Study Initiation Visits Begin for Phase 3 Trials of MDMA-Assisted Therapy for PTSD
April 30, 2018
Dear friends and supporters,
Last week, MAPS conducted the first Study Initiation Visits for our U.S. Food and Drug Administration (FDA)-regulated Phase 3 trial of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD) at study sites in New Orleans, Louisiana, and Fort Collins, Colorado, and Boulder, Colorado. The Phase 3 trials starting in the summer of 2018 will assess the efficacy and safety of MDMA-assisted psychotherapy in adult participants with PTSD at sites in the U.S., Canada, and Israel.
Throughout April 2018, MAPS hosted Discovering LSD: 75 Years of Experiences and invited our community to celebrate the 75th anniversary of Dr. Albert Hofmann’s first intentional LSD experience on April 19, 1943. Thank you to the 47 storytellers who recorded videos about why LSD is important, all of our webinar participants, and everyone who supported psychedelic education by shopping in the MAPS Store.
Recently, TEDxSalem invited MAPS Director of Strategic Communications Brad Burge to provide psychedelic education for the TEDx community through a presentation about the medical benefits of MDMA-assisted psychotherapy for PTSD. "Today, I’m going to tell you about a new approach being developed to helping people overcome deeply engrained trauma, and it involves only 3 administrations of a drug that’s been around for over 100 years," explains Burge.
We have a large amount of news to share in the April 2018 edition of the MAPS Newsletter, including:
- Our Therapy Training Program is currently supporting the final segment of training for Phase 3 therapy teams
- The 55th of 76 participants enrolls and receives study drug in our clinical trial of smoked marijuana for PTSD in U.S. veterans
- Our ongoing therapist training study enrolls the 56th participant
- Condolences for Larry Harvey, Founder of Burning Man (1948-2018)
Thank you for being a crucial part of the MAPS universe.
MAPS Web and Email Marketing Associate
Watch Brad Burge’s TEDxSalem talk about MDMA-assisted psychotherapy.
Table of Contents
Treating PTSD with MDMA-Assisted Therapy
- Study Initiation Visits Begin for Phase 3 Trials of MDMA-Assisted Therapy for PTSD
- Therapist Training Study: 56th Participant Enrolls
- MDMA Therapy Training Program: Update on Supervision Process and Expanded Access
- Participate in Research
- 55th Participant Enrolls in Smoked Marijuana Trial for Chronic PTSD in Veterans
- Are You a U.S. Military Veteran with PTSD?
- Signed, Original Copy of LSD: My Problem Child by Albert Hofmann
- LSD Psychotherapy by Stanislav Grof, M.D., Ph.D.
- The Manual of Psychedelic Support
- The Mushroom Cure with Adam Strauss: Now – June 16, 2018, Berkeley, California
- Marginalized Voices, Racial Trauma, and the Psychedelic Healing Movement: May 4, 2018, San Francisco, California
- On Ethnobotany – A Conversation With Kathleen Harrison and Natalie Metz: May 4, 2018, San Francisco, California
- Zendo Project Public Workshop at Lightning in a Bottle: May 24, 2018
- Rick Doblin and Ingmar Gorman speaking at Beyond Psychedelics: June 21 – 24, 2018, Prague, Czech Republic
- How to Change Your Mind with Michael Pollan: June 4, 2018, Santa Cruz, California
- SAND18 Italy: July 3-9, 2018, Orvieto, Italy
- 126th Annual APA Convention: August 9 – 12, 2018, San Francisco, California
- Horizons: Perspectives on Psychedelics: October 5 – 7, 2018, New York, New York
- Psychedelic Psychotherapy Forum 2018: October 11 – 14, 2018, Victoria, BC, Canada
- Colloquium on Psychedelic Psychiatry 2018: October 13 – 14, 2018, Nacka, Sweden
- Science and Nonduality (SAND) 2018: October 24 – 28, 2018, San Jose, California
- Thank you, Larry Harvey, Founder of Burning Man! (1948-2018)
- MAPS Public Benefit Corporation (MPBC) is Hiring: Site Medical Director
- New Surveys Launched by Psychedelic Research Group (PRG) at Imperial College
- Study of Psilocybin for Alcohol Dependence is Now Recruiting
- DMT Survey
- Support Sandor Iron Rope, Researcher and Community Member
Treating PTSD with MDMA-Assisted Therapy
Study Initiation Visits Begin for Phase 3 Trials of MDMA-Assisted Therapy for PTSD
On Thursday, April 26, 2018, Rebecca Matthews, Clinical Operations Manager of the MAPS Public Benefit Corporation (MPBC), traveled to New Orleans, Louisiana, to conduct the first Study Initiation Visit for the Phase 3 trial of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD). After the New Orleans Phase 3 site was initiated, researchers completed Study Initiation Visits at planned Phase 3 sites in Fort Collins and Boulder, Colorado.
