Newsletter: July 2017 - Multidisciplinary Association for Psychedelic Studies

MAPS Submits Breakthrough Therapy Designation Application to FDA for Phase 3 Trials of MDMA-Assisted Therapy for PTSD

Zendo Project launches crowdfunding campaign to expand psychedelic peer support services at Burning Man and beyond

July 28, 2017

Dear friends and supporters,

We are forging a path toward legal psychedelic medicine.

Last month, MAPS submitted to the U.S. Food and Drug Administration (FDA) an application for Breakthrough Therapy designation for our upcoming Phase 3 trials of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD). The potential approval of this application could significantly expedite the development and review of MDMA-assisted psychotherapy for PTSD.

We are also proud to officially announce the completion of our Phase 2 trial of MDMA-assisted therapy for social anxiety in autistic adults, and our Israeli Phase 2 trial of MDMA-assisted psychotherapy for PTSD. Results from these studies are being prepared for publication, and we look forward to sharing what we learn.

Two days ago, the Zendo Project launched a crowdfunding campaign to expand psychedelic peer counseling services at Burning Man and other large-scale events around the world. With your help, we can continue transforming difficult psychedelic experiences into opportunities for learning and growth. All donations are currently being doubled by a $20,000 matching grant, and $5,655 has already been matched! Act quickly to make the most of your gift and claim exclusive perks: zendoproject.org

In the July 2017 edition of the MAPS Email Newsletter, you’ll also learn:

The U.S. Drug Enforcement Administration (DEA) approves our upcoming Phase 1 study on the effect of MDMA on startle testing at Emory University
Seven participants have completed 12-month follow-up interviews in our study of MDMA-assisted psychotherapy for anxiety associated with life-threatening illness
A total of 20 of 76 participants have enrolled and received study drug in our clinical trial of smoked marijuana for PTSD in U.S. veterans
Limited edition merchandise from Psychedelic Science 2017 is available in the MAPS Store

Receive updates from MAPS on social media by following us on Facebook, Twitter, YouTube, reddit, Tumblr, Pinterest, Google+, LinkedIn, and Instagram.

The first half of 2017 was incredible for psychedelic research, and we’re off to a great start for the rest of the year.

With appreciation,

Bryce Montgomery
MAPS Associate Director of Communications and Marketing

The Zendo Project needs your help to create a compassionate environment for transforming challenging psychedelic experiences at festivals this year.

Psychedelic Science 2017 is highlighted in a new short documentary film produced by Cinematic Syndicate.

Watch over 100 conference videos online free!

Treating PTSD with MDMA-Assisted Therapy

MAPS Submits Breakthrough Therapy Designation Application to FDA for Phase 3 Trials of MDMA-Assisted Therapy for PTSD

On June 22, 2017, MAPS submitted to the U.S. Food and Drug Administration (FDA) an application for Breakthrough Therapy designation for our upcoming Phase 3 trials of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD). If approved, Breakthrough Therapy designation could expedite the development and review of MDMA-assisted psychotherapy for PTSD.

On June 27, the U.S. Food and Drug Administration (FDA) provided clearance for the initiation of our upcoming open-label Phase 2 study of MDMA-assisted psychotherapy for PTSD, taking place at all upcoming Phase 3 study sites in the United States. Participants with PTSD will receive MDMA-assisted psychotherapy from supervised co-therapy teams who will receive supervision by our our adherence raters and clinical training team in order to provide necessary experience for therapists transitioning to Phase 3 trials. Site initiation visits will begin in August and continue through September.

Our revised Phase 3 protocol evaluating MDMA-assisted psychotherapy for PTSD was granted unconditional approval by the Copernicus Group Institutional Review Board (IRB) on June 27. We expect to receive a response from the FDA regarding the Special Protocol Assessment process and our revised Phase 3 protocol by July 27.

