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FDA Approves Large Clinical Trial For Ecstasy As Relief For PTSD Patients (arstechnica.com)
An anonymous reader quotes a report from Ars Technica: The Food and Drug Administration on Tuesday approved the first large-scale, phase 3 clinical trial of ecstasy in patients suffering from post-traumatic stress disorder (PTSD), the New York Times reported. The regulatory green-light follows six smaller-scale trials that showed remarkable success using the drug. In fact, some of the 130 PTSD patients involved in those trials say ecstasy -- or 3,4-Methylenedioxymethamphetamine (MDMA) -- saved them from the devastating impacts of PTSD after more than a decade of seeing no improvement with the other treatment options available. Currently, the best of those established treatment options can only improve symptoms in 60 to 70 percent of PTSD patients, one expert noted. However, after one of the early MDMA studies, the drug had completely erased all traces of symptoms in two-thirds of PTSD patients. The new Phase 3 trial will involve at least 230 patients and is planned to start in 2017. Like the other trials, it is backed by the Multidisciplinary Association for Psychedelic Studies (MAPS), a nonprofit created in 1985 to advocate for the medical benefits and use of psychedelic drugs, such as MDMA and marijuana. Also like the others, the new, larger trial will involve a limited number of MDMA treatments administered by professional psychotherapists as part of a therapy program. In previous trials, patients spent 12 weeks in a psychotherapy program, including three eight-hour sessions in which they took MDMA and talked through traumatic memories.
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I don't know the process here between FDA and DEA, which has which ultimate powers regarding final say on drug scheduling, but I have a feeling the drug is going to be rescheduled by the FDA (it is a "good," drug, a miracle drug, and the benefits to patients far outweighs the damage to those who abuse drugs), and then something fishy will happen at the DEA, and someone will overstep their authority, just like last time, and it will again be decided in court who gets their way, the nanny-staters and asshole control freaks or the doctors, scientists, and patients that need the drug.
The Admin and the Engineer
The cure for a LOT of things is essentially 'a drug trip'.
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To clarify what catmistake means by "just like last time": MDMA was a psychotherapy drug used for, among other things, PTSD. That's how it got its start, before breaking out into the recreational scene. When the FDA considered banning it, there was a court hearing on the topic, which turned into a constant stream of psychiatrists stepping up and saying, "Don't do this!". The FDA at the time was unaware that it was used in psychotherapy. The judge ruled that it should be classed as a Schedule III drug, aka something with an established medical use but also the potential for abuse. However, the DEA administrator overrode him and classified it as a Schedule I drug. The DEA was sued by a Harvard psychiatrist for misclassification, and he won; the court stripped the DEA's Schedule I classification. The DEA responded by simply reclassifying it yet again as Schedule I.
The scheduling has made research difficult over the years, but the widespread attestment to its effectiveness is compelling. Research in other regards has shown that the act of recalling a memory also involves, to some degree, writing it back; there's been treatment researched for trauma wherein the patient recalls memories while on drugs that induce mild amnesia. I wouldn't be surprised if something similar is at work here.
People said I was dumb, but I proved them.
MDMA is a gateway drug, and we shouldn't be risking addiction by patients who already have mental health issues.
While we thank the DEA for their view on this sensitive matter; And no doubt you have similar views on Morphine. Sadly your 'ain't gonna have no hippie scientists givin' kids drugs' attitude belies the fact you clearly have no concept of how utterly devastating a life crippled with PTSD can be.
You and your ilk are basically everything that's wrong with knee-jerk legislators across the western world.
'I don't understand science, but this could look bad in the news papers, therefore I must ban it...... speaking as a parent..... '
Given that the FDA's purpose is to approve drugs for their therapeutic value, why don't they have the ability to overrule the DEA? Why does the DEA have the authority to block access to drugs with a compelling case for therapeutic value to the extent that you can't even perform research to prove their therapeutic value?
I mean, I can't escape the (only slightly) tinfoil hat explanation that they do it to perpetuate and expand their power and ensure they have a near immutable list of banned substances to justify their power and budget. And of course they hang onto marijuana as schedule I because it provides the vast bulk of "illegal" drug use, and complete legalization might usher into public consciousness the idea that the entire premise of the DEA is suspect.
It seems highly likely that most drugs with a recreational potential are likely to have some kind of therapeutic use as well. I guess we're just fortunate that opiates, amphetamines and tranquilizers had a long and mostly irrefutable clinical history of therapeutic value before the DEA existed or they would have long ago scheduled them away.
A single dose of magic mushrooms can make people with severe anxiety and depression better for months, according to a landmark pair of new studies.
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Are you fucking kidding me? Ecstacy? Everyone freaks out about weed being legalized. But, the FDA says, "Hey guys, try out ecstacy for your mental issues!". Wow, what an ass backwards fucking world we live in here in the US of A.
I think it's interesting the two drugs that are legal - alcohol and cigarettes, two drugs that do absolutely nothing for you at all - are legal, and the drugs that might open your mind up to realise how you're being fucked every day of your life? Those drugs are against the law. Coincidence?
- Bill Hicks
"What the American public doesn't know is what makes them the American public." -Ray Zalinsky (Tommy Boy)
I too suffer from CPTSD or as it is known by the WHO ICD-10 F62.0 (Enduring personality change after catastrophic
experience.) I was sexually and physically abused by my primary school principal when I was 10 (the perpetrator was criminally charged). Life is hell for me. Normal social interactions, trust in people and institutions, holding down jobs, participating in education, and keeping sane relationships is near impossible. I am constantly on my own suicide watch. I found a niche for myself being a lone cowboy coder. It allows me to manage my time and reduce my social exposure, though it is still extremely difficult to survive economically, the coding world is much more collabrative than it once was which makes it harder for me to participate. I pick up small contracts here and there, I am lucky my wife understands the illness and helps me but it is not easy for her I know (I am lucky to have a wife). Being a basement geek is a refuge for PTSD sufferers. Just talking with people on the phone is stressful, in fact I never pick up a ringing phone. I manage to message my way through life. I am looking at a life time of anti-depressants and psycho-therapy just to cope. If MDMA is doing what they say it can do it could be a shining light. So as OP mentioned, support the trials. This is not about recreation, this is about controlled relief and a possible cure from a debilitating illness.