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FDA Approves Large-Scale Clinical Trial for Ecstasy

image: Wikimedia
image: Wikimedia

Ecstasy isn’t only for ravers—a small series of clinical trials have demonstrated taking MDMA can be an effective treatment for post-traumatic stress disorder. On Tuesday, the Food and Drug Administration granted permission for large-scale, Phase 3 clinical trials for MDMA, which is the next step in the process to get it approved as a prescription drug.

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While rolling on Molly might sound like fun and games to you, it changes lives. The New York Times spoke to C. J. Hardin, a veteran who served three tours in Iraq and Afghanistan, who suffered from severe PTSD that left him a divorced, suicidal alcoholic who cut himself off from the world. He tried psychotherapy, group therapy, and almost a dozen different psychiatric medications. “Nothing worked for me, so I put aside the idea that I could get better,” he said.

But in 2013, Hardin was lucky enough to join a small clinical trial studying MDMA as a PTSD treatment. “It changed my life. It allowed me to see my trauma without fear or hesitation and finally process things and move forward,” he told The New York Times.

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This is a huge step for the community fighting to legalize the medical use of drugs like MDMA, LSD and marijuana. The Multidisciplinary Association for Psychedelic Studies, a non-profit founded in 1985 to advocate for the medicinal benefits of these illicit substances, has funded six Phase 2 studies that treated 130 PTSD patients with the drug. It will also sponsor the Phase 3 clinical trials, which will consist of at least 230 patients.

A 2012 study conducted in Charleston treated veterans, victims of sexual assault, police officers and firefighters who had struggled with PTSD symptoms for an average of 17 years. None of the patients responded to traditional PTSD treatments. “After three doses of MDMA administered under a psychiatrist’s guidance, the patients reported a 56 percent decrease of severity of symptoms on average,” The New York Times reported.

When the study ended, two-thirds of participants didn’t even meet the criteria for having PTSD. “On average, subjects maintained statistically and clinically-significant gains in symptom relief, although two of these subjects did relapse,” the study said.

Doctors have legitimate concerns when it comes to using MDMA as a prescription drug—after all, there’s a high risk for abuse, and in an era of rampant prescription opioid addiction, that’s scary.

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So how does MDMA treat PTSD? Throughout a 12-week PTSD study, patients went through extensive psychotherapy, which involved three 8-hour MDMA sessions. In these sessions, psychiatric nurse Ann Mithoefer and her husband, Dr. Mithoefer, guided each patient through his or her past traumas, playing soothing music. The Mithoefer’s terrier mix Flynn often kept patients company throughout their journey.

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“The medicine allows them to look at things from a different place and reclassify them. Honestly, we don’t have to do much. Each person has an innate ability to heal. We just create the right conditions,” Ann Mithoefer said.

The New York Times reports there’s also been research which shows that MDMA triggers “the brain to release a flood of hormones and neurotransmitters that evoke feelings of trust, love and well-being, while also muting fear and negative emotional memories that can be overpowering in patients with post-traumatic stress disorder.”

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There are currently two drugs on the market approved to treat PTSD, both of which barely worked better than the placebo in trials. Edward Thompson, a firefighter traumatized by the frequent gory tragedies he responded to at work turned to benzos, alcohol and opioids to escape the persistent state of utter panic he felt trapped in. After taking MDMA in a clinical trial, Thompson was much better able to manage his PTSD and kick his drug addiction. He explained, “It gave me my life back, but it wasn’t a party drug. It was a lot of work.”

A promising step forward for our nation’s veterans who suffer in silence.

[NYT]

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Eve Peyser was the night editor at Gizmodo.

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DISCUSSION

geekymitch
geekymitch

Point of order: you mention in the article the tendency for MDMA to be abused...and I’d like to point out a couple factoids.

1. You cannot OD on MDMA. It is not possible. While it does raise your core body temp, people that have “died” from ecstasy died in one of two ways - not peeing enough (MDMA kinda kills the urge to pee, and you are probably drinking lots of water because of hearing about the other way people day), or via dehydration. People who die in clubs while rolling do so because they’re partying in a hot environment, not drinking enough, their body temp spikes, and they’re toasted.

2. While you can certainly abuse MDMA, you get a pretty hard decrease on return of investment after awhile. MDMA makes you feel good because it releases your body’s natural stash of serotonin. Once it’s gone, it’s gone until some time goes by. You can take supplements to hurry it up a bit, but it still is just going to take time. If I roll for 12 hours and pop another pill, my roll isn’t going to keep going: I’m tapped out. Makes it very hard to abuse in any real meaningful way when a true “drug use” dose can only be handled once a week or so, at most.

3. As someone who dabbled in drugs, I have to say, MDMA did help me put some things together. It really does unlock your ability to be reflective...not so much while rolling but in the 24-48 hours afterwards. The last time I rolled was shortly after my separation, and the insight I was able to gather in those couple of days was absolutely invaluable. Not PTSD treatment level, but still something I was fortunate to experience.