Our FDA-regulated Phase 3 clinical trials of MDMA-assisted psychotherapy for PTSD have officially launched. These trials are taking place at 14 locations across the United States, Canada, and Israel.
On November 19, 2018, MAPS received a shipment of pharmaceutical-grade MDMA, made under current Good Manufacturing Practices (GMP) in a certified laboratory, which will be administered in conjunction with psychotherapy to study participants in our upcoming trials.
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 to mid-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…