavor. Approximately 60 therapists and researchers will attend a training in the Netherlands this fall, led by Annie Mithoefer, B.S.N., and Michael Mithoefer, M.D., to prepare potential sites to conduct Phase 3 trials in Europe. Another training is planned in Colombia, South America in early November, led by Marcela Ot’alora, L.P.C., to prepare researchers in Columbia and Chile. The training program is not currently accepting applicants. Future international trainings will be planned as additional providers are needed. 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…
Medical Marijuana
69th Participant Enrolls in Smoked Marijuana Trial for Chronic PTSD in Veterans
As of Wednesday, July 18, 2018, 69 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. Gabrielle Fortier, M.P.H., Clinical Research Associate of the MAPS Public Benefit Corporation (MPBC), monitored the site from July 16 – 20, 2018. Our 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 Fundraising Campaign
Thanks to 248 donors from 14 countries, the Zendo Project has raised $72,397 within the past two weeks, fulfilling our $22,200 matching grant and exceeding our initial $70,000 fundraising goal. All donors who make a tax-deductible gift over $10 are still eligible to receive unique perks, so don’t miss your chance.
We extend our sincere gratitude to all donors who have helped us with such expediency. We were quickly able to meet our initial goal thanks in large part to Tim Ferriss, a New York Times best-selling author who donated $24,000 to help us expand psychedelic peer support services and education.
Our stretch goal is currently $100,000. This will allow us to further develop our outreach and education initiatives. By reaching our stretch goal, we will also have the opportunity to purchase a beautiful new structure for our events in the U.S., which will provide an additional safe space for our guests for years to come.
The Zendo Project is sponsored by MAPS, a 501(c)(3) non-profit organization. Donations are tax-deductible, and limited edition perks are still available!
Help us maintain the momentum! Donate now and claim your unique perk. Donate now… | Learn More…
Support MAPS
June 2018 Giving Report: MAPS Seeks Funding for European Studies
MAPS is currently seeking $9 million for European Medicines Agency (EMA) trials to supplement the data gathered for the FDA. MAPS will have a clearer estimate of costs for Phase 3 EMA trials after we complete our negotiations with EMA around the end of the Summer or Fall 2018 and with regulatory agencies in each country where we will have Phase 3 sites.
In June 2018, MAPS raised over $443,000 in new donations and pledges from 553 supporters.
We extend a special thanks to those who so generously supported MAPS last month:
General Support:
- Andre Ornish ($6,509)
- Mandy Gray ($5,000)
- Nicholas Maddix ($2,291)
- Grant Leonard ($1,100)
- Anonymous ($1,000)
- Sean Lawlor ($1,000)
Phase 3 MDMA/PTSD U.S.:
- David Rockefeller Estate Fund ($250,000)
- David Rockefeller Fund ($50,000)
- Anonymous ($30,399)
- Anonymous ($20,000)
- Michael Quattrone ($20,000)
- Candra Docherty ($1,500)
Phase 3 MDMA/PTSD Europe:
- Nicholas Reville ($24,892)
MDMA/PTSD Therapist Training:
- Kai Nygard ($5,153)
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
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: July 2018
- PRESS RELEASE: Zendo Project Seeks $70,000 To Expand Psychedelic Peer Support Education
- Written by Brad Burge on July 24, 2018
- Playboy: MDMA-Assisted Therapy Mitigates PTSD Symptoms
- Written by Deanna DeBara on June 26, 2018.
- Playboy: The Proof Is in the Trip: Alternative Psychedelic-Laced Therapy Is Changing Lives
- Written by Michelle Janikian on July 10, 2018.
- Psych Congress: A Turning Point for Psychedelics?
- Written by Andrew Penn on June 6, 2018
- High Times: First-of-its-Kind Conference Brings Psychedelics Into the Mainstream
- Written by Kyle Jaeger on June 29, 2018.
- Big Think: Study: Ecstasy Could Be a Less Dangerous Than Past Research Suggests
- Written by Stephen Johnson on June 20, 2018.
- East Bay Express: Can Cannabis Be Considered a Psychedelic?
- Written by Kathleen Richards on July 11, 2018.
MAPS Podcast
MAPS Podcast: Episode 30 – Live from LAPSS: Transcending the Medical Frontiers
Recorded live at the first ever Los Angeles Psychedelic Symposium (LAPSS), this hour-long conversation is a lively exploration into what lies beyond the medical applications of psychedelic drugs. The panel includes David Jay Brown, Daniel Pinchbeck, James Oroc, and Ben Stewart. Moderated by Zach Leary.
