Phase 3 MDMA trial finds huge potential for treating severe PTSD

Brittany A. Roston - May 11, 2021, 7:10pm CDT
Phase 3 MDMA trial finds huge potential for treating severe PTSD

The Multidisciplinary Association for Psychedelic Studies (MAPS) has announced the results of a Phase 3 trial involving MDMA-assisted therapy for people suffering from chronic and severe PTSD. The results were ‘highly statistically significant,’ according to MAPS, which reports that 67-percent of the participants who underwent three of these MDMA-assisted therapy sessions saw enough improvement that they no longer met the requirements for a PTSD diagnosis.

MDMA is a psychoactive compound commonly acquired as part of a drug called ecstasy. This drug remains a Schedule I substance in the US, meaning it has ‘no currently accepted medical use and a high potential for abuse.’ A growing body of research is challenging this label, however, with MAPS driving the research that may lead to a change in the way this compound is scheduled.

The newly announced results are the first from MAPS’ Phase 3 trial of therapy assisted by MDMA specifically targeted at people suffering from posttraumatic stress disorder. According to the organization, the trial both replicated and expanded upon the results from the Phase 2 trial, underscoring that MDMA-assisted therapy may prove to be a rapid and effective way to treat PTSD.

The trial involved having the participant take MDMA or a placebo and undergo therapy for PTSD. Whereas 32-percent of the placebo group no longer qualified for a PTSD diagnosis after three sessions, the figure jumped substantially to 67-percent among those who received MDMA instead of the placebo.

The benefits were particularly observed among people who suffered from a subtype of PTSD involving dissociation; they benefited more from the MDMA-assisted therapy compared to those who did not have the dissociative subtype. The benefits may be due, in part, to putting the patient into a mental state in which their fear is reduced and their sense of understanding and compassion is increased.

Beyond this, the Phase 3 trial found no major tolerance or safety issues with the participants who were given MDMA. These participants did not experience an increase in heart risk, abuse potential, or suicidal behaviors and thoughts. Temporary side effects were observed, however, including a decrease in appetite, feeling cold, nausea, sweating, and muscle tightness.


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