MAPS Receives $1 Million Grant from Mercer Family Foundation for PTSD Research in Veterans
February 23, 2018
Dear friends and supporters,
International researchers are currently preparing for MAPS-sponsored Phase 3 trials of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD) with the goal of obtaining prescription approval from the European Medicines Agency (EMA) by 2021. These teams will start treating subjects within a Phase 2 open-label lead-in study to provide them with necessary training to prepare for Phase 3 research.
To support MAPS-sponsored Phase 3 research, the Mercer Family Foundation, founded by the family of Robert Mercer, hedge fund executive, and his daughter Rebekah Mercer, announced that it will make a $1 million contribution to MAPS.
The Pineapple Fund is providing 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.
The Zendo Project is currently at Envision Festival in Costa Rica to provide psychedelic peer counseling services and education for the sixth consecutive year. Watch our new video to learn how difficult psychedelic experiences can transformed into opportunities for growth.
For more opportunities to learn about psychedelic peer counseling and harm reduction, join the Zendo Project for upcoming workshops in Seattle, Portland, and Arcata.
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 February 2018 edition of the MAPS Newsletter, you'll also learn:
- Our ongoing therapist training study enrolls the 50th participant
- The 42nd of 76 participants enrolls and receives study drug in our clinical trial of smoked marijuana for PTSD in U.S. veterans
- We have new items in the MAPS Store, including the MAPS Messenger Bags and Zendo Project beanies.
Follow MAPS on Facebook, Twitter, YouTube, reddit, Tumblr, Pinterest, Google+, LinkedIn, and Instagram.
We are proud of the momentum surrounding MAPS’ progress, and we absolutely could not accomplish our goals without your support.
Thank you!
Bryce Montgomery
MAPS Associate Director of Communications and Marketing
Table of Contents
Treating PTSD with MDMA-Assisted Therapy
- Participant Enrollment and Treatment Continues in Open-Label Lead-In Study of MDMA-Assisted Therapy for PTSD at Phase 3 Sites
- Therapist Training Study: 50th Participant Enrolls
- Startle Testing with MDMA: Recruitment Update
MDMA-Assisted Therapy for Anxiety Associated with Life-Threatening Illness
Medical Marijuana
- 42nd 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
Media
MAPS Store
MAPS Podcast
Events
- Plantas Sagradas en las Américas: February 23 – 25, 2018 (Mexico)
- The Students for Sensible Drug Policy Annual Conference: March 2 – 5, 2018 (Baltimore, Maryland)
- Zendo Project Peer Support Workshops: March 15 (Portland, Oregon), March 17 (Seattle, Washington), and March 31, 2018 (Arcata, California)
- Global Psychedelic Dinners
More News
Treating PTSD with MDMA-Assisted Therapy
Participant Enrollment and Treatment Continues 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 13 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.
On February 13, 2018, Senior Clinical Research Associate Charlotte Harrison of MAPS Public Benefit Corporation (MPBC) traveled to Colorado for a Site Initiation Visit of the open-label lead-in study site in Boulder where we will conduct MDMA-assisted psychotherapy for PTSD. 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.
Charlotte also led an Interim Monitoring Visit on February 12 and 14 at the open-label lead-in study site in Fort Collins, Colorado.
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.
A total of 6 study sites have been granted a Schedule I license by the U.S. Drug Enforcement Administration (DEA):
- Los Angeles, CA
- San Francisco, CA
- Fort Collins, CO
- New Orleans, LA
- New York, NY
- Charleston, SC
The Phase 3 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. Once approved, MDMA will be required to be used in conjunction with psychotherapy in an outpatient setting.
Within the next month, sites in Charleston, South Carolina and in New York City will begin screening and recruiting participants for enrollment.
