"MDMA-assisted therapy for PTSD is on track to be considered for approval by the FDA in 2024," says MAPS founder and president Rick Doblin.
71 percent of people who received the psychedelic drug with therapy were healed of post-traumatic stress disorder, compared with 48 percent of those cured who underwent therapy with a placebo.
The second phase-3 trial of MDMA-assisted therapy for PTSD produced similar results to the first trial, which found 67 percent participants receiving the combination of MDMA and therapy no longer qualified for a PTSD diagnosis, compared to 32 percent who underwent the same therapy with a placebo.
104 participants diagnosed with moderate to severe PTSD were randomly selected to receive either MDMA or a placebo after three preparation sessions with a two-person therapy team, including at least one licensed therapist. Then, the treatment consisted of three 8-hour therapeutic dosing sessions, spaced approximately 1 month apart. Neither the clinician nor the participants were told which medication they were being given.
Of the 53 participants who received MDMA, 86.5 percent responded with what study authors describe as “a clinically meaningful improvement” in their condition 18 weeks into the trial.
According to Rick Doblin, the founder and president of the Multidisciplinary Association for Psychedelic Studies (MAPS), the results put the illegal Schedule 1 drug on track to possibly be approved by the FDA as early as next year.
“Thanks to the combined efforts of dozens of therapists, hundreds of participants who volunteered in MAPS-sponsored trials, and many thousands of generous donors, MDMA-assisted therapy for PTSD is on track to be considered for approval by the FDA in 2024,” he said in a statement today. “We hope that MDMA-assisted therapy for PTSD will be approved by the FDA next year — and that our Open Science, Open Books will inspire researchers to make this just the the first of many psychedelic-assisted therapies to be validated through diligent research.”
Because the federal agency had already designated MDMA as a “breakthrough therapy” for the disorder that causes daily suffering and can lead to suicide, MAPS' application for approval will be evaluated more quickly, potentially ending a decades-long ban on the psychedelic substance in the United States, and allowing researches to seek federal funding for larger clinical trials.
Payton Nyquvest, co-founder and CEO of Numinus — a psychedelic medicine company that supports MAPS research — told Psychedelic Spotlight that the study “represents a significant milestone not just for the healthcare and psychedelic industries, but also for humanity as a whole.”
“These positive Phase 3 results represent a genuine and promising leap toward formally acknowledging this treatment and providing universal access,” he continued. “It goes without saying that the industry tips its hat to Rick Doblin and the entire MAPS team.”
According to research published in the Annals of General Psychiatry, MDMA makes it easier for patients to work through traumatic events during psychotherapy because the drug decreases defensiveness and anxiety, increases relaxation, improves mood, and can increase insight and memory.
“Not only is MDMA-assisted therapy efficacious in individuals with severe PTSD, but it may also provide improved patient safety,” researchers concluded in 2020. “Compared with current first-line pharmacological and behavioral therapies, MDMA-assisted therapy has the potential to dramatically transform treatment for PTSD and should be expeditiously evaluated for clinical use.”