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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.
Side effects include getting into trance music, edm and attending raves. ðY
Only for long term users. This therapy is short term.
And here, as in every, "study" about drug use I'd like to know whether it is certain the reason is the drug itself and not some of the junk the dealers mix into it to increase their profit.
We used to have a Bill of Rights. Now, with the rights gone, all we have left is the bill.
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."
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"?
"we did a double blind test to see if it worked" seems like science to me.
What is unscientific about proposing a hypothesis and testing it?
They would have a hypothesis, observation and conclusion which may simply be "more research needed" that IS science. Science isn't the answer, it's the process.
What other long time study of MDMA do you know about? MDMA is in no country on this planet a substance that you can use in human studies, so where do you think these results come from?
We used to have a Bill of Rights. Now, with the rights gone, all we have left is the bill.
Your showing your age Grandpa. It's not called Ecstasy anymore, it's Molly.
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.
Show me another placebo with 60+% efficacy in a double blind trial and get back to me.
Even safe antidepressants can cause permanent changes in the brain, what do you expect from a substance than is much more potent?
"It's such a fine line between stupid and clever" -- David St. Hubbins, Spinal Tap
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.
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).
It can still be science if part of the process is black boxed. If anything, science shines a harder light on what the boundaries of the black box are.
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.
Well, what I'd expect from a more potent drug is lower dosage and shorter use.
We used to have a Bill of Rights. Now, with the rights gone, all we have left is the bill.
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.
Because potency in the sense you are meaning does not scale with damage. They are different classes of drugs, so the side effects are not going to line up.
Regarding MDMA specifically, there is a long history of adulterants, and long term, consistent usage is going to tend to increase the chances and levels of exposure to said adulterants.
This is my signature. There are many like it, but this one is mine.
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 :)
You're an idiot.
Science requires a testable hypothesis ... which in this case could be "we have people who are not happy, we have a compound which induces happy, what happens if we combine the two".
MDMA, LSD, and in fact cocaine as famously applied by Freud, and quite possibly marijuana; these are things which have been identified as possibly impacting some aspects of mental health in a positive way.
But when you can't perform any research because some idiot politician has summarily decided it is illegal and without redeeming value, that isn't science.
We lack a firm understanding of the mechanics of many diseases, but that doesn't stop us from looking for possible correlations in how to treat it.
You are stupidly saying "you have diseases, and you have cures, tried and tested to work in most cases", but how the fuck do you think we found the goddamned cures you moron? Do you really think it was from a complete and total understanding of the disease from the start?
Science is the willingness to try things, keep track of your results, and measure the effects.
Saying you can't conduct science because the decision has already been made with out .. that's not fucking science, that's religion.
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.
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.
Safe antidepressants? This term is foreign to me. Please, elaborate.
APK quotes people (including myself) without context and should not be trusted. Just thought you should know.
Have gnu, will travel.
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
https://www.nhs.uk/news/mental...
The only slippery road is allowing the government to decide what you are allowed to put in your body (absolutely against the Constitution at the federal level).
In order to ban alcohol, they had to amend the Constitution. But one re-interpretation of the Commerce clause later and we can ban all drugs with only legislation!
"What the American public doesn't know is what makes them the American public." -Ray Zalinsky (Tommy Boy)
I've wondered what it would be like if you could go back in time and explain to George Washington (first US President), James Madison (author of the US Constitution), and Thomas Jefferson (author of the declaration of independence) that the government that they fought so hard to establish would one day demand that it's subjects^W citizens receive permission from that same government to have food and medicine.
Wh47 d1d j00 541, 31337 15n't t3h r0xor5 ne m0r3???
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.
Most modern antidepressants are safe to use if used as prescribed. No need to be careful with food anymore, like it used to be required for MAO inhibitors.
"It's such a fine line between stupid and clever" -- David St. Hubbins, Spinal Tap
MDMA:
https://erowid.org/library/boo...
MDA:
https://erowid.org/library/boo...
Only in excessive doses.
Studies have shown that there is no discernable effect on the brain for doses of less than 4ug/kg. So for a 220lb person that would be 400mg.
