Therapist Training: 11th Participant Treated

On March 19, 2016, the 11th participant was treated in our ongoing Phase 1 study ofMDMA-assisted psychotherapy for therapists in training to conduct clinical trials of MDMA-assisted psychotherapy for PTSD, with enrollment by invitation only. Led by Principal Investigator Michael Mithoefer, M.D., this study is a placebo-controlled, double-blind study to assess the psychological effects of MDMA when administered to healthy volunteers in a therapeutic setting. On May 4, in preparation for Phase 3 of our MDMA-assisted psychotherapy for PTSD development program, we submitted to the FDA a series of amendments to the study protocol. The amendments include increasing total enrollment to 100 participants and adding a new location in Boulder, Colorado, under the direction of Marcela Ot’alora, in order to increase enrollment to cover training needs over the next five years.