MPBC clinical research staff have completed 13 of 14 Study Initiation Visits for our 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. The purpose of this study is to provide the final training for our co-therapy teams.
The Phase 3 trials starting in the summer of 2018 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 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 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 design of our Phase 3 trials after a six-month long Special Protocol Assessment (SPA) process. This agreement confirms 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 $26.7 million to successfully execute the Phase 3 studies required to gain approval from the FDA for MDMA-assisted psychotherapy by 2021. With $26.2 million in hand or in multi-year pledges, there’s still a funding gap we need to close. Approval from the European Medicines Agency (EMA) will likely require additional funds. MAPS began negotiations with EMA in January 2018, and MAPS staff will likely travel to London, United Kingdom, to meet with EMA in June 2018. 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: 56th Participant Enrolls
On April 3, 2018, the 56th 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…
MDMA Therapy Training Program: Update on Supervision Process and Expanded Access
The MDMA Therapy Training Program, operated by the MAPS Public Benefit Corporation (MPBC), is currently supporting the final segment of training for Phase 3 therapy teams, eighty-two researchers who will provide MDMA-assisted psychotherapy for severe posttraumatic stress disorder (PTSD) at sites across the United States and Canada. These trainees are in the midst of our supervision program, which will be an integral part of our training program going forward. We are also excited to prepare for a multi-site study of MDMA-assisted psychotherapy for PTSD in Europe. This fall in Europe, we will host a closed training to prepare European Phase 3 researchers for this endeavor.
We are working to prepare for MAPS’ anticipated application to Expanded Access. Expanded Access is an Food and Drug Administration (FDA) program that allows the use of an investigational drug outside of a clinical trial. The program is designed to address urgent and life-threatening conditions in patients who currently do not have promising treatment options.
If Expanded Access is approved, new sites meeting the requirements below can seek approval to be part of MPBC’s multi-center Expanded Access protocol, which will allow them to administer open-label MDMA-assisted psychotherapy for PTSD. Qualified applicants will have a team of therapy providers, a physician, and a facility suitable to conduct MDMA-assisted psychotherapy, with approval by regulatory agencies. You can learn more about Expanded Access on the FDA’s website.
Currently we’re working on updating the training program website, and hope to have an online training application for eligible Expanded Access sites and providers later this year. 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.
While our Phase 3 team is complete, and the MDMA Therapy Training Program is not accepting applications at this time. Learn more…
Participate in Research
MAPS sponsors clinical trials around the world that require human subjects. 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.
55th Participant Enrolls in Smoked Marijuana Trial for Chronic PTSD in Veterans
On April 6, 2018, the 55th 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. A new recruitment website can be visited here. Learn more…
Are You a U.S. Military Veteran with PTSD?
Military veterans with PTSD are invited to participate in a confidential and federally‐authorized clinical research study of the impact of cannabis on PTSD symptoms. Volunteers must be local to the Phoenix, AZ area. Compensation for time and travel is provided. If you are interested in learning more about this confidential research study, or would like to see if you qualify to participate, please contact Scottsdale Research Institute, LLC: wecanstudy.org
March 2018 Giving Report
In March 2018, MAPS raised over $265,000 in new donations and pledges from 451 supporters.
