Newsletter: August 2017 - Multidisciplinary Association for Psychedelic Studies

MDMA-Assisted Therapy for PTSD Receives Breakthrough Therapy Designation by FDA

MAPS’ Phase 3 Program to Include Two Trials in 14 Locations

August 30, 2017

Dear friends and supporters,

On August 26, 2017, the Multidisciplinary Association for Psychedelic Studies (MAPS)’ announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to MDMA for the treatment of posttraumatic stress disorder (PTSD). MAPS and the FDA have also reached agreement under the Special Protocol Assessment Process (SPA) for the design of two upcoming Phase 3 trials (MAPP1 and MAPP2) of MDMA-assisted psychotherapy for patients with severe PTSD.

MAPS can now start Phase 3 studies with confidence. By granting Breakthrough Therapy Designation, the FDA has agreed that this treatment may have a meaningful advantage and greater compliance over available medications for 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, we need your help to fill the funding gap.

To learn more about MAPS’ Phase 3 studies, read our press release or visit the new Phase 3 page on our website.

Celebrate this success with MAPS – help fund Phase 3 trials.

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

Researchers gathered at Emory University to conduct the official initiation visit for the Phase 1 study on the effect of MDMA on startle testing at Emory University
The eighth 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 25 of 76 participants have enrolled and received study drug in our clinical trial of smoked marijuana for PTSD in U.S. veterans
Over 339 people have donated $95,303 to support our crowdfunding campaign to expand the Zendo Project’s psychedelic peer counseling services
Experiences with Microdosing LSD are described by author Ayelet Waldman in her new book A Really Good Day, now available in the MAPS Store
Upcoming conferences and events featuring psychedelic education are highlighted on the MAPS Event Calendar

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

Thank you for helping MAPS reach new milestones.

Onward to Phase 3,

Bryce Montgomery
MAPS Associate Director of Communications and Marketing

Integrating Psychedelic Experiences with Ingmar Gorman M.A., Katherine MacLean, Ph.D., Julie Megler, N.P., and Tanya Maté, N.D., a full-day workshop from Psychedelic Science 2017, is now available for free online.

The Zendo Project is raising money for psychedelic peer counseling services.

Treating PTSD with MDMA-Assisted Therapy

FDA Grants MAPS Breakthrough Therapy Designation for Phase 3 Trials of MDMA-Assisted Therapy for PTSD

On August 16, 2017, the FDA granted Breakthrough Therapy Designation to MDMA for the treatment of PTSD. 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. Breakthrough Therapy Designation also means that the FDA will work closely with MAPS to provide guidance on the development of MDMA for post-traumatic stress disorder to design and conduct the development program as efficiently as possible.

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. Learn more…

Therapist Training Study: Four New Participants Enroll

On August 15, 2017, the 34th 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: Fourth Dyad Finishes Treatment

On July 30, 2017, the fourth dyad finished experimental treatment in our study of MDMA combined with Cognitive Behavioral Conjoint Therapy (CBCT) for PTSD at our Charleston, South Carolina site led by Principal Investigator, Michael Mithoefer, M.D., and Sub-Investigator, Candice Monson, Ph.D. The fifth dyad participated in their first preparation session on August 14. Four dyads have finished receiving experimental treatments, and will now move on to follow-up interviews.

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…

Startle Testing with MDMA: Initiation Visit Completed

On August 2, 2017, researchers gathered at Emory University to conduct the official initiation visit for our upcoming Phase 1 study on the effect of MDMA on startle testing in healthy volunteers. This study is scheduled to begin screening subjects in mid-September and will be led by Principal Investigator Barbara Rothbaum, Ph.D., at Emory University. 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: Eighth Participant Completes Long-Term Follow-Up Interviews

On August 2, 2017, the 8th 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

25th Participant Enrolls in Smoked Marijuana Trial for Chronic PTSD in Veterans

On August 9, 2017, the 25th 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 arizona@marijuanasites.org (SRI).

Psychedelic Harm Reduction

Zendo Project: Help Fund Psychedelic Peer Counseling

The Zendo Project is currently providing psychedelic peer support for a community of 70,000 people at Burning Man.

