Reduction in Social Anxiety After MDMA-Assisted Therapy with Autistic Adults: A Randomized, Double-Blind, Placebo-Controlled Pilot Study
Psychopharmacology publishes MDMA research results
September 28, 2018
Dear friends and supporters,
We are proud to announce Psychopharmacology’s publication of peer-reviewed results from the MAPS-sponsored clinical trial of MDMA-assisted psychotherapy for social anxiety in autistic adults. To learn more, read the press release and the published results.
This month, CBS News televised an investigative report on MAPS-sponsored studies of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD), featuring an overview of scientific success through interviews with MAPS Founder Rick Doblin, Ph.D., and U.S. Army SGT (R) Jon Lubecky.
Fifteen 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. Seven study sites are now enrolling and 7 sites are fully enrolled. The study is expected to be completed in early 2019. We are excited to begin conducting MAPS-sponsored Phase 3 trials this autumn.
On October 6, 2018, MAPS will host our annual fundraising dinner in New York City, Breakthrough for Psychedelic Therapy, a benefit event to support MAPS. We are pleased to announce that more tickets are now available for sale, thanks to changing our venue to The Assemblage John Street. This event takes place during Horizons: Perspectives on Psychedelics, an annual conference taking place in New York City from October 5-7, 2018. Thank you to all who have purchased tickets. We appreciate your support and we are excited to see you in New York City!
From August 27, 2018 – September 3, over 300 volunteers for the Zendo Project volunteers provided 24/7 psychedelic peer support services for the seventh consecutive year at Burning Man in Black Rock City, Nevada. A public 3-hour training on the principles of psychedelic harm reduction was hosted, along with integration sessions facilitated by the Zendo Project. Our recent crowdfunding campaign raised $125,448 to help expand psychedelic peer support services and education at events around the world. Thank you to all who contributed and helped make this year a success!
In the September 2018 edition of the MAPS Newsletter, you’ll also learn::
- 75 out of 76 participants have enrolled and received the study drug in our clinical trial of smoked marijuana for PTSD symptoms in U.S. veterans
- The eighth participant receives treatment our ongoing study of the effect of MDMA on startle testing in healthy volunteers
- See our Event Calendar for upcoming events
- The Summer 2018 Research Edition of the MAPS Bulletin is now available online and in subscribers’ mailboxes
The MAPS Podcast offers a window into the psychedelic universe. Our podcasts are sourced from discussions, presentations, and panels that have occurred at psychedelic research conferences and other unique events. The MAPS Podcast is hosted by Zach Leary.
Thank you for following us on our journey. We hope you have a beautiful autumn!
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
Fifteen 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.
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: Eighth Participant Receives Experimental Treatment
On August 27, 2018, the eighth 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 study will be followed by another study exploring the combination of MDMA with Prolonged Exposure in PTSD patients. Learn more…
MDMA Therapy Training Program: September 2018 Update
In the coming year, MAPS plans to apply for a special U.S. Food and Drug Administration (FDA) program called Expanded Access (EA), which allows the use of an investigational medical product (one that has not yet been approved by the FDA) outside of a clinical trial. The program’s purpose is to grant access to potentially beneficial investigational treatments for people facing a serious or immediately life-threatening condition for which there is no satisfactory treatment currently available. The FDA’s website has more information on its Expanded Access program.
MAPS has already had positive preliminary discussions about Expanded Access with DEA on December 19, 2017, and with FDA on December 20, 2017. If Expanded Access for MDMA-assisted psychotherapy for PTSD is approved, new sites in the U.S. meeting the requirements may obtain approval and undergo training to administer open-label MDMA-assisted psychotherapy to eligible patients with treatment-resistant PTSD, under a MAPS protocol. Qualified Expanded Access site applicants will have 1) a suitable facility to conduct MDMA-assisted psychotherapy and meet drug storage requirements, 2) qualified therapy team who have completed the MDMA PTSD Therapy Training Program, operated by MPBC, 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 better understood.
Currently MPBC is updating its website, including web pages for the Therapy Training Program and an online training application for eligible sites and providers. Completed applications for potential sites to work on a U.S. FDA Expanded Access protocol for MDMA-assisted psychotherapy will be reviewed on an ongoing basis, starting late 2018 and continuing through the duration of the protocol, pending approval. Registration for the first training cohort will take place early 2019; training events will take place starting March 2019, in locations across the U.S.
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. The MDMA Therapy Training Program will also host a training event in 2019 specifically for therapy providers of color, led in part by Monnica Williams, PhD.
