STUDY: PSYCHEDELIC DRUG EASES PTSD SYMPTOMS
MDMA-assisted therapy seems to be effective in reducing symptoms of post-traumatic stress disorder, according to a study published Thursday.
The research is the final trial conducted by MAPS Public Benefit Corp., a company that is developing prescription psychedelics. It plans to submit the results to the Food and Drug Administration as part of an application for approval to market MDMA, the psychedelic drug, as a treatment for PTSD, when paired with talk therapy.
If approved, “MDMA-assisted therapy would be the first novel treatment for PTSD in over two decades,” said Berra Yazar-Klosinski, the senior author of the study, which was published in Nature Medicine, and the chief scientific officer at the company. “PTSD patients can feel some hope.”
PTSD affects about 5 percent of the adult population of the United States each year. But conventional therapies and medications only help, at best, around 50 percent of patients.
MDMA, also known as Ecstasy or Molly, has been an illegal substance since 1985. Before that, MDMA was administered by an estimated hundreds of therapists for couples counseling, personal growth and to address trauma.
The 104 participants in the study had been diagnosed with moderate to severe PTSD and had lived with the condition for an average of 16 years.
Each participant worked with a two-person therapy team and received three 90minute preparatory, talk therapy sessions followed by three treatment cycles, spaced one month apart. Each consisted of an eighthour experimental session in which the participant took either MDMA or a placebo paired with talk therapy and then attended three 90-minute talk therapy sessions.
During the experimental sessions, 53 participants were given MDMA and 51 were given an inactive placebo. Neither the therapists nor the participants were informed which patients had received the MDMA.
By the end of the study, 86.5 percent of people in the MDMA group achieved a measurable reduction in severity of symptoms, researchers reported. About 71 percent in the MDMA group improved enough that they no longer met the criteria for a PTSD diagnosis. Of those who took the placebo, 69 percent improved and nearly 48 percent no longer qualified for a PTSD diagnosis.
MAPS PBC plans to submit a new drug application to the FDA seeking approval for MDMA-assisted therapy. The agency, which does not comment on pending drug reviews, could reach a decision within a year.