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FDA Designates MDMA As 'Breakthrough Therapy' For PTSD (futurism.com)
In what could lead to a faster path to pharmaceutical approval, the U.S. Food and Drug Administration (FDA) has designated methylenedioxymethamphetamine (MDMA) as a "breakthrough therapy" in the treatment of post-traumatic stress disorder (PTSD). Futurism reports: The Multidisciplinary Association for Psychedelic Studies (MAPS) announced the FDA's ruling last week, revealing that they can now move forward on two of their upcoming "Phase 3" trials. The goal of these trials is to determine how effectively the drug can be used to treat those suffering from PTSD. The trials will include 200 to 300 participants, and the first trial will begin to accept subjects in 2018. The trials will be held in the U.S., Canada, and Israel, and MAPS plans to open talks with the European Medicines Agency in the hopes of expanding testing to include Europe. For now, the focus is on securing the funding they require. According to Science, the organization is still in the process of raising money for the trials, and thus far, they've only managed to secure $13 million, about half of their goal.
Previous MAPS trials exploring how well MDMA could treat PTSD have yielded favorable results, contributing to the FDA's aforementioned decision. In the association's Phase 2 trails, 107 people who had PTSD for an average of 17.8 years were treated using MDMA-assisted psychotherapy. After two months, 61 percent of the participants no longer suffered from PTSD. After a year, that number increased to 68 percent, according to the MAPS press release.
Previous MAPS trials exploring how well MDMA could treat PTSD have yielded favorable results, contributing to the FDA's aforementioned decision. In the association's Phase 2 trails, 107 people who had PTSD for an average of 17.8 years were treated using MDMA-assisted psychotherapy. After two months, 61 percent of the participants no longer suffered from PTSD. After a year, that number increased to 68 percent, according to the MAPS press release.
As nonclinical studies have shown...
Then again, who'd want people to not be depressed and compensate by buying shit?
We used to have a Bill of Rights. Now, with the rights gone, all we have left is the bill.
When did Shulgin first synthesise this? Wasn't there a huge push at the time to use it for therapy, before the government scheduled and stomped on it with a 'no possible medical use' bullshit?
Thanks, war on drugs pricks, for condemning tens of thousands of people to decades of suffering.
Now this is something I would sign-up for! Some good MDMA mixed with a dash of acid and a bit of Goa trance music... shaken, not stirred. Nothing better!!!
Saul Goodman..
Side effects include getting into trance music, edm and attending raves. ðY
So you might consider this treatment something akin to shock treatment or lobotomies. It could probably treat all sorts of fear syndromes. I wonder how well it might be able to treat epilepsy or bipolar disorder or even anxiety.
We are scientists and engineers and should know better than post links to websites. ;)
Why should I trust MAPS instead of getting an actual FDA release? I couldn't confirm this myself on the FDA website.
I don't know these people and they seem to have a vested interest in promoting this stuff, so it may be a bit overhyped.
Let me know when Pfizer and Merck are looking into it
"In the association’s Phase 2 trails, 107 people who had PTSD for an average of 17.8 years were treated using MDMA-assisted psychotherapy. After two months, 61 percent of the participants no longer suffered from PTSD. After a year, that number increased to 68 percent, according to the MAPS press release."
cease fire stand down,,, sing along.. https://www.youtube.com/watch?v=H-kA3UtBj4M ..own worst enemy clause applies..
this is not science; we have no firm idea how "disease" or drug works, but let us try it anyway to see whether it will work.
this is like old traditional medicine. you have diseases, and you have cures, tried and tested to work in most cases, throughout hundreds of years. explanations for sickness and its cure are usually bogus speculations, about humors, energy balance, etc
it is not science.
but it works, in most cases. so should be allowed . but it can be a slippery road.
You'll notice that every medicament that actually DOES work and where it's pretty much impossible to find something better gets outlawed, curiously around the same time the patent expires?
But I'm sure it's mere coincidence that we find out what horrible, horrible side effects they might have just around that time.
Wtf is a "medicament"?
Is called placebo, with a wonderful drug.
Is the drug able to be patented to guarantee billions in Big Pharma profits?
Is the drug addictive to guarantee endless repeat customers?
Is the drug deadly enough to guarantee benefits to population control?
No?
Forget it. Won't ever be approved.
We now return to our regularly scheduled programming of Opium! Opium! Opium!
Your showing your age Grandpa. It's not called Ecstasy anymore, it's Molly.
Some people clearly know a little more about the subject than yourself and they've used evidence to make a well-reasoned proposal that medical professionals have been more than happy to support. Given that some people have PTSD at one point in their lives and then eventually manage to no longer have PTSD I'd hazard a guess that it can be cured. Sure, your opinion might be important to you, but the rest of us would prefer to leave these subjects to people who know something about it.
says no such thing. In WIKI it says that sideeffects need further study. Then again - memory impairment means you forget about stuff that made you sick right? If that could work with mother of my kids I would buy this shit immediately.
looooooooooooooooooool
>Your comment violated the "postercomment" compression filter. Try less whitespace and/or less repetition.
Thing you can do is go out clubbing.
