The non-profit Multidisciplinary Association of Psychedelic Studies (MAPS) has confirmed it has now fully enroled its Phase III trial of MDMA-assisted therapy for PTSD.
It is currently estimated that more than 300 million people are living with PTSD worldwide, with around 12 million experiencing the condition each year in the US.
About half of people with PTSD achieve symptom reduction through psychotherapy or pharmaceutical interventions. However, for some, PTSD is a chronic condition resulting in serious comorbidities including anxiety, insomnia, hypertension, depression and substance use disorder.
MDMA for PTSD
The MAPS Phase III trial is aiming to help meet the unmet need for treatment in this area, and is expected to take place at 13 sites across the US and Israel. The second, confirmatory Phase III trial of MDMA-assisted therapy for PTSD is now fully enrolled at 13 sites in the United States and Israel.
MAPS’ first Phase III trial indicated that MDMA may be a safe and effective treatment for PTSD resulting from any cause, with 88 per cent of participants demonstrating a clinically significant reduction in PTSD symptoms two months after the last experimental session, with no serious safety signals emerging.
After negotiating a special protocol agreement with the US Food and Drug Administration (FDA) for the confirmatory trial, MAPP2 was designed to enrol at least 100 participants in order to confirm the efficacy and further investigate the safety of the treatment.
If the MAPP2 study results, available after October 2022, are statistically significant for a reduction in PTSD symptoms and meet the FDA standards for safety, MAPS and MAPS PBC are planning to submit a New Drug Application to the FDA in the first half of 2023.
CEO of MAPS Public Benefit Corporation, Amy Emerson, commented: “For nearly 20 years, MAPS has sponsored innovative, careful research into the potential of MDMA to treat PTSD.
“MAPS PBC, supported through the dedication of staff, consultants, participants in the studies, and donors, has organised world-class research into a novel treatment for a devastating condition with too few treatment options.
“Together, we are eagerly awaiting the possibility that our scientific inquiry may be confirmed in this critically important trial scheduled to be completed in October 2022.”
Associate director for Pivotal Programs, Charlotte Harrison, B.A., commented: ”The completion of enrolment brings us one step closer to making this novel treatment available to the many people who were not able to participate and accessible to those who need it most.
“We are ever grateful for the participants who spent many hours on their healing journeys in this trial and to the therapists, study coordinators, doctors, and MAPS PBC staff who have dedicated their careers to this effort.”
BIPOC and LGBTQIA+
MAPS is implementing Health Equity initiatives to enrol BIPOC and LGBTQIA+ participants improved representation of populations most likely to develop PTSD following exposure to trauma.
MAPS highlights that, among Americans exposed to trauma, people of colour and LGBTQ+ individuals are more likely to develop PTSD, yet less likely to receive a diagnosis or have reasonable access to treatment.
Research demonstrates that racial and ethnic alignment among healthcare providers and their patients can improve survival, safety and trust for patients. However, marginalised populations are historically underrepresented in clinical research, including in MAPS-sponsored trials.
Through equity initiatives in therapist training and participant recruitment, participants in MAPP2 are more representative of the population of people living with PTSD.
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