The US Food and Drug Administration (FDA) has given the green light to phase three trials of MDMA to treat post-traumatic stress disorder, the final phase of validation required to turn the party drug into a legal medicine.
The treatment involves giving patients the drug just three times – once a month – during long talking therapy sessions, interspersed with weekly sessions without the drug. Early trials of the drug, currently listed as a schedule 1 substance by the Drug Enforcement Administration along with heroin and LSD, have shown encouraging results for patients with treatment-resistant PTSD.
“Moving from phase two to phase three shows we have strong scientific reason to believe that MDMA is an effective treatment for PTSD in therapy. The fact the FDA is ready to move forward with phase three signals that they agree,” said Brad Burge, from the Multidisciplinary Association for Psychedelic Studies (Maps), a not-for-profit based in Santa Cruz, California, that has spearheaded efforts to turn MDMA into a medicine.
If the trials go well, MDMA could be legalized as soon as 2021, providing a novel way to treat those battling with PTSD, a debilitating mental condition that can be caused by witnessing or experiencing a life-threatening event.