Effective dose for such a person is 50-100mg.
Recreational dose is the same, plus another dose more after 4 hours.
While the risk is not zero, theraputic doses are going to be quite safe for a majority of the population. (Insert disclaimer about those with undiagnosed psycological disordered)
I'd suggest you take a look at this university's page before you make such categorically incorrect statements.
Just a sample quote: "In recent years, we have set up a group to explore the modes of action of psychedelic drugs on brain activity and connectivity and have performed some of the first human neuroscience studies ever with LSD and psilocybin."
I recently read an article based on an interview with one of their heads of research in which they also mentioned trials involving MDMA, and DMT, in addition to the two in the quote above.
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.
I'm still calling [citation needed] on this. We must have very very different definitions of the word safe when "suicidal urges" are listed as a potential (and common) side effect.
APK quotes people (including myself) without context and should not be trusted. Just thought you should know.
Disco sucks!
Call it what you want, it still sucks.
John McAfee 'It was like that time I hired that Bangkok prostitute; to do my taxes, while I fucked my accountant'
Give them a couple of case studies of food filled with adulterants and contaminants, or of listeria outbreaks, and I suspect they'd understand why oversight became necessary.
The Quirkz Handbook of Self-Improvement for People Who Are Already Pretty Okay
... 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
The only safe stuff that's used as medicine that I know about is homeopathetic. If it doesn't have any effect, it's pretty safe to assume that it also doesn't have any side effects.
We used to have a Bill of Rights. Now, with the rights gone, all we have left is the bill.
Indeed. Beyond that, everything is dietary so long as you don't let things get out of the range of what natural andimicrobials and antifungals can handle (and you actually use them when necessary) and you maintain your gut flora.
If you fail that, you're in the danger zone anyway. There's a certain threshold where the danger of not using a drug is greater than the potential danger of using it; that's when you should start considering drugs. Specifically on the subject of antidepressants (as raised by dunkelfalke), they should only be considered when the patient's symptoms are worse that the potential side effects. Why give someone a pill that might make them want to kill themselves? Seriously, why? I mean, if they're in your office already talking about doing it, well, there ya go! But if they're not? Why?
Similarly, why give someone with non-aura-inducing migraines a hallucinogen? That's how migraines are typically treated, by the way. Now, for someone whose migraines already make them trip balls, the hallucinogen often works wonders. I know Cafergot and Immitrex were both great when I had aura-inducing migraines but they both really fucked me up (e.g. put me out of commission for a couple days) for non-aura migraines. Then I discovered CBD, which just plain fucking works with no mental fog or nasty effects.
And still, we give people with potentially nerve-compromising conditions opioid painkillers to mask the "HEY! STOP FUCKING MOVING LIKE THAT BEFORE YOU SEVER THAT NERVE!" pain signals. Sure, it lets them get up and do things (as well as you can when you're effectively stoned on heroin), but at the very real risk of doing permanent and potentially immobilizing nerve damage. At least, that's the experience I and others I know have had with them; and that's when they did anything for the pain at all. I have a basically pulverized spinal disc which causes intermittent and severe sciatica, I have plenty of experience with (prescribed) opiods. One day, I was suffering that and got a migraine; imagine my delight when the CBD I took for my migraine dulled the constant pain, without any shitty mental fog, and still let me feel the "HEY! STOP FUCKING MOVING LIKE THAT BEFORE YOU SEVER THAT NERVE!" pain signals well enough to know when I needed to take a break.
I'm so glad I live in a state where CBD is legal with a recommendation (and I have that recommendation as I have a legitimate need for it); if I lived elsewhere I might not be able to be productive most days.
And while it may seem that I've veered off topic, I've actually brought this line of discussion closer to where it started. Dunkelfalke's supposed "safe antidepressants" are not schedule 1 drugs like MDMA, the drug this discussion is supposed to be about; CBD, on the other hand...
No medical benefit, my ass.
APK quotes people (including myself) without context and should not be trusted. Just thought you should know.
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.