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. 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…
75th Participant Enrolls in Smoked Marijuana Trial for Chronic PTSD in Veterans
As of September 18, 2018, 75 of 76 participants 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, nearly completing enrollment. 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. Our 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
Psychedelic Peer Support
Zendo Project at Burning Man 2018 and Fundraising Campaign
The Zendo Project provided 24/7 essential psychedelic peer support at Burning Man for the seventh consecutive year. Over 300 volunteers served 380 guests throughout the week. The Zendo Project was highlighted in the official materials provided to attendees upon arrival, and our new prominent location on the Esplanade led to more visibility than ever before.
We are proud to share that the Zendo Project collaborated closely with medical staff from the Emergency Services Department, law enforcement officers from the Bureau of Land Management, and Black Rock City Rangers during the event. A public 3-hour training on the principles of psychedelic harm reduction was hosted, along with integration sessions facilitated by the Zendo Project.
We are grateful to our community for helping our recent fundraising campaign exceed our original $70,000 goal as well as our $100,000 stretch goal. With multiple generous donations, we reached 93% of our $130,000 stretch goal.
Thank you to all of those who donated and supported the Zendo Project’s recent crowdfunding campaign. Your support allows us to further our mission to provide support at transformational gatherings around the globe. Learn More… | Donate now…
August 2018 Giving Report: Fundraising for Zendo Project Psychedelic Peer Support Services
MAPS is currently seeking $9 million for European Medicines Agency (EMA) trials to supplement the data gathered for the FDA, with $397,735 already raised, $500,000 more pledged, and roughly $8.1 million still to go. We have now completed our key negotiations with EMA and we will have a clearer estimate of costs for Phase 3 EMA trials in early 2019, after completion of our negotiations with Phase 3 sites and with the regulatory agencies for each country in which we will have a Phase 3 site.
In August 2018, MAPS raised nearly $613,000 in new donations and pledges from 745 supporters.
On July 16, we began fundraising for the Zendo Project, a harm reduction program of MAPS, which provides peer support services at festivals and events around the world. The campaign recently concluded and we’ve raised over $126,000, an unprecedented success.
We extend a special thanks to those who so generously supported MAPS last month:
- The Greenwald Foundation ($10,000)
- Allan Walstad ($10,000)
- Amit Singh ($5,000)
- Flanny Productions, Ltd. ($4,049)
- Max Kerr ($3,000)
- Steve Gehrman ($2,500)
- AmazonSmile Foundation ($2,177)
- Stephanie Schwindenhammer ($1,800)
- Anthony Hidalgo ($1,000)
- Brooke Stone ($1,000)
- Greg Logan ($1,000)
- John Laveta ($1,000)
- Shane Leather ($1,000)
- Todd Bureau ($1,000)
Phase 3 MDMA/PTSD U.S.:
- Good Ventures ($500,000)
- Reboot Float Spas ($8,010)
- Float Seattle ($1,335)
- Capitol Floats ($1253)
- Tankhouse Float & Massage ($1,024)
Phase 3 MDMA/PTSD Israel:
- Michael & Anita Siegel Family Foundation ($4,000)
Marijuana for PTSD:
- Julie Holland ($1,779)
- Anonymous ($15,000)
- Ben Halper ($1,500)
- Jelena Antonic ($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
- PRESS RELEASE: MDMA-Assisted Therapy Shows Promise for Reducing Social Anxiety in Autistic Adults, New Study Shows
- Written by Brad Burge on September 18, 2018
- CBS News: MDMA Could Be Key in Helping Veterans With PTSD
- Written by Jim Axelrod on September 18, 2018
- Psychedelic Support: First Clinical Trial: Social Anxiety in Autistic Adults Successfully Treated with MDMA Therapy
- Written by Alli Feduccia, Ph.D., on September 13, 2018
- Reason Magazine: FDA May Soon Allow MDMA Prescriptions for PTSD
- Written by Jacob Sullum on August 2, 2018
- Stars And Stripes: DEA’s Lack of Action to License Marijuana Growers Threatens Next Phase of PTSD Study
- Written by Nikki Wentling on August 3, 2018
- Big Think: A Prescription for MDMA? We’re Getting Closer
- Written by Derek Beres on August 6, 2018
- Live Science: These Psychedelic Drugs Show Promise for Treating Mental Health Disorders
- Written by Rachael Rettner on August 11, 2018
- Daily Beast: Suicidal Vet Calls MDMA Treatment ‘A Miracle’
- Written by Thor Benson on August 16, 2018
MAPS Podcast: Subscribe for New Episodes
The MAPS Podcast, hosted by Zach Leary, has the most up-to-date content from the psychedelic universe. We feature discussions with prominent psychedelic researchers, scientists, cultural luminaries, members of the MAPS team, comedians, and other unique individuals who contribute to the expanding MAPS community. Subscribe or listen using your favorite podcast portal: iTunes, Stitcher, or Google Play. Listen now…
Signed Glassware from Sasha Shulgin’s Laboratory and Other Psychedelic Memorabilia
Signed by world-renowned chemist Alexander “Sasha” Shulgin, this is a genuine piece of chemical glassware used by Sasha in his personal laboratory where he invented and synthesized several hundred psychoactive compounds. It’s 14.5 inches tall and made of Pyrex glass in the U.S.A. The base and stand in the photo are not included. Other psychedelic memorabilia available are copies of PiHKAL: A Chemical Love Story and TiHKAL: The Continuation, signed by Alexander ‘Sasha’ Shulgin and Ann Shulgin.
