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MAPS Granted Historic Approval to Conduct Phase-3 Trials for MDMA-Assisted Therapy

It seems the day when MDMA (ecstasy) gets widely regarded as a valuable therapeutic tool for the treatment of serious psychological problems, instead of an illegal party drug, is now closer at hand. Last week MAPS –the Multidisciplinary Association for Psychedelic Studies– issued a press release announcing they had reached an agreement with the FDA to grant MDMA the designation of ‘Breakthrough Therapy’, and are now ready to design two Phase 3 trials of MDMA-assisted psychotherapy for patients with severe PTSD (post-traumatic stress disorder).

These new trials will be conducted next year, as a follow-up to a previously completed Phase 2 trial in which 107 subjects participated. After three sessions of MDMA-assisted psychotherapy, 61% no longer qualified for PTSD, and at a 12-month follow up, 68% of the subjects were found completely cured of PTSD. Now let those figures sink in for a moment: Patients who had been suffering from extremely-deteriorating stress symptoms FOR DECADES, who had resorted to all sorts of prescription pills to counter the symptoms, and countless hours of traditional psychotherapy to no avail, were cured forever of their fears and phobias after taking MDMA three times.

“Reaching agreement with FDA on the design of our Phase 3 program and having the ability to work closely with the agency has been a major priority for our team,” said Amy Emerson, Executive Director of the MAPS Public Benefit Corporation (MPBC). “Our Phase 2 data was extremely promising with a large effect size, and we are ready to move forward quickly. With breakthrough designation, we can now move even more efficiently through the development process in collaboration with the FDA to complete Phase 3.”

The FDA’s unusual openness to acknowledge the huge therapeutic potential of what is still considered a Schedule I drug in most countries, is sadly the result of the continuous belic conflicts in the Middle East for the last 16 years. With hundreds of veterans returning home from Iraq and Afghanistan suffering from the brunt of traumatic experiences and unable to successfully reintegrate to civilian life, there’s a big political push to try unorthodox methods to help all these young men and women who served their country. All this is mentioned on an article published on the Washington Post on the same day MAPS issued its press release.

This is not only great news for people currently suffering from PTSD or other issues which have proven too resilient for traditional therapies, but also a major victory for MAPS and its founder, Rick Doblin; a man who has been fighting for the legitimacy of psychedelic treatments for 45 years. Over at Narratively there’s a great article delving into Rick’s career, which talks about how his conviction that psychedelics have the potential to cure some of the world’s deepest ills, has pushed him to go through all the legal red tape and stigma these substances have been carrying since the 1960’s, conducting scientific studies and publishing papers in reputable journals, so that one day the Western world will finally makes its peace with entheogens, and openly regard them the same way our ancestors did for thousands of years: As a gift of the gods to mankind.

Rick Doblin at Burning Man, accompanied by author Daniel Pinchbeck to the left, and psychedelic artist Alex Grey to the right.


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