Study Results: MDMA-Assisted Therapy May Reduce Anxiety for Those Diagnosed with Life-Threatening Illness
Navy SEAL Foundation Contributes $50,000 to Support Major PTSD Study
November 30, 2020
Dear friends and supporters,
While we eagerly prepare for publication of the results of the first of two Phase 3 trials of MDMA-assisted psychotherapy for PTSD, we are celebrating the publication of a peer-reviewed study published on November 24 in the journal Scientific Reports. The study provides sufficient evidence to support further research into the palliative effects of MDMA-assisted psychotherapy for anxiety associated with life-threatening illness. The pilot study, sponsored by MAPS and using protocols developed by MAPS Public Benefit Corporation (MAPS PBC), demonstrated greater reduction in anxiety among participants who received MDMA relative to participants who received placebo with identical psychotherapy. While the difference between the two groups was not statistically significant, this small pilot study demonstrates the addition of MDMA to the intervention had a large effect size and justifies continued research. Read the press release here.
On November 11, 2020, the Navy SEAL Foundation (NSF), a non-profit organization providing ongoing assistance to the Naval Special Warfare (NSW) community and its families, announced its $50,000 donation to support the completion of MAPS-sponsored Phase 3 clinical trials of MDMA-assisted psychotherapy for PTSD, the first grant for research in the NSF’s 20-year history. “By supporting the advancement of research into MDMA-assisted psychotherapy for PTSD, the Foundation is responding to an urgent need for their constituents: a PTSD treatment that may prove to be more effective than other currently available options. This grant from the Foundation will facilitate the final drug approval Phase 3 study through the FDA — a gift to Navy SEALs and all who live with PTSD,” explains MAPS Founder Rick Doblin, Ph.D.
In partnership with noted author, podcaster and entrepreneur Tim Ferriss, the Foundation committed $50,000 to what may become the first psychedelic-assisted psychotherapy to earn approval from the FDA. The treatment is intended to help injured military personnel, including Naval Special Warfare (NSW) veterans. The Foundation joins more than 2,500 individual, corporate and benevolent foundation donors that contributed $30 million in under a year toward MAPS’ psychedelic research fundraising campaign. Ferriss was one of the early challenge organizers who has personally contributed to the project through a generous $1 million gift.
Localgiving Foundation Chairman Tom Latchford is generously supporting the expansion of psychedelic therapy in England by offering £25,000 in matching funds for a MAPS-sponsored trial of MDMA-assisted psychotherapy for PTSD with a study site in London. The clinical trial site is at King’s College, in partnership with Supporting Wounded Veterans (SWV). For gifts larger than £5,000, please contact firstname.lastname@example.org. Donate now and your gift will be doubled!
MAPS Founder and Executive Director Rick Doblin, Ph.D., and Dr. Robin Carhart-Harris are featured in a new episode of Real Sports with Bryant Gumbel on HBO. The episode explores the medicinal benefits of using psychedelics for mental health conditions in athletes.
In a new article published by Dr. Bronner’s for the Heal Soul Campaign, MAPS Founder Rick Doblin, Ph.D., offers reflections on the 34-year history of our non-profit organization and highlights some of our most notable achievements.
Amy Emerson, Chief Executive Officer (CEO) of the MAPS Public Benefit Corporation (MAPS PBC), is featured in a new video discussing the organization. MAPS Public Benefit Corporation (MAPS PBC) is a Delaware public benefit corporation and a wholly owned subsidiary of MAPS with the special purpose to balance income from legal sales of MDMA with the social benefits of MAPS’ mission. As the CEO, Amy has led the growth and development of this new subsidiary and is responsible for overall global regulatory strategy and implementation of research programs with a focus on the MDMA-assisted psychotherapy program within MAPS PBC.
The Way of the Psychonaut audiobook is available for purchase in the MAPS Store. The MAPS-published audiobook is a two-volume book set in single file. You can purchase access to the film and audiobook at thewayofthepsychonaut.com. The print book and Kindle version of The Way of the Psychonaut is also available for purchase.
New insulated stainless steel bottles are now available in the MAPS Store! The vacuum-insulated MAPS bottle was created by Kleen Kanteen with versatility, portability, and performance to create the best water bottle, coffee mug, sport bottle, and insulated cup in one package. The 32oz TKWide comes with the vacuum-insulated Wide Loop Cap which creates a full stainless steel interior, increases thermal performance, features Kleen Kanteen’s TK Closure™ internal thread design, and has an easy-carry swivel loop. The MAPS Kleen Kanteen bottle keeps contents hot for up to 22 hours or iced up to 75 hours. Made from stainless steel, it is BPA free and won’t retain or impart flavors.