Suicidal urges are definitely not a side effect of antidepressants, they are present due to the actual depression in first place and they only are held in check by a serious lack of drive which also often comes with the depression.
You see, when people start taking antidepressants that lack of drive part of the depression usually goes first, but the soul ache stays for a few more weeks resulting in a person that feels like shit, but is suddenly motivated to actually do something about it.
This is why the suicide warnings in the pill leaflets generally are adressed at people younger than 25, because grown-ups aren't that impulsive anymore and can bear to wait for a couple of weeks before doing something stupid.
Moreover, this particular effect - curing the lethargy long before enhancing the mood - is only present in a very specific group of antidepressants - SSRI. Other types can make people even more lethargic and sleepy (this is actually a very large problem for me with all the antidepressants I have tried - I feel better immediately, which is highly unusial, but I seriously lose motivation to do anything at all) or they already start suppressing depression after a couple of days, removing any suicide thoughts left together with it.
"It's such a fine line between stupid and clever" -- David St. Hubbins, Spinal Tap
Except safety is not binary. If the active ingredient also does serious harm and there are safer alternatives, they will be the first-line medicaments and the more harmful one either falls to disuse or is used as the second or even third line treatment if everything else fails. Hence, if MDMA really burns out the serotonin pathways and has such a low therapeutic ratio, it only should be used for treatment-resistant PTSD.
"It's such a fine line between stupid and clever" -- David St. Hubbins, Spinal Tap
Have you actually read these leaflets you're referring to? They cite an increase in suicidal thoughts in the first month of treatment. That could very well be an increase from zero and no, it does not only affect people 25 and younger. Do you have any actual experience with these things or are you just looking at random articles online?
Let's just say there are a couple antidepressants someone very close to me can't take because they make her very suicidal; she's not suicidal without them, so they're not amplifying existing urges, and she's fine on what she's currently talking (if the dosage is right -- otherwise, suicidal thoughts again). She's been on antidepressants for years, so it's not just a "first month of treatment" thing, either; and it's been a while since she was under 25.
And she's not the first person I've seen actually exhibit that behavior on certain antidepressants, either. But, then, I literally grew up around depression and antidepressant use and I've been around it through every stage of my life. I've got over 3 decades of real world study here, even discounting events prior to my earliest recallable memories.
And you've got some printed leaflets stuffed in boxes with pills. Which you clearly didn't read. Because most of them actually list suicide with the side effects, along with the warning you mentioned.
APK quotes people (including myself) without context and should not be trusted. Just thought you should know.
Of course I have read these leaflets. And yes, I have actual personal experience with various antidepressants, specifically with sertraline, citalopram, bupropion and mirtazapine, having used each of these for about a year. Sertraline - that is one of the antidepressants that have danger of suicide listed in its leaflet - actually stopped me from offing myself because at that point of time I hit the rock bottom after two decades of trying to function somehow.
"It's such a fine line between stupid and clever" -- David St. Hubbins, Spinal Tap
Well, your sample size of one surely dictates reality for the rest of the world. My sample size is considerably larger and disagrees with yours, so I must be wrong, right? Mind you, neither of us have a sample size large enough to determine how common that particular side effect is, but mine's certainly large enough to determine that it exists.
APK quotes people (including myself) without context and should not be trusted. Just thought you should know.
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.
A psychiatrist once told me that serotonin levels don't seem to correlate with depression, but that raising serotonin levels in depressed people helps get them undepressed. (Personally, I'd suggest a combination of drug, talk, and cognitive therapy.)
"When you have eliminated the unacceptable, whatever is left, however improbable, must be the truthiness" - Holmes
My mother is a medical doctor, she had a very large sample size and she was the one who got me sertraline in first place - because it is safe. So yes, you are probably wrong.
"It's such a fine line between stupid and clever" -- David St. Hubbins, Spinal Tap
Ah, I see the disconnect now. In the medical world, safe is a relative term. Brain surgery is often referred to as safe, and in context it is, but it's not something we do without good reason because it's not without risk; just as an example.
APK quotes people (including myself) without context and should not be trusted. Just thought you should know.
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.