Boulder: Amended Protocol Submitted to FDA and IRB

On August 6, 2013, we submitted to the Institutional Review Board an amended protocol for our new study of MDMA-assisted psychotherapy for PTSD in Boulder, Colorado. The amended protocol was submitted the following day, August 7, to the U.S. Food and Drug Administration. The amendments include changes to the dosing schedule and the addition of two safety measures. Led by Principal Investigator Marcela Ot’alora, this study is exploring the safety and effectiveness of MDMA-assisted psychotherapy while also exploring whether we can reduce the costs of the research while maintaining effectiveness by pairing experienced therapists with intern co-therapists.