The MAPP2 study is the second randomized, double-blind, placebo-controlled study to demonstrate the safety and efficacy of MDMA-assisted therapy for PTSD.
The investigators confirm results of the MAPP1 study, which were published in Nature Medicine. Patients who received MDMA-assisted psychotherapy in MAPP1 demonstrated greater improvement in PTSD symptoms, mood, and empathy, compared with participants who received psychotherapy with placebo.
The design of the MAPP2 study was similar to that of MAPP1, and its results were similar, the nonprofit Multidisciplinary Association for Psychedelic Studies (MAPS), which sponsored MAPP1 and MAPP2, said in a news release.
No specific results from MAPP2 were provided at this time. The full data from MAPP2 are expected to be published in a peer-reviewed journal later this year, and a new drug application to the U.S. Food and Drug Administration will follow.
The FDA granted breakthrough therapy designation to MDMA as an adjunct to psychotherapy for adults with PTSD in 2017.
MAPS was founded in 1986 to fund and facilitate research into the potential of psychedelic-assisted therapies; to educate the public about psychedelics for medical, social, and spiritual use; and to advocate for drug policy reform.
“When I first articulated a plan to legitimize a psychedelic-assisted therapy through FDA approval, many people said it was impossible,” Rick Doblin, PhD, founder and executive director of MAPS, said in the news release.
“Thirty-seven years later, we are on the precipice of bringing a novel therapy to the millions of Americans living with PTSD who haven’t found relief through current treatments,” said Dr. Doblin.
“The impossible became possible through the bravery of clinical trial participants, the compassion of mental health practitioners, and the generosity of thousands of donors. Today, we can imagine that MDMA-assisted therapy for PTSD may soon be available and accessible to all who could benefit,” Dr. Doblin added.
According to MAPS, phase 2 trials are being planned or conducted regarding the efficacy of MDMA-assisted therapies for substance use disorder and eating disorders, as well as couples therapy and group therapy among veterans.
Currently, no psychedelic-assisted therapy has been approved by the FDA or other regulatory authorities.
A version of this article first appeared on Medscape.com.