Newsletter: October 2017 - Multidisciplinary Association for Psychedelic Studies

Health Canada Clears Training Study of MDMA-Assisted Therapy for PTSD at Canadian Phase 3 Sites

October 30, 2017

Dear friends and supporters,

On October 4, 2017, Health Canada, the Canadian federal institution that regulates drug and health products, sent a No Objection Letter on the protocol and design for the MAPS-sponsored Phase 2 Training Study of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD), conducted at planned Phase 3 study sites in Vancouver and Montreal.

We are honored to announce that the International Society for Traumatic Stress Studies (ISTSS) has invited MAPS-sponsored Principal Investigator Michael Mithoefer, M.D., to share research results from clinical trials of MDMA-assisted psychotherapy for PTSD during the Master Clinicians portion of the annual ISTSS conference, taking place in Chicago, Illinois, from November 9-11, 2017.

This past month, MAPS provided psychedelic education to growing communities across North America. We express our gratitude to the event organizers behind Horizons: Perspectives on Psychedelics (New York), the International Drug Policy Reform Conference (Atlanta, Georgia), Psychedelic Medicine: New Frontiers in Palliative Care (Seattle, Washington), and an Evening with Rick Doblin (Vancouver, B.C., Canada).

Next week, MAPS will be in Washington, D.C., for a Zendo Project training on psychedelic peer counseling services on November 9, then Catharsis on the Mall: A Vigil for Healing from November 10-12. MAPS is proud to be a founding partner and fiscal sponsor for the third annual Catharsis on the Mall, a free event taking place once again on the National Mall.

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

The 30th of 76 participants enrolls and receives study drug in our clinical trial of smoked marijuana for PTSD in U.S. veterans
A new participant enrolls in our ongoing therapist training study
The sixth dyad (pair of participants) receives experimental treatment in our study of MDMA-assisted cognitive behavioral conjoint therapy for PTSD
Limited copies of PiHKAL and TiHKAL, signed by authors Alexander “Sasha” Shulgin and Ann Shulgin, are available in the MAPS Store

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

Thank you for supporting the future of psychedelic medicine.

Take care,

Bryce Montgomery
MAPS Associate Director of Communications and Marketing

Perspectives Grant Awardee Karina Muscarina, from Mexico City, directed and produced a documentary featuring a collection of testimonials from Perspectives Grant Awardees at Psychedelic Science 2017, who share their stories from attending the conference. Thank you, Karina Muscarina, for your excellent film!

Table of Contents

Treating PTSD with MDMA-Assisted Therapy

Medical Marijuana

Support MAPS

” target=”_blank”>September Giving Report: Breaking Through

Media

American Psychiatric Association, Wall Street Journal Magazine, The Boston Globe, and more…

MAPS Store

Events

Treating PTSD with MDMA-Assisted Therapy

Health Canada Clears Training Study of MDMA-Assisted Therapy for PTSD at Canadian Phase 3 Sites

On October 4, 2017, Health Canada, the Canadian federal institution that regulates drug and health products, sent a No Objection Letter on the protocol and design for the MAPS-sponsored Phase 2 Training Study of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD), conducted at planned Phase 3 study sites in Vancouver and Montreal.

MAPS Public Benefit Corporation (MPBC) clinical research staff have now completed 10 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.

We will conduct the 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-therapy 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 adult participants with PTSD at sites in the U.S., Canada, and Israel. Participants will be randomized to receive three day-long sessions of either MDMA or placebo in conjunction with psychotherapy under direct observation 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.

Enrollment is expected to start in the spring 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
Israel | research institution

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.

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 $25 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…

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

Therapist Training Study: New Participant Enrolls in Boulder

On October 10, 2017, the 38th 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: Sixth Dyad Receives Experimental Treatment

On October 10, 2017, the sixth 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 fifth dyad received their their final experimental session on October 12, and the second dyad completed the six-month follow-up interview on September 17.

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…

Medical Marijuana

30th Participant Enrolls in Smoked Marijuana Trial for Chronic PTSD in Veterans

On October 26, 2017, the 30th 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).

Support MAPS

September Giving Report: Breaking Through

In September 2017, MAPS raised nearly $545,000 in new donations and pledges from 308 supporters. As Burning Man 2017 came to a close, so too did our Zendo Project fundraising. We raised over $102,000 for the Zendo Project, far exceeding our initial $60,000 goal. With these funds, we are able to completely fund Zendo Project ‘s services at Burning Man 2017 as well as support Zendo ‘s activities throughout the year.