As an optional add-on, purchase a wide spout Chug Cap attachment that lets you take in fluids fast when you need them most. Chug Cap’s versatile design features a convenient spout cover that protects against spills mid-workout, and screws down securely for a leakproof seal when you’re ready to call it a day. Chug Cap features new TK Closure™ internal thread design to keep drinks ice cold.
Contribute to psychedelic research by applying for one of our manyjob opportunities with MAPS, MAPS Public Benefit Corporation (MAPS PBC), or MAPS Europe. Our newest opportunity is the Director of Sales and Major Gifts.
We are currently seeking research volunteers for Phase 3 clinical trials of MDMA-assisted psychotherapy for PTSD. Trials are recruiting in Charleston, South Carolina, Boulder, Colorado, Fort Collins, Colorado, New Orleans, Louisiana, United States, Boston, Massachusetts, Los Angeles, California, and San Francisco, California. Volunteers will help contribute to scientific knowledge and will help us better understand if MDMA-assisted psychotherapy works for treatment of PTSD. MAPS conducts clinical trials under the guidance and regulations of the U.S. Food and Drug Administration (FDA) in collaboration with federal regulators, including the Drug Enforcement Administration (DEA). To learn more about our clinical trials or apply to be a study participant, visit our website.
In this month’s edition of the MAPS Newsletter, you’ll also learn:
- MAPS is mentioned in major media publications including Rolling Stone, Vice, Vogue, Vanity Fair, and Psychology Today
- Understanding Ketamine, a training for therapists, psychologists, physicians, and other healthcare professionals who want to better understand the basics of ketamine, is taking place online on January 23 and 24, 2021
- Our MDMA Therapy Training Program provided an online training this month with trainees from around the world
Happy 67th birthday to MAPS Founder and Executive Director Rick Doblin, Ph.D.! Today, we celebrate Rick’s leadership, achievements, and decades of dedication to psychedelic science and medicine. Give Rick a birthday gift by making a donation to MAPS and help make MDMA a legal medicine.
We are honored to deliver you monthly psychedelic research news! Be sure to share.
MAPS Web and Email Marketing Associate
Treating PTSD with MDMA-Assisted Therapy
Phase 3 Trials of MDMA-Assisted Therapy for PTSD: Seeking Research Volunteers
We are currently seeking research volunteers for Phase 3 clinical trials of MDMA-assisted psychotherapy for PTSD. Volunteers will help contribute to scientific knowledge and will help us better understand if MDMA-assisted psychotherapy works for the treatment of PTSD. MAPS conducts clinical trials under the guidance and regulations of the U.S. Food and Drug Administration (FDA) in collaboration with federal regulators, including the Drug Enforcement Administration (DEA). To learn more about our clinical trials or apply to be a study participant, visit our website.
We are recruiting participants in the following locations:
- Charleston, South Carolina, United States
- Boulder, Colorado, United States
- Fort Collins, Colorado, United States
- New Orleans, Louisiana, United States
- Boston, Massachusetts, United States
- Los Angeles, California, United States
- San Francisco, California, United States Private Practice
Not yet recruiting:
- New York, New York, United States
- San Francisco, California, United States Institution
- Madison, Wisconsin, United States
- New York, New York, United States
- Vancouver, British Columbia, Canada
- Be’er Ya’akov, Israel
- Tel Aviv, Israel
MDMA-Assisted Therapy for Treatment of Anxiety and Other Psychological Distress Related to Life-threatening Illnesses: A Randomized Pilot Study
On November 24, 2020, a peer-reviewed study published in the journal Scientific Reports provided sufficient evidence to support further research into the palliative effects of MDMA-assisted psychotherapy for anxiety associated with life-threatening illness. The pilot study, sponsored by the Multidisciplinary Association for Psychedelic Studies (MAPS) and using protocols developed by MAPS Public Benefit Corporation (MAPS PBC), demonstrated greater reduction in anxiety among participants who received MDMA relative to participants who received placebo with identical psychotherapy.While the difference between the two groups was not statistically significant, this small pilot study demonstrates the addition of MDMA to the intervention had a large effect size and justifies continued research. • Learn More
An Open-Label, Phase 2, Multicenter Feasibility Study of Manualized MDMA-Assisted Therapy with an Optional fMRI Sub-Study Assessing Changes in Brain Activity in Subjects with Posttraumatic Stress Disorder
Taking place in the United Kingdom, Germany, Portugal, Norway, the Czech Republic, and the Netherlands, this open-label Phase 2 study of MDMA-assisted psychotherapy for PTSD will serve as the lead-in to the planned Phase 3 study in Europe providing an opportunity for clinical supervision of therapy teams to complete their training, and to validate assumptions made for statistical power calculations supporting the planned Phase 3 clinical trial. This study will also provide cross-cultural validation data on the updated version of the Primary Outcome measure, the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5), which will be used in the Phase 3 study. In addition, the study will gather supportive data on the safety and effectiveness of manualized MDMA-assisted psychotherapy.. This study will be the first multi-center study of MDMA-assisted psychotherapy for PTSD in Europe and will explore reproducibility of findings from FDA-regulated Phase 2 and Phase 3 trials to confirm the Phase 3 study design.
