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Legal MDMA Therapy Could Be Just a Few Years Away

In a pilot study, 83 percent of subjects no longer met the criteria for PTSD following treatment with the drug.
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The trauma of war can rage on long after the fighting is over.

"Each patient of mine that died, I felt like their soul was wrapped around my body, constricting me like a snake," said James, a former Army medic who served in Afghanistan in 2011 and 2012 when he was still a teenager.

"After Afghanistan I had to sever the connection between my heart and head because a lot of fucked-up shit happens there," he recalled. "Once I came back I was very emotionally numb."


James, who asked that his last name be withheld due to the stigma surrounding psychedelic substances, said he eventually found relief from post traumatic stress disorder by way of MDMA-assisted psychotherapy. He started on that path by participating in a Phase 2 trial of the treatment three years ago. The sponsor of the study, the Multidisciplinary Association for Psychedelic Studies (MAPS), is currently waiting on a pair of final approvals from the FDA, expected this summer, to start Phase 3 trials and continue its decades-long march toward a legal therapy.

The group's goal is to receive prescription approval from the FDA by 2021.

So far, results have been promising. In a pilot MDMA study, 83 percent of subjects no longer met the criteria for PTSD following the treatment protocol. A long-term followup from one of the initial studies, administered 17 to 74 months following treatment, found that only two out of 19 subjects had relapsed, and none reported harm from their participation in the therapy.

For a year and a half after James returned to the United States, he said, he didn't even seek treatment. After all, he lacked the major physical wounds—missing arms or legs—haunting many of his fellow service members. But soon his symptoms became undeniable. "Every time fireworks went off, I saw mangled bodies," he told me. "And I had horrible anger episodes. I'd go from a neutral mood to just being fucking furious. I'd break anything around, punch holes in things. It got really bad."


The veteran sought various treatments through the military, including seeing psychologists, taking prescription medication, attending group therapy—he even tried a controversial cranial electrotherapy stimulation. But nothing worked, or helped for very long, until he discovered the MDMA trials. "It confronts you with who you are, the skeletons in your closet, makes you face them and work through them or at least be okay with it," he said. "It makes you look yourself in mirror and challenges you to be OK with who's looking back at you."

Dr. Will Van Derveer, a psychiatrist who helped administer the Phase 2 trials in Boulder, was skeptical when he first heard about MDMA-assisted therapy. But the more he learned, the more intrigued he was. "I'm interested in using the least amount of medication possible in getting people well," Derveer said. "Giving people drug three times only over the whole course of treatment is a lot less than when I use traditional pharmaceuticals that people end up taking for years and years. Those drugs tend to work like anesthesia, which is helpful for repressing symptoms but doesn't get to the bottom of the problem." During the trials, a team of therapists held about three-dozen total sessions with each patient. In three of the sessions, the subject was given an MDMA pill and laid on a couch with an eyeshade while the drug took effect. Other sessions focused on screening, preparation and integration of the experience into the patients' everyday lives.


During the treatment, James said, "it felt like love was coming out of every cell in my body. I hadn't felt relaxed for like two years at that point." He compared the therapy to a carnival game that consists of fishing ducks out of a pond. "Each one of those duckies going around was like a trauma," James said. "It was like I was picking them at random."

Although MDMA, technically known as 3,4-Methylenedioxymethamphetamine, was originally developed over a century ago, it went largely unused and unexplored until the 1970s. That's when psychiatrists began administering it to patients during couples therapies. But around the same time, the chemical started popping up in clubs as the main ingredient in ecstasy or molly. Once it gained a reputation as a party drug, the nation's drug warriors swept in and slapped MDMA with a Schedule I label under the Controlled Substances Act in 1985, classifying it as a drug of abuse with no medical value. Official research ground to a halt—at least until MAPS picked up the baton. A spokesperson for the FDA explained that while the agency cannot discuss specific drug trials, Schedule I substances can be the subject of clinical research under an Investigational New Drug Application and are held to the same standards as other drugs considered for FDA approval.

Of course, there's still a long way to go before this treatment is accessible to the general public. In the event the FDA does grant prescription approval, MDMA-assisted therapy would still be illegal as long as the chemical remains on Schedule I. However, any interested person or group could petition the DEA to reschedule it, at which point the agency might be compelled to conduct an investigation soliciting information from the FDA and other federal agencies. These medical and scientific evaluations are considered binding. FDA approval could therefore force the DEA to move MDMA down to at least Schedule II, which recognizes accepted medical use for a substance and permits doctors to prescribe it to patients.

From there, individual states would have to loosen their own restrictions on MDMA. Not to mention that insurance issues would have to be worked out, and professional guidelines clarified. (A spokesperson for the American Psychiatric Association said the group does not have a position on using MDMA to treat PTSD.)

Meanwhile, MAPS and other groups are looking into using MDMA—as well as psychedelics such as psilocybin and LSDas a treatment for other mental disorders, including anxiety, depression and addiction. If approval for PTSD treatment does move forward as hoped, it could open the door to an entire new wave of psychedelic-assisted therapies.

For some patients, the treatment has already made a world of difference. "It gave me my life back," James said. "I really mean that."

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