MAPS - Phase II: MDMA-Assisted Psychotherapy for PTSD

[PepperSocks]

I realized we did not have a thread for this little milestone of an article. It's completed and been published for a couple years, so no recruiting, but I just thought I'd give it an entry.

Phase II pilot study investigating MDMA as an adjunct to psychotherapy for treating PTSD.

And its Long Term Follow Up

As listed in the articles flaws are low sample size, mostly female, all Caucasian, no active placebo (within 45 minutes the difference between lactose and 125mg of MDMA is kind of obvious). Great piece of work for being the very first in the field though; very promising results. Kudos to those researchers who persevere through the bureaucracy and professional ostracism.

Here's a glimpse of how the DEA and other government agencies invokes delays and increased expenditures on these non-profit researchers; Ot'Alora Study Timeline

I hope we have an entry for that study in the near future.

 

[Jabberwocky]

so if that was phaseII, what's next? When does FDA approval become topic of discussion?

fascinating topic for sure, given mdma flies in the faces of both US and international drug controls (still schedI here IIRC)

 

[PepperSocks]

Well in the basic sense after Phase II comes a Phase III trial (very large sample number, diverse, etc.) and after that comes prescription drug approval applications.

In reality, there's a few different Phase I's before a few different Phase II's, etc. I believe MAPS is about to start their second Phase II study. Don't forget there's other organizations in the world doing this too; A completed Swiss study replicating the Phase II trial in this thread is scheduled to be published in February 2013. I'm sure there's others I'm missing. MAPS has studies (even international ones, not their own) listed on their website.

The timeline in the last link of my first post gives an idea of the process of getting a study going. For it to be a prescription drug, it'll need a few more phase II's and then the super expensive phase III's; needless to say, it'll be a while. Time for studies, funding, political climate, my ballpark would say in non-US nations it might make prescription status in 10 years. The US is putting out some of the best research on MDMA, but the political system is so damn stubborn and obtuse. I think European countries would be the first to make it a prescription drug. We Canadians are too sissy to do anything that might upset the elephant we lie next to.

New drugs, on-patent from big pharma get rolled through relatively quickly (drug discovery>pre-clin>I,II,III, in about 10 years total) because of the abundant funds, compounds aren't controversial, and they're good friends with the FDA.

The FDA is involved in every step after pre-clinical studies (animal toxicity trials). When basic safety is proven from animal studies it goes to phase I (first human consumption). The FDA is all about the human consumption aspect.

 

[Jabberwocky]

^thanks good stuff to know!