$35.00 | Get Your Artifacts Today!
PiHKAL/TiHKAL Commemorative Edition
PiHKAL: A Chemical Love Story tells the tale of a psychopharmacologist and his wife/research partner and their decades devoted to the creation and investigation of psychedelic drugs as tools for the study of the human mind. Altered state experiences are explored in the context of intimacy. In TiHKAL: The Continuation, the authors continue their exploration of the chemistry and transformative power of psychedelic drugs, devoting this volume to tryptamines, β-carbolines and LSD analogues.
You are invited to meet Ann Shulgin on October 8 at an event dedicated to these memorial books in Berkeley, California. See our Events section below for more details.
$200.00 | Buy Now…
Cannabis Hemp Conference and Expo: September 28–30, 2018, Vancouver, Canada
Millions of people are re-awakening to the potential and benefits of plant medicines. Thought leaders, practitioners, patients, families, business entrepreneurs, government officials, cultivators and geneticists will come together to explore the endless benefits of cannabis. 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…
Breakthrough for Psychedelic Medicine: October 6, 2018, New York City
You are invited to join MAPS in New York City for a benefit event with special guests including author Michael Pollan, MAPS Founder Rick Doblin, Ph.D., MDMA researcher Monnica T. Williams, Ph.D., and Rodrigo Niño, founder of The Assemblage. Celebrate the launch of our new psychedelic research sites in New York City, where MDMA-assisted psychotherapy will be investigated as a treatment for posttraumatic stress disorder (PTSD) in an FDA-regulated Phase 3 clinical trial. Learn more…
Ann Shulgin, Jon Hanna and David Presti: Psychedelic Stories, Art and Cookbooks: October 8, 2018, Berkeley, California
You are invited to an opportunity to meet Ann Shulgin, co-author of PiHKAL and TiHKAL, and contributing authors Jon Hanna and David Presti, at Moe’s Books in Berkeley, California on October 8th, 2018. Learn more…
The Mushroom Cure: October 8, 2018, New York, New York
This performance coincides with Horizons: Perspectives on Psychedelics. 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…
Psychedelic Medicine: From Tradition to Science: October 10, 2018, Cambridge, Massachusetts
The discussion of psychedelic medicine makes a historic return to Harvard. Featuring a panel and audience Q&A with best-selling author Michael Pollan, MAPS Founder & Executive Director Rick Doblin, Ph.D., psychedelic and brain science researchers Robin Carhart-Harris of Imperial College, London, Matthew Johnson of Johns Hopkins School of Medicine, psychedelic therapist Anja Lozaiga-Velder of Centro Nierika, and psychiatrist Franklin King of Massachusetts General Hospital. Moderated by psychiatrist and author Julie Holland. Request a seat or join the live webcast. 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…
Portland Psychedelic Society Conference: October 27, 2018, Portland, Oregon
Portland Psychedelic Conference is a day-long conference with CEs for mental health professionals, naturopaths, and the public. The Portland Psychedelic Society is community of people who come together to foster evolutionary work on ourselves and help others integrate their experiences and foster their self-work. We emphasize creating an atmosphere of safety and mutual guidance and support, honor, trust, and integrity. Learn more…
Spirit Plant Medicine Conference: November 2-4, 2018, Vancouver, British Columbia
Our intention with this eighth annual Spirit Plant Medicine Conference is to offer accurate, respectful, and most of all beneficial information and inspiration on the use of and larger context around such plant medicines. This is an intention arising from a vision and a prayer carried in the hearts of many. To that end, we have assembled an exceptional group of knowledgeable, engaging, and heartfelt speakers to share their wisdom. You’re warmly invited to join us for a remarkable weekend of insight, inspiration, compassion, and yes, humour. 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…
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
MAPS Public Benefit Corporation is Hiring
The MAPS Public Benefit Corporation, a wholly owned subsidiary of MAPS, is hiring for upcoming clinical trials. Learn More…
Global Ayahuasca Survey
If you have consumed ayahuasca, you are invited to join over 4,000 people from more than 50 countries in the first global survey of ayahuasca drinking. The research is based at the University of Melbourne and involves an international team of collaborators and partners including MAPS. Take the survey…