Page 349 - Total War on PTSD Final

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 accessibility to MDMA-assisted psychotherapy as possible once it’s approved, including getting it covered by private insurance and public health care plans.
We have the FDA determining that a psychedelic-assisted therapy could be a significant advance over what’s currently available for mental health treatment. That’s very different from the last 40 years of regulatory, political and cultural attitudes around these drugs. It’s been decades since psychiatry has had a new set of tools available to it. And here we have
349 of 837