Therapist Training Study: 13th Participant Enrolled

On July 5, 2016, the 13th participant was enrolled in our ongoing Phase 1 study of the psychological effects of MDMA when taken in a therapeutic setting by healthy volunteers. Enrollment in this study is limited to therapists in training to work on MAPS-sponsored clinical trials of MDMA-assisted psychotherapy for PTSD, with enrollment by invitation only. The Principal Investigator of this study is Michael Mithoefer, M.D. On May 9, in preparation for expanding our MDMA-assisted psychotherapy for PTSD development program into Phase 3, we submitted an amendment to the study protocol to the FDA. The amendment included increasing total enrollment to 100 participants and adding a second site in Boulder, Colorado, under the direction of Marcela Ot’alora, M.A., L.P.C., in order to increase enrollment to cover training needs over the next five years. The FDA gave clearance for the third protocol amendment on June 21, 2016. “We felt quite strongly that we should go through the therapist’s training,” says study participant Dr. Mathew Hoskins in a recent interview with Inverse. “We’re asking our participants in our study to do really quite a lot.”