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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.
If this proves to be a success, then this treatment will definitely be something to rave about.
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Here's the ruling
here is the story
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
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..... '
What is a "gateway drug"? You know why "gateway drugs" are leading to other drugs? Because the only way to get them is at some dealer who wants to sell you stuff that has a bigger cut for him.
MDMA a gateway drug for Heroin. Yeeeah, that makes sense. "Hey, I had this one drug that was allowing me to dance all night and party, why not try something now that makes me extremely drowsy and apathetic, that's exactly what I want."
C'mon. At least make some credible claims. I smoked some MJ and I even had a few Es back when they were still made of good stuff, but why the fuck would I have wanted to shoot some junk into my veins?
If you want to look for "gateways" to heroin, look at society. Society is what pushes people into the arms of drugs like heroin that promise an exit from this world.
We used to have a Bill of Rights. Now, with the rights gone, all we have left is the bill.
Just chase your mom back to her room and you'll be fine.
We used to have a Bill of Rights. Now, with the rights gone, all we have left is the bill.
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.
Myself and others who actually suffer from PTSD (In my case CPTSD) are always looking for a way out. It's a disorder caused by experiencing severe trauma- in my case the traumatic experience went for a period of 15 years as a kid. Child abuse victims and those who were abused as POWs are the ones who suffer the most from this disease. But remember this disease is caused by traumatic things happening around you, or worse, traumatic things done to you.
This is a disease that is inflicted on it's victims both others.
You never really get out of the PTSD symptoms... flashbacks keep repeating. Your current day relationships are held hostage to your condition. In some cases (like mine) it's accompanied by a sleep disorder. And the combination of flashbacks and lack of sleep can lead to psychosis. As you age you become unable to "tough it out" by staying up for a couple of days. So working becomes difficult or impossible. I used to be an IT executive.
Sure there are treatments like "Eye Movement Desensitization and Reprogramming". And they help a little. Or you can drug yourself out. Or just do the best you can and hope your loved ones are willing to keep you in food and housing. As a non veteran my chances at disability through Social Security are zero.
The only drug that has ever worked for me to totally eradicate the symptoms- are narcotics. If I can legally obtain them for another legitimate issue then I get to be normal for a few days, or a week. Norco and Hydrocodone seem to work the best.
So if someone told me I could get my PTSD treated at a pain clinic with narcotics- under doctors supervision I'd be there in a second. The hell I go through is shattering.
So- this new treatment is making me so happy. I want to get in on the trial... or try the therapy as soon as possible.
If you have a heart for people who are truly suffering. Please support these trials and be supportive of the idea. You'll be helping a lot of people.
Another consultant who stuck it out.
"We are the Priests, of the Temples of Syrinx..."
From the summary (no, I didn't read the article): "Currently, the best of those established treatment options can only improve symptoms in 60 to 70 percent of patients" and " the drug had completely erased all traces of symptoms in two-thirds of PTSD patients." To me, the 60 to 70 percent sounds very close to the two-thirds of patients (roughly 66.667%). So, this is better how?
Re-read what you wrote, and consider the difference between "improve symptoms" and "completely erase symptoms." IT's the difference between improvement and elimination.
The shepherds did so well protecting the flock that the sheep no longer believed that wolves existed.
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.
Best Slashdot Co
...going on a drug trip is the cure? Might as well just get drunk, it's cheaper.
Liver cancer and alcoholism is cheaper? Please, do tell. Oh wait, let me get my boots on. I have a feeling the flow of bullshit is going to be rather high.
Dammit, I know I put my chest waders around here somewhere...
So is milk.
Huh?
Use of milk leads to interest in breasts?
Why'd I want to switch from K to H?
Heroin is most of all a "get me out of here, no matter the cost" drug. I do not know a SINGLE person who reached for Heroin who wasn't already at the "I don't give a fuck about my life anymore" stage. It's not like people don't know what heroin does to them. You pretty much cannot NOT know what it really means to shoot that crap into your body. The problem is that people fully KNOW what's going on, and they STILL do it.
If you want proof for that, take a look at the drug Crocodile (Desomorphin). Do NOT Google it. Seriously. Do not. The pictures you'll see will stay with you for the rest of your life. That crap makes your body rot. Literally. You rot away alive. And people know that and STILL do it.
If you can keep people from getting to the point where they don't give a fuck about their life anymore, there simply is no longer a market for heroin. Or worse shit.
We used to have a Bill of Rights. Now, with the rights gone, all we have left is the bill.