Donations are currently being sought to reach MAPS’ goal of raising $25 million, with $10 million already raised, to successfully execute the Phase 3 studies required to gain approval from FDA for MDMA-assisted psychotherapy by 2021. Learn more…

Therapist Training Study: 31st Participant Enrolls

On July 12, 2017, the 31st 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 study is limited by invitation only to therapists in training to work on MAPS-sponsored clinical trials of MDMA-assisted psychotherapy for PTSD. The new participant was enrolled at the Boulder, Colorado, study site 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…

Israel: Study Officially Completed

On July 16, the 10th and final participant completed their 12-month follow-up interview in our Israeli Phase 2 study of MDMA-assisted psychotherapy for PTSD. Led by Principal Investigator Moshe Kotler, M.D., this Phase 2 study has treated 10 subjects with chronic, treatment-resistant PTSD from any cause. All treatment sessions and long-term follow-up interviews for this study have now been completed. Data from this study will be included in an international meta-analysis of the safety and efficacy of MDMA-assisted psychotherapy for the treatment of PTSD. Learn more…

Cognitive Behavioral Conjoint Therapy for PTSD: Fourth Dyad Begins Treatment

On July 7, 2017, the fourth dyad received their first experimental treatment our new 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 fourth dyad was enrolled on June 29. Three dyads have finished receiving experimental treatments, and will now move on to follow-up interviews.

The study will enroll 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. There are several important reasons to include significant others in PTSD treatment, in addition to the data supporting the efficacy of CBCT for PTSD. Learn more…

Startle Testing with MDMA: DEA Approves Study

In July 2017, the U.S. Drug Enforcement Administration (DEA) approved our upcoming Phase 1 study on the effect of MDMA on startle testing in healthy volunteers by providing a Schedule I research license for a scientist working with Principal Investigator Barbara Rothbaum, Ph.D., at the Emory University study site. The official site initiation visit will take place in August 2017. 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: Seventh Participant Completes Long-Term Follow-Up Interviews

On July 17, 2017, the 7th 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…

MDMA-Assisted Therapy for Social Anxiety in Autistic Adults

Social Anxiety in Autistic Adults: Study Officially Completed

On July 10, 2017, investigators gathered for the formal closeout of our study of MDMA-assisted therapy for social anxiety in adults on the autism spectrum. The closeout was conducted by Rebecca Matthews, and included a thorough review of the study’s documentation, database, files, and adherence to regulations. Led by Principal Investigators Charles Grob, M.D., and Alicia Danforth, Ph.D., this is a collaborative study between MAPS and the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center. The final results are currently being prepared for publication. Learn more…

Medical Marijuana

20th Participant Enrolls in Smoked Marijuana Trial for Chronic PTSD in Veterans

On July 10, 2017, a total of 20 of 76 participants have 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…

Psychedelic Harm Reduction

Zendo Project: Help Fund Psychedelic Peer Counseling

The Zendo Project needs your support to create safe spaces for transforming challenging psychedelic experiences at festivals and events this year.

Join the Zendo Project in providing a supportive environment and specialized care to transform difficult psychedelic experiences into valuable learning opportunities, and potentially offer healing and growth. Peer counseling services are beginning to be seen as essential in festival environments. We need your help to get there.

This year’s fundraising goal is $60,000. Make a donation and we’ll double it! Every donation will be matched dollar for dollar until we’ve used up our $20,000 matching grant from a generous supporter. Learn more…

Support MAPS

June Giving Report: Start of the New Fiscal Year

In June 2017, MAPS raised $675,013 in new donations and pledges from 326 supporters. June 1st marked the start of the new Fiscal Year.

MAPS is moving forward with its 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 pledged or in hand, 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

Adam Wiggins ($50,000)
Max Kerr ($3,500)
John Buchanan ($2,500)
Stephen & Eve Milstein ($1,000)
Mark Smith ($1,000)

MDMA/PTSD Phase 3 Studies

Libra Foundation ($600,000 pledged over two years)

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

The New York Times, Forbes, HuffPost, Reason, and more…

New York Times
Can Psychedelics Be Therapy? Allow Research to Find Out
Aaron E. Carroll | July 17, 2017

Reason
Medical Researchers Are Steps From Legalizing Ecstasy. Here’s How They Did It.
Mike Riggs | July 18, 2017

Huffington Post
In World First, MDMA Will Be Used To Treat Alcohol Addiction In Clinical Trial
Dominique Mosbergen | July 3, 2017

