U.S. Intern Study: DEA Approves MDMA/PTSD Protocol, Reviews License
On May 15, 2012, the U.S. Drug Enforcement Administration approved the protocol for our upcoming study of MDMA-assisted psychotherapy for PTSD, to take place in Boulder, Colorado, with Marcela Ot’alora as lead investigator. This study will begin recruiting and enrolling subjects once the DEA grants the Schedule 1 license to the study physician and the necessary site preparations are complete. We are now in the process of moving the safe from the physician’s office to the treatment site, installing alarms, and completing remaining security requirements. The MAPS clinical team is now preparing the documents to be used to collect the data for the study and creating a reference manual for conducting the protocol. Meanwhile, the site team is preparing the treatment room and compiling music for the therapy sessions.