Study finds MDMA-assisted therapy to be safe and highly effective to treat severe PTSD

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The First Phase 3 Suc­cess for Psy­che­delics Will Pave the Way for an Indus­try (Bar­ron’s):

Post-trau­mat­ic stress dis­or­der is a crip­pling, hard-to-treat psy­chi­atric afflic­tion. Amer­i­ca spends bil­lions of dol­lars year­ly just on the vet­er­ans who suf­fer from PTSD. So it’s heart­en­ing to see the report of a promis­ing new treat­ment, pub­lished Mon­day in Nature Medicine.

In Monday’s report, an inter­na­tion­al team of researchers describe their test of a treat­ment com­bin­ing psy­chother­a­py with dos­es of MDMA—the ille­gal drug pop­u­lar­ly known as Ecsta­sy or Mol­ly. The MDMA-assist­ed ther­a­py was dra­mat­i­cal­ly effec­tive at reduc­ing PTSD symp­toms and improv­ing dai­ly func­tion­ing in the 42 treat­ed par­tic­i­pants, when com­pared with the 37 par­tic­i­pants who got psy­chother­a­py and a place­bo drug.

Two months after their last drug-assist­ed ses­sion, two-thirds of the MDMA-treat­ed patients no longer met the diag­no­sis for PTSD, com­pared with one third of those treat­ed with place­bos … The Nature authors spec­u­late that MDMA-assist­ed ses­sions pro­duce a “win­dow of tol­er­ance,” in which patients are able to revis­it trau­mat­ic mem­o­ries, with less shame and anger, and with­out being over­whelmed by PTSD symp­toms. The treat­ment worked equal­ly well for patients with his­to­ries of drug and alco­hol abuse.

The Study:

MDMA-assist­ed ther­a­py for severe PTSD: a ran­dom­ized, dou­ble-blind, place­bo-con­trolled phase 3 study (Nature Med­i­cine). From the Abstract:

  • Post-trau­mat­ic stress dis­or­der (PTSD) presents a major pub­lic health prob­lem for which cur­rent­ly avail­able treat­ments are mod­est­ly effec­tive. We report the find­ings of a ran­dom­ized, dou­ble-blind, place­bo-con­trolled, mul­ti-site phase 3 clin­i­cal tri­al (NCT03537014) to test the effi­ca­cy and safe­ty of 3,4‑methylenedioxymethamphetamine (MDMA)-assisted ther­a­py for the treat­ment of patients with severe PTSD, includ­ing those with com­mon comor­bidi­ties such as dis­so­ci­a­tion, depres­sion, a his­to­ry of alco­hol and sub­stance use dis­or­ders, and child­hood trau­ma. After psy­chi­atric med­ica­tion washout, par­tic­i­pants (n=90) were ran­dom­ized 1:1 to receive man­u­al­ized ther­a­py with MDMA or with place­bo, com­bined with three prepara­to­ry and nine inte­gra­tive ther­a­py ses­sions … These data indi­cate that, com­pared with man­u­al­ized ther­a­py with inac­tive place­bo, MDMA-assist­ed ther­a­py is high­ly effi­ca­cious in indi­vid­u­als with severe PTSD, and treat­ment is safe and well-tol­er­at­ed, even in those with comor­bidi­ties. We con­clude that MDMA-assist­ed ther­a­py rep­re­sents a poten­tial break­through treat­ment that mer­its expe­dit­ed clin­i­cal evaluation.

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