This month, MAPS study sites in New Orleans, Louisiana, Charleston, South Carolina, Fort Collins, and Boulder, Colorado received a shipment of pharmaceutical-grade MDMA, made under current Good Manufacturing Practices (GMP) in a certified laboratory, to be administered in conjunction with psychotherapy to study participants.
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.
Our Phase 3 researchers have completed a total of eight study site initiation visits for Phase 3 within the United States, and we are scheduling seven study site initiation visits for remaining study sites in the United States, Canada, and Israel in early 2019.
Do you have PTSD? You may qualify for a study of an investigational drug (MDMA) used in combination with psychotherapy. • Learn More
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