Participant Enrollment and Treatment Begins in Open-Label Lead-In Study of MDMA-Assisted Therapy for PTSD at Phase 3 Sites
January 31, 2018
Dear friends and supporters,
The first month of 2018 has been monumental for the expansion of psychedelic science. On January 10, the Pineapple Fund announced a $4 million matching grant to support MAPS’ FDA Phase 3 trials of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD). All donations, multi-year pledges, and cryptocurrency gifts in support of Phase 3 trials will be doubled until this opportunity expires on March 10, or when the match is fulfilled. If MAPS is able to meet this entire match, we will have obtained all the funding we currently estimate we’ll need for approval by FDA of MDMA-assisted psychotherapy as a legal treatment available by prescription, and likely covered by health insurance.
MAPS-sponsored researchers at new study sites in Fort Collins, Colorado, and New Orleans, Louisiana, have begun enrolling participants and conducting experimental treatment sessions for our open-label lead-in study of MDMA-assisted psychotherapy for PTSD at planned Phase 3 sites. Each new co-therapy team will work with a single participant at their respective study site with supervision provided by MAPS’ therapy training team.
Last week, MAPS staff members traveled to Colorado to host fundraising events and strengthen communities in Boulder and Fort Collins, the cities in Colorado with planned Phase 3 sites, and then visited Los Angeles, where we also have a Phase 3 site. We are grateful for everyone who connected with us while in Colorado and California, and we especially enjoyed seeing study participants share their experiences in-person at these events.
This Sunday, February 4, MAPS will be in Austin, Texas, to gather with our supporters at Psychedelic Possibilities, a sold out fundraising event co-hosted by Aubrey Marcus and Whitney Miller. Though tickets are now sold out, we are still accepting additions to our waiting list.
In February, MAPS staff members will be featured speakers at three upcoming events in Mexico. The CryptoPsychedelic Summit on February 3 in Tulum, Mexico, will unite leaders in the fields of cryptocurrency and psychedelic science. MAPS Executive Director, Rick Doblin, Ph.D., has been invited to the Satoshi Roundtable on February 7 in Cancun, Mexico, to speak with cryptocurrency pioneers about MAPS’ studies of MDMA-assisted psychotherapy for PTSD.
From February 23-25, experts from around the world, including several MAPS staff members, will discuss the role of plant medicines in science and culture at Plantas Sagradas en las Américas, a conference in Ajijic, Jalisco, Mexico. Learn about the scope of this 3-day conference by reading the new press release written by the Sacred Plants in the Americas, an international congress.
In the January 2018 edition of the MAPS Newsletter, you'll also learn:
- Our ongoing therapist training study enrolls the 49th participant
- The 38th of 76 participants enrolls and receives study drug in our clinical trial of smoked marijuana for PTSD in U.S. veterans
- Psychedelic Medicine, the new book by Dr. Richard Miller, is available for purchase in the MAPS Store
- A new testimonial video produced by Krenshaw Films features study participant John Saul in an exploration of MDMA-assisted psychotherapy as a treatment for anxiety-associated with life-threatening illness
- Our team shares intentions for 2018
Follow MAPS on Facebook, Twitter, YouTube, reddit, Tumblr, Pinterest, Google+, LinkedIn, and Instagram.
Thank you for creating time to learn about our progress.
Take care,
Bryce Montgomery
MAPS Associate Director of Communications and Marketing
Table of Contents
Treating PTSD with MDMA-Assisted Therapy
- Participant Enrollment and Treatment Begins in Open-Label Lead-In Study of MDMA-Assisted Therapy for PTSD at Phase 3 Sites
- Therapist Training Study: 49th Participant Enrolls
Medical Marijuana
- 38th Participant Enrolls in Smoked Marijuana Trial for Chronic PTSD in Veterans
- Are You a U.S. Military Veteran with PTSD?
