Newsletter: January 2020 - Multidisciplinary Association for Psychedelic Studies

FDA Agrees to Expanded Access Program for MDMA-Assisted Therapy for PTSD

January 28, 2020

Dear friends and supporters,

We began the new year with the conclusion of our most successful year-end fundraising campaign ever! We raised over $888,000 from 1,555 generous donors from 36 countries, achieving an amazing 222% of our initial $400,000 fundraising goal. The contributions we received from our community will keep us strong in 2020. Thank you again to all who participated!

On December 20, 2019, the U.S. Food and Drug Administration (FDA) agreed to MAPS’ application for an Expanded Access program for MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD). The purpose of the Expanded Access program is to allow early access to potentially beneficial investigational therapies for people facing a serious or life-threatening condition for whom currently available treatments have not worked, and who are unable to participate in Phase 3 clinical trials. The program will enroll 50 PTSD patients at up to 10 sites in the U.S. Site locations will be announced in the next few months.

“We commend FDA for recognizing the great unmet medical need of PTSD by allowing access to MDMA-assisted psychotherapy on a compassionate basis for people with treatment-resistant PTSD,” said MAPS Founder and Executive Director Rick Doblin, Ph.D. “We are delighted to begin generating real-world evidence about this potential new treatment. • Read the Press Release

The Way of the Psychonaut by Stanislav Grof, M.D., Ph.D., is available for purchase in the MAPS Store and on Amazon. One of the most important books ever written about the human psyche and the spiritual quest, this comprehensive work is possibly Grof’s greatest contribution. Purchase the two-book paperback set in the MAPS Store or buy eBook Volume 1 and eBook Volume 2 on Amazon.

MAPS is proud to be the recipient of a 2019 Gold Seal of Transparency from GuideStar, an organization that gathers and distributes information about U.S. non-profit organizations. By adding information about our goals, strategies, capabilities, and vision, we are highlighting the difference we help to make in the world. We are so grateful for this recognition!

MAPS and Zendo Project Phone Grips are now available in the MAPS Store! Designed for better phone handling, these expandable phone grips allow you to effortlessly take pictures so you never drop your phone again. These phone grips are very durable and will stay in place until you remove it. Phone grips also function as a stand; prop up your phone while playing games, reading, or watching videos.

We are continuing to accept applications for research volunteers for MAPS-sponsored Phase 3 clinical trials of MDMA-assisted psychotherapy for PTSD. Volunteers in this study will help us better understand if MDMA-assisted psychotherapy works for the treatment of PTSD. MAPS conducts clinical trials under the guidance and regulations of the U.S. Food and Drug Administration (FDA) in collaboration with all federal regulators, including the Drug Enforcement Administration (DEA). For more information on study participation, please visit our website.

In this month’s edition of the MAPS Newsletter, you’ll also learn:

Our ongoing therapist training study enrolls the 89th study participant
The Plant Medicine Podcast features MAPS Public Benefit Corporation (MAPS PBC) Director of Training and Supervision Shannon Clare Carlin, M.A., A.M.F.T., on MDMA practitioner methods
MAPS Public Benefit Corporation (MAPS PBC) and MAPS Europe are hiring!

Follow MAPS on Facebook, Twitter, Instagram, YouTube, LinkedIn, and reddit.

On behalf of all of us at MAPS, thank you for being with us on this journey.

With appreciation,

Amy Mastrine
MAPS Web and Email Marketing Associate

Treating PTSD with MDMA-Assisted Therapy

Phase 3 Trials of MDMA-Assisted Therapy for PTSD: Now Enrolling

We are currently seeking research volunteers for Phase 3 clinical trials of MDMA-assisted psychotherapy for PTSD. Volunteers will help contribute to scientific knowledge and will help us better understand if MDMA-assisted psychotherapy works for the treatment of PTSD. MAPS conducts clinical trials under the guidance and regulations of the U.S. Food and Drug Administration (FDA) in collaboration with all federal regulators, including the Drug Enforcement Administration (DEA). To learn more about our clinical trials or apply to be a study participant, visit our website: mdmaptsd.org.

