Results Published: Colorado Study Shows Lasting Benefits of MDMA-Assisted Therapy for Treating Chronic PTSD
Encouraging results published in the Journal of Psychopharmacology
October 30, 2018
Dear friends and supporters,
On October 29, 2018, the results of the largest-ever U.S. Food and Drug Administration (FDA)-regulated clinical trial of MDMA-assisted psychotherapy for the treatment of chronic posttraumatic stress disorder (PTSD) were published in the peer-reviewed Journal of Psychopharmacology.
Sponsored by the non-profit Multidisciplinary Association for Psychedelic Studies (MAPS), the double-blind, placebo-controlled, Phase 2 pilot study in 28 participants found that one month after their second day-long experimental session, 42.9% in the active-dose (100 mg and 125 mg) MDMA groups did not qualify for a diagnosis of PTSD, compared to 33.3% in the low-dose MDMA (40 mg active placebo) control group. The results were even more notable 12 months after the third active-dose experimental session, which found that one year following treatment with MDMA-assisted psychotherapy, 76% of participants no longer had PTSD. Read the full press release here.
We are excited to announce that twenty-one participants have now completed treatment in our Phase 2 open-label lead-in study of MDMA-assisted psychotherapy for PTSD at planned Phase 3 sites across the United States and Canada. Eight study sites are now enrolling and 6 sites have completed enrollment. We are excited to begin conducting MAPS-sponsored Phase 3 trials with MDMA-assisted psychotherapy soon!
In addition, all 76 participants have enrolled and received the study drug in our clinical trial of smoked marijuana for PTSD symptoms in U.S. veterans. All subjects will have completed their final outcome measures in about 2 ½ months when we can uncover the blind and evaluate the data.
From October 17 – December 5, 2018, join us on Wednesdays for the first online education series about the latest advancements and challenges in psychedelic science. Psychedelic Science Webinar Series explores the latest research into the medical and therapeutic uses of MDMA, ayahuasca, and psilocybin. In seven sessions, you’ll learn directly from key players in psychedelic research and therapy about the hottest topics in the field. You’ll also get a chance to ask your questions and have them answered live. By registering for this webinar series, you’re helping make the dream of legal psychedelic therapy into a reality. To learn more or buy an individual session or the full series, visit our webpage.
On October 6, 2018, more than 200 donors joined us for our annual fundraising dinner in New York City, Breakthrough for Psychedelic Therapy. We extend a special thank you to Rodrigo Niño of The Assemblage for being our lead sponsor for the evening and How To Change Your Mind author Michael Pollan. It was wonderful to connect with the psychedelic community in New York City. Thank you to all who attended our benefit!
On November 3, 2018, the Zendo Project will host a psychedelic peer support training in Chicago, Illinois. This workshop is designed for those who are interested in learning how to assist someone having a difficult psychedelic experience. This training will include how to apply the Four Principles of Psychedelic Support as well as immersive exercises to improve sitter presence and support capabilities. To buy tickets for the workshop, visit the Zendo Project webpage.
In the October 2018 edition of the MAPS Newsletter, you’ll also learn::
- The ninth participant is treated our ongoing study of the effect of MDMA on startle testing in healthy volunteers
- The Economist interviews U.S. Army SGT (R) Jon Lubecky about his participation in a MAPS-sponsored trial of MDMA-assisted psychotherapy for PTSD
- See our Event Calendar for upcoming events
On November 19, 2018, the Women’s Psychedelic Forum at the California Institute of Integral Studies (CIIS) in San Francisco, California will feature prominent female voices from both the psychedelic underground and academic research.
We are excited for the future of psychedelic education and research. Thank you for your interest in our work!
MAPS Web and Email Marketing Associate
Treating PTSD with MDMA-Assisted Therapy
Phase 3 Trials: Study Initiation Visits for 8 Sites Completed
MAPS-sponsored researchers have completed study initiation visits for FDA-regulated Phase 3 trials of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD) at 8 United States locations:
- New Orleans, Louisiana
- Fort Collins, Colorado
- Boulder, Colorado
- Private Practice, San Francisco, California
- University of California, San Francisco, California
- Los Angeles, California
- Charleston, South Carolina
- New York, New York
Twenty-one 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. Seven study sites are now enrolling and 7 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.