Starting on January 10, MAPS has been raising funds to be matched by a $4 million matching grant, offered by the Pineapple Fund. MAPS completed the matching grant on March 7, raising $8 million for our FDA Phase 3 clinical trials of MDMA-assisted psychotherapy for the treatment of PTSD.
With these gifts, MAPS has now raised $26.2 million of the $26.7 million needed for our upcoming Phase 3 clinical trials. MAPS now needs an additional $500,000 to complete funding for the final stage of research needed to make MDMA-assisted psychotherapy a legal prescription treatment for PTSD in the U.S. MAPS is currently seeking an additional $5 million for European Medicines Agency (EMA) trials to supplement the data gathered for the FDA. MAPS has raised over $400,000 toward our European studies, but we still need $4.6 million.
We extend a special thanks to those who so generously supported MAPS last month:
- Grant Leonard ($1,100)
MDMA/PTSD Phase 3 Studies (U.S.):
- Fundamental ($25,000)
- Karl Richard ($2,500)
- Elliod Godzich ($1,200)
- Kevin Reed ($1,000)
- Shawna and Steve Huser ($1,000)
MDMA/PTSD Phase 3 Studies (Europe):
- Christian Halper ($200,000)
- Ronald A. Mis ($10,000)
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 $10 or more. maps.org/donate
Featured Media: April 2018
- TEDxSalem: MDMA, Psychotherapy, and the Future of PTSD Treatment | Brad Burge
- Published on April 5, 2018
- Rolling Stone: Flashback: LSD Creator Albert Hofmann Drops Acid for the First Time
- Written by Trina Calderon on April 19, 2018
- Forbes: GOP Leaders’ Bill Could Let Patients Use Medical Marijuana
- Written by Tom Angell on March 13, 2018
- ABC Radio National: “Is Psychiatry Ready for MDMA?”
- Written by Gillinder Bedi on March 26, 2018
- Seeker: 75 Years After First LSD Trip, Psychedelic Science is Making a Comeback
- Written by Dave Roos on March 14, 2018
- Dazed and Confused Magazine: The UK Ecstasy Guru from the 90s Who Influenced MDMA Research Forever
- Written by Lucy Uprichard on March 16, 2018
- ABC News Now: Taylor: Results of PTSD treatment trial should not be ignored
- Written by Laura Geller on March 15, 2018
Signed, Original Copy of LSD: My Problem Child by Albert Hofmann
This rare collector’s item is signed by Albert Hofmann, Ph.D., the first chemist to intentionally experience LSD. Buy Now…
LSD Psychotherapy by Stanislav Grof, M.D., Ph.D.
“If I am the father of LSD, Stan Grof is the godfather. Nobody has contributed as much as Stan for the de-velopment of my problem child.” — Dr. Albert Hofmann, research chemist and author of LSD: My Problem Child. Buy Today…
The Manual of Psychedelic Support
The Manual of Psychedelic Support is a 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. Buy Today
MAPS Podcast: Episode 26 – Duncan Trussell: The Psychedelic Evolution of a Comedian Mystic
Zach Leary sits down with Duncan Trussell, comedian and host of The Duncan Trussell Family Hour podcast, in this original MAPS Podcast to discuss the world through the psychedelic lens as only Duncan can see it. Topics covered are how to better to integrate our experiences in a complex world, the future of psychedelic research, and Duncan’s own evolution as a psychonaut growing up in America. Listen now…
The Mushroom Cure with Adam Strauss: Now – June 16, 2018, Berkeley, California
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. The Mushroom Cure is written and performed by Adam Strauss, and directed by Jonathan Libman. Learn more…
Zendo Project Public Workshop at Lightning in a Bottle: May 24, 2018
The Zendo Project workshop is open to all Lightning in a Bottle attendees. If you are attending LIB and are not volunteering with the Zendo Project, you are welcome to attend our workshop on Thursday, May 24 at the Crossroads stage from 11:00 AM – 2:00 PM PST. Learn more…
Marginalized Voices, Racial Trauma, and the Psychedelic Healing Movement: May 4, 2018, San Francisco, California
Dr. Monnica Williams will discuss the traumatizing impact of life in the United States on people of color and the work being done at the MAPS-sponsored MDMA-assisted psychotherapy research program UConn site, which is focused on the traumas of people of color. This presentation will explore if and how psychedelics can contribute to the healing trauma that stems from racism and contribute to a more just society. Learn more…
On Ethnobotany – A Conversation With Kathleen Harrison and Natalie Metz: May 4, 2018, San Francisco, California
Field ethnobotany is the observation of the human-plant relationship in places where it is visible and may be experienced or documented. Ethnobotanist Kathleen Harrison’s decades of fieldwork, with a special focus on psychoactive substances, has given her extensive and fascinating knowledge on indigenous history, contemporary culture, and consciousness. Join naturopathic doctor and CIIS professor Natalie Metz for a conversation with Kathleen on entheogens and the rich and complex relationship between plants, mushrooms, and human beings. Learn more…
