MAPS Officially Begins Phase 3 Trials of MDMA-Assisted Therapy for PTSD
November 29, 2018
Dear friends and supporters,
Today, the non-profit Multidisciplinary Association for Psychedelic Studies (MAPS) is proud to announce that recruitment has begun for our much-anticipated multi-site Phase 3 clinical trials of MDMA-assisted psychotherapy for the treatment of posttraumatic stress disorder (PTSD).
The research will take place at 14 sites and enroll up to 100-150 volunteers with severe PTSD. Volunteers must be at least 18 years old and have been diagnosed with PTSD, and must be in good health to participate. • Read the Press Release
Do you have PTSD? You may qualify for a study of an investigational drug (MDMA) used in combination with psychotherapy. • Participate in Research
Our annual year-end fundraising campaign supports MAPS’s mission to develop new medicines to heal suffering. We need your help to reach $300,000 in tax-deductible donations by December 31! In just 15 days, 490 donors have already raised $86,132 in support of psychedelic research. For a limited time, the next $6,934 in tax-deductible donations will be doubled by the remainder of a generous $50,000 matching grant provided by Justin Rosenstein.
$86,132 raised by 490 generous donors
Since launching our annual fundraising campaign, we have received over 130 new monthly donors! All new monthly donors who pledge to give $15 per month will receive a special edition silver dichroic MAPS logo pendant.
The Winter 2018 edition of the MAPS Bulletin is now available online, featuring our annual report and 15 new articles about the progression of psychedelic science. In this publication, we are sharing articles from psychedelic research organizations including Compass Pathways and the Heffter Research Institute. The Usona Institute will contribute an article to a future edition of the MAPS Bulletin. • Read the Bulletin
The Zendo Project psychedelic peer support services will be returning to Envision Festival, which will take place just outside of Uvita, Costa Rica from February 28 – March 3, 2019. • Apply to Volunteer
In the November 2018 edition of the MAPS Newsletter, you’ll also learn:
- You can join leading researchers for the Psychedelic Science Webinar Series
- Our ongoing therapist training study enrolls the 69th participant
- MAPS continues to receive positive media coverage, including a new article from the Associated Press profiling MAPS Founder Rick Doblin, Ph.D.
- Take a trip through the current state of psychedelic comedy on the MAPS Podcast with comedian Shane Mauss
With the support of our community, we will continue to reach new milestones in the field of psychedelic science.
MAPS Web and Email Marketing Associate
Treating PTSD with MDMA-Assisted Therapy
Phase 3 Trials: Recruitment Opens for New Trials of MDMA-Assisted Therapy for PTSD
Our FDA-regulated Phase 3 clinical trials of MDMA-assisted psychotherapy for PTSD have officially launched. These trials are taking place at 14 locations across the United States, Canada, and Israel.
On November 19, 2018, MAPS received a shipment of pharmaceutical-grade MDMA, made under current Good Manufacturing Practices (GMP) in a certified laboratory, which will be administered in conjunction with psychotherapy to study participants in our upcoming trials.
Our Phase 3 researchers have completed a total of eight study site initiation visits for Phase 3 within the United States, and we are scheduling seven study site initiation visits for remaining study sites in the United States, Canada, and Israel in early to mid-2019.
Do you have PTSD? You may qualify for a study of an investigational drug (MDMA) used in combination with psychotherapy. • Learn More
Phase 3 clinical trials are assessing the efficacy and safety of MDMA-assisted psychotherapy in adult participants with severe PTSD. Over a 12-week treatment period, participants will be randomized to receive twelve non-drug preparatory and integration sessions lasting 90 minutes each along with three day-long sessions about a month apart of either MDMA or placebo in conjunction with psychotherapy. The primary endpoint will be the Clinician Administered PTSD Scale (CAPS-5), as assessed by a blinded pool of independent raters.
The trials are the final phase of research required by the FDA before deciding whether to approve MDMA as a legal prescription treatment for PTSD. If approved, MDMA will be required to be used in conjunction with psychotherapy in an outpatient setting. • Learn More
Open-Label Lead-In Study of MDMA-Assisted Therapy for PTSD: 23rd Participant Completes Treatment
Twenty-three participants have completed treatment in our Phase 2 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. Five study sites are now enrolling and seven sites are fully enrolled. The study is expected to be completed in early 2019. The purpose of this study is to provide the final training and provide supervision for our co-therapy teams.
