MAPS Completes Enrollment for Phase 3 Trial of MDMA-Assisted Therapy for PTSD
May 26, 2022
We have exciting news! On May 9, the interim analysis of MAPS’ second Phase 3 trial of MDMA-assisted therapy for PTSD indicated that no new subjects needed to be added to the study, which is now fully enrolled at 13 sites in the United States and Israel. Interim analysis determines the likelihood that the targeted number of participants in a study is adequate to demonstrate differences in response between the control group and the test group. This finding confirms the projected end of the trial in October 2022. Assuming statistical significance is indeed obtained with an acceptable safety record, we plan to submit the first New Drug Application for a psychedelic-assisted therapy to the FDA in early 2023.
We are honored to celebrate this extraordinary milestone with the people who made it possible: you, our donors, who have invested in our novel treatment for the sake of public benefit; the trial participants who courageously took a chance on an experimental treatment; and the hundreds of researchers and staff who have supported the trials. With your continued support, we’re working harder than ever to bring MDMA-assisted therapy to people living with PTSD. Read our announcement to learn more about this monumental progress.
Donors Contribute $15,304 for Harm Reduction
So far this month, 101 donors funded the work of the Zendo Project by contributing $15,304! All donations were doubled thanks to a generous matching gift to help the Zendo Project provide psychedelic harm reduction and education at events like Burning Man and music festivals across the country.
Thank you for your continued support of the Zendo Project! Every gift provides training, infrastructure, and public education resources where they are needed most.
Two Expanded Access Study Sites Now Open for Enrollment
Two new study sites are now enrolling for our MDMA-assisted therapy for PTSD Expanded Access program. The Pearl Institute in Waynesville, North Carolina, and Sage Integrative Health in Berkeley, California, opened for enrollment in early May. These sites are continuing to actively screen for patients.
Expanded Access is a program that allows patients to receive an investigational treatment not yet approved by the United States Food and Drug Administration (FDA) outside of a clinical trial. The program is for patients with serious or life-threatening conditions who do not have promising treatment options and are unable to participate in ongoing clinical trials.
MAPS, MAPS PBC, and MAPS Europe Are Hiring
We’re continuing to accept referrals and applications for open job positions. All of our organizations — MAPS, MAPS Public Benefit Corporation, and MAPS Europe — are hiring for full-time roles including Director of Strategy, Major Gifts Officer, Strategy and Operations Officer, and Head of Clinical Science. We’re always adding new jobs, so be sure to check our Careers page regularly for new opportunities in psychedelic research and education!
Register for Psychedelic Science 2023
Get ready for Psychedelic Science 2023, taking place from June 17-25, 2023, in Denver, Colorado! MAPS members, researchers, students, clinicians, therapists, political leaders, leaders ahd shareholders of for-profit psychedelic companies, and psychedelic enthusiasts will gather from around the world to share the latest advances in psychedelic research, art, and culture. Be sure to sign up for exclusive email updates to receive news, schedules, and details about this extraordinary event.
Thank you for celebrating our latest milestone with us! Be sure to share the MAPS Newsletter with a friend.
Screening Begins in Phase 2 MDMA-Assisted Therapy Study of Participants with PTSD in Berlin and London
One Subject Treated, Four Subjects Evaluated in Phase 2, Open-Label, Randomized Comparative Effectiveness Study for MDMA-Assisted Therapy in U.S. Military Veterans with Chronic PTSD
April 2022 Giving Report: Donors Fund Psychedelic Research and Education With More Than $540,000 in Philanthropic Contributions
MAPS in the Media
- Psychedelic Health: Phase 3 Trial of MDMA Therapy for PTSD Fully Enrolled
- The Bluntness: 11 Women Contributing to Psychedelics Research
- PBS: Healthy Minds With Dr. Jeffrey Borenstein: Psychedelic-Assisted Psychotherapy and Post-Traumatic Stress with Rachel Yehuda
- Fox 7 Austin: Research on Psychedelic Mushrooms, Ecstasy as PTSD Treatment Shows Positive Results
- Life Science Leader: MAPS: Walking The Talk On Intellectual Property?
- Forbes: GoDaddy Billionaire Bob Parsons Believes Psychedelics Can Heal Trauma—And He’s Putting His Money (And Brain) On The Line
Fifteen new books are available for purchase in the MAPS Store! Some examples include Heartbreak: A Personal and Scientific Journey by Florence Williams, Intoxicating Zion: A Social History of Hashish in Mandatory Palestine and Israel by Haggai Ram, Psychedelic Mysteries of the Feminine, Braiding Sweetgrass: Indigenous Wisdom, Scientific Knowledge and the Teachings of Plants by Robin Wall Kimmerer and more.
Weaving Justice Into the Post-Prohibiton World: Transformation, Tradeoffs, & the Politics of Healing, June 3, 2022, Online
Polaris Insight Center: Training and Retreats, January 2022-August 2022, Online
Integrative Psychiatry Institute Psychedelic-Assisted Therapy Training, July 2022 – May 2023
Interdisciplinary Conference on Psychedelic Research 2022, September 22-24, 2022, Haarlem, Netherlands
Thank you to Dr. Bronner’s for their support of the MAPS Newsletter!