Psychedelic Peer Counseling
Support MAPS
- December 2017 Giving Report: Legalizing Psychedelic Medicine
- Pineapple Fund Offers $4 Million Matching Grant to MAPS
Media
MAPS Store
Events
- The CryptoPsychedelic Summit: February 3, 2018 (Tulum, Mexico)
- SOLD OUT – Psychedelic Possibilities: February 4, 2018 (Austin, Texas)
- Plantas Sagradas en las Américas: February 23 – 25, 2018 (Mexico)
- The Students for Sensible Drug Policy Annual Conference: March 2 – 5, 2018 (Baltimore, Maryland)
- Global Psychedelic Dinners
More News
Treating PTSD with MDMA-Assisted Therapy
Participant Enrollment and Treatment Begins in Open-Label Lead-In Study of MDMA-Assisted Therapy for PTSD at Phase 3 Sites
MAPS Public Benefit Corporation (MPBC) clinical research staff have completed 12 of 14 Study Initiation Visits for an 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 for our co-therapy teams. These Study Initiation Visits provide training on study procedures to study sites where new co-therapy teams will receive clinical supervision of MDMA-assisted psychotherapy in preparation for Phase 3. Each new co-therapy team will work with a single participant at their respective study site with supervision provided by MAPS’ therapy training team.
The study site in Fort Collins has conducted experimental treatment sessions with two participants, and the New Orleans study site has completed their first experimental treatment session, and other sites will start enrolling participants soon.
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.
Enrollment for Phase 3 trials is expected to start in the summer of 2018 in the following locations:
- Los Angeles, CA | private practice
- San Francisco, CA | research institution
- San Francisco, CA | private practice
- Boulder, CO | private practice
- Fort Collins, CO | private practice
- New Orleans, LA | private practice
- New York, NY | research institution
- New York, NY | private practice
- Charleston, SC | private practice
- Madison, WI | research institution
- Boston, MA | research institution
- Montreal, Canada | private practice
- Vancouver, Canada | research institution
- Tel Aviv, Israel | research institutions
The trials build on the promising results of MAPS’ completed Phase 2 clinical trials, and 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.
On July 28, 2017, MAPS and the FDA reached agreement on the design of our Phase 3 trials after a six-month long Special Protocol Assessment (SPA) process. This agreement confirms that the protocol design, clinical endpoints, planned conduct, and statistical analyses for the Phase 3 trial are acceptable to support regulatory approval by the FDA.
On August 15, 2017, the FDA granted Breakthrough Therapy Designation (BTD) to MDMA-assisted psychotherapy for the treatment of PTSD. FDA rejects about two-thirds of applications for BTD. The FDA grants this designation for treatments that (1) are intended alone or in combination with one or more other drugs to treat a serious or life-threatening disease or condition; and (2) preliminary clinical evidence indicates may demonstrate substantial improvement over existing therapies. BTD also means that the FDA will work closely with MAPS to conduct the development program as efficiently as possible and to plan ahead of time regarding issues of commercialization should Phase 3 studies prove successful.
MAPS and MPBC staff are excited to reach this milestone toward bringing healing to those diagnosed with PTSD through MDMA-assisted psychotherapy. Donations are currently being sought to reach MAPS’ goal of raising $26 million to successfully execute the Phase 3 studies required to gain approval from the FDA for MDMA-assisted psychotherapy by 2021. With $18 million in hand or in multi-year pledges, there’s still a funding gap we need to close. Approval from the European Medicines Agency (EMA) will likely require additional funds, with MAPS beginning negotiations with EMA in February 2018. EMA agreement is anticipated by the end of Summer 2018. Learn more…
There is now a clear path ahead to make MDMA a legal medicine for millions of people suffering from PTSD. Help us heal trauma: maps.org/donate
Therapist Training Study: 49th Participant Enrolls
On January 16, 2018, the 49th 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…
Medical Marijuana
38th Participant Enrolls in Smoked Marijuana Trial for Chronic PTSD in Veterans
On January 30, 2018, the 38th 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. 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: Psychedelic Peer Counseling at Envision Festival 2018
For the sixth consecutive year, the Zendo Project will provide psychedelic harm reduction services at Envision Festival in Costa Rica, an event taking place in February 2017. Last year at Envision Festival, Zendo Project volunteers provided compassionate support for over 100 guests, and dozens more used the Zendo Project facilities as a space to rest and/or rehydrate. Learn more…
Support MAPS
January Giving Report: Legalizing Psychedelic Medicine
In December 2017, MAPS raised over $5.4 million in new donations and pledges from 960 supporters. In the same month, MAPS released the final in a collection of new video testimonials from clinical trial participants Roxxann, Hapi, James, Eric, Karen, and Suzanne as part of our year-end drive to raise $200,000 for evidence-based psychedelic and marijuana research and to develop new treatments for posttraumatic stress disorder (PTSD), anxiety, addiction, and other conditions. MAPS far exceeded our $200,000 goal and raised over $400,000. Gratitude goes to our supporters who provided matching grants: Sarlo Foundation, Justin Rosenstein, Bonnie Brunet & Martin Rist, and three other anonymous supporters.