Based on an article written by David Jay Brown, the panel took on many of the core concepts originally presented in the piece. The science of pleasure, increased creativity, increased problem solving ability, ESP, and psychic phenomena are just some of the potential psychedelia applications touched on by these incredible minds.
Tune in to hear this engaging, funny, and inspiring conversation that opens up the myriad of possibilities on the psychedelic horizon. Listen now…
MAPS Store
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 Manual of Psychedelic Support
The Manual of Psychedelic Support provides a comprehensive overview of how people can provide compassionate care to people undergoing difficult psychedelic experiences during large-scale music festivals and events.
$19.95 | Shop Now…
Events
Browse our Event Calendar and Featured Events page for more opportunities.
The Mushroom Cure: July 20, 2018 – September 7, 2018, 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 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…
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…
Moshe Kasher and Friends: A Benefit for MAPS: August 13, 2018, Los Angeles, California
Join comedian Moshe Kasher and special guests Eric Andre, Duncan Trussell, Shane Mauss, and more in Los Angeles, California, for a benefit for MAPS. 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…
Psycherence: September 21, 2018, Tallinn, Estonia
Psycherence is the Baltic’s biggest consciousness and psychedelics conference. This is an opportunity to meet the planet’s four leading experts in the field as they present their greatest ideas from their lifelong work. Psycherence offers a vision — a complementary approach to what science has already given us in understanding this intriguing and interesting spectrum of ideas. 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…
Spirit Plant Medicine Conference: November 2 – 4, 2018, Vancouver, British Columbia
Our intention with this eighth annual Spirit Plant Medicine Conference is to offer accurate, respectful, and most of all beneficial information and inspiration on the use of and larger context around such plant medicines. This is an intention arising from a vision and a prayer carried in the hearts of many. To that end, we have assembled an exceptional group of knowledgeable, engaging, and heartfelt speakers to share their wisdom. You’re warmly invited to join us for a remarkable weekend of insight, inspiration, compassion, and yes, humour. Learn more…
KRIYA Ketamine Conference – November 3 – 4, 2018, Hillsborough, California
KRIYA Conference is devoted to the use of ketamine in psychiatry and psychotherapy. Ketamine has been shown in numerous studies to be helpful in the treatment of severe depression and a variety of psychiatric disorders. Ketamine is emerging as a useful adjunct to psychotherapy or as a tool for psycho-spiritual exploration. Learn more…
More News
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
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…
DMT Survey
Johns Hopkins School of Medicine researchers are conducting an anonymous, internet-based survey study about DMT experiences. Learn More…
Huxley’s Last Trip: A Psychedelic Opera
“Huxley’s Last Trip” is a psychedelic performance based on “LSD: The Opera,” which unveils astonishing relationships among literary, scientific, academic, and political leaders in the early period of psychedelic experimentation. Learn more…
Usona Institute: Psilocybin as a Treatment for Depression
The Usona Institute, a psychedelic research organization, is conducting research into the therapeutic potential of psilocybin as a treatment for depression. To learn more and apply as a participant, visit the Usona Institute website.
Now Hiring: The Beckley Foundation (United Kingdom)
The Beckley Foundation is hiring a full-time Communications Officer to join their thriving communications team in Oxford for August. Applicants must have excellent writing and administrative skills, a background in media and communications, and experience working with an NGO or similar organisation, in addition to a right to work in the United Kingdom. Learn More….
Support Psilocybin Research in the United Kingdom
The Psychedelic Society UK’s new video reviews scientific research into the therapeutic potential of psilocybin as a treatment for mental health disorders, highlighting efforts to expedite research in the United Kingdom through government reclassification of psilocybin. Watch the video…
New Documentary: Microdose Me
MAPS Founder Rick Doblin, Ph.D., will be featured in Microdose Me, an upcoming documentary about the effects of psychedelics on depression, anxiety, PTSD, and addiction. Support the completion of this film by contributing to their Indiegogo campaign. Learn more…
Johns Hopkins Survey: Psychedelic Experiences and Psychological Insights
Support psychedelic research by taking a new survey about psychedelic experiences, conducted by researchers from Johns Hopkins University’s Psychedelic Research Team. Take the survey…
MDMA The Movie: 21 Minutes of Footage
Documentary filmmakers producing MDMA: The Movie have released 21 minutes of edited footage, along with the full treatment of the upcoming educational film. This film features interviews with multiple study participants who received MDMA-assisted psychotherapy as a treatment for PTSD in MAPS-sponsored clinical trials. Learn more…