A total of 6 study sites have received the necessary study drug:
- San Francisco, CA (received Jan.9)
- Los Angeles, CA (received Jan. 25)
- Fort Collins, CO(received Dec. 19)
- New Orleans, LA (received Dec. 20)
- Charleston, SC (received Feb. 21)
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 $20+ 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 on March 1. 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: 50th Participant Enrolls
On February 6, 2018, the 50th 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. On February 15, 2018, Senior Clinical Research Associate Charlotte Harrison of MAPS Public Benefit Corporation (MPBC) traveled to Colorado for a monitoring visit of the study site in Boulder, which included a thorough review of the study’s documentation, database, files, and adherence to regulations. Learn more…
Startle Testing with MDMA: Recruitment Update
As of February 15, 2018, a total of 23 people have completed preliminary phone screening for enrollment opportunities in our study of the effect of MDMA on startle testing in healthy volunteers conducted by Principal Investigator Barbara Rothbaum, Ph.D., at Emory University in Atlanta, Georgia. In-person screening will begin March 2018 with enrollment to follow. This study will be followed by another study exploring the combination of MDMA with Prolonged Exposure in PTSD patients. Learn more…
MDMA-Assisted Therapy for Anxiety Associated with Life-Threatening Illness
Marin: Eleventh Participant Completes Long-Term Follow-Up Interviews
On February 15, 2017, the 11th of 18 participants completed their 12-month follow-up interview in our ongoing Marin, Calif., study of MDMA-assisted psychotherapy for anxiety associated with life-threatening illness. 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…
Medical Marijuana
42nd Participant Enrolls in Smoked Marijuana Trial for Chronic PTSD in Veterans
On February 12, 2018, the 42nd of 76 participants enrolled and received study drug in the first-ever clinical trial of smoked marijuana (cannabis) for posttraumatic stress disorder (PTSD) in U.S. veterans. Taking place at the Scottsdale Research Institute (SRI) in Phoenix, Arizona, this clinical trial will evaluate the safety and efficacy of four different potencies of marijuana for symptoms of PTSD in 76 U.S. veterans. A new recruitment website can be visited here. Learn more…
Are You a U.S. Military Veteran with PTSD?
Military veterans with PTSD are invited to participate in a confidential and federally‐authorized clinical research study of the impact of cannabis on PTSD symptoms. Volunteers must be local to the Phoenix, AZ area. Compensation for time and travel is provided. If you are interested in learning more about this confidential research study, or would like to see if you qualify to participate, please contact Scottsdale Research Institute, LLC: wecanstudy.org
Psychedelic Peer Counseling
Zendo Project: Psychedelic Peer Counseling at Envision Festival 2018 and Upcoming Workshops
For the sixth consecutive year, the Zendo Project is providing psychedelic harm reduction services at Envision Festival 2018 in Costa Rica this month. 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 rehydrate.
This March, the Zendo Project is hosting Peer Support Workshops in 3 different locations: Portland, Seattle, and Humboldt. For more information and to register, visit the Zendo Project events page.
The Zendo Project is accepting volunteer applications for Lightning in a Bottle, a 5-day festival taking place at Lake San Antonio, California, from May 23 – 28, 2018. Applications are due on March 1, 2018, and a select number of accepted volunteers will receive a ticket to the event in exchange for their services. Apply to Volunteer | Learn more…
Support MAPS
January Giving Report: $4 Million Match From Pineapple Fund
In January 2018, MAPS raised $1,148,633 in new donations and pledges from 720 supporters.
Starting on January 10, the Pineapple Fund has offered MAPS a $4 million matching grant for Phase 3 studies of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD). The Pineapple Fund will match dollar-for-dollar all donations until March 10. Matching funds will be made in Bitcoin. If MAPS meets the match, we will have nearly funded our entire Phase 3 research for U.S. Food and Drug Administration (FDA) approval of MDMA as a legal medicine. In January, MAPS has raised $744,041 toward the Pineapple Fund match.
In the same month, MAPS hosted four fundraising events across Colorado and California, which altogether raised $49,594 for Phase 3 research.
In August 2017, MAPS was granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA). 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. Additional expenses include research for other regulatory agencies around the world, therapist training, Expanded Access, and Phase 4 pediatric studies, which altogether will require at least $10 million more.
