On June 9, 2011, our Institutional Review Board (IRB) approved the protocol for our new “relapse study” of MDMA-assisted psychotherapy for PTSD. The Food and Drug Administration approved the protocol for this study on May 24, but the DEA must now conduct its own review before granting us the license to store and administer the MDMA. On June 14, Clinical Investigator and co-therapist Michael Mithoefer, M.D., submitted the protocol for the relapse study to the DEA. We anticipate that the DEA will approve the study soon, allowing us to schedule the study initiation and begin enrolling subjects.
This study, which will take place in Charleston, SC, is limited to up to three subjects whose PTSD symptoms returned after participating in our flagship Phase 2 clinical trial of MDMA-assisted psychotherapy for PTSD. Over 80% of the subjects in our previous study no longer met criteria for PTSD two months after treatment. These benefits tended to persist over time until our long-term follow-up, conducted an average of 41 months after treatment. However, for several subjects symptoms did eventually return. This relapse study will attempt to determine whether a single additional open-label MDMA-assisted psychotherapy session along with several non-drug psychotherapy sessions can be effective for once again enabling these subjects to be free of a diagnosis of PTSD.