MDMA Research Highlighted in Three Scientific Journals
November 30, 2017
Dear friends and supporters,
This month, three renowned scientific journals published information about MAPS-sponsored research into treating posttraumatic stress disorder (PTSD) with MDMA-assisted psychotherapy. We're proud of our team and researchers who contributed to a new article appearing in Psychopharmacology, and two letters to the editor published in Biological Psychiatry, and the New England Journal of Medicine:
Two weeks since announcing our goal to raise $200,000, over 175 generous donors have given $35,219 to help heal people living with posttraumatic stress disorder (PTSD), anxiety, addiction, and other conditions. We have quickly fulfilled the $15,000 matching grant provided by an anonymous donor, and our momentum is strongly moving forward. We extend our gratitude to all supporters who have contributed towards our mission to legalize psychedelic medicine, especially those who recently gave to MAPS for their first time.
In the November 2017 edition of the MAPS Email Newsletter, you'll also learn:
- MAPS Public Benefit Corporation (MPBC) clinical research staff have now completed 11 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 32nd of 76 participants enrolls and receives study drug in our clinical trial of smoked marijuana for PTSD in U.S. veterans
- The 44th participant enrolls in our ongoing therapist training study
- The sixth dyad (pair of participants) receives their final experimental treatment in our study of MDMA-assisted cognitive behavioral conjoint therapy for PTSD
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MAPS Associate Director of Communications and Marketing
Table of Contents
Treating PTSD with MDMA-Assisted Therapy
- Study Initiation Visits Continue for Phase 3 Lead-In Trials of MDMA-Assisted Therapy for PTSD
- Therapist Training Study: 44th Participant Enrolls
- Cognitive Behavioral Conjoint Therapy for PTSD: Sixth Dyad Receives Final Experimental Treatment
MDMA-Assisted Therapy for Anxiety Associated with Life-Threatening Illness
- 32nd Participant Enrolls in Smoked Marijuana Trial for Chronic PTSD in Veterans
- Are You a U.S. Military Veteran with PTSD?
Psychedelic Peer Counseling
- Entheogenesis Australis Outdoor Psychedelic Symposium: December 8 – 10, 2017 (Australia)
- Plantas Sagradas en las Américas: February 23 – 25, 2018 (Mexico)
- SSDP 2018: The Students for Sensible Drug Policy Annual Conference: March 2-5, 2017, Baltimore, Maryland
- Global Psychedelic Dinners
Treating PTSD with MDMA-Assisted Therapy
Study Initiation Visits Continue for Phase 3 Lead-In Trials of MDMA-Assisted Therapy for PTSD
MAPS Public Benefit Corporation (MPBC) clinical research staff have now completed 11 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. These Study Initiation Visits provide training on study procedures to clinical trial sites that will receive clinical supervision of MDMA-assisted psychotherapy in preparation for Phase 3.
Starting at some Phase 3 sites now and continuing until June 2018, we will conduct the open-label lead-in training study. We will enroll 1-4 participants per site. 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 Phase 3 trials starting next year 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 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 Special Protocol Assessment for Phase 3 clinical trials. This agreement confirms that 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 approval from the European Medicines Agency (EMA) possibly requiring additional funds. With $15.5 million in hand or in multi-year pledges, there’s still a funding gap we need to close. 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: 44th Participant Enrolls
On November 14, 2017, the 44th participant enrolled in our ongoing Phase 1 study of the psychological effects of MDMA when used in a therapeutic setting by healthy volunteers. Enrollment in this multi-site study is limited by invitation only to therapists in training to work on MAPS-sponsored clinical trials of MDMA-assisted psychotherapy for PTSD. The Boulder, Colorado, study site is led by Principal Investigator Marcela Ot’alora, M.A., L.P.C. Michael Mithoefer, M.D., is serving as Principal Investigator at the site in Charleston, South Carolina with Sub-Investigator Ann Mithoefer, B.S.N. Learn more…
Cognitive Behavioral Conjoint Therapy for PTSD: Sixth Dyad Receives Final Experimental Treatment
On October 28, 2017, the sixth dyad received their final experimental treatment in our ongoing study of MDMA combined with Cognitive Behavioral Conjoint Therapy (CBCT) for posttraumatic stress disorder (PTSD) at our Charleston, South Carolina site led by Principal Investigator, Michael Mithoefer, M.D., and Sub-Investigator, Candice Monson, Ph.D. The third dyad completed the six-month follow-up interview on October 25.
The study enrolls dyads comprised of one participant diagnosed with PTSD and one concerned significant other who does not have PTSD but does experience psychosocial distress. MDMA will be administered to both participants to help facilitate communication and connection between participants and therapists. The primary goal of this study is to develop a combined method of MDMA with CBCT for PTSD. This is the first MAPS-sponsored MDMA study conducted with VA-affiliated researchers and the first to employ measures developed for the DSM-5. Learn more…
MDMA-Assisted Therapy for Anxiety Associated with Life-Threatening Illness
Marin: Tenth Participant Completes Long-Term Follow-Up Interviews
On November 17, 2017, the 10th 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…
32nd Participant Enrolls in Smoked Marijuana Trial for Chronic PTSD in Veterans
On November 14, 2017, the 32nd 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?
Adult military veterans who experienced trauma while in military service are needed for a research study. Study volunteers will complete 17 outpatient study visits over 12 weeks and a 6-month follow-up visit. The study will evaluate the effects of an investigational drug. Eligibility is determined by medical evaluation and modest compensation for participation is provided. All study visits occur at Scottsdale Research Institute. For more information, email firstname.lastname@example.org (SRI).
