Several MDMA/PTSD Protocol Documents Revised
In light of the results from our US MDMA/PTSD pilot study and preliminary results from our Swiss and Israeli pilot studies, we have completed an overall review of our methodology and study documents used in our studies. We have incorporated what we have learned in revised versions of our MDMA/PTSD protocols and Case Report Forms (CRFs). The revised protocols are designed to be more efficient. We have narrowed down our research focus and have eliminated some redundant outcome measures from the protocols. Weve also added a measure of suicidality required by the FDA for all studies using drugs that have psychological effects.
One of the strengths of MAPS drug development approach is our willingness to do the extra work required to incorporate lessons learned in our protocols as they are in process. This fine-tuning is the essence of what Phase 2 pilot studies are all about. They are learning opportunities for the development and design of Phase 3 multi-site studies. The Phase 3 studies will evaluate in a large number of subjects the safety and efficacy of MDMA-assisted psychotherapy for the treatment of PTSD. The outcome of these Phase 3 studies will determine if the FDA and other regulatory agencies eventually approve MDMA for prescription use.