How to Change Your Mind with Michael Pollan: June 4, 2018, Santa Cruz, California
Bookshop Santa Cruz is delighted to welcome back Michael Pollan, author of five New York Times bestsellers, for a discussion and signing of his latest book, How to Change Your Mind: What the New Science of Psychedelics Teaches Us About Consciousness, Dying, Addiction, Depression, and Transcendence. Learn more…
Rick Doblin and Ingmar Gorman speaking at Beyond Psychedelics: June 21 – 24, 2018, Prague, Czech Republic
Beyond Psychedelics is the global multidisciplinary forum on psychedelics in the Czech Republic, the country with a longstanding history of psychedelic research. Conference organizers intend to discuss the potential of psychedelics, alternative states of consciousness and technologies in the current social climate. Conference presentations will review current challenges and risks, explore the basis of safe use and sensible integration, and create new synergies. Learn more…
SAND18 Italy: July 3-9, 2018, Orvieto, Italy
Join the Science and Nonduality (SAND) gathering in Italy for six inspiring days with scientists, philosophers, spiritual teachers and artists, in an openhearted exploration to expand and embody our interconnectedness and further our individual and collective evolution. Our tools are many and diverse: experiential workshops, talks, conversations, meditation, movement, music and more. Learn more…
126th Annual APA Convention: August 9 – 12, 2018, San Francisco, California
MAPS will have a table at this event and there will be a series of talks about psychedelics at the annual American Psychological Association conference from August 9 – 12, 2018, in San Francisco, California. Learn more…
Horizons: Perspectives on Psychedelics: October 5-7, 2018, New York, New York
Horizons: Perspectives on Psychedelics is an annual forum in New York City that examines the role of psychedelic drugs and plant medicines in science, medicine, culture and spirituality. In recent years, a growing community of scientists, doctors, scholars, and activists have orchestrated a renaissance in psychedelic research and practice. Horizons brings together the brightest minds and the boldest voices of this movement to share their knowledge, insights, and dreams for the future. Now in its twelfth year, Horizons is the largest and longest-running annual gathering of the psychedelic community in the world. Learn more…
Psychedelic Psychotherapy Forum 2018: October 11 – 14, 2018, Victoria, BC, Canada
The Psychedelic Psychotherapy Forum engages mental health professionals and all others interested in advancing the ethical and legal use of psychedelic medicine for healing and growth. Highlight topics at the Forum include psychedelics and the “entropic” brain, Ketamine-assisted psychotherapy, activist therapists who are taking initiatives to change laws, and the training of psychedelic psychotherapists. Learn more…
Colloquium on Psychedelic Psychiatry 2018: October 13 – 14, 2018, Nacka, Sweden
A high quality, 2-day international academic seminar on psychedelic science, with a special focus on the use of psychedelics in psychiatry. “Colloquium” is a latin term with three interpretations, the most common of which refers to an academic seminar. The Colloquium on Psychedelic Psychiatry 2018 will be a high quality, 2-day international academic seminar on psychedelic science, with a special focus on the use of psychedelics in psychiatry. Learn more…
Science and Nonduality (SAND) 2018: October 24 – 28, 2018, San Jose, California
This year, the Science and Nonduality conference will bring together some of the brightest minds in science, along with spiritual teachers from various traditions, to expand and deepen our understanding and experience of what it means to be human. Learn more…
Thank you, Larry Harvey, Founder of Burning Man! (1948-2018)
Burning Man Founder Larry Harvey passed away in San Francisco on April 28, 2018. Larry founded Burning Man in 1986, the same year that MAPS was founded. Starting in 2003, MAPS staff have regularly traveled to Black Rock City for Burning Man to provide psychedelic education and harm reduction. After several years of working in Burning Man’s Sanctuary space to support people going through difficult psychedelic experiences, MAPS created the Zendo Project to offer additional compassionate care, psychedelic harm reduction, and peer support for people in need, initially in our own village and over time in closer coordination with Burning Man. The Burning Man organization has led the way in being accepting and encouraging of the Zendo Project at Burning Man, leading to an ever-increasing cultural acceptance of harm reduction and public health approaches to psychedelics.