Show me another placebo with 60+% efficacy in a double blind trial and get back to me.
Herm back in the day it was called e
ecstasy, but it was usually mixed with something usually meth... Molly from my understanding is very pure MDMA
Nightclubs are full of people with PTSD.
Your showing your age Grandpa.
It's not called Ecstasy anymore, it's Molly.
Which kind of Molly are you supposed to use? I swallowed a dozen sailfin Molly and didn't feel anything except disgust and regret.
"That's the way to do it" - Punch
Cinnamon Toast Crunch.
"For now, the focus is on securing the funding they require. According to Science, the organization is still in the process of raising money for the trials, and thus far, they've only managed to secure $13 million, about half of their goal. "
If only there was some way that people with access to pure, recreational drugs could make some money
Show me another placebo with 60+% efficacy in a double blind trial and get back to me.
The success rate for placebo depends on the symptoms and diagnosis. It's not common, but neither unheard of to have symptoms where placebo has a higher than 60% improvement rate. Band-Aids on children is the prime example (and doubly relevant because it's a placebo in both meanings of the word), where placing a band-aid on an inconsequential cut or bruise brings immediate relief.
As for double blind trials, "Waber RL, Shiv B, Carmon Z, Ariely D. Commercial features of placebo and therapeutic efficacy. JAMA. 2008 Mar 5; 299(9):1016-7" from MIT shows an 85% pain reduction for headaches in people who took an expensive placebo (but less when it was priced lower).
This is going to be a huge conundrum for conservatives. How will they reconcile this? A face off between their war on drugs and treating the damage of their nation building exercises. Oops not nation building, the war on terror.
I am ecstatic about this.
Take it to the limit, everybody to the limit, come on, everybody fhqwhgads.
And was recommended by FDA. Then reagan got into office and they declared that it had no use. Figures. There was very little done right by reagans admin
I prefer the "u" in honour as it seems to be missing these days.
We now return to our regularly scheduled programming of Opium! Opium! Opium!
We've rebranded the commercially available prescription version of tihs Opiod.
Opiod! Opiod! Opiod!
Addcitive, and we'll milk you and your insurance company for every cent before pushing you out of the system and sending you to your local heroin dealer, then judge you a worthless loser and criminal, and incarcerate you in one of our for-profit prisons.
Win-win for the 0.1% and their cronies. Oh, it destroyed your life and your community? Doesn't matter, you're just "little people."
Way back in my day, before both of your days, it was called MDA. And street drugs are fairly unreliable when it comes to purity, even if it's called molly.
Molly usually means MDMA in crystal/powder form, ecstasy in pill form.
Pills contain inactive binders but besides this, it says nothing about purity. Molly crystals can also be meth, alum, anything. There is no shortage of vaguely crystalline translucent substances. If you look at esctasydata.org you'll see that the most pills sold as ecstasy contain only MDMA as an active substance and that not all "molly" is pure.
As for safety, crystal is easier to dose visually but pills are more a bit more traceable. In the end, one is not better than the other.
instead of more & more wmd on credit.. change is what's missing?
One of the main targets in the war on drugs could well become a drug to treat the scars of war.
I bet the journalist who came up with that sentence felt good about himself :)
It would be interesting to see this contrasted with an array of psychedelics as this sort of thing seems to have been well known for quite a while.
Those sparkles on your Cinnamon Toast Crunch ain't sugar, kid.
They are supposed to be an incentive to make folks more healthy.
The opoid crisis shows that they have been twisted into a way to do the reverse.
Using Ecstasy as a tool to help eliminate PTSD sounds great.
But if it trades one chronic problem for another, not so much.
If there are large profit incentives to cause it be used on folks where it shouldn't, really not so much.
Is this a cheap, new short term use for an old generic drug?
Or is is a long term expensive cash flow which will be heavily marketed for anybody with anything that can be called PTSD?
Given the opoid story, the drug industry really needs to be doing something to help folks this time.
Very clever how this current effort to legalize MDMA was designed. Focusing on PTSD as the indication, and how it could help all those brave patriotic veterans.
Instead of dirty depressed hippies and single mom assault victims, who are leeches on society totally undeserving of pharmaceutical treatment.
This political smokescreen is the only reason the study managed to survive the tender minstrations of the DEA.
You'd need one hell of a placebo to ensure that participants weren't sure if they got MDMA or not. Could placebo effect even really work in a case like this where the noticeable effects of the drug are quite substantial.
You're wrong there I'm afraid. That's a totally different substance and is far less desirable.
Have gnu, will travel.
PTSD is a "disease" that people under stress find within themselves because they've been taught the symptoms. In the Civil War soldiers would clutch their chests and fall to the ground in pain. In WW1 soldiers would have spasmodic body movements that would incapacitate them for months, (videos available on YouTube). People in non western countries during natural disasters show none of the western PTSD symptoms. Drug companies don't just provide the treatment, they manufacture the disease.
Fantastic. Another drug to get the masses addicted to, makes Big Pharma millions, and fuck the patient. Again.
And 100% had a really good time.
