The potential is growing for MDMA-assisted therapy, also known as ecstasy, to be approved for treating PTSD as more research finds success.
A phase 3 study evaluating the therapeutic effects of MDMA in patients diagnosed with post-traumatic stress disorder met two endpoints: reduced symptom severity and decreased functional impairment. The study was published Sept. 14 in Nature Medicine.
Researchers at MAPS Public Benefit Corp., a clinical company that tests psychedelics, enrolled 104 patients who, on average, have been diagnosed with moderate to severe PTSD for 16 years. The participants included combat veterans, survivors of sexual assault and others.
After 18 weeks of taking MDMA, 86 percent of participants experienced at least a 10-point reduction in CAPS-5 total severity score for PTSD. The placebo group recorded 69 percent for this measure. Also, about 70 percent of those who received the MDMA-assisted therapy no longer met DSM-5 diagnostic criteria for PTSD, compared to 47 percent of participants receiving the placebo and therapy.
The research is the second phase 3 study to find positive results between MDMA and quelled PTSD symptoms; the first was conducted by the same company and published in 2021.
Ninety-eight percent of participants experienced at least one adverse outcome during the latest study, and some reported cardiac issues, but none had a serious adverse event. Two study participants in the placebo group left the research because of treatment-emergent adverse events.
The most common side effects were muscle tightness, nausea, decreased appetite and excessive sweating. No MDMA abuse, misuse, physical dependence or diversion were reported. Four in five participants had a history of suicidal ideation, and many were diagnosed with depression and alcohol use disorder.
MAPS Public Benefit Corp. plans to submit the experimental therapy for FDA approval.