Phase 2 Open-Label Lead-In Study of MDMA-Assisted Therapy for PTSD: Data Under Review

On December 10, 2019, MAPS Public Benefit Corporation (MAPS PBC) completed an interim lock of the existing database for our Phase 2 open-label lead-in study of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD) at sites across the United States and Canada. A total of 42 people were enrolled in the study, with 37 treated, and a total of 36 participants completed the study. With this preliminary set of data from 36 subjects, the research team will analyze the data for submission to FDA and will write a paper for submission to a peer-reviewed scientific journal. The purpose of this study is to provide the final training and supervision for our co-therapy teams as they work with one study participant with PTSD. The same treatment approach will be used in Phase 3. We have developed a long-term follow-up protocol for this multi-site open-label Phase 2 study, which will assess symptoms of PTSD in participants 12 months after completing treatment. • Learn More

Therapist Training Study: 89 Participants Enrolled

As of January 17, 2020, 89 total participants are 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., the Charleston, South Carolina, is led by Principal Investigator Zhenya Gelfand, M.D., and the Santa Fe, New Mexico, study site is led by Principal Investigator George Greer, M.D. • Learn More

Startle Testing with MDMA: Recruiting Volunteers

Our ongoing study of the effect of MDMA on startle testing is recruiting healthy volunteers. Led by Principal Investigator Barbara Rothbaum, Ph.D., this study is conducted at Emory University in Atlanta, Georgia. If you have tried MDMA, you may be eligible to enroll in this study investigating the effects of MDMA on the startle response. You will receive monetary compensation for completing the study. All involvement is confidential. This study takes place at Emory University in Atlanta, Georgia. For more information, please contact callan.m.coghlan@emory.edu. • Learn More

MDMA Therapy Training Program Update: January 2020

In 2019, the MDMA Therapy Training Program launched a series of trainings to prepare therapy providers to become eligible to work on an MDMA-assisted psychotherapy for PTSD protocol.

The training team is currently taking time to focus on program development to support the growth and evolution of the training program for future practitioners. Dates and tuition fees for the 2020 training year will be announced through the Training Program Newsletter once they are scheduled.

Sites in the U.S. and U.S. territories interested in being considered to participate in an Expanded Access MDMA/PTSD protocol may now apply with MAPS Public Benefit Corporation (MAPS PBC) to assess eligibility and obtain the prerequisite training to administer MDMA-assisted psychotherapy.  The basic requirements of a qualified site are 1) treatment facility conducive to MDMA-assisted psychotherapy, 2) therapy team, qualified and able to complete MDMA Therapy Training Program, and 3) prescribing physician who can obtain a DEA Schedule I license for MDMA. MAPS PBC is in discussions to select the first 10 sites for the first 50 Expanded Access subjects. Additional subjects and EA sites will depend on discussions with FDA and are unlikely to be approved for another year or so.

Additional site and practitioner requirements are posted on the MAPS PBC website. Each site must submit one site questionnaire and all applicants interested in training need to complete a therapy training application for providers. Only applicants affiliated with a qualifying site can be considered for training at this time. MAPS PBC will review applications on an ongoing basis, as they are received. The MAPS PBC Therapy Provider Connect Portal is a community discussion forum for therapy providers, physicians and facilities to connect with one another to develop a site or treatment staff, in order to become eligible to participate in a MAPS PBC Expanded Access MDMA/PTSD protocol.