Thanks to 332 donors from 17 countries, the Zendo Project crowdfunding campaign raised $95,303 to expand psychedelic have within the past month, which fulfilled our $20,000 matching grant and exceeded the campaign’s initial $60,000 fundraising goal. We extend our immense gratitude to the RiverStyx Foundation for generously donating $30,000 to support the Zendo Project’s expansion.

We just need $4,859 to complete our new $100,000 Stretch Goal, which will completely fund the Zendo Project at Burning Man and support our presence at upcoming events. These additional gifts will help us travel to a new event, acquire new tools, and secure vehicles for transporting guests and supplies. Our stretch goal of $125,000 will help us cover the remainder of our operating expenses for this Fiscal Year, as well as purchase a new beautifully designed structure for our events. Learn more…

Support MAPS

July Giving Report: Fundraising for Psychedelic Peer Counseling

In July 2017, MAPS raised $56,485 in new donations and pledges from 365 supporters. In the same month, we launched our summer fundraising campaign to raise $60,000 for the Zendo Project, a psychedelic harm reduction and peer counseling program. Donate and learn more at zendoproject.org.

MAPS is moving forward with our research into 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, 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

Patricia & Richard Simon ($10,000)
Sally & Ted Schwartz ($2,500)
Kevin Herbert ($2,000)
Fernanda Weiden ($1,535)
Grant Leonard ($1,100)
John & Barbara Crary ($1,000)
Robert & Nancy Ley ($1,000)
Robert Gansser ($1,000)
Sahajia Sarkisian ($1,000)
William F. Harrison ($1,000)

MDMA/PTSD Phase 3 GMP Drug

Michael Mullins ($1,000)

MDMA/PTSD Israel Study

Michael & Anita Siegal Family Foundation ($4,000)

Zendo Project

Erik Bouchard ($1,000)
Peter Taubkin ($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

The Washington Post, Science Magazine, ELLE UK, Vice, and more…

FEATURED

PRESS RELEASE

FDA Grants Breakthrough Therapy Designation for MDMA-Assisted Therapy for PTSD, Agrees on Special Protocol Assessment for Phase 3 Trials
MAPS | August 26, 2017

The Washington Post
Ecstasy Could Be ‘Breakthrough’ Therapy for Soldiers, Others Suffering from PTSD
William Wan | August 26, 2017

Science Magazine
All Clear for the Decisive Trial of MDMA in PTSD Patients
Kai Kupferschmidt | August 26, 2017

Elle UK
Could MDMA Save Your Relationship?
Natasha Preskey | July 21, 2017

Vice
Legal MDMA Therapy Could Be Just a Few Years Away
Aaron Kase on | August 1, 2017

The Washington Post
Justice Department at Odds with DEA on Marijuana Research, MS-13
Matt Zapotosky and Devlin Barrett | August 15, 2017

Bitcoin News
MAPS to Accept Altcoins for Research on MDMA Psychedelic Medicine
Sterlin Lujan | August 10, 2017

Open Society Foundations
The War on Drugs Is Holding Science Back
Naomi Burke-Shyne | August 4, 2017

MAPS Store

Manual of Psychedelic Support

The Manual of Psychedelic Support is a new harm reduction resource providing a comprehensive overview of how people can provide compassionate care to people undergoing difficult psychedelic experiences during large-scale music festivals and events. All proceeds generated from the sale of this book will be used for psychedelic peer support at festivals and events.

$19.95 | Purchase Now

A Really Good Day

The true story of how a renowned writer’s struggle with mood storms led her to try a remedy as drastic as it is forbidden: microdoses of LSD. Her revealing, fascinating journey provides a window into one family and the complex world of a once-infamous drug seen through new eyes.

$25.95 | Purchase Now

Events

Browse our Event Calendar for more upcoming events.

“A Trip to the Past”: Stories from Boston’s Psychedelic History: September 15-17, 2017 (Boston, MA)

Retrace the steps of the Harvard Psychedelic Club with author Don Lattin and Rick Doblin, Ph.D., in Boston, Massachusetts! 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…

The Legal History of Psychedelics: September 13, 2017 (New York, New York)

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…

The European Ibogaine Forum: September 8 – 10, 2017 (Vienna, Austria)

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…

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

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…

MDMA-Assisted Therapy for PTSD Receives Breakthrough Therapy Designation by FDA