MAPS Receives Donation from Two Cryptocurrency Philanthropists of 111 Bitcoin Worth $2 Million at Time of Donation

December 22, 2017

Dear friends and supporters,

The rapid progression of support for psychedelic research is awe-inspiring. Within the past week, MAPS received 111 Bitcoins (BTC) as donations from cryptocurrency philanthropists who support our mission to legalize psychedelic medicine.



On December 14, 2017, the Pineapple Fund, set up by an anonymous philanthropist, donated 59.89 BTC, initially valued at $1,000,000, to MAPS as part of a plan to give away over $86 million in BTC to charities and causes around the world. To learn more about this gift, read the press release.

After announcing the Pineapple Fund’s gift, on December 18, MAPS received a second Bitcoin donation of 51.54 bitcoins from another anonymous donor. On December 20, MAPS received 88,000 LUN tokens worth over $740,000 from yet another anonymous donor. MAPS accepts cryptocurrency donations in Bitcoin, Bitcoin Cash, Litecoin, Ethereum, and LUN.



On Monday, December 18, MAPS’ clinical team met with our pro-bono pharmaceutical lawyer, Peter Barton Hutt of Covington & Burling. On Tuesday, December 19, MAPS’ clinical team leaders, Executive Director, and U.S. Drug Enforcement Administration (DEA) consultant met with the DEA at their headquarters in Arlington, Virginia. We discussed streamlining plans for Schedule I licenses for researchers and potential Expanded Access therapists.



On Wednesday, December 20, 17 staff from the U.S. Food and Drug Administration (FDA) met with MAPS researchers and staff from MAPS Public Benefit Corporation (MPBC) at FDA's White Oak Campus in Silver Spring, Maryland. This was our first meeting under the Breakthrough Therapy Designation program to discuss various issues related to our Phase 3 clinical trials and potential prescription approval of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD).



There are less than two weeks left to make a tax-deductible donation to MAPS before the year ends. To learn how these donations can help heal trauma, watch our new testimonial videos from study participants.

In the December 2017 edition of the MAPS Email Newsletter, you'll also learn:

Medscape publishes an editorial in which MAPS defends MDMA as a treatment for PTSD

Local screening of candidates begins for our study of the effect of MDMA on startle testing in healthy volunteers in Atlanta, Georgia

Our ongoing therapist training study enrolls the 46th participant

Shop during the MAPS Store Winter Sale to receive up to 40% off on select items in our online store. Find gifts for yourself or friends by browsing our collection of psychedelic books, rare artifacts, apparel, and more.

Shop during the MAPS Store Winter Sale to receive up to 40% off on select items in our online store. Find gifts for yourself or friends by browsing our collection of psychedelic books, rare artifacts, apparel, and more.

Follow MAPS on Facebook, Twitter, YouTube, reddit, Tumblr, Pinterest, Google+, LinkedIn, and Instagram.

Thank you for supporting MAPS' mission to legalize psychedelic medicine.

Take care,

Bryce Montgomery

MAPS Associate Director of Communications and Marketing

Table of Contents



Treating PTSD with MDMA-Assisted Psychotherapy



Medical Marijuana



Psychedelic Peer Counseling



Support MAPS



Media



MAPS Podcast



MAPS Store



Events

Treating PTSD with MDMA-Assisted Psychotherapy

MDMA Phase 3 Trials: FDA and DEA to Host Breakthrough Therapy Meetings

On Monday, December 18, MAPS’ clinical team met with our pro-bono pharmaceutical lawyer, Peter Barton Hutt of Covington & Burling. On Tuesday, December 19, MAPS’ clinical team leaders, Executive Director, and U.S. Drug Enforcement Administration (DEA) consultant met with the DEA at their headquarters in Arlington, Virginia. We discussed streamlining plans for Schedule I licenses for researchers and potential Expanded Access therapists.



On Wednesday, December 20, 17 staff from the U.S. Food and Drug Administration (FDA) met with MAPS researchers and staff from MAPS Public Benefit Corporation (MPBC) at FDA's White Oak Campus in Silver Spring, Maryland. This was our first meeting under the Breakthrough Therapy Designation program to discuss various issues related to our Phase 3 clinical trials and potential prescription approval of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD).



MAPS Public Benefit Corporation (MPBC) clinical research staff have 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...