Zendo Project Featured on Forbes.com

David Carpenter features MAPS and the Zendo Project in a recent article for Forbes.com. He writes:

“Made up of volunteers assisting individuals at events who experience challenging emotional encounters on psychedelics, team members provide calm spaces and support to ride out the roller-coaster ride of difficult moments. Zendo’s presence at events has effectively helped to reduce the number of psychiatric hospitalizations and arrests that sometimes occur for people overwhelmed by ingesting substances.” • Read the Article

Support MAPS

December 2019 Giving Report: MAPS Raises $2,110,377 in December in Donations and Pledges, Raises $908,943 in Year-End Fundraising Campaign

In December 2019, MAPS raised $2,110,377 in donations and pledges from 1932 supporters. Of that amount, $780,349 was for general support, $723,373 was for GMP MDMA, $600,792 for MDMA research, $50,000 for therapy training, $5,663 for the Zendo Project, and $200 for ibogaine research. Additional funds were raised for fiscal sponsorships ($81,636).

MAPS launched its year-end fundraising campaign, Expanding Psychedelic Medicine, on November 19, 2019. Over 1,450 donors from 36 different countries helped us exceed our initial fundraising goal, raising a total of $908,943 for psychedelic research and education! We are particularly grateful to our supporters who offered matching grants including John A. Griffin ($100,000), Frank Kavanaugh ($25,000), Matt Khoury ($15,000) and the TinMan Fund ($10,000).

We extend a special thanks to those who so generously supported MAPS last month:

General Support:

Robert Anthony Granieri – $100,000
Vinny Smith – $100,000
John Gilmore – $30,000
Ron Beller – $25,000
Anonymous – $25,000
Madeline Farver Berky – $15,000
The TinMan Fund – $10,000
Anonymous – $10,000
Samuel Friedman – $10,000
Kwang Ho Kim – $10,000
Jennifer Allen and John R. Hain – $8,788
Jennifer Abele – $7,500
Hess Moallem – $7,500
Jeffrey Gordon – $6,000
Jordan Swartz Kareem – $5,410
Roger Doughty – $5,000
Pamela and Don Lichty – $5,000
Patricia Ahumada and Tip Paul – $5,000
Ashley Gordon – $5,000
Frank Kienast – $5,000
Pamela S. Lewis – $5,000
Stephen Skiano – $5,000
Richard and Patricia Simon – $5,000
Michael McPhee – $3,000
Anonymous – $3,000
Hilary Silver – $3,000
Roman Stalder – $3,000
Anonymous – $3,000
Andrew Kirk Gradison – $2,500
Adam Hupp – $2,500
David Armistead – $2,500
Latané Temple Keeler – $2,500
Carolyn Mary Kleefeld – $2,500
Jeffrey Brown – $2,000
Buckmaster Foundation – $2,000
Cameron Cheever – $2,000
Pamela Fortino – $2,000
Make Fuhrer – $2,000
Mark S. Smith – $2,000
Eve and Stephen Milstein – $1,800
Spencer Dunn – $1,500
Anonymous – $1,500
Tyler Theofilos – $1,500
Joel Zadak – $1,500
Sarah Renee Ayala – $1,416
C.A. Winn Management Trust – $1,000
Anonymous – $1,000
Barden Family Giving – $1,000
David and Karen Branson – $1,000
Buckmaster Foundation – $1,000
Roland and Elizabeth Gibson – $1,000
Mr. and Mrs. James Minarik – $1,000
Thomas Terry – $1,000
Roger Mason – $1,000
Anonymous – $1,000
Anonymous – $1,000
Anne Kate Becker – $1,000
Erik Bouchard – $1,000
Peter Brock – $1,000
Martin Brown – $1,000
Natalka Burian – $1,000
James Stewart Campbell – $1,000
John and Barbara Crary – $1,000
Joshua Diriam – $1,000
Ian Dominguez – $1,000
Alan Feiger – $1,000
Jonathan Feyer – $1,000
MentorMore Foundation – $1,000
Vincent Franze – $1,000
Bill Freimuth – $1,000
Robert Gansser – $1,000
Anonymous – $1,000
Kent Hoffman – $1,000
Ed Hunsinger – $1,000
Andrew Koraleski – $1,000
Robert and Nancy Ley – $1,000
Mary Mahood – $1,000
Emily Maier – $1,000
Carol and Wally Marks – $1,000
Leigh Marz and Michael Ziegler – $1,000
Keith McCoy – $1,000
Anonymous – $1,000
Fredi Muller – $1,000
Daren Nordhagen – $1,000
John O’Hara – $1,000
Tim Rigg – $1,000
Kenneth Ryan – $1,000
Martha Stampfer – $1,000
Bessel A. Van Der Kolk – $1,000
Cynthia Whitham – $1,000
Caleb Whitten – $1,000
Merrily Wyman – $1,000
Stee Senone – $1,000