We extend a special thanks to those who so generously supported MAPS last month:
General Support:
- Pineapple Fund ($33,455)
- Spark Directed Fund ($10,000)
- Matteo de Nora ($5,000)
- Payam Panbechi ($2,346)
- James D. Northrup ($1,000)
- Anonymous ($1,000)
- Peter Majerczak ($1,000)
MDMA/PTSD Phase 3 Studies:
- Anonymous ($400,000)
- Pineapple Fund ($292,369)
- William H. Donner Foundation ($250,000)
- George Goldsmith and Katya Malievskaia ($25,000)
- Hub Spoke and Wheel ($10,850)
- Devon Aoki and James Bailey ($10,000)
- Paul and Kristina Eklund ($7,000)
- Jeffrey Zucker ($5,000)
- Anonymous ($2,000)
- Mark C. Passerini, OM of Medicine ($1,200)
- Sean McCabe ($1,000)
- Allan M. Badiner ($1,000)
- Anonymous ($1,000)
- Anonymous ($1,000)
- John H. Buchanan ($1,000)
- Martin Chilcutt ($1,000)
- Anonymous ($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.
Media
Featured Media: February 2018
- PRESS RELEASE: Mercer Family Foundation Grants $1 Million to MAPS for PTSD Research in Veterans
- Written by Brad Burge on February 14, 2018
- Rolling Stone: Why Is it So Hard to Study Pot?
- Written by Eric Killelea on February 8, 2018
- U.S. News: Colorado Vet Fights a New Battle Over Pot Treatment for PTSD
- Written by Donna Bryson on February 9, 2018
- 13News Now: FDA Trial Uses Ecstasy To Treat PTSD
- Written by Laura Geller on February 7, 2018
- Herb: Inside the Fight to Break Down the Barriers to Marijuana Research
- Written by Rob Hoffman on January 31, 2018
- Tonic: MDMA Could Help Treat Eating Disorders
- Written by Natasha Preskey on February 8, 2018
MAPS Store
NEW! MAPS Messenger Bags
Proudly support psychedelic research and be ready for every outing with these limited edition MAPS Messenger Bags! These spacious bags feature many pockets for your belongings, a detachable and adjustable shoulder strap, and padded compartment to carry a laptop up to 15″.
$50.00 | Get Yours Today!
NEW! Zendo Project Beanies
Show your support for psychedelic peer counseling and harm reduction with these soft Zendo Project beanies! They are produced with organic RPET from Recycled eco-organic fibers and combed spandex, and made in America by Royal Apparel.
$20.00 | Available Now!
MAPS Podcast
MAPS Podcast: Episode 24 – Psychedelics and The Future: A Panel of Luminaries from 1990
This episode of the MAPS podcast takes us on a journey way back into the archives of psychedelic lore by pulling some classic audio from a historic event in 1990. Tucked in the cozy enclave of Maryland, many of the world’s great psychedelic luminaries gathered to reflect on the state of psychedelic research, culture and policy.
Rick Doblin moderates a panel from this gathering entitled “Psychedelics and The Future” that features Timothy Leary, Ram Dass, Terence McKenna, Ralph Metzner, Andy Weil, Emerson Jackson and Robert Zanger.
Rick sets the tone by putting forth the question “Where do you see us in the year 2000? What will psychedelics look like in the 90’s and where will it take us?”
Events
Browse our Event Calendar for upcoming events.
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, 2018, 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…
Zendo Project Peer Support Workshops: March 15 (Portland, Oregon), March 17 (Seattle, Washington), and March 31, 2018 (Arcata, California)
Workshops will be held in 3 cities during the month of March. Topics include: physical, mental, and emotional effects of psychedelics; factors that contribute to a difficult experience; Zendo Project’s four principles of psychedelic support; tools, techniques, and protocols; sitter self-care; assisting the integration of a psychedelic journey; ethical guidelines for psychedelic peer counseling. 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
Kratom/Oxycodone Comparison Survey
Have you consumed opiates or tranquilizers in the past few months/years? Data on the wellness and risk factors of natural and synthetic psychoactive drug use is being collected for research. The psychoactive drugs of interest are kratom and oxycodone. Take the Surveys…