Therapist Training Study: 69th Participant Enrolls
On November 15, 2018, the 69th participant officially 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 Investigators, Marcela Ot’alora, M.A., L.P.C., and Wael Garas, M.D. 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
MDMA Therapy Training Program: November 2018 Update
MAPS recently received a grant from Open Society Foundation (OSF) to support an MDMA Therapy Training program for Therapists of Color, led by Marcela Ot’alora, LPC, and Monnica Williams, Ph.D., in the second half of 2019. The purpose of this training is to ensure that MDMA therapy will be available to communities of color by training therapy providers of color in this modality, to expand thinking about PTSD to include racial trauma, and to inform the ongoing development of culturally-informed curriculum within the MDMA Therapy Training Program. In addition to the training’s focus on MDMA-assisted psychotherapy, community leaders will join trainees for a closing workshop entitled Psychedelic Medicine and Cultural Trauma, to engage in dialogue about the social, political, cultural and historical causes of trauma, as well as to discuss barriers to acceptance of MDMA-assisted psychotherapy in communities of color while envisioning ways forward. MAPS will continue to fundraise for this specific event, and to provide training opportunities for therapy providers who come from or work with marginalized communities. More information on this event, including date, time and application information will be posted online in the coming weeks.
Currently, the MDMA Therapy Training Program is preparing for the launch of a series of Expanded Access training events in the U.S. next year. In the coming weeks, MAPS will apply for a special U.S. FDA program called Expanded Access (EA), which allows the use of an investigational treatment outside of a clinical trial. The program’s purpose is to grant access to potentially beneficial investigational treatments for individuals or populations facing a serious or immediately life-threatening condition for which there is no satisfactory treatment currently available. You can learn more about Expanded Access on the FDA’s website.
If approved, Expanded Access for MDMA-assisted psychotherapy for PTSD would allow additional qualified sites in the US to provide this treatment to eligible patients under a MAPS treatment protocol. The basic requirements of a qualified site are: 1) facility conducive to this treatment, 2) qualified and trained therapy team, 3) Medical Doctor who can obtain a DEA Schedule 1 license for MDMA. Sites must also gain Drug Enforcement Administration (DEA) approval to manage, store, and administer MDMA, a controlled substance. As MAPS gets closer to application, the requirements will be further clarified.
Since Expanded Access is a U.S. FDA program, only sites in the U.S. and U.S. territories may participate. International programs may become available in the future. As one example, the MDMA Therapy Training Program will host a training event in Israel in January, as a collaboration with the Israeli Ministry of Health, to prepare Israeli therapists to work on an Open Access protocol.
An online application for sites in the U.S. and U.S. territories that are interested in the MDMA/PTSD Expanded Access protocol will be published late 2018 at maps.org. The tuition fee for the training program is still being determined. An additional application for each therapy provider affiliated with the site will also be posted; only applicants affiliated with a qualifying site can be considered for the Expanded Access training. The MPBC Training and Supervision Department will review applications on an ongoing basis; in 2019 approximately seven cohorts of 50-60 trainees will be enrolled. The training department is developing a platform for therapists and sites to connect online in the interest of establishing clinics for Expanded Access. If you would like to receive updates about the MDMA Therapy Training Program and Expanded Access plans, as well as learn about upcoming requirements for Expanded Access sites and providers, please sign up online for our training newsletter and stay tuned for website updates and application material in the new year. • Learn More
Participate in Research
MAPS sponsors clinical trials around the world that require human participants. 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 will open in the coming months. Please bookmark our Participate in Research page and check it frequently for updates. • Learn More
All Participants Completed Treatment in Smoked Marijuana Trial for Chronic PTSD in Veterans
As of November 1, 2018, all participants completed treatment in the first-ever clinical trial of smoked marijuana (cannabis) for treatment of symptoms of posttraumatic stress disorder (PTSD) in U.S. veterans. Taking place at the Scottsdale Research Institute (SRI) in Phoenix, Arizona, this clinical trial is evaluating the safety and efficacy of four different potencies of marijuana for symptoms of PTSD in 76 U.S. veterans. • Learn More
Psychedelic Peer Support
Zendo Project Seeking Volunteers for Envision Festival 2019 in Costa Rica
The Zendo Project psychedelic peer support services will be returning to Envision Festival, which will take place just outside of Uvita, Costa Rica from February 28 – March 3, 2019.
