Study Initiation Visits Begin for Phase 3 Lead-In Trials of MDMA-Assisted Therapy for PTSD
September 30, 2017
Dear friends and supporters,
Psychedelic research is accelerating at an unprecedented rate. Last month, the U.S. Food and Drug Administration (FDA) decided to grant Breakthrough Therapy Designation to MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD), which led to widespread media coverage of MAPS' research. Breakthrough Therapy Designation is the FDA's most valuable program, which is reserved for treatments with preliminary clinical evidence demonstrating substantial improvement on one or more clinically significant endpoints over existing therapies for a serious or life-threatening condition or disease.
Throughout September 2017, MAPS and MAPS Public Benefit Corporation (MPBC) clinical staff completed 9 of 14 study initiation visits for sites selected to conduct Phase 3 lead-in trials of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD) across the United States and Canada. These study initiation visits serve to train clinical trial sites in study procedures, and remaining visits will take place over the coming months.
Leading researchers will speak about MAPS-sponsored Phase 3 clinical trials at Legalizing Psychedelic Medicine, the MAPS-hosted fundraising events taking place on October 7 in New York City during the Horizons: Perspectives on Psychedelics conference, and on October 13 in Atlanta, Georgia during the International Drug Policy Reform Conference. These events are unique opportunities to network with psychedelic scientists, and tickets are still available!
In the September 2017 edition of the MAPS Email Newsletter, you'll also learn:
- The tenth of 18 participants completed their long-term follow up in the ongoing study of MDMA-assisted psychotherapy for anxiety associated with a life-threatening illness
- A total of 27 of 76 participants have enrolled and received study drug in our clinical trial of smoked marijuana for PTSD in U.S. veterans
- The Zendo Project assisted 456 guests at Burning Man 2017 by providing psychedelic peer counseling services
- The science of ayahuasca is explored in The Fellowship of the River, a new book by researcher Joe Tafur, M.D.
Thank you for embarking on this journey with us.
MAPS Associate Director of Communications and Marketing
Table of Contents
Treating PTSD with MDMA-Assisted Therapy
- Study Initiation Visits Begin for Phase 3 Lead-In Trials of MDMA-Assisted Therapy for PTSD
- Therapist Training Study: Boulder Site Enrolls Three New Participants
- Cognitive Behavioral Conjoint Therapy for PTSD: Fifth Dyad Receives Experimental Treatment
MDMA-Assisted Therapy for Anxiety Associated with Life-Threatening Illness
- 27th Participant Enrolls in Smoked Marijuana Trial for Chronic PTSD in Veterans
- Are You a U.S. Military Veteran with PTSD?
Psychedelic Harm Reduction
- Psychedelic Science 2017 Shirts
- The Fellowship of the River: A Medical Doctor's Exploration into Traditional Amazonian Plant Medicine
- Legalizing Psychedelic Medicine: October 7, 2017 (New York, New York)
- Horizons: Perspectives on Psychedelics: October 7 – 9, 2017 (New York, New York)
- Microdosing with Duncan Trussell: October 7, 2017 (Brooklyn, New York)
- Legalizing Psychedelic Medicine: October 13, 2017 (Atlanta, Georgia)
- International Drug Policy Reform Conference: October 11 – 14, 2017 (Atlanta, Georgia)
- Hack Your Reality with Jason Silva: October 14, 2017 (Virtual)
- Science and Nonduality Conference: October 19 – 22, 2017 (San Jose, California)
- Psychedelic Medicine: New Frontiers in Palliative Care: October 27, 2017 (Seattle, Washington)
- Students for Sensible Drug Policy (SSDP) Regional Mini Conferences: October – December 2017 (United States)
- Altered Conference: Novemeber 3 – 4, 2017 (Berlin, Germany)
- Entheogenesis Australis Outdoor Psychedelic Symposium: December 8 – 10, 2017 (Australia)
- Plantas Sagradas en las Américas: February 23 – 25, 2018 (Mexico)
- Global Psychedelic Dinners
Treating PTSD with MDMA-Assisted Therapy
Study Initiation Visits Begin for Phase 3 Lead-In Trials of MDMA-Assisted Therapy for PTSD
Throughout September 2017, MAPS and MAPS Public Benefit Corporation (MPBC) clinical staff completed 9 of 14 study initiation visits for sites selected to conduct Phase 3 lead-in trials of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD) across the United States and Canada. These study initiation visits serve to train clinical trial sites in study procedures.
