“Moving from phase two to phase three shows we have strong scientific reason to believe that MDMA is an effective treatment for PTSD in therapy. The fact the FDA is ready to move forward with phase three signals that they agree,” said Brad Burge, from the Multidisciplinary Association for Psychedelic Studies (Maps), a not-for-profit based in Santa Cruz, California, that has spearheaded efforts to turn MDMA into a medicine.
"Starting this year, phase-three clinical trials for MDMA will begin with a goal of ultimately enrolling somewhere between 200 and 250 patients across 14 sites in the U.S., Canada, and Israel. Emerson, the former pharmaceutical researcher who is leading the study, is focused on maintaining its scientific integrity. "We want to do everything up to snuff," she says. "There can be no question about our methods." MAPS has jumped through numerous hoops since Grob submitted his first protocol in the early '90s, and the group has more work to do. But the end is in sight.
In May, Doblin met with the FDA to go over MAPS' protocol for its stage-three trial. After the meeting, Doblin emailed his staff with good news: "Every single thing we proposed was acceptable to FDA." He signed his email, "happily, Rick.”"
MDMA Links:
http://reason.com/archives/2017/07/18/mdma-ecstasy-legalization-psychedelic#comment
https://www.theguardian.com/science/2016/dec/01/fda-mdma-ptsd-final-trials