Psychedelic Peer Counseling
Zendo Project: Training Immediately Before Catharsis
Zendo Project Manager Ryan Beauregard facilitated a psychedelic harm reduction training in Washington, D.C., with over 100 individuals attending. Attendees learned how to best support people going through difficult psychedelic experiences. This training addressed the four principles of psychedelic harm reduction and included experiential tools and exercises.
October Giving Report: We’re Making Evidence-Based Treatments
In October 2017, MAPS raised $404,110 in new donations and pledges from 543 supporters. In the same month, MAPS hosted two fundraising events, one in New York City and one in Atlanta. Together, both events raised over $100,000.
In January 2018, MAPS will travel to Colorado to host Legalizing Psychedelic Medicines events near our study sites in Boulder and Fort Collins. We are still finalizing details, though we expect to be in Colorado sometime around January 25-28.
As MAPS shifts focus to beginning its Phase 3 studies of MDMA-assisted psychotherapy for PTSD, we face a fundraising challenge. In August, 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-$36 million for both FDA and European Medicines Agency (EMA) approval. With $15.5 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:
- Anonymous ($175,000)
- Fire Monkey Fund ($100,000)
- Maeve Rockefeller ($10,000)
- Anonymous ($5,000)
- Ryan Crane ($2,500)
- Chris Freund ($1,618)
- SpinCycle ($1,100)
MDMA/PTSD Phase 3 Studies
- Laura & Ed Littlefield ($40,000)
- Rodrigo Nino ($20,000)
- Anonymous ($5,000)
- Robert Eisenberg ($2,000)
- Clifford Perlman ($1,000)
MDMA/PTSD Phase 2 Study in Vancouver, BC
- Normand Boivin ($2,500)
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.
Recap: Catharsis on the Mall 2017
From November 10-12, 2017, thousands of people gathered on the National Mall in Washington, D.C. for the third annual Catharsis on the Mall. Catharsis is a 48-hour vigil for healing, inspired by the principles of Burning Man. MAPS co-created Catharsis with D.C. community activists and Dr. Bronners, and serves as its fiscal sponsor. We are looking forward to hosting this event again in 2018. This year, the gathering focused on equal rights, and healing from gender-based inequality. Catharsis was founded as a vigil for healing from the war on drugs, and last year focused on healing from trauma, in the immediate wake of the presidential election. Catharsis features panels, visionary art, dancing, yoga, conversations, and harm reduction services provided by the Zendo Project.
Within 24 hours after the conclusion of Catharsis, MAPS Policy and Advocacy Director Natalie Lyla Ginsberg, M.S.W., and MAPS Policy and Advocacy Counsel Ismail L. Ali, J.D., headed to Capitol Hill to try to persuade Republican Senators to write a letter to Attorney General Sessions urging him to eliminate the largest remaining barrier to cannabis research: the government monopoly on federally-legal research cannabis.
Featured Media: November 2017
- The New York Times: The Promise of Ecstasy for PTSD
- Written by Khaliya on November 3, 2017
- Scientific American: MDMA’s Journey from Molly to Medicine
- Written by Alfonso Serrano on November 3, 2017
- Reason: Enlisting Marijuana and MDMA to Fight PTSD
- Written by Jacob Sullum on October 29, 2017
- FOX31: MDMA Shows Promising Results for PTSD Treatment
- Written by Kevin Torres on November 21, 2017
- Herb: Therapists are Taking MDMA to Learn How to Treat PTSD
- Written by Miroslav Tomoski on November 19, 2017
- Tonic: Inside the Fight to Study Marijuana for Vets with PTSD
- Written by Shelby Hartman on November 10, 2017
MAPS Store Winter Sale
The MAPS Store Winter Sale is a great opportunity to get a gift for a friend, expand your psychedelic research library, or acquire a rare historic artifact for your collection. All sales support MAPS work to make psychedelic-assisted psychotherapy a legal treatment and to expand the scientific, medical, and spiritual uses of psychedelics and marijuana.
Up to 40% off | Shop Now
MAPS 40oz Water Bottle
This wide mouth, 40oz water bottle is essential for anyone who takes hydration seriously with a large volume capacity and light weight. Crafted from high quality food grade stainless steel, it won’t retain or impart flavors. 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
Browse our Event Calendar for upcoming events.
Entheogenesis Australis Outdoor Psychedelic Symposium: December 8-10, 2017, Australia
We are excited to officially announce Australia’s premier psychedelic symposium, Entheogenesis Australis (EGA) 2017. The 2017 EGA Outdoor Psychedelic Symposium (Retreat) is set to unfold on a beautiful bushland property 2 hours drive east of CBD Melbourne Australia. MAPS Founder Rick Doblin, Ph.D., will be speaking and MAPS is a proud partner of this event, which will cover a diverse range of fields from the botanical, academic, and philosophical, to arts and drug law reform. Learn more…
Plantas Sagradas en las Américas: February 23-25, 2018, 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.
The western campus of the Center for Research and Advanced Studies in Social Anthropology (CIESAS in Spanish) and anthropologist Beatriz Labate invite researchers and those interested in topics related to traditional, therapeutic use, history, politics and the legality of psychoactive plants to submit abstracts with proposals to participate in this international conference. 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…