We will conduct an open-label lead-in training study at Phase 3 sites starting this fall, which will enroll 1-4 participants per site over the next 6-8 months. Each co-therapist team will work with a single participant at their respective study site.
The Phase 3 trials starting early next year will assess the efficacy and safety of MDMA-assisted psychotherapy in participants with PTSD, aged 18 and older, at sites in the U.S. and Canada. Participants will be randomized to receive three day-long sessions of either MDMA or placebo in conjunction with psychotherapy over a 12-week treatment period, along with 12 associated 90-minute non-drug preparatory and integration sessions. The primary endpoint will be the Clinician Administered PTSD Scale (CAPS-5), as assessed by a blinded pool of independent raters. Learn more…
Therapist Training Study: Boulder Site Enrolls Three New Participants
On September 24, 2017, the 37th participant enrolled in our ongoing Phase 1 study of the psychological effects of MDMA when used in a therapeutic setting by healthy volunteers. The 36th participant enrolled on September 18, and the 35th participant enrolled on September 17. 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: Fifth Dyad Receives Experimental Treatment
On August 26, 2017, the fifth dyad received their first 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 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 Interview
On August 29, 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…
27th Participant Enrolls in Smoked Marijuana Trial for Chronic PTSD in Veterans
On September 20, 2017, the 27th 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 Harm Reduction
Zendo Project Assists 456 Guests at Burning Man 2017
The Zendo Project served over 456 guests at Burning Man 2017, providing 24/7 essential support for psychedelic peer counseling services for the sixth consecutive year.
We are excited to share that Zendo Project’s psychedelic peer counseling services were highlighted on Burning Man’s official map of Black Rock City. Our central location near Rampart Medical featured multiple safe spaces, including two large structures and one smaller structure.
The Zendo Project collaborated closely with medical staff from Emergency Services Department, law enforcement officers from the Bureau of Land Management, and Black Rock City Rangers throughout the week. A public 3-hour training on the principles of psychedelic harm reduction was hosted along with two integration sessions.
Thank you to all of those who donated and supported the Zendo Project’s recent crowdfunding campaign. A special thank you to the Riverstyx Foundation for their large contribution. We exceeded our original $60,000 goal and our $100,000 stretch goal receiving a total of over $102,000 from 383 donors in 22 countries! All donations helped to provide psychedelic peer counseling at Burning Man 2017 and upcoming events throughout this year. We couldn’t have done it without all of you! Learn more…
August Giving Report: Fundraising for Psychedelic Peer Counseling
In August 2017, MAPS raised nearly $100,000 in new donations and pledges from 572 supporters. During August, MAPS raised funds for the Zendo Project, a psychedelic harm reduction and peer counseling program.
MAPS is moving forward with our research on MDMA-assisted psychotherapy for the treatment of PTSD. Phase 3 studies will cost between $25-$35 million for both FDA and European Medicines Agency (EMA) approval. With $12.5 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:
- Fred and Kate Weber ($10,000)
- AmazonSmile Foundation ($1,800)
- Chris Coburn ($1,000)
- Howard Fallon ($1,000)
MDMA/PTSD Phase 3 Studies
- Ullmann Family Foundation ($20,000)
- Riverstyx Foundation ($30,000)
- Anonymous ($17,508)
- Kirk Strawn ($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
NBC News, MD Magazine, A Plus, The Cannabist, Stars and Stripes, and more…
Will Psychedelic Therapy Transform Mental Health Care?