We are pleased to congratulate our Phase 3 study therapists who recently gave birth - congratulations on your growing family!

Study Therapist Sophia "Sosha" Zaretsky, M.D., in New Orleans, Louisiana

Co-Principal Investigator and Study Therapist Christopher Nicholas, Ph.D., and wife Chantelle Thomas in Madison, Wisconsin

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

New Testimonials from MDMA Study Participants

Learn more about MDMA-assisted psychotherapy by watching our four new study participant testimonial videos:















Medscape: Defending MDMA as Treatment for PTSD

Medscape publishes an editorial with MAPS' response to a recent Medscape video presentation by Dr. Jeffrey Lieberman in which the author expresses concern about psychedelic therapy research, including MDMA research. In the editorial, MAPS researchers and staff highlight recent research, explaining how Dr. Lieberman's critiques do not accurately reflect the results of Phase 1 and Phase 2 trials of MDMA-assisted psychotherapy for PTSD, nor do they correctly describe its proposed mechanism of action. "We firmly agree that, like any other treatment, MDMA should be investigated with rigor and care, and its acceptance based on results from randomized, controlled clinical trials," the researchers write. "However, his statements do not accurately reflect findings from phase 1 and 2 studies of MDMA in clinical settings, nor its proposed mechanism of action as an adjunct to therapy." Read the publication...

Therapist Training Study: 46th Participant Enrolls

On December 12, 2017, the 46th 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...

Startle Testing: Recruitment Update

On November 9, 2017, the Institutional Review Board approved the protocol amendment for the study of the effect of MDMA on startle testing in healthy volunteers. This MAPS-sponsored study will be conducted by Principal Investigator Barbara Rothbaum, Ph.D., at Emory University in Atlanta, Georgia. Local recruitment via phone screening began on December 13, 2017. In-person screening will begin January 2018. This study will be followed by another study exploring the combination of MDMA with Prolonged Exposure in PTSD patients.

Learn more...

Medical Marijuana

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 This email address is being protected from spambots. You need JavaScript enabled to view it. (SRI).

Psychedelic Peer Counseling

Zendo Project: Psychedelic Peer Counseling at Envision Festival 2018

For the sixth consecutive year, the Zendo Project will provide psychedelic harm reduction services at Envision Festival in Costa Rica, an event taking place in February 2017. Last year at Envision Festival, Zendo Project volunteers provided compassionate support for over 100 guests, and dozens more used the Zendo Project facilities as a space to rest and/or rehydrate.

Zendo Project: Collaboration with Project #OpenTalk at Countdown 2017

Zendo Project staff and volunteers will offer services at Countdown, an electronic dance music event taking place New Year's weekend in San Bernardino, CA. At this Insomniac-produced event, we support Project #OpenTalk, a non-profit initiative developed by Insomniac in collaboration with the Drug Policy Alliance, Healthy Nightlife, and the Zendo Project, with the aim of providing drug and sexual health information and emotional support provided services under one umbrella. The Zendo Project wishes everyone a safe and fun New Year!

Support MAPS

November Giving Report: Legalizing Psychedelic Medicine

In November 2017, MAPS raised $250,000 in new donations and pledges from 630 supporters. In the same month, MAPS released the first in a collection of new video testimonials from clinical trial participants Roxxann, Hapi, and James as part of its year-end drive to raise $200,000 for evidence-based psychedelic and marijuana research and to develop new treatments for posttraumatic stress disorder (PTSD), anxiety, addiction, and other conditions.

Since November 15, 389 donors have already given nearly $121,000—60% of our $200,000 goal—and quickly met our initial $15,000 matching grant. An additional $35,000 in matching grants has been offered by The Sarlo Foundation ($10,000), Justin Rosenstein ($15,000), and an anonymous donor ($10,000) to ensure that the momentum continues.

As MAPS shifts focus to beginning our 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 $25-$35 million for both FDA and European Medicines Agency (EMA) approval. With $17.3 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:

William H. Donner Foundation ($50,000)

Anonymous ($15,000)

Anonymous ($26,017)

The Libra Foundation ($10,000)

Anonymous ($10,000)

Russell Haywood ($4,400)

Sean Abraham ($2,000)

AmazonSmile Foundation ($1,932)

Nathan Magness ($1,775)

Eileen Nikki Super ($1,000)

Emily Marie Grossell ($1,000)

Jerry Greenfield ($1,000)

Meredith Orthwein ($1,000)

Lombardino Family Fund ($1,000)

Pennyghael Foundation ($1,000)

Stephen & Eve Milstein ($1,000)

Peggy Dulany ($51,040)

Rebecca Lambert ($5,000)

James Anderson ($1,000)

Joshua Seth White ($1,000)

Kevin S. Feldman ($1,000)

Zevic Mishor ($5,000)

Julie Holland ($1,450)

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.