Phase 3 clinical trials starting Fall 2018 will assess the efficacy and safety of MDMA-assisted psychotherapy in adult participants with 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…
Startle Testing with MDMA: Ninth Participant Receives Experimental Treatment
On October 17, 2018, the ninth participant completed experimental treatment in our ongoing study of the effect of MDMA on startle testing in healthy volunteers. Led by Principal Investigator Barbara Rothbaum, Ph.D., this study is conducted at Emory University in Atlanta, Georgia. This research group is planning to conduct a subsequent study exploring the combination of MDMA with Prolonged Exposure in people with PTSD. Learn more…
Therapist Training Study: 67th Participant Enrolls
On October 18, 2018, the 67th 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 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: October 2018 Update
From September 26-October 3, 2018, Annie Mithoefer, B.S.N., and Michael Mithoefer, M.D., led a weeklong in-person training in the Netherlands focused on MDMA-assisted psychotherapy in the treatment of Posttraumatic Stress Disorder (PTSD). Sixty therapists and researchers representing fourteen countries learned about the foundation of MAPS’ approach to MDMA-assisted psychotherapy. Many of these trainees will provide MDMA-assisted psychotherapy to participants with PTSD under a MAPS protocol at several European sites starting in 2019. Over the next year or two, as Phase 2 and 3 trials in Europe progress and additional protocols are developed and approved internationally, the MDMA Therapy Training Program will offer more training opportunities for international providers. Please sign up online for our training newsletter for updates.
As Phase 3 clinical trials begin in the U.S., Israel, and Canada, 82 therapy providers are now completing their final stage of training in clinical supervision, which will continue to be an integral part of the MDMA Therapy Training Program. The results of the Phase 3 studies will support a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) to make MDMA-assisted psychotherapy into a legal prescription medicine anticipated to take place in 2021.
In November 2018, 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 U.S. to provide this treatment to eligible patients under a MAPS treatment protocol, starting as early as Spring 2019. 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.
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. 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 60 trainees will be enrolled.
We encourage each site, in choosing location and therapy teams, to consider diversity, inclusivity, and cultural and racial competence. One of the most robust ways to provide accessible care is to train therapists and practitioners from diverse backgrounds, including people of color and from the LGBTQ+ community. If you are a therapist from a marginalized community, we encourage you to reach out to us at firstname.lastname@example.org.Learn more…
New International Investigator-Sponsored MDMA Studies
We are collecting documents and initiating investigator-sponsored MDMA studies in Colombia, Australia, Canada, United Kingdom, Yale University, Brazil, and we are discussing opportunities to expand these studies further.
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…
76th Participant Enrolls in Smoked Marijuana Trial for Chronic PTSD in Veterans
As of October 8, 2018, the 76th and final participant enrolled and received study drug in the first-ever clinical trial of smoked marijuana (cannabis) for treatment of symptoms of posttraumatic stress disorder (PTSD) in U.S. veterans, completing enrollment. 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 Workshop in Chicago
The Zendo Project is hosting a psychedelic peer support workshop in Chicago, Illinois on November 3, 2018. This workshop is designed for those who are interested in learning how to assist someone having a difficult psychedelic experience.
This workshop is an immersive training complete with experimental exercises, theoretical and practical frameworks for handling difficult psychedelic experiences, and a detailed discussion of the Zendo Project’s principles of harm reduction. This day-long immersive training is for peer counselors, educators, mental health clinicians, event producers, and individuals who are interested in volunteering for harm reduction organizations like the Zendo Project, developing their own grassroot peer support networks, or helping others in psychedelic challenge. Continuing Education Credits are available. Learn More | Buy Tickets
September 2018 Giving Report: MAPS Seeks Funding for European Studies
MAPS is currently seeking $9 million for European Medicines Agency (EMA) 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 Phase 3 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 September 2018, MAPS raised nearly $100,000 in new donations and pledges from 638 supporters.
