Phase 3 Trials of MDMA-Assisted Psychotherapy for PTSD: 8 Sites Screening Participants
This month, our Phase 3 multi-site study of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD) is continuing to open sites for screening. Eight sites are open for screening at this time. Study volunteers will be administered MDMA or placebo in conjunction with psychotherapy at research sites in Charleston, SC, Boulder, CO, Fort Collins, CO, Los Angeles, CA, New Orleans, LA, San Francisco, CA and New York City, NY. To learn more about currently recruiting national and international studies, visit our participate in research webpage
Our FDA-regulated Phase 3 clinical trials of MDMA-assisted psychotherapy for PTSD are taking place at 15 locations across the United States, Canada, and Israel. Eight study sites are currently recruiting participants.
Our Phase 3 researchers have completed a total of eleven study site initiation visits for Phase 3 within the United States, and we are scheduling three study site initiation visits for additional study sites in the United States, Canada, and Israel in the coming months.
The Phase 3 clinical trials are assessing the efficacy and safety of MDMA-assisted psychotherapy in adult participants with severe PTSD. Over a 12-week treatment period, participants will be randomized to receive twelve non-drug preparatory and integration sessions lasting 90 minutes each along with three day-long sessions about a month apart of either MDMA or placebo in conjunction with psychotherapy. The primary endpoint will be the Clinician Administered PTSD Scale (CAPS-5), as assessed by a blinded pool of independent raters.
The trials are the final phase of research required by the FDA before deciding whether to approve MDMA as a legal prescription treatment for PTSD. If approved, MDMA will be required to be used in conjunction with psychotherapy in an outpatient setting. • Learn More