Joseph Bennington-Castro | September 28, 2017
A History of Psychedelics in Psychiatry
Thomas Castles | September 20, 2017
The U.S. Just Took A Big Step Towards Legalizing This ‘Party Drug’ As Treatment For PTSD
Isaac Saul | September 1, 2017
American Legion Calls for ‘Direct Involvement’ from VA Secretary for Federally-Approved Cannabis PTSD Study
Douglas Quenqua | September 21, 2017
Stars and Stripes
Study of Marijuana’s Effects on PTSD Struggles to Recruit Vets
Nikki Wentling | September 7, 2017
How a Party Drug Could Become The Next Blockbuster Anti-Depression Treatment
Douglas Quenqua | September 14, 2017
MDMA: Stories of Treatment
September 14, 2017
Santa Cruz Sentinel
Santa Cruz-Based MDMA Therapy for PTSD Reaches Final Testing Phase
Kara Guzman | September 22, 2017
The Fellowship of the River: A Medical Doctor’s Exploration into Traditional Amazonian Plant Medicine
Follow Dr. Joe Tafur through the Amazon jungle as he develops a breakthrough understanding of how psychoactive plants interact with the complex network that connects our minds and hearts to our physical anatomy. What Dr. Tafur presents here is nothing short of a paradigm shift for modern medicine, where sacred plants, used properly in ceremony, take their place as important tools in the doctor’s medicine chest, offering the missing elements of emotional and spiritual healing that have eluded us for so long.
$13.99 | Purchase Now
Psychedelic Science 2017 Shirts
Show your support for Psychedelic Science with this soft, v-neck shirt! They are lightweight and durable with a casual, yet professional look. Made from 65% polyester and 35% combed ring-spun cotton, in the USA by Next Level Apparel, and screen printed locally in Santa Cruz, by The Print Gallery. Available in charcoal, in most sizes.
$30.00 | Purchase Now
Browse our Event Calendar for upcoming events.
Legalizing Psychedelic Medicine: October 7, 2017, New York, New York
Join us on Saturday, October 7 for Legalizing Psychedelic Medicine, our annual gathering in New York with psychedelic visionaries. Enjoy an evening including dinner, wine, and a psychedelic comedy performance while connecting with like-minded individuals. Leading researchers will gather to discuss recent strides made towards the legalization of psychedelic medicines, featuring a review of progress from MAPS-sponsored clinical trials investigating MDMA-assisted psychotherapy as a treatment for posttraumatic stress disorder (PTSD). Featured speakers include MAPS Founder Rick Doblin, Ph.D., author and study participant Rachel Hope, researcher Shannon Clare Carlin, and comedian Adam Strauss. Learn more…
Horizons: Perspectives on Psychedelics: October 7 – 9, 2017, New York, New York
Horizons: Perspectives on Psychedelics is an annual forum in New York City that examines the role of psychedelic drugs in science, healing, culture and spirituality. In recent years, a growing community of scientists, doctors, artists, activists, seekers and scholars have orchestrated a renaissance in psychedelic thought and practice. Horizons brings together the brightest minds and the boldest voices of this movement to share their research, insights, and dreams for the future.
Learn more about MAPS’ research during the conference from Shannon Clare Carlin, M.A., and Thomas Kingsley Brown, Ph.D., who will be presenting recent updates about their respective work with MAPS’ MDMA Therapy Training Program, Phase 3 clinical trials, new research on ibogaine, and more! Author Phil Wolfson, M.D., will speak about ketamine research and his process of creating The Ketamine Papers, a MAPS-published book of essays. Learn more…
Microdosing with Duncan Trussell: October 7, 2017, Brooklyn, New York
Hosted by Psymposia and co-sponsored by MAPS, this event will explore the risks and benefits of microdosing psychedelics during a live discussion featuring comedian Duncan Trussell, Hamilton Morris (VICELAND’s Hamilton’s Pharmacopeia), Katherine MacLean, Ph.D., Sophia Korb, Ph.D., and Paul Austin. Learn more…
Legalizing Psychedelic Medicine: October 13, 2017, Atlanta, Georgia
Join us in Atlanta during the International Drug Policy Reform Conference for a MAPS-hosted fundraising event. MAPS Founder and Executive Director, Rick Doblin, Ph.D., will host an illuminating conversation about how the path to legalizing psychedelic medicine leads to his vision of a post-prohibition world; where psychedelics are used as prescription medicines, as valuable tools for inspiring creativity, for personal and spiritual growth, and for catalyzing resolutions to global and social conflicts. Buy tickets…
International Drug Policy Reform Conference: October 11 – 14, 2017, Atlanta, Georgia
The International Drug Policy Reform Conference is a biennial event that brings together people from around the world who believe that the war on drugs is doing more harm than good. This year attendees will have the opportunity to spend three days interacting with people committed to finding alternatives to the war on drugs while participating in sessions given by leading experts from around the world.
