Novel PTSD Treatment Advances Toward Regulatory Evaluation with New Collaboration
- On PTSD Awareness Day, MAPS PBC announced plans to develop the New Drug Application for MDMA-assisted therapy in collaboration with MMS Holdings
- The second Phase 3 trial of the Breakthrough-Designated Therapy for PTSD will be completed in late 2022, with a targeted NDA submission in 2023 supported by MMS Holdings
- MMS Holdings was selected for extensive experience supporting neuroscience-related and first-in-class NDAs
MAPS-Sponsored Phase 1 & 2 Trials
MDMA-Assisted Group Therapy for PTSD Among Veterans Study Will Proceed Following Successful Safety Negotiations
- The FDA lifted the clinical hold from a MAPS-sponsored Phase 2 study of MDMA-assisted group therapy for the treatment of posttraumatic stress disorder among veterans at the VA Portland Health Care System
- This essential proof-of-principle study tests safety and logistics of group therapy, the first step in fully investigating the treatment for efficacy and broader patient access
- The data-driven negotiation strategy included substudies of participants’ no-overnight stay conducted in the first Phase 3 trial of MDMA-assisted therapy for PTSD
A Phase 2, Open-Label, Randomized Comparative Effectiveness Study for MDMA-Assisted Therapy in U.S. Military Veterans with Chronic PTSD
As of August 8, 2022, a total of five participants have been enrolled and the Bronx VA site continues to actively screen for new participants.
As of July 19, 2022, one subject completed the trial. Two additional subjects have been treated, and four subjects are enrolled into this study.
Enrollment is continuing for this Phase 2, open-label study on the effectiveness of MDMA-assisted therapy in U.S. Veterans with chronic PTSD. This study is a comparative study that assesses two versus three active MDMA-assisted sessions.
Food Effect on Bioavailability of MDMA in Healthy Volunteers Study (MPKF) Open for Enrollment
On July 28, 2022, the first participant was screened for the Phase 1 food effects study. This study is enrolling healthy volunteers and examines the effect of food on the bioavailability of MDMA. The study is being conducted at the Alliance for Multispecialty Research, a Phase 1 unit in Knoxville, TN.
First Participant Screened in 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 PTSD in Europe
On July 18, 2022, the first UK participant in our open-label Phase 2 study of MDMA-assisted therapy for PTSD was screened by the research team at the Institute of Psychiatry, Psychology & Neuroscience at King’s College London – South London and Maudsley NHS Trust (KCL-SLaM). The site Principal Investigator is Dr. James Rucker.
Investigator-Initiated Trials
We are excited to share recent progress with our investigator-initiated trial (IIT) program! The MAPS Public Benefit Corporation (MAPS PBC) IIT program is designed to create an ever-growing network of qualified clinicians whose passion and innovative questioning help to inspire new possibilities within the path to expanding patient access and the conditions that MDMA-assisted therapy may be possible in treating. To learn more about these studies, visit the official study page: maps.org/iit
Now Recruiting for Investigator-Initiated Trial in Portland, Oregon
Recruitment of participants has begun at our investigator-initiated trial at Portland Psychotherapy in Portland, Oregon. Dr. Jason Luoma and a team of researchers are conducting this study to assess the safety and effectiveness of MDMA-assisted therapy in treating individuals with moderate-to-severe social anxiety disorder (SAD). The team at Portland Psychotherapy plans to treat up to 20 participants. Visit the recruitment website to apply to participate.
Enrollment continues for other study sites conducting Investigator-Initiated Trials. The MAPS Public Benefit Corporation (MAPS PBC) Investigator-Initiated Trial (IIT) program is designed to create an ever-growing network of qualified clinicians whose passion and innovative questioning help to inspire new possibilities within the path to expanding patient access and the conditions that MDMA-assisted therapy may be possible in treating.
Therapy Training
MDMA Therapy Training Program Updates
Cohorts for 2022 are now full. The MDMA Therapy Training Program is no longer accepting applications. For updates on future opportunities, please sign up for the training newsletter: mapspublicbenefit.com/training
In August, the training team hosted the first MAPS PBC Trainers retreat in New York. The 4-day retreat was delivered in collaboration with Reconsider. The gathering brought together more than 25 MAPS PBC trainers and assistant trainers to discuss best practices for developing and delivering gold-standard MDMA-assisted therapy training. The training team also supported a week-long in-person training retreat in Boston in collaboration with the California Institute of Integral Studies (CIIS) Certificate in Psychedelic-Assisted Therapies and Research.
In September, the therapy training team delivered two in-person trainings in New York and Colorado. In July 2022, the MDMA Therapy Training team delivered training for Naropa University’s inaugural psychedelic-assisted therapies certificate cohort.
In June 2022, the MDMA Therapy Training Team delivered two more trainings, including a week-long in-person training retreat in New York and a week-long training in California in collaboration with the California Institute of Integral Studies (CIIS) Certificate in Psychedelic-Assisted Therapies and Research. The New York training was led by mentor trainers Bruce Poulter, MPH, and Marcela Ot’alora G., MA, LPC. In addition to the synchronous and online course content, the training retreat incorporated art therapy projects, an evening music experiential evening, and Holotropic Breathwork, among other immersive learning components. The retreat was supported by a team of Assistant Trainers including Harvey Schwartz, Ph.D., LCP; Veronika Gold, LMFT; Jennifer Jones, LCSW; Genesee Herzberg, LCP; and Jason Butler, Ph.D., LCP. The CIIS training was led by mentor trainers Michael Mithoefer, M.D., and Annie Mithoefer, BSN, and supported by Assistant Trainers Eric Sienknecht, Ph.D., LCP, and Joanna Simundic, LPC, LCSW.
In May 2022, the MDMA Therapy Training Team hosted their second 100-hour blended (online/in person) training program and hosted a week-long in-person training retreat in Colorado (pictured above). In addition to the synchronous and online course content, the training retreat incorporated immersive learning components including art therapy projects, an evening music experiential evening, gong bath performance, and the SoundSelf technology by EntheoDigital, which engages your voice in a biofeedback loop enhanced by vibro-acoustics and light therapy.