The study site in the Czech Republic is currently screening participants, screening at the first of two Netherlands sites will begin imminently, and screening at the Norway site is expected to start before the end of the year. The sites in the United Kingdom and Germany require further permissions before they can begin screening, most likely in early 2021, and the study set-up in Portugal is still in an early stage. Data gathered in European trials would provide support for a planned Marketing Authorization Application for potential approval by the European Medicines Agency (EMA). For more information, please visit: mapseurope.eu/researchor our webpage.
MDMA Therapy Training Program Update: November 2020
From September 25 – November 1, Marcela Ot’alora G., L.P.C., and Bruce Poulter, M.P.H., delivered a three-weekend course on MDMA-assisted psychotherapy in collaboration with Naropa University. The 9-day course included training in contemplative psychotherapy from Naropa faculty.
Annie Mithoefer, B.S.N., and Michael Mithoefer, M.D., provided an online training from November 5-6 and November 9-12. The November training included trainees from Netherlands, Germany, Norway, Portugal, United Kingdom, Canada, Somaliland, South Africa, and the United States. In October, therapists preparing to work in Europe participated in virtual training calls focused on culturally-informed care for refugee participants, led by Adele Meyer and Nooria Mehraby, M.D.
Over the summer, the training program launched the first of a series of Phase 3 Quarterly Consultation groups. These virtual group supervision calls are facilitated by trainers Marcela Ot’Alora, L.P.C., Bruce Poulter, M.P.H., Annie Mithoefer, B.S.N., and Michael Mithoefer, M.D., and cover therapeutic topics, peer discussion, case presentations, and consultation. Therapists have appreciated gathering in this community of their peers to learn from each other’s insights and challenges delivering MDMA-assisted psychotherapy. These are the MDMA Therapy Training Program’s first experiment with group supervision; we look forward to offering group supervision on the upcoming expanded access protocol as well, which will be facilitated by Associate Supervisors who have recently completed supervision training.
October 2020 Giving Report: MAPS Raises Over $289,000 for Psychedelic Research and Education
In October 2020, MAPS raised $289,116 in donations and pledges from over 900 supporters. Of this amount, $260,988 is for general support, $25,000 for Grof Legacy Training, $2,710 for MDMA-related projects, $250 for ibogaine research, and $168 for psychedelic harm reduction and peer support.
An additional $70,147 was raised by organizations that MAPS fiscally sponsors including: ICEERS ($40,010); Expanded Access sites ($24,992); Bay Area Healers Resilience Fund ($2,500); Bluelight ($2,060); Auryn Project ($283); Ayahuasca Foundation ($100); Chacruna ($100); Ceremony Health ($80); MAPS Canada ($20); and Kaphi ($2). We extend a warm congratulations to Chacruna and VETS, Inc. on each achieving their 501(c)(3) status this year. We look forward to this new chapter in the growth of your organizations. Donations may now be made directly to Chacruna and VETS, Inc.
We appreciate donations of any size and are particularly grateful to the following supporters for their generous contributions of $1,000 or more:
John and Gwen Smart Foundation ($185,000)
Audra Foster ($14,232)
The Kislak Family Foundation ($10,000)
Andrew Left, Citron Research ($5,000)
Jiri Techet ($1,000)
MentorMore Foundation ($1,000)
Peter Luce ($1,000)
Tina Koopersmith ($1,000)
Grof Legacy Training
David Bronner, Dr. Bronner’s Magic Soaps ($25,000)
Fiscal Sponsorship Grantees
MAPS is honored to support a number of like-minded organizations by providing a fiscal sponsorship so that contributions for their social benefit projects may be tax-deductible as allowed by law.
