MDMA Approved for Final Stage of Clinical Trials

People suffering from post-traumatic stress disorder (PTSD) could soon be prescribed MDMA, commonly referred to as ecstasy or molly, to help ease the debilitating symptoms of this severe anxiety disorder.

A report from the New York Times indicates that the U.S. Food and Drug Administration has approved the drug for clinical trials in an effort to study its effects on patients struggling with PTSD. The latest phase of research, which is being funded by the Multidisciplinary Association of Psychedelic Studies (MAPS), will involve more than 200 patients—mostly veterans, sexual assault victims and others living with the disorder.

Phase 3 clinical trials—the final step before the FDA considers the drug for market—comes after MDMA was shown successful in calming the intensity of PTSD in preliminary studies. If the latest study provides similar results, it is distinctly possible that a wide variety of patients living with this disorder could be using MDMA therapeutically within the next five years.

Some of the patients who were involved in MAPS’ previous studies of the drug say it is more effective than standard therapies.

“One of the first things I said when it kicked in was ‘this is what I’ve been looking for,'” Tony Macie, an Iraqi War veteran, said in a video. “I reconnected with myself and did a lot of internal work, and afterwards, it was like a huge weight was lifted off my shoulders.”

The latest statistics show 83 percent of the participants in the MDMA trials thus far no longer seem to suffer from PTSD after completing two months of treatment. MAPS says the results became more permanent when the patient followed through with a long-term mental health plan, including outpatient check ups with a psychotherapist.

Although it is still too early to tell whether MDMA will land on the shelves of pharmacies all across the nation in the near future, researchers are so far encouraged by their work.

“We can sometimes see this kind of remarkable improvement in traditional psychotherapy, but it can take years, if it happens at all,” researcher Michael Mithoefer told the Times. “We think it works as a catalyst that speeds the natural healing process.”

The latest research is scheduled to begin in 2017, and it is expected to take up to five years to complete. It will then be up to the FDA to determine whether MDMA is safe and effective medicine.

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from
http://hightimes.com/news/mdma-approved-for-final-stage-of-clinical-trials/