MDMA Approved for FDA Clinical Trial for Treatment of PTSD

For decades, MDMA (also referred to as Ecsta­sy or Mol­ly, for mol­e­c­u­lar) has been an illic­it drug of abuse. In Decem­ber of 2016, how­ev­er, it received FDA approval for a Phase 3 clin­i­cal tri­al for treat­ment of PTSD, which will include 230 patients.

MAPS (Mul­ti­dis­ci­pli­nary Asso­ci­a­tion for Psy­che­del­ic Stud­ies) is under­tak­ing a rough­ly $25 mil­lion plan to make MDMA into a Food and Drug Admin­is­tra­tion (FDA)-approved pre­scrip­tion med­i­cine by 2021, and is cur­rent­ly the only orga­ni­za­tion in the world fund­ing clin­i­cal tri­als of MDMA-assist­ed psy­chother­a­py.

Phase 2 study results appear promis­ing when MDMA is admin­is­tered care­ful­ly by psy­chi­a­trists, in con­junc­tion with psy­chother­a­py. Patients who had strug­gled with PTSD for over sev­en­teen years showed a 56% decrease in sever­i­ty of symp­toms after three dos­es of MDMA.

MDMA (meth­yl­ene­dioxymetham­phet­a­mine) was devel­oped in Ger­many in the ear­ly 1900s as a par­ent com­pound to be used to syn­the­size oth­er phar­ma­ceu­ti­cals. Dur­ing the 1970s, in the Unit­ed States, some psy­chi­a­trists began using MDMA as a psy­chother­a­peu­tic tool, despite the fact that the drug had nev­er under­gone for­mal clin­i­cal tri­als nor received approval from the U.S. Food and Drug Admin­is­tra­tion (FDA) for use in humans. Nev­er­the­less, the drug gained a small fol­low­ing among psy­chi­a­trists in the late 1970s and ear­ly 1980s, because it was per­ceived to enhance com­mu­ni­ca­tion in patient ses­sions and report­ed­ly allowed users to achieve insights about their prob­lems. It was also dur­ing this time that MDMA first start­ed becom­ing avail­able on the street and became pop­u­lar in the club or “rave” scene due to its stim­u­lant and psy­che­del­ic prop­er­ties. It is often tak­en for the feel­ings of well-being, stim­u­la­tion, and the dis­tor­tions in time and sen­so­ry per­cep­tions that it pro­duces. In 1985, the U.S. Drug Enforce­ment Admin­is­tra­tion (DEA) banned the drug, plac­ing it on its list of Sched­ule I drugs, cor­re­spond­ing to those sub­stances with no proven ther­a­peu­tic val­ue.

It’s impor­tant to note that MDMA is not the same as “Ecsta­sy” or “Mol­ly.” Sub­stances sold on the street under these names may con­tain MDMA, but fre­quent­ly also con­tain unknown and/or dan­ger­ous adul­ter­ants. In lab­o­ra­to­ry stud­ies, pure MDMA has been proven suf­fi­cient­ly safe for human con­sump­tion when tak­en a lim­it­ed num­ber of times in mod­er­ate dos­es.