David Bronner, Dr. Bronner’s Magic Soaps ($40,000 – ICEERS)
Tom McAllister ($5,000 – Expanded Access: Santa Fe Integrative Therapy)
Anonymous ($5,000 – Expanded Access: Santa Fe Integrative Therapy)
David Bronner, Dr. Bronner’s Magic Soaps ($2,500 – Bay Area Healers Resilience Fund)
Carol Estwick ($2,000 – Bluelight)
MAPS, MAPS Public Benefit Corporation (MAPS PBC) and MAPS Europe are currently hiring!
- Adherence and Supervision Coordinator
- Clinical Data Manager (CDM)
- Document Control Specialist
- Executive Assistant
Santa Cruz, California
- Head of GCP Quality & Compliance
- Manager, GxP Quality Assurance
- Medical Monitor
- Staff Accountant
- Study Coordinator
Psychedelic Peer Support
Thank You To All Zendo Project Webinar Participants!
We extend gratitude to the Zendo Project: Beyond The Festival webinar speakers for their dedication to psychedelic education, the webinar attendees, and the MAPS volunteers who helped edit the transcripts of the webinar sessions.
We look forward to continuously expanding our online educational offerings, and hope to see you at the next MAPS webinar series!
Policy and Advocacy
MAPS in the Media:
- PRESS RELEASE: Study: MDMA-Assisted Therapy May Reduce Anxiety for Those Diagnosed with Life-Threatening Illnesses
- November 24, 2020
- Navy SEAL Foundation Contributes $50,000 to Support Major PTSD Study
- November 11, 2020
- The Washington Post: Who Will Benefit From Psychedelic Medicine?
- September 21, 2020
- PRESS RELEASE: Smoke Signals and Acid Dreams: An Evening with Martin Lee and MAPS in Santa Cruz
- November 10, 2020
- Stars and Stripes: Navy Seal Foundation Backs Study of Ecstasy Component for PTSD Treatment
- November 16, 2020
- Statement from the Multidisciplinary Association for Psychedelic Studies (MAPS) on Drug Policy Reform in the 2020 U.S. Election
- November 4, 2020
- Vanity Fair: Inside Psilocybin’s Big Week, from a Pioneering Depression Study to Election Day Wins
- November 11, 2020
- Rolling Stone: First, It Was Weed — Now, Voters Have a Chance for Legal Psychedelics
- October 23, 2020
- Psychology Today: How to Become a Psychedelic Therapist
- November 1, 2020
- Vogue: Why 2020 Is a Banner Year for Drug Decriminalization—And What It Means for Public Health
- November 5, 2020
- Vice: What All the New Drug Policies Mean For You, Personally
- November 9, 2020
- Ten Laws with East Forest: Sara Gael – The Power of Integration & Harm Reduction (#131)
- November 16, 2020
Browse our Event Calendar page for more opportunities.
Polaris Insight Center: Trainings for Clinicians, December 2020 – June 2021, San Francisco, California
Polaris Insight Center provides didactic, experiential, and residential trainings in ketamine-assisted therapy. These programs are designed to provide interested physicians, psychologists, therapists, nurses, and other healthcare professionals with principles and procedures of KAP and how to use ketamine in combination with psychotherapy in a clinical setting. • Learn More
Understanding Ketamine, January 23 & 24, 2021, Online
Ketamine is a dissociative anesthetic also classified as a psychedelic. In the last decade it has become frequently sought as a treatment for depression and mood disorders. This training is designed for therapists, psychologists, physicians, and other healthcare professionals who want to better understand the basics of ketamine and how they can ensure the best clinical outcomes for patients. •Learn More
Participate in Psychedelic Research
MDMA Studies Sponsored by MAPS
MAPS sponsors clinical trials around the world that offer volunteers the opportunity to participate in our research studies. Our studies have strict enrollment criteria based on the goal of the study and the condition the study is investigating.
Phase 3 MDMA/PTSD trial participant enrollment is now open. Please bookmark our Participate in Research page and check it frequently for updates.
Thank you to Dr. Bronner’s for their company’s support of the MAPS Newsletter!