Our volunteer profile includes new questions and sections – if you are a volunteer applicant, please update your profile to be considered for this event. Applicant profiles that have not been updated will not be considered.
Accepted volunteers will receive a complimentary ticket to Envision Festival. Volunteers commit to working with the Zendo Project for a total of 24 hours during the event in addition to a 3-hour mandatory onsite training and are responsible for organizing their own food, travel, etc. • Apply to Volunteer
Zendo Project Hosts Successful Training in Chicago
On November 3, 2018, Zendo Project staff facilitated a training in Chicago at the Preston Bradley event center. The 8-hour training brought 140 attendees together in a beautiful venue to learn about harm reduction and peer support. Zendo Project Director Sara Gael Giron and Manager Ryan Beauregard delivered the training. There was an opportunity for many professionals to earn Continuing Education credits for their respective fields. A post-training gathering brought attendees together to connect, network and grow their local community. The event was co-organized with Students for Sensible Drug Policy Drug Education Manager Dr. Vilmarie Narloch and public sector psychiatrist Dr. Paige Lassen. We appreciate the support and hospitality provided by Chicago SSDP and the greater Chicago community. The Zendo Project hosted over a dozen public trainings in 2018 and will be offering trainings in other major cities across the country in 2019. • Learn More
October Giving Report: MAPS Seeks Funding for European Studies
MAPS is currently seeking $9 million for European Medicines Agency (EMA) Phase 3 trials to supplement the data gathered for the FDA, with $897,735 already raised and roughly $8.1 million still to go. We have completed key negotiations with EMA, and we will have an ever more precise estimate of timetables and costs for EMA trials in mid-2019 after completion of our negotiations with each country in the EMA in which we will have a Phase 3 site, and with each site.
In October 2018, MAPS raised nearly $845,000 in new donations and pledges from 607 supporters.
On October 6th, MAPS hosted its annual Breakthrough for Psychedelic Medicine benefit dinner in New York City, raising over $104,000. Over 200 people were in attendance this year to enjoy a beautiful evening of food and conversation around the future of psychedelic medicine.
We extend a special thanks to those who so generously supported MAPS last month:
- Threshold Foundation ($23,000)
- Mary & Robert Haft Foundation ($20,000)
- Anonymous ($150,000)
- Joel Kubby Estate & Laura Parks ($94,500)
- Dick and Patty Simon ($10,000)
- Ethan Ruby ($7,000)
- Michael Auerbach ($5,000)
- Ethan Devine ($3,000)
- Robert Eisenberg ($3,000)
- AmazonSmile Foundation ($2,225)
- Ricardo Baca ($1,200)
- Anonymous ($1,014)
- Robert Anton Patterson ($1,000)
- James Youngblood ($1,000)
- Daniel Finster ($1,000)
Donations under $1,000:
- Total: $29,621
Phase 3 MDMA/PTSD Europe:
- Riverstyx Foundation ($500,000)
Phase 3 Therapy Training:
- Anna Gandelman ($3,000)
- Riverstyx Foundation ($30,000)
- Tyler Norris ($1,000)
- Sir Ivan ($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 non-family foundations.
Help us reach our goal to make MDMA a medicine by 2021 by establishing a monthly gift of $15 or more. maps.org/donate
Featured Media: November 2018
- PRESS RELEASE: Participant Screening Begins in Phase 3 Clinical Trials of MDMA-Assisted Therapy for PTSD
- Written by MAPS on November 29, 2018.
- Rolling Stone: Psilocybin Could Be Legal for Therapy by 2021
- Written by Shelby Hartman on November 9, 2018.
- Associated Press News: Long Trip: Psychedelic Advocate Nears Goal of Legal Ecstasy
- Written by Matthew Perrone on November 1, 2018.
- WebMD: ‘Ecstasy’ Study Results Promising for PTSD
- Written by Matt Smith on October 30, 2018.
