(Interviewing the Multidisciplinary Association for Psychedelic Studies has been a dream of mine for years. I’m honored to present this conversation with their Director of Communications & Marketing Brad Burge. Not only does he give us an update on the SIX (6!) Phase II clinical trials of MDMA for PTSD, but he also shares totally new developments & tips on how to talk about this stuff for people who don’t quite dig yet. And a couple of his favorite tunes to boot!)
~Interview By Terry Gotham
1. How was 2015 for MAPS? Any good news from the front to share?
Just a little.
I can say without hesitation that 2015 was our busiest, most exciting year yet. This year (2016) we celebrate MAPS’ 30th anniversary, and all that we’ve accomplished in those three decades. Our Phase 2 clinical trials of MDMA-assisted psychotherapy for the treatment of posttraumatic stress disorder (PTSD) are now nearly complete, and this year we’ll be meeting with the U.S. Food and Drug Administration (FDA) to plan the much larger Phase 3 trials needed to make MDMA a legal prescription medicine, approved for use in conjunction with psychotherapy to treat PTSD. We are on track for FDA approval as soon as 2021.
As one of the first steps to getting this first approval, in February 2015, we announced the formation of the MAPS Public Benefit Corporation (MPBC), a new wholly owned subsidiary of MAPS which will serve as a vehicle for conducting MAPS’ research, and for balancing social benefits with income from the legal prescription sale of MDMA, other psychedelics, and marijuana. We also initiated the purchase of one kilogram of pharmaceutical grade MDMA manufactured under current Good Manufacturing Practices (GMP) to be used in our Phase 3 trials. This batch of MDMA will cost us approximately $400,000, which we are seeking to raise this year through the Global Psychedelic Dinners and 30th Anniversary Banquet in Oakland, Calif.
Another major 2015 success is our Canadian Phase 2 study of MDMA-assisted psychotherapy for PTSD, which finally started after eight years of effort. This study has already completed treatments as of early 2016, and has been the first clinical psychedelic therapy trial in Canada in over 40 years. In 2015, we also completed and fully funded our two largest Phase 2 clinical trials, one in South Carolina primarily in U.S. military veterans, and one in Colorado primarily in female survivors of sexual assault and abuse.