In December, MAPS received tremendous support from the cryptocurrency community. The Pineapple Fund, started by an anonymous Bitcoin philanthropist with a mission of donating over $86 million in Bitcoin, awarded MAPS $1 million in Bitcoin. Soon to follow, another anonymous philanthropist donated $1 million in Bitcoin, and another supporter gave over $769,000 in LUN tokens. MAPS now accepts Bitcoin, Bitcoin Cash, Ethereum, Litecoin, and LUN, and will accept other cryptocurrencies that are offered.
In December, MAPS received tremendous support from the cryptocurrency community. The Pineapple Fund, started by an anonymous Bitcoin philanthropist with a mission of donating over $86 million in Bitcoin, awarded MAPS $1 million in Bitcoin. Soon to follow, another anonymous philanthropist donating $1 million in Bitcoin, and another supporter gave over $769,000 in LUN tokens. MAPS now accepts Bitcoin, Bitcoin Cash, Ethereum, Litecoin, and LUN, and will accept other cryptocurrencies that are offered.
On August 15, 2017, MAPS was granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for MDMA-assisted psychotherapy for PTSD. This encouraging news demonstrates the FDA’s support and desire to expeditiously make MDMA into a legal medicine. Phase 3 studies will cost between $26-$35 million for both FDA and European Medicines Agency (EMA) approval. With $18 million in hand or in multi-year pledges, there’s still a funding gap we need to close.
We extend a special thanks to those who so generously supported MAPS last month:
General Support:
- Anonymous ($1 million in Bitcoin)
- Christian Halper ($100,000)
- Joshua Bezoni ($20,000)
- Dean Nolan ($15,721 in Bitcoin)
- Justin Rosenstein ($15,000)
- Anonymous ($10,000)
- René Ruiz ($10,000)
- Frank Kavanaugh ($10,000)
- The Sarlo Foundation ($10,000)
- Theda and Tamblin Clark Smith ($6,000)
- Anne F. St Goar & Shippen Page ($5,011)
- Bonnie Brunet & Martin Rist ($5,000)
- Paul & Kristina Eklund ($5,000)
- Carolyn Mary Kleefeld ($5,000)
- Anonymous ($5,000)
- Rhonda S. Zinner Foundation ($5,000)
- Anonymous ($5,000)
- Mack Fuhrer ($4,250)
- Matteo de Nora ($3,000)
- Elliot Godzich ($3,000)
- Constance & H. Roemer McPhee ($3,000)
- Meghan Kennedy ($2,500)
- Yavanna Foundation ($2,500)
- Gardner Grout Foundation ($2,500)
- Jamie Snider ($2,500)
- Tyler Theofilos ($2,018)
- Sean Abraham ($2,000)
- James Anderson ($2,000)
- Anonymous ($2,000)
- Anonymous ($2,000)
- The Peace Fund ($2,000)
- Adam Hupp ($2,000)
- PADOSI Foundation ($2,000)
- Orli Rinat ($1,800)
- Lars King ($1,500)
- Lumpkin Family Foundation ($1,500)
