Page 299 - Total War on PTSD

2019. We hope to apply for similar programs internationally, at a later date. You can learn more about Expanded Access on the FDA’s website.
If Expanded Access is approved in the U.S., new sites meeting the requirements listed below may seek approval to participate in the MAPS Public Benefit Corporation (MPBC) multi-center Expanded Access protocol under an FDA Treatment protocol, which would allow them to administer open-label MDMA-assisted psychotherapy for PTSD in line with the single approved protocol. Qualified applicants will have a team of therapy providers, a physician, and a facility suitable to conduct MDMA-assisted psychotherapy per Schedule 1 regulations with approval by regulatory agencies and under supervision of MPBC.
Research into MDMA-assisted psychotherapy as a treatment for PTSD is continuing in three countries. The first of the 15 Phase 3 trial sites in the US, Canada, and Israel started enrolling participants in November 2018.
Information about enrollment as well as an email sign-up for people interested in learning about enrolling in our clinical trials is available here: https://maps.org/participate/participate-in- research
If the clinical trials continue to show success, MDMA could soon be approved as a treatment for PTSD by federal regulators. Assuming that the Phase 3 trial results are satisfactory to the FDA, the agency would approve the treatment as soon as 2021. Once that happens, MDMA, which is currently a Schedule 1 drug under the Controlled Substances Act, would have to be reclassified to Schedule 2 or lower. Then, MAPS plans to help make the treatment available to as many people with PTSD who need it as possible. We are working hard to ensure as wide
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