MAPS is now shifting focus to raising funds for its Phase 3 studies of MDMA-assisted psychotherapy for PTSD. 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 $15.5 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:

General Support

Audra Foster ($8,500)
James Stewart Campbell ($1,000)
Lynne Farrow ($1,000)
Andrew Ryan ($1,000)
John Buchanan ($1,000)

MDMA/PTSD Phase 3 Studies

Good Ventures ($500,000)
Matthew Lessard ($4,100)
Candra Docherty ($2,000)
Sean Abraham ($1,000)

MDMA/PTSD Phase 2 Study in Boulder, CO

Highfield Foundation ($2,500)

Zendo Project

Dale Okuno ($2,000)
Tyler Norris ($1,000)
Jeremy Tunnell ($1,000)
Kirsty and Amir Nathoo ($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

American Psychiatric Association, Wall Street Journal Magazine, The Boston Globe, and more…

The American Psychiatric Association
MDMA Advances Another Step As Tool to Treat PTSD
Richard Karel | October 20, 2017

Wall Street Journal Magazine
How MDMA Went From Club Drug to ‘Breakthrough Therapy’
Josh Dean | October 18, 2017

The Boston Globe
Lucy In The Sky With Doctors
Livia Gershon | October 14, 2017

Psymposia
I was in the MAPS MDMA for PTSD study. It freed me from a childhood of abuse.
Jessi Appleton | October 3, 2017

Mint Press News
FDA Action On MDMA Gives New Hope To Researchers And Victims Of PTSD
Derrick Broze | October 18, 2017

Breitbart
FDA Labels MDMA a ‘Breakthrough Therapy’ for PTSD
Nate Church | August 29, 2017

Nature Medicine
Mission Control: Drug Developers Test the ‘Benefit Corporation’ Business Model
Arran Frood | October 17, 2017

MAPS Store

PiHKAL and TiHKAL: Signed Books by Alexander “Sasha” Shulgin

Signed editions of PiHKAL and TiHKAL by Alexander “Sasha” and Ann Shulgin are available for 25% off during the MAPS Store Winter Sale. Sasha and Ann lovingly donated a limited number of these psychedelic literature classics before Sasha’s death in June 2014 to help raise funds for psychedelic research.

$500.00 | Purchase Now

The Ultimate Journey: Consciousness and the Mystery of Death

In The Ultimate Journey, Dr. Stanislav Grof discusses his own patients’ experiences of death and rebirth in psychedelic therapy, investigates cross-cultural beliefs, paranormal and near-death research, and argues that, contrary to the predominant Western perspective, death is not necessarily the end of consciousness.

$19.95 | Purchase Now

Events

Browse our Event Calendar for upcoming events.

Students for Sensible Drug Policy (SSDP) Regional Mini Conferences: November – 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…

Spirit Plant Medicine Conference: November 4 – 5, 2017, Vancouver, Canada

Learn about ayahuasca, psilocybin mushrooms, ibogaine, peyote, cannabis, LSD, and MDMA with experts in the field of psychedelic science and plant medicine at the Spirit Plant Medicine Conference 2017 in Vancouver, Canada, from November 4-5. 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…

Exponential Medicine: November 6-9, 2017, San Diego, California

Exponential Medicine is a unique and intensive four-day experience that gathers world-class faculty, innovators and organizations from across the biomedical and technology spectrum to explore and leverage the convergence of fast moving technologies in the reinvention and future of health and medicine. MAPS Director of Strategic Communications Brad Burge will be a featured presenter at this conference. Learn more…

Zendo Project Psychedelic Peer Counseling Workshop: November 9, 2017, Washington, D.C.

Join the Zendo Project for a psychedelic peer counseling workshop in Washington, D.C., designed to educate those who are interested in learning how to assist in difficult psychedelic experiences through providing harm reduction services.

Topics include:

Physical, mental, and emotional effects of psychedelics
Factors that contribute to a difficult experience
Zendo Projects ‘s four principles of psychedelic support
Tools, techniques, and protocols
Sitter self-care
Assisting the integration of a psychedelic journey
Ethical guidelines for psychedelic peer counseling

This training a great opportunity for peer counselors, educators, mental health clinicians, event producers, and individuals who are interested in volunteering for harm reduction organizations like the Zendo Project. The Zendo Project demonstrates that safe, productive psychedelic experiences are possible without the need for law enforcement-based prohibitionist policies. Learn more…

Catharsis on the Mall: A Vigil for Healing: November 9-12, 2017, Washington, D.C.

You are invited to participate in the third annual Catharsis on the Mall: A Vigil for Healing! Beginning at 12 noon, Thursday, November 9, 2017 and concluding at 12 noon, Sunday, November 12, 2017, Catharsis on the Mall will feature guest speakers, workshops, narrative-braiding, education, art, music, cathartic dance, and direct participation. We invite everyone to bring art, collaboration, skill share, workshops, healing modalities, gifts, and involvement that explores our art theme of “Nurturing the Heart”. We reflect on the deep connection of Us and Them, how personal struggles and wounds are mirrored in politics and culture, and the need for essential compassion and vulnerability to start with one’s self.

We seek to create spaces and experiences together that reflect these ideas and our mission of healing trauma. We intend to hold space and especially support contributions from folks who are often pushed to the margins and those bringing the wisdom of less colonized cultures. We know we don ‘t yet have all the answers, and encourage further questioning and curiosity about these areas of the human experience. MAPS is a founding partner and fiscal sponsor of Catharsis on the Mall. 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

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…