Phase 3 GMP MDMA:

Psychedelic Science Funders Collaborative – $722,974

MDMA/PTSD

Dr. Bronner’s – $250,000
The George Sarlo Foundation – $200,000
Mental Insight Foundation – $100,000

MDMA Therapy Training Program

Open Society Foundations – $50,000

Zendo Project

Kareem Kouddous – $5,000

Fiscal Sponsorships:

Dr. Bronner’s – ICEERS ($60,000)
Moshe Tov Kreps – ICEERS ($15,000)
Lily Spencer – ICEERS ($3,300)
Meg and Jeff Fisher – VETS ($1,000)

MAPS relies on the generosity of individual donors to achieve its 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.

Together, we can legalize psychedelic medicine.
Donate now at maps.org/donate. Learn how to include MAPS in your will or estate plans.

We’re Hiring!

MAPS Public Benefit Corporation (MAPS PBC) and MAPS Europe are currently hiring!

MAPS PBC:

Video Systems Developer (Contractor) (Remote with occasional visits Santa Cruz, California)
Medical Monitor (Remote)
Administrative Assistant for Clinical Operations (Santa Cruz, California)
Clinical Study Assistant (Santa Cruz, California)
Clinical Research Associate (Remote)
Study Coordinator (Brookline, Massachusetts)
Study Coordinator (New Orleans, Louisiana)

MAPS Europe:

Clinical Research Associates (Finland, Germany, and Portugal)
Clinical Trial Assistant (Remote)
Independent Rater (Norway, Portugal, Germany and Finland)
Video Systems Support Specialist (European Union)

You can support psychedelic science by referring qualified applicants to these open positions.

Media

Featured Media

PRESS RELEASE: FDA Agrees to Expanded Access Program for MDMA-Assisted Therapy for PTSD

January 17, 2020

The Independent: The New Year Is Prime Time for Unnecessary Drug-Related Deaths – Legalising MDMA Could Stop Them

December 28, 2019

Plant Medicine Podcast: MDMA Scientific Research with Marcela Ot’alora

January 2, 2020

WHYY: Psychedelics and Therapy

January 10, 2020

Ozy: When MDMA Was the Secret to a Happy Marriage

January 3, 2020

DoubleBlind Magazine: How to Make Sense of Your Last Trip

January 8, 2020

MAPS Store

MAPS and Zendo Project Phone Grips

Easily hold your phone with Zendo Project Phone Grips! Designed for better phone handling, these expandable phone grips allow you to effortlessly take pictures so you never drop your phone again. Phone grips also function as a stand; prop up your phone while playing games, reading, or watching videos. These phone grips are very durable and will stay in place until you remove it. Proceeds support the Zendo Project’s psychedelic peer support and education services. • Buy MAPS Phone Grip • Buy Zendo Project Phone Grip

The Way of the Psychonaut: Encyclopedia for Inner Journeys by Stanislav Grof, M.D., Ph.D. (Two-Volume Book Set and eBook)

The Way of the Psychonaut is one of the most important books ever written about the human psyche and the spiritual quest. The new understandings were made possible thanks to Albert Hofmann’s discovery of LSD–the microscope and telescope of the human psyche–as well as other psychedelic substances. This comprehensive work is a tour de force through the worlds of psychology and psychotherapy, Holotropic Breathwork, maps of the psyche, birth, sex, and death, psychospiritual rebirth, the roots of trauma, spiritual emergency and transpersonal experiences, karma and reincarnation, higher creativity, great art, and archetypes. • Two-Volume Book Set: Volumes 1 and 2 • eBook (Volume 1) • eBook (Volume 2)

Events

Browse our Event Calendar page for more opportunities.