MAPS Receives $1,000,000 in Bitcoin from The Pineapple Fund

On December 14, 2017, the Pineapple Fund (pineapplefund.org), set up by an anonymous cryptocurrency philanthropist, donated 59.89 Bitcoin (BTC), with a value of $1,000,000, to MAPS as part of a plan to give away over $86 million in BTC to charities and causes around the world. Read the press release...

Media

Featured Media: December 2017

MAPS Podcast

Episode 22 - Cannabis and Spirituality - Kathleen Harrison, M.A.

This episode of the MAPS Podcast is hosted by Zach Leary and taken from the Psychedelic Science 2017 conference in Oakland, CA. The talk is by the legendary and luminous Kathleen Harrison, M.A. and is entitled "Cannabis and Spirituality - Exploring the Plant Human Spirit Relationship".

Kat's decades of work as an ethnobotanist focussed largely on the deeply inter-connected history and relationship between human beings and cannabis. A relationship existing not just in a cultural setting but also a spiritual one. This talk explores the nuances of the relationship, cultural appropriation in respect to psychedelic mysticsm and a holistic blueprint for how one might approach spirituality with cannabis as a guide.

Kathleen (Kat) Harrison, M.A. is an ethnobotanist who loves to explore the relationship between plants, mushrooms and human beings—particularly in the realms that are often hidden: cultural beliefs, personification of species, rituals of healing and initiation, vision-seeking modalities, and artistic creations that illustrate the plant-human relationship. She also studies and teaches the deep history of humans in nature, encompassing both before and since the advent of agriculture.

Kathleen founded Botanical Dimensions in 1985 with her then-husband, the late Terence McKenna.

MAPS Store

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

Psychedelic Medicine by Dr. Richard Louis Miller

Published in November, Dr. Miller reviews medical uses of psychedelics such as LSD, MDMA, psilocybin, and ayahuasca, exploring what the future holds for these substances. This book features pieces from revolutionaries and researchers including Rick Doblin, Ph.D., Stanislav Grof, M.D., Ph.D., James Fadiman, Ph.D., Julie Holland, M.D., Dennis McKenna, Ph.D., David Nichols, Ph.D., Charles Grob, M.D., Phil Wolfson, M.D., Michael Mithoefer, M.D., Annie Mithoefer, B.S.N., Roland Griffiths, Ph.D., Katherine MacLean, Ph.D., and Robert Whitaker.

Only $16.95 | Purchase Now

Psychedelic Science Collector's Tumblers: 15% off during Winter Sale

These beautifully hand-crafted pieces by artist Ipek Kotan feature signatures from MAPS Founder Rick Doblin, Ph.D., and The Beckley Foundation Founder Amanda Fielding. Buy your Collector's Tumbler while supplies last!

$30.00 Now $25.50 | Purchase Now

Events

Browse our Event Calendar for upcoming events.

The Mushroom Cure: December 7, 2016 - January 7, 2018, New York, New York

They say that laughter is the best medicine, but for one comedian suffering from obsessive compulsive disorder, it just might be psychedelic mushrooms. The Mushroom Cure is the hilarious, harrowing, and heartrending tale of how, inspired by a scientific study, Adam Strauss tried to treat his severe OCD with psychedelics. This is a completely true story. (Meaning, everything in this story is true. There are many true things that are not in this story.) The Mushroom Cure is written and performed by Adam Strauss, and directed by Jonathan Libman. Learn more...

TEDxSalem: "Through the Looking Glass" with Brad Burge: January 6, 2018, Salem, Oregon

Step "Through the Looking Glass" at TEDxSalem for a day full of mind-bending experiences at the Salem Convention Center. Brad Burge, Director of Strategic Communications for the Multidisciplinary Association for Psychedelic Studies (MAPS), will offer us a glimpse into an unexpected future for psychiatry in America. 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...