In 2006, in a highlight of our relationship, Larry Harvey met at First Camp with Sasha Shulgin, Ph.D., MAPS Founder Rick Doblin, Ph.D., and MAPS Board of Director John Gilmore after Larry heard that Sasha and Ann had came to Burning Man for the first time for MAPS’ 20th Anniversary celebration. Throughout MAPS’ many years at Burning Man, we have strengthened community, created lasting connections, helped transform difficult psychedelic experiences, educated the public about clinical psychedelic and marijuana research, and had lots of fun. Without Larry Harvey and his continuous gift of Burning Man, MAPS would not be the organization that we are today. Thank you for your visionary leadership, Larry! Learn more…
MAPS Public Benefit Corporation is Hiring
The MAPS Public Benefit Corporation, a wholly owned subsidiary of MAPS, is hiring a Site Medical Director for a clinical trial investigating the use of marijuana for treatment of posttraumatic stress disorder (PTSD) symptoms in military veterans in Phoenix, Arizona. Learn More…
New Surveys Launched by Psychedelic Research Group (PRG) at Imperial College
The Psychedelic Research Group (PRG) at Imperial College has three large-scale psychedelic survey studies. All surveys are reaching out to people who intend to take a classical psychedelic, but with different focuses:
1.) Psychedelic Survey – a broad survey for users who plan to have a psychedelic experience in the future in any kind of setting except from a ceremony/retreat
2.) Microdosing Survey – a survey for users intending to microdose
3.) Ceremony Survey – a survey for users who will have a psychedelic experience within the frame of a psychedelic drug retreat/ceremony
Study of Psilocybin for Alcohol Dependence is Now Recruiting
New York University is currently recruiting participants for A Double-Blind Trial of Psilocybin-Assisted Treatment of Alcohol Dependence. The team is seeking males and females ages 25-65 who want to stop or decrease their drinking and are not currently participating in treatment for alcohol dependence. Learn More…
Johns Hopkins School of Medicine researchers are conducting an anonymous, internet-based survey study about DMT experiences. Learn More…
Support Sandor Iron Rope, Researcher and Community Member
We would like to ask for your support in the healing from a recent trauma of member of our community.
On the night of March 28, 2018, in Rapid City, Sandor Iron Rope, a Lakota road man and former president of the Native American Church of North America, was shot nine times in his car by a random shooter, along with his wife Geraldine who sustained two bullet wounds, and their two children who suffered shrapnel injuries in the back seat. Sandor and his family all miraculously survived and are expected to have a full recovery.
Sandor supports countless tribes in the U.S., Canada, and Mexico in the preservation of the peyote sacrament and peyote way of life, and presented at Psychedelic Science 2017 on the imperative of Peyote conservation.
We hope that the broader psychedelic community can join us in supporting Sandor and his family, these great allies in the fight for indigenous rights, healing, and access to the Peyote medicine. Please visit their GoFundMe page here which is raising funds for related medical expenses. Learn more…