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 ($5,000)
- Andrew Ryan ($2,500)
- Mack Fuhrer ($2,500)
- Anonymous ($2,229)
- Oril Rinat ($1,800)
- Grant Leonard ($1,100)
- Latane Temple Keeler ($1,000)
- Anonymous ($1,000)
- Ethan Devine ($1,000)
Phase 3 MDMA/PTSD U.S.:
- Highfield Foundation ($2,500)
Phase 3 GMP Drug:
- Lora Sasiela ($1,000)
- George Goldsmith ($5,000)
- Ben Williamson ($1,000)
- Jared Luxenberg ($1,000)
- Ethan Devine ($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 $10 or more. maps.org/donate
Featured Media: September 2018
- The Economist: How MDMA Is Being Used to Treat PTSD
- Published on October 11, 2018
- New Atlas: Groundbreaking Trial Finds MDMA Reduces Social Anxiety in Autistic Adults
- Written by Rich Haridy on September 19, 2018
- Rolling Stone: Study: MDMA Could Help Autistic Adults with Social Anxiety
- Written by Lilly Dancyger on September 25, 2018.
- Rooster Magazine: An MDMA Therapist on How It Works and Why It’s Better Than Current Treatments
- Written by Sean Lawlor on October 1, 2018.
- 11Alive News: This Is Why There’s a Push to Make MDMA Legal
- Written by Natisha Lance, Donesha Aldridge on October 2, 2018.
- Business Insider: Therapy in a Pill: Breaking Down the Science Behind the Strange, Surreal World of Netflix’s “Maniac”
- Written by Charlotte Hu on October 9, 2018.
MAPS Hooded Fleece
An organic cotton and recycled polyester blend, these zippered, hooded fleeces are extremely soft and warm and made in the USA. Available in dark blue, in limited sizes and quantities. Screen printed by hand by local Santa Cruz artist, Clay Chollar.
$60.00 | Buy Now
How To Change Your Mind: What the New Science of Psychedelics Teaches Us About Consciousness, Dying, Addiction, Depression, and Transcendence by Michael Pollan
When Michael Pollan set out to research how LSD and psilocybin (the active ingredient in magic mushrooms) are being used to provide relief to people suffering from difficult-to-treat conditions such as depression, addiction and anxiety, he did not intend to write what is undoubtedly his most personal book. But upon discovering how these remarkable substances are improving the lives not only of the mentally ill but also of healthy people coming to grips with the challenges of everyday life, he decided to explore the landscape of the mind in the first person as well as the third. Thus began a singular adventure into the experience of various altered states of consciousness, along with a dive deep into both the latest brain science and the thriving underground community of psychedelic therapists.
$28.00 $21.00 | Buy Now
Psychedelic Science Webinar Series: Now – December 5, 2018
Join host Bia Labate, Ph.D., and leading researchers for online education about the latest advancements and challenges in psychedelic science. Discover the latest research into the medical and therapeutic uses of MDMA, ayahuasca, and psilocybin. You’ll learn directly from key players in psychedelic research and therapy about the hottest topics in the field. You’ll also get a chance to ask your questions and have them answered live. 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…
KRIYA Ketamine Conference: November 3-4, 2018, Hillsborough, California
KRIYA Conference is devoted to the use of ketamine in psychiatry and psychotherapy. Ketamine has been shown in numerous studies to be helpful in the treatment of severe depression and a variety of psychiatric disorders. Ketamine is emerging as a useful adjunct to psychotherapy or as a tool for psycho-spiritual exploration. Learn more…
Women and Psychedelics Forum: November 19, 2018, San Francisco, California
The field of psychedelic science has been historically heavily male-oriented with a deep under-representation of women. This unique forum aims to challenge the effects of this imbalance. Among the twelve women presenting are some of our most esteemed elders; the forum features prominent voices from both the psychedelic underground and academic researchers. Presenters will address such topics as gendered psychedelic spirituality and ways of healing; personal use and professional risk; biomedical and social science research; drug policy reform and activism; intersections of gender, race and class; and sex, seduction, and safety within psychedelic communities. Learn more…
Sacred Plants Forum: November 21-22, 2018, Mexico City, Mexico
This two-day event will make visible the current debates regarding psychoactive plants and substances as well as generate a space for the interdisciplinary and intercultural perspectives of the different uses of plants and substances. Learn more…
The Mushroom Cure: November – January 2018, New York City and San Antonio, Texas
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…
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
Ayahuasca at Parliament of Religions
The Parliament of the World’s Religions is the world’s largest and most diverse interfaith gathering, which happens every four years in different cities, involving over 10,000 people from over 200 religions and spiritual traditions gathering in mutual respect and working together to solve Humanity’s problems such as climate change, war, poverty, sexism and racism.
