Therapist Training Study: New Protocol Amendment Accepted by the FDA

On May 12, 2020, a new protocol amendment which increases the number of study participants to a total of 120 was accepted by the U.S. Food and Drug Administration (FDA). This protocol amendment was submitted to the Institutional Review Board (IRB) on April 30, 2020. This study is our ongoing Phase 1 study of the psychological effects of MDMA when used in a therapeutic setting by healthy volunteers. Enrollment in this multi-site study is on hold due to COVID-19 and is limited by invitation only to therapists in training to work on MAPS-sponsored clinical trials of MDMA-assisted psychotherapy for PTSD. The Boulder, Colorado, study site is led by Principal Investigator Marcela Ot’alora, M.A., L.P.C., the Charleston, South Carolina, is led by Principal Investigator Zhenya Gelfand, M.D., and the Santa Fe, New Mexico, study site is led by Principal Investigator George Greer, M.D. • Learn More