- Newsweek: Small Study Shows More Promise for MDMA Therapy in Treatment of Chronic PTSD
- Written by Aristos Georgiou on November 1, 2018.
- Reason: PTSD Study Finds Dramatic Improvement With MDMA-Assisted Therapy
- Written by Jacob Sullum on October 29, 2018.
- ABC News Australia: The Hidden World of Underground Psychedelic Psychotherapy in Australia
- Written by Jenny Valentish on August 29, 2018.
- Connecticut Magazine: Psychedelic Drugs Show Promise For Treatment of PTSD
- Written by Erik Ofgang on October 22, 2018.
- Okayplayer: Black Americans Are Building A Space In Psychedelic Drug Culture After Being Ignored For Decades
- Written by Elijah C. Watson on November 1, 2018.
- High Times: Latest Study Shows Lasting Benefits of MDMA-Assisted Therapy for Treating PTSD
- Written by A.J. Herrington on October 30, 2018.
- Radio Health Journal: MDMA for PTSD
- Published by Radio Health Journal on November 12, 2018.
- WRAL: MDMA – You May Know it as Ecstasy – Proves to be Effective Against PTSD
- Written by Randall Kerr on October 29, 2018.
- NonProfit Quarterly: Free Your Mind, and Your Nonprofit Will Follow: Racial Equity in Psychedelic Research
- Written by Cyni Suarez on November 8, 2018.
MAPS Podcast: Episode 31 – Shane Mauss
Take a trip through the current state of psychedelic comedy on the MAPS Podcast with hilarious and insightful psychedelic comedian Shane Mauss. Shane discusses his new film Psychonautics – A Comedian’s Exploration of Psychedelics out in March 2019. The film explores Shane’s first-hand experiences with psychedelic use and their results on his life and work. • Listen Now
MAPS Store Winter Sale
From now until January 11, 2019, take this special opportunity to receive discounts up to 30% off when expanding your psychedelic library, purchasing a gift for a friend, or acquiring a historic artifact for your collection. All sales contribute to MAPS’ mission to make psychedelic-assisted therapy a legal treatment. Shop and Receive Discounts
Psychedelic Science Webinar Series: Now – December 5, 2018
There is still time to join the Psychedelic Science Webinar Series! Join host Bia Labate, Ph.D., and leading researchers for Diversity and Inclusion in Psychedelic Medicine on November 28 and Breakthrough Therapy: Making MDMA a Medicine for PTSD on December 5. All registration proceeds go to psychedelic research and education. • Learn More
Free 90-Minute Live-Session Online Breathwork Workshop For Friends of MAPS
A large percentage of people who experience Dr. Stan Grof’s Holotropic Breathwork feel they access the same range of experiences that they do during psychedelic sessions. In this special offer for MAPS supporters, we’re offering you a free workshop to try this powerful modality for yourself. • Claim Your Code • Learn More
The Mushroom Cure: Now – January 2019, 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 hallucinogenic mushrooms. The Mushroom Cure is the true story of how Adam Strauss tried to cure his severe OCD with psychedelics. Learn More
Arizona Psychedelics Conference: February 8-10, 2019 Tempe, Arizona
The first psychedelic conference of Arizona is a three-day event seeking to examine the therapeutic potential of psychedelics like psilocybin, ayahuasca, peyote, MDMA, DMT, ibogaine, ketamine, cannabis, and more. Join us to examine the role of psychedelic drugs and plant medicines in science, medicine, culture, and spirituality. Over the course of the weekend, we will explore these topics through a series of presentations, workshops, panel discussions, and a marketplace. • Learn More
Iboga/Ibogaine Community Engagement Initiative
The International Center for Ethnobotanical Education, Research & Service (ICEERS) is leading working on engaging the global iboga/ibogaine community in a process of inquiry that captures key strengths and assets, identifies promising strategies and best practices, and builds the foundation for a shared vision. ICEERS is now launching a survey about iboga and ibogaine, and you are invited to participate. The survey takes between 10 to 25 minutes to fill out, depending on your profile and on how many ideas and opinions you have on various issues. Your participation is completely voluntary and anonymous; all information will be treated with the strictest confidentiality. No identifying information from any of the participants will be recorded or disclosed under any circumstances. Survey responses will be stored on a private, secure server. • Take the Survey