A new study published in the journal Psychopharmacology is presenting a comprehensive look at the long-term efficacy of MDMA-assisted psychotherapy for the treatment of post-traumatic stress disorder (PTSD). The study finds not only do the substantial beneficial effects of the therapy hold strong for well over a year after completing the treatment, but patients continue to improve as time passes following the few MDMA sessions.
After decades of prohibition and stigma, MDMA is finally on the precipice of becoming a clinically approved medicine. Currently deep in Phase 3 human trials for severe treatment-resistant PTSD, the therapy has proved so effective the U.S. Food and Drug Administration (FDA) recently approved it for Expanded Access, a program allowing certain patients access to the therapy before full market approval is granted.
While several studies have been published outlining positive Phase 2 trial results, this new paper investigates long-term outcomes from the treatment, compiling follow-up data from six prior trials. Around 100 subjects were included in the study.
At the original end-point of the trials, 56 percent of the cohort no longer met the clinical criteria for PTSD. The long-term follow-up data revealed continued improvements in most subjects for well over a year, with 67 percent of the cohort subsequently no longer meeting the PTSD criteria. Other long-term results noted in the cohort include reductions in suicidal thoughts and clinically significant symptom improvements.
"These long-term follow-up findings show that once people with PTSD learn that they can productively process traumatic memories instead of suppressing them, they can continue to heal themselves even after they have stopped receiving MDMA-assisted psychotherapy,” notes Rick Doblin, co-author on the new study.
It is important to note the MDMA-assisted psychotherapy treatments involve more than just a simple dose or two of the drug. The entire treatment process takes between eight and 12 weeks, encompassing two to three day-long MDMA psychotherapy sessions, each spaced around a month apart. Extensive preparatory therapy sessions are conducted before the MDMA treatments, and follow-up integrative therapy sessions are conducted in the days and weeks after the active drug sessions.
The new study also suggests the long-term follow-up data finds the treatment does not lead to MDMA abuse, or any other substance abuse, and no significant adverse effects are detected from the therapy. At the 12-month follow-up point it is noted around 94 percent of subjects did want to engage in additional MDMA-assisted psychotherapy sessions. While the researchers do acknowledge this desire may be underpinned by some subjects wanting to experience the pleasurable effects of MDMA, the study suggests the urge to complete additional treatments is more likely a result of the positive outcomes of the treatment.
“Although our Phase 3 trials are not yet completed, these long-term data support the hypothesis that MDMA-assisted psychotherapy may provide significant advantages in treatment outcomes, safety, and durability over available PTSD treatments,” says Berra Yazar-Klosinski, co-author on the new study. “This is the breakthrough that the world needs right now.”
Phase 3 clinical trials are currently underway at a number of sites in the United States, Canada and Israel. These trials are expected to run for 12 to 18 months, and FDA approval for the treatment should come sometime in 2022.
The new study was published in the journal Psychopharmacology.
Source: MAPS