During the conference, MAPS staff members will be featured speakers during the following panel discussions:
- Psychedelic Research: Remaining Obstacles and New Visions (featuring Rick Doblin, Ph.D., MAPS Founder and Executive Director)
- Colonialism, Race and Psychedelics: How Do We Repair the Harms of Psychedelic Prohibition? (featuring Ismail Ali, J.D., MAPS Policy and Advocacy Counsel)
- Psychedelics 101: What Do Psychedelics Have To Do With Drug Policy Reform? (featuring Natalie Lyla Ginsberg, M.S.W., MAPS Policy and Advocacy Director)
Don’t miss the opportunity to be a part of this event. Learn more…
Hacking Reality with Jason Silva: October 14, 2017, Virtual
Join Jason Silva and thousands of others on October 14 in a live exploration and transformative learning experience that will help you create abundance in your life today. In this unprecedented live and live-streamed event by Emmy-nominated and world renowned storyteller, filmmaker, speaker, and futurist Jason Silva helps conscious change-makers create abundance in their lives by hacking their reality through ecstatic experiences, technology and wonder! Participants will learn how to raise individual consciousness in order to raise collective consciousness resulting in global social change.
A portion of proceeds from the livestream will be donated to paradigm shifting organizations such as the Multidisciplinary Association for Psychedelic Studies and more!
The event is $27 CAD with PROMO code: maps
Science and Nonduality Conference: October 19 – 22, 2017, San Jose, California
Join Science and Nonduality Conference (SAND) for a 5-day immersive experience where leading scientists, philosophers and spiritual teachers gather to explore a new understanding of who we really are, both as individuals and as a society. Experience 2 days of pre-conference workshops followed by a 3-day conference filled with talks, panels, meditation, performances, music, and dance. Learn more…
On Thursday, October 19, join SAND for an evening gathering to celebrate the start of the conference. Learn more…
Psychedelic Medicine: New Frontiers in Palliative Care: October 27, 2017, Seattle, Washington
This conference brings together doctors, scientific researchers, attorneys and ethicists to consider the medical, legal and ethical implications of this evolving research and to situate our evolving understanding of psychedelics in the shifting policies and priorities of our state and national drug control strategies. The Drug Policy Alliance (DPA) is co-organizing and co-sponsoring this day-long symposium along with the End of Life Liberty Project and University of Washington.
Attendees will be joined in Seattle by some fantastic speakers, including MAPS Executive Director Rick Doblin, Washington State Representative Roger Goodman and End of Life Liberty Project Executive Director Kathryn Tucker.
This event will take place at the University of Washington School of Law in William H. Gates Hall. You must register to attend. Lunch will be provided. Learn more…
Students for Sensible Drug Policy (SSDP) Regional Mini Conferences: October – December 2017, United States
Students for Sensible Drug Policy (SSDP) is the only international network of students dedicated to ending the war on drugs. Network with your local SSDP community and receive drug policy education by attending an upcoming regional mini-conference in the United States. Learn more…
Altered Conference: Novemeber 3 – 4, 2017, Berlin, Germany
Altered Conference is an international gathering of consciousness explorers from all backgrounds to take part in talks, workshops and rituals on the subject of psychedelics, conscious practices, and social issues facilitated by leading experts and researchers. This year, Altered takes place November 3-4 in Berlin at the beautiful Essentis Ecohotel and will present more than 30 speakers and workshops across a broad spectrum of topics including integrative psychedelic therapy, Ayahuasca and shamanic plant medicine, contemporary ritual and the latest microdosing research.
The theme this year is Altered States, Crisis and Opportunity, and the event organizers believe that within crisis lies a unique opportunity to self-reflect, evolve, and improve and we aim to explore how these states can be used as a tool to examine crisis and our relationship to it both as individuals and communities. This event intends to answer current questions about psychedelics and altered states of consciousness and move forward the dialogue about issues such as harm reduction, balancing indigenous wisdom with respect for the cultures it comes from and the conscious, therapeutic and integrative use of psychedelics. Learn more…
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
WThe 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…
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…