Forbes
Psychedelic Drugs Could Radically Improve Asia’s Mental Healthcare — If It Wasn’t For Stigma
Tim Chen | June 29, 2017

Vice
The Psychedelic Revolution Is Being Led by a 79-Year-Old Holocaust Survivor
Maia Szalavitz | June 24, 2017

YouGov
Majority of Americans Ready to Embrace Psychedelic Therapy
Gregory McCarriston | June 23, 2017

Inverse
Why Dr. Bronner’s Soap is Paying Millions on MDMA Research
Sarah Sloat | June 13, 2017

MAPS Store

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. Supplies of some sizes are limited so pick yours up while they are still available.

$30.00 | Buy it now before they disappear!

Psychedelic Science 2017 Collector’s Tumblers

These gorgeous hand-crafted, individually numbered (x/500) edition mugs are a beautiful reminder of the community that came together to share research findings and celebrate at Psychedelic Science 2017, the world’s largest conference ever on psychedelic research. Each mug features logos from MAPS, The Beckley Foundation, and Psychedelic Science 2017, along with signatures from MAPS Founder Rick Doblin, Ph.D., and Beckley Foundation Founder Amanda Feilding.

$30.00 | Get yours now while supplies last!

Events

Browse our Event Calendar for more upcoming events.

Float Conference 2017: August 12-13, 2017, Portland, OR

The world’s leading experts on float tanks are gathering for the Float Conference, the world’s largest float tank event. Last year, MAPS Founder Rick Doblin, Ph.D., spoke about psychedelic research during the event, and we are thankful to be invited back. MAPS will host a booth at this year’s conference, so make sure to visit us if you’re attending! Learn more…

“A Trip to the Past”: Stories from Boston’s Psychedelic History: September 16, 2017, Boston, MA

Retrace the steps of the Harvard Psychedelic Club with author Don Lattin at Harvard University, Boston University, and other landmarks in the Boston area! Learn more about the stories behind Timothy Leary, Ram Dass, Huston Smith, Andrew Weil, Walter Panhke and more. Come be a part of the Psychedelic Renaissance and learn more about the promising research about psychedelic medicines, entheogenic experiences, and the future of psychiatry, mental health, healing, spiritual emergence and drug policy! Learn more…

International Transpersonal Conference: September 28 – October 1, 2017, Prague, Czech Republic

The mission of the conference is to present an exclusive series of lectures, panel discussions and experiential workshops delivered by legendary founders of transpersonal psychology and key figures of the current transpersonal movement. Since the first and highly successful conference at “the heart of Europe” 25 years ago, we are again calling a transpersonal assembly in our beautiful and “magic” city of Prague, famous for its role in the history of spirituality, alchemy and science.

In order to make this one-of-its-kind event accessible to committed enthusiasts from around the world and from wide range of economic contexts, we are offering the ITC Prague 2017 Scholarship. Selected applicants will have the opportunity to buy their admission tickets for an individually discounted price. The application is open from July 1, 2017 – July 31, 2017. Learn more…

Horizons: Perspectives on Psychedelics: October 7 – 9, 2017, New York, NY

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…

International Drug Policy Reform Conference: October 11 – 14, 2017, Atlanta, GA

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. Don’t miss the opportunity to be a part of this event. 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 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…

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

Course: Ayahuasca, Science & Spirituality

This Fall, the California Institute of Integral Studies (CIIS) will host a new educational course about ayahuasca led by anthropologist Bia Labate, Ph.D. This course will systematize and reflect on the academic knowledge of ayahuasca from an anthropological perspective. An interdisciplinary understanding and comprehensive view of this Amazonian brew will be promoted, stimulating an exchange between academic knowledge and the knowledge of practitioners. The course will offer a historical and socio-cultural overview of ayahuasca shamanism, ritual, and religion in multiple modalities. By its conclusions, methodological, ethical, and political aspects of research will be addressed. The ultimate aim of this course is to stimulate intellectual reflection and research on this topic and enhance the development of this emergent field of studies. Learn more…

MAPS Submits Breakthrough Therapy Designation Application to FDA for Phase 3 Trials of MDMA-Assisted Therapy for PTSD