This global stage is a perfect opportunity to introduce the ayahuasca spiritual movement, at a time when ayahuasca ceremony facilitators are suffering religious persecution because the tea is defined as illegal in most countries. Furthermore, the indigenous ayahuasca spiritual traditions have profound spiritual wisdom, and deep connection with Mother Nature, which are precisely the positive influences that Western society needs in this critical era.
Iboga Saves: Ending the Opiod Epidemic
Iboga is a natural plant medicine that can halt addiction in its tracks and save lives. Iboga is reported to eliminate cravings and restore a sense of wholeness and purpose with just one treatment. Why is ibogaine illegal in the USA when we are in the grip of a deadly opioid epidemic with 179 or more lives lost daily? Why don’t more people know about iboga? These were the questions that motivated Lakshmi Narayan, founder of Awake Media, to join forces with Academy Award nominated filmmaker and social documentarian Eric Thiermann, founder of Impact Creative to launch a movie and a movement to spread the word and change the law.
The new film, Iboga Saves: Ending the Opiod Epidemic, will shine a light on the crisis of the prescription-induced addiction epidemic and the failure of the current system to address it—as well as the solution that Tabernathe iboga, the entheogenic root bark from Central Africa represents for healing. We will follow patients and practitioners at clinics around the world through their journey, from precare, to treatment with iboga, to integration. In addition to clinics, we will also be featuring the ceremonial/shamanic use of iboga from the traditional Bwiti ceremony to the modern western adaptation of that ritual. Their goal is to reframe and recontextualize addiction, iboga/ibogaine, and the entheogenic plant medicine category in general. Their goal is also to present the legal situation that surrounds iboga, both in terms of the scheduling, and in terms of the religious freedom laws, both in the U.S., and in places like Portugal and Canada where it is legal.
The movie, Root to Liberation, aims to shift the paradigm of what a psychedelic experience is, by recreating an iboga journey in 3D. Iboga is unlike other psychedelics in that it presents information on a literal screen in one’s mind, a tech metaphor that we are all too familiar with. By recreating the inner journey in the context of an opioid addict’s real-life transformation, we feel that we will be able to reveal through the narrative the spiritual dimension that iboga potentiates, which is the vital element for healing and reconciling the deep wounds and trauma that cause addiction. This film will help addicts in their daily dance with death understand what their real choices are. It will help people in the mainstream understand the issues and the importance of changing the law quickly. Their app, Reschedule Ibogaine, will allow them to gather signatures virally for a petition to change the U.S. law.
Their Iboga Directory already existing on awake.net will allow those who need treatment now to find clinics outside the USA. Their Iboga Saves social media campaign hosted on awake.net will begin during the month of November 2018 with articles, videos and interviews with experts and experiencers alike, so that anyone can get a comprehensive understanding of what iboga is and does. They are currently crowdfunding to raise $375,000 by Christmas 2018. Contrary to the usual movie crowdfunding pattern of raising funds bit by bit, they feel that time is truly of the essence here with so many people dying everyday of overdose, and they want to be able to get the app and movie made and distributed as soon as possible. The app budget is $10k and would take 2-3 months to produce and the movie would be a miracle if they could complete in 18 months, but that’s the goal. They don’t want to have to take timeout for crowdfunding again, hence the big push. Thank you for your support.
“In the midst of a crisis of opiate-related deaths and dependencies, it’s a tragedy that there is no federal or for-profit pharmaceutical funding for research into ibogaine which can help people through withdrawal and at the same time provide profound therapeutic/spiritual benefits. The next step for FDA-approved Ibogaine research is a roughly $2 million Phase 1/2 dose-response safety study, primarily focusing on heart function. As with research into MDMA-assisted psychotherapy for PTSD, research into ibogaine for opiate dependence can be a gift to the world from the psychedelic and cryptocurrency communities with some additional support from unexpected allies who will support the healing potential of psychedelics.” —MAPS Founder Rick Doblin, Ph.D.
If you’re not sure about donating but want to stay tuned and learn more sign up for the free Iboga Saves Blog during the month of November.