- Swami Ajaya ($1,200)
- Paul & Emily Eastham ($1,130)
- Grant Leonard ($1,100)
- Jeya Aerenson ($1,000)
- Sheila Burgel ($1,000)
- Diana & Matt Chapman ($1,000)
- Martin Chilcutt ($1,000)
- Joshua Dirlam ($1,000
- Vinh Do ($1,000)
- Bill Freimuth ($1,000)
- John Garand ($1,000)
- Anonymous ($1,000)
- Ed Hunsinger ($1,000)
- Shane Leather ($1,000)
- Salyer Jess Lee ($1,000)
- David L. Lewis ($1,000)
- Jared A. Luxenberg ($1,000)
- Magaly Mauer ($1,000)
- Michael Montagne ($1,000)
- Matthew S. Pazar ($1,000)
- Paul Renn ($1,000)
- Steven Rooke ($1,000)
- Anonymous ($1,000)
- Flavio Rump ($1,000)
- Martha Stampfer ($1,000)
- Marc & Astrid Vaccaro ($1,000)
- Andrew Wiggins ($1,000)
- Steve Zenone ($1,000)
- Steve Gehrman ($1,000)
- Michael Pollan & Judith Belzer ($1,000)
MDMA/PTSD Phase 3 Studies:
- Riverstyx Foundation ($2 million pledge)
- Pineapple Fund ($1 million in Bitcoin)
- Anonymous ($769,000 in LUN tokens)
- Paul & Emily Eastham ($50,000)
- Mental Insight Foundation ($50,000)
- Jennifer Allen ($21,956)
- Jonathan Cain ($2,500)
- Nathaniel Putnam ($2,500)
- Anonymous ($1,000)
- Elisha A. Gottstein ($1,000)
- Anja Saunders ($1,000)
MDMA/Anxiety Associated with Life-Threatening Illness:
- Mental Insight Foundation ($50,000)
MDMA/PTSD Couples Therapy Study:
- William F. Harrison ($10,000)
Marijuana for PTSD Study in Arizona:
- Arizona Natural Pain Solution ($10,000)
Zendo Project:
- Allen Hopper ($45,000)
- Eric Angell ($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 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.
Pineapple Fund Offers $4 Million Matching Grant to MAPS
On January 10, 2018, the Pineapple Fund (pineapplefund.org), founded by an anonymous cryptocurrency philanthropist, announced that it will match, dollar-for-dollar, $4 million in contributions to the non-profit Multidisciplinary Association for Psychedelic Studies (MAPS). The purpose of the match, which expires on March 10, 2018, is to inspire others to complete funding for MAPS’ upcoming Phase 3 clinical trials of MDMA-assisted psychotherapy for the treatment of posttraumatic stress disorder (PTSD).founded by an anonymous cryptocurrency philanthropist, announced that it will match, dollar-for-dollar, $4 million in contributions to the non-profit Multidisciplinary Association for Psychedelic Studies (MAPS). The purpose of the match, which expires on March 10, 2018, is to inspire others to complete funding for MAPS’ upcoming Phase 3 clinical trials of MDMA-assisted psychotherapy for the treatment of posttraumatic stress disorder (PTSD).
