California-based researchers have completed the first phase-three clinical trial for any psychedelic-assisted therapy and found that MDMA-assisted therapy is more effective at treating PTSD than current methods.
While most typically think of MDMA as an illicit party drug, research into the psychoactive chemical and its potential for improving patient outcomes with different forms of the disorder has been ongoing for years.
MDMA remains a Schedule 1 drug in the US, which classifies it as having no discernible medical benefit, despite a 2017 FDA description as a “breakthrough therapy” for Post-Traumatic Stress Disorder.
In this recent phase-three trial, however, over three sessions, patients given MDMA during their therapy were 35% less likely to be later diagnosed with PTSD than those given placebo.
In addition, two months after the trial had concluded, 88% of participants in the MDMA-assisted therapy experienced a clinically significant drop in their symptoms, a 28% improvement on those who received just a placebo.
"Far from having no medical benefit, MDMA, when combined with talk therapy in this protocol, has the potential to catalyze the therapeutic process and generate positive mental health outcomes," says Rick Doblin, executive director of the Multidisciplinary Association for Psychedelic Studies (MAPS), which is running the trials.
The exact mechanism by which MDMA combines with therapy to achieve better outcomes remains unclear, though some have speculated it may increase a patient's tolerance when reflecting on their traumatic experiences, allowing them to delve deeper with limited negative consequences.
Previously, over a 12-month period during the phase-two clinical trials, 67% of patients who underwent two to three sessions of MDMA-assisted therapy no longer showed signs of PTSD, compared with just 23% of the control group.
In the phase-three trials, 90 participants with both severe and chronic PTSD were divided into two double-blinded groups, where one group was provided with three MDMA-assisted therapy sessions and the other received a placebo.
Researchers found "significant and robust attenuation of PTSD symptoms" over the course of the 18-week study.
"While many forms of PTSD therapy involve recalling previous trauma, the unique ability of MDMA to raise compassion and understanding while tamping down fear is likely what enables it to be so effective," says neurologist Jennifer Mitchell from the University of California, San Francisco.
The authors did not test MDMA-assisted therapy against other pharmaceutical interventions such as selective serotonin reuptake inhibitors (SSRIs), though these are known to have severe limitations in efficacy and wider suitability among diverse groups of PTSD patients.
Regardless, the authors remain optimistic that MDMA could soon be fast-tracked for FDA approval as soon as 2023.
The second half of the phase-three trial is already underway and will include an additional 50 patients, while the initial participants will be monitored as part of longer-term research.
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