Molly is already taken youngster, and it's used for grease. https://en.wikipedia.org/wiki/Molybdenum_disulfide
MDA is not MDMA. Usually produced by those too lazy to do the last stage. It's really not as nice and has more negative side effects.
trance and EDM all in the same sentence. Hell ha frozen over.
Speaking of which I went to my first rave in 15 years last April. Got some nice MDMA and danced my ass off. Luckily there was no new newfangled EDM or TwerkingBroStepBass to give me convolutions, just Techno and Psy/Goa.
by TheSpoom (715771) Uncaring Linux user here. I have nothing to add to this but please continue. *munches popcorn*
Anyone not familiar with MAPS: Multidisciplinary Association for Psychedelic Studies should check them out and support them if possible. They have been at the forefront of supporting research and helping researchers navigate the complex legal/political terrain for decades. Highly recommended group.
-a.e.mossberg
Wrong... that's a different drug.
https://www.nhs.uk/news/mental...
Sorry, little kiddle. Molly is a mystery drug cocktail that is supposed to contain MDMA, but molly is like a box of chocolates, you never know what you're going to get. These days, odds are good are you're buying some fentanyl and cutting agents.
Let's how you learn to respect your elders before you kill yourself with your ignorance, junior.
Are the risks and rates low because psychotherapy is safe?
No.
The risks and rates are low because there is not one case in the history of United States law in which a psychiatrist or psychologist was found to have made a mistake in diagnosing a person as mentally ill and required to pay damages for harm and suffering caused by the mistake. This is an extraordinary statistic considering the fact that for many decades approximately one-half of all the hospital beds in the nation have been occupied by persons diagnosed as mentally ill.
Sure, medical professionals are infallible. Especially when money is on the line.
Or how about not sending 10,000's of Americans into war in the first place?
Actually political bi-partisanship only seems to manifest itself when the US decides to bomb, invade, or otherwise destabilize distant lands at the expense of the U.S. soldiers thrust into the cauldron.
I guess it was the drug companies that caused the priests to rape all those little boys. (videos available online)
...the organization is still in the process of raising money for the trials, and thus far, they've only managed to secure $13 million, about half of their goal.
Show me another placebo with 60+% efficacy in a double blind trial and get back to me.
Actually, 60% is the usual number for the efficiency of placebo in GAD, depression, PTSD and similar disorders.
MDMA:
https://erowid.org/library/boo...
MDA:
https://erowid.org/library/boo...
Don't play up the side effects and don't tell the participants the name of the drug they're taking. That would be a good start. "This pill doesn't seem to be doing much"... "No problem, the chances of side effects are very low. Seems you are a lucky participant."
Let's require every global warming activist to take MDMA. Then we could actually sit down and start fixing the carbon problem.
I'm not sure if you're suggesting that the President of the United States is a global warming activist or if you're implying that the roadblock in fixing the "carbon problem" is not the current majority party's two-decade stance against the existence of said problem.
I suppose the former might be valid if one considers "rolling coal" to be a form of activism.
Those who advocate genocide deserve every protection afforded by law, and none afforded by common human decency.
How do you double blind test a placebo?
... trials intended to evaluate its effect on US aggression. Simply enhance the water supply of anyone involved with foreign policy/military and get to work recording those data points - ideally to a repetitive beat.
Requiem for the American Dream
Perhaps you don't consider Time Leftist, but a lot of people do:
I grew up reading Time in the 80's, so I'm well aware of their pro-drug bias.
Perhaps someone on the Right can explain to me why putting someone in jail for years, and ruining their employment prospects when they get out is preferable to them having a drug habit.
I can explain it: forgiveness . Perhaps you live in Leftist utopia where everything is permissable, but nothing is forgiven, but the rest of the world doesn't think that way. If you wouldn't judge someone for mistakes in their past, and I understand (and the Right understands) that people make mistakes, who is there left to judge someone for their past mistakes? However, I can understand your sentiment - you've surely seen how the Left doesn't forgive racists - and you extrapolate that to a criminal record. You might be right in this regard, but at least you could still work for a conservative.
I imagine most Leftists wouldn't care about past drug use, and should you find yourself interviewed by a Conservative, you can always refer to Romans 3:23: "for all have sinned and fallen short of the glory of God..." So, from this perspective, the deterrent of prison time helps keep people from picking up the habit in the first place, and gives them reason to seek treatment should it happen to them. When this is combined with the Conservative preference for small government, you end up with a system where the role of police is not to lock everyone up for minor drug crimes, but rather, "to keep an honest man honest".
The society for a thought-free internet welcomes you.
Band-Aids on children is the prime example (and doubly relevant because it's a placebo in both meanings of the word), where placing a band-aid on an inconsequential cut or bruise brings immediate relief.
In my (adult) estimation, an adhesive bandage causes relief by canceling two sources of anxiety: contact with rough surfaces reopening the cut, and blood staining my clothes until a strong clot has formed.
Shouldn't there be some punctuation around the name of the magazine, so it doesn't look like some oracle or god named "Science" is providing that information, rather than a prominent publication?
Could have been worse, I suppose. "In accordance with the prophecy", for instance.
There's no time like the present. Well, the past used to be.