The Pineapple Fund will match all new donations to MAPS for Phase 3 trials in US dollars, multi-year pledges, or cryptocurrency, up to $4 million in Bitcoin (BTC). If this funding challenge is met, MAPS will have raised sufficient funds to complete U.S. Food and Drug Administration (FDA) Phase 3 trials. Read the press release… | Donate today…
Media
Featured Media: January 2018
- Scientific American: As Vets Demand Cannabis for PTSD, Science Races to Unlock Its Secrets
- Written by Alfonso Serrano on January 4, 2018
- MAPS Press Release: Pineapple Fund Offers $4 Million Matching Grant to MAPS
- Written by Brad Burge on January 10, 2018
- 9NEWS (KUSA): Local Researchers Hope MDMA Can Cure PTSD
- Written by 9NEWS (KUSA) on January 15, 2018
- International Business Times: Anonymous Bitcoin Philanthropist will Match $4m in Donations to Research Mental Health Benefits of MDMA
- Written by Kashmira Gander on January 12, 2018
- Psychedelic Frontier: From “X” to Rx: Discussing MDMA with Rick Doblin
- Written by Psychedelic Frontier on January 23, 2018
- Newsweek: MDMA for PTSD Therapy Enters Final Round of Trials, Could be Approved in U.S. and Canada by 2021
- Written by Lauren Gill on January 21, 2018
MAPS Store
Psychedelic Medicine by Dr. Richard Louis Miller
Published in November, Dr. Miller reviews medical uses of psychedelics such as LSD, MDMA, psilocybin, and ayahuasca, exploring what the future holds for these substances. This book features pieces from revolutionaries and researchers including Rick Doblin, Ph.D., Stanislav Grof, M.D., Ph.D., James Fadiman, Ph.D., Julie Holland, M.D., Dennis McKenna, Ph.D., David Nichols, Ph.D., Charles Grob, M.D., Phil Wolfson, M.D., Michael Mithoefer, M.D., Annie Mithoefer, B.S.N., Roland Griffiths, Ph.D., Katherine MacLean, Ph.D., and Robert Whitaker.
$16.95 | Purchase Now
MAPS 40oz Water Bottle
This wide mouth, 40oz water bottle is essential for anyone who takes hydration seriously. Crafted from high quality food grade stainless steel, it won’t retain or impart flavors. The included Loop Cap has a stainless steel base so your favorite beverage never touches plastic. Proudly show your support of MAPS while reducing the use of disposable containers with this functional Kanteen.
$30.00 | Purchase Now
Events
Browse our Event Calendar for upcoming events.
The CryptoPsychedelic Summit: February 3, 2018, Tulum, Mexico
Join us for this world-bridging event on the gorgeous beaches of Tulum. The CryptoPsychedelic Summit will bring together leaders in blockchain and psychedelic science to discuss new possibilities in research, innovation, and community building. Learn more…
SOLD OUT – Psychedelic Possibilities: February 4, 2018, Austin, Texas
Hosted by Onnit CEO Aubrey Marcus and Whitney Miller, this event will feature discussions about supporting MAPS’ mission to a post-prohibition world, where psychedelics can be used for therapy, to inspire creativity, to promote environmental stewardship, to help solve global conflicts, and to accomplish personal or spiritual growth. Learn more…
Plantas Sagradas en las Américas: February 23-25, 2018, Ajijic, Jalisco, Mexico
The international congress Sacred Plants in the Americas has the objective of exposing and discussing aspects related to the diversity of uses that have been given to psychoactive plants throughout history and in different geographical areas, as well as the use that they already have Its active compounds are nowadays, both in traditional contexts and outside them, scientific research, empirical experience, cultural manifestations and the ways in which the State has administered these practices. The Multidisciplinary Association for Psychedelic Studies (MAPS) is a co-sponsor of the conference. Read the press release… | Learn more…
SSDP 2018: The Students for Sensible Drug Policy Annual Conference: March 2-5, 2017, Baltimore, Maryland
Students for Sensible Drug Policy (SSDP) is the only international network of students dedicated to ending the war on drugs. SSDP2018 will bring more than 400 student members, alumni, and supporters to Baltimore, Maryland, from March 2-4, 2018, for their annual gathering. Learn more…
Global Psychedelic Dinners
By hosting your own Global Psychedelic Dinner, you’ll join people around the world in gathering your community, having an open conversation about psychedelics, and raising funds to support MAPS. Host a dinner…
More News
Intentions for 2018
MAPS and MAPS Public Benefit Corporation staff members have come together to establish the following intentions for 2018:
- “Deepen MAPS’ engagement with the legal and policy sphere around the world to establish ourselves as a leader in the sphere of psychedelic politics”
- “Equity”
- “Quality time with family, chosen and given”
- “Access”
- “Develop a community and collective embodiment of a more transformational, connected, and healing planet”
- “Alignment regenerative”
- “Vindication”
- “Create safe spaces for individuals and communities to heal from generations of trauma so that we may co-create a future of peace, ending the cycle of violence toward each other and the planet”
- “Blossom”