Fantastic Fungi Film Screenings, Now – March 2020, International

Fantastic Fungi, a new documentary directed by Louie Schwartzberg, is an important scientific exploration of the little-known realm of fungi, featuring interviews with well-known figures like Paul Stamets, Michael Pollan, and Andrew Weil, M.D. Special film screenings of Fantastic Fungi are taking place around the world from now through January 2020. • Learn More

Head Talks with Shane Mauss Tour, February 2019, United States

Shane Mauss is an award-winning stand-up comedian, science podcaster and a psychedelic advocate. Head Talks is his new tour where he is joined by a psychedelic researcher in each city for a show combining all three of his worlds into one two-hour show. You’ll get psychedelic comedy, a science talk, a Q&A, and a community meet & greet in one event. • Learn More

Pushing the Envelope in Psychiatric Treatments: Rapid Acting Agents, Psychedelic-Assisted Therapy, and More, March 21, 2020, Stanford, California

This conference emphasizes the need for high-quality research, scientific/empirical evidence, and safeguards against adverse effects and outcomes in psychedelic research. Additionally, we need the scholarly efforts of all relevant fields and interprofessional collaborations. This CME activity will cover emerging treatment areas in psychiatry including the related basic science, benefits, risks and clinical trial evidence. • Learn More

The Interdisciplinary Conference on Psychedelic Research, April 24-26, 2020, Haarlem, The Netherlands

This is the fourth edition of the Interdisciplinary Conference on Psychedelic Research. ICPR 2020 takes place from Friday, April 24 to Sunday, April 26, 2020, in the beautiful city of Haarlem, The Netherlands. ICPR 2020 is an academic conference focused on high quality scientific and scholarly research into psychedelics. Many academic disciplines have important contributions to make within the field of psychedelic studies. ICPR aims to bridge and connect these disciplines, and to facilitate a dialogue between the diverse academic fields and researchers involved in the study of psychedelics. • Learn More

Psychedelic Liberty Summit, April 25-26, 2020, San Francisco, California

This summit will bring together experts from around the world to discuss the legal, cultural, and political issues around the emerging psychedelic renaissance. The topics addressed will include: the process of applying for religious exemptions with the DEA; psilocybin decriminalization initiatives; the right to ameliorate pain and suffering; cognitive liberty; drug use and human rights; ibogaine bills; the upcoming FDA regulation of MDMA and psilocybin; psychedelic harm reduction; licensed health care providers and psychedelic-assisted therapy; the paradoxes of cannabis regulation and NIDA monopoly for research cannabis; conservation of endangered species; human’s relationship to sacred plants and nature; the continuities and discontinuities between recreational, therapeutic and religious use of drugs; the future legal markets; and the commercialization of psychedelics. • Learn More

Participate in Psychedelic Research

MDMA Studies Sponsored by MAPS

MAPS sponsors clinical trials around the world that offer volunteers the opportunity to participate in our research studies. Our studies have strict enrollment criteria based on the goal of the study and the condition the study is investigating.

Phase 3 trial participant enrollment is now open. Please bookmark our Participate in Research page and check it frequently for updates.

University College London (UCL) Psychedelic Survey

Researchers based at University College London (UCL) are aiming to better understand the relationship between psychedelic drug use and characteristics of people who have used them at least once. We are firstly interested to learn about both the ‘mystical’ and challenging experiences which can occur. We are also interested in psychedelic drug use in people who do and do not meditate, and finally in whether psychedelic use is related to mental health. • Take the Survey

More News

Joe Rogan Experience Podcast #1385 – Paul Stamets

Listen to Paul Stamets on the Joe Rogan Experience as he discusses mycology, microdosing, psilocybin research, and MAPS Phase 3 trials of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD). • Watch Now

Thank you to Dr. Bronner’s for their company’s support of the MAPS Newsletter!