U.S. Intern Study: IRB Grants Unconditional Approval for Study Protocol

On March 9, the protocol for our planned U.S. intern study of MDMA-assisted psychotherapy for PTSD received approval from the Institutional Review Board, conditional on the pending approval of the study physician’s Schedule I license. The day before, on March 8, the IRB had requested several changes to the subject informed consent documents. MAPS’ clinical team made the changes, resubmitted the documents, and obtained approval in less than 24 hours. The study initiation meeting will be scheduled once the DEA approves the study physician’s license application, which was submitted on March 6. The DEA has no time limit on its response, but we are hopeful that we will be able to begin the study before the summer.