FDA Designates MDMA As 'Breakthrough Therapy' For PTSD (futurism.com) 266
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.
Also works great against depression (Score:3)
As nonclinical studies have shown...
Then again, who'd want people to not be depressed and compensate by buying shit?
Re:Also works great against depression (Score:4, Insightful)
People are not supposed to be happy, at least not for very long. If people are happy they will not change anything to risk it going away.
That's pretty braindead, even by the standards of conspiracy thinking.
In the same paragraph, you say that happy people are less likely to want a revolution, but that the ruling elite don't want the masses to be happy. Am I missing something?
Not to mention that the topic of discussion is clinical depression, not happiness.
ACs never fail to disappoint.
Re:Also works great against depression (Score:5, Informative)
The topic under discussion is PTSD, not clinical depression (btw - it's not called clinical depression any more - it's now known as major depressive disorder, to better distinguish it from run-of-the-mill depression that everyone gets once in a while and that's completely normal).
PTSD is a form of anxiety disorder - a different kettle of fish. Sure, it's often accompanied by major depressive episodes, but it's important to understand that you're dealing with two different illnesses, and that curing PTSD won't necessarily cure MDD (especially since the brain is pretty plastic, and the more often you have an episode of major depression, the more likely you are to have another one).
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Quite right, I must've latched on too literally to Opportunist's post.
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That's a common side-effect of listening to bullshit.
Re:Also works great against depression (Score:4, Insightful)
Well, those pills rarely make you happy, but they motivate you. And the very last thing you want is a motivated and unhappy mob.
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So I'll assume you're not one of those people that get calm by taking your drugs, yes?
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Looks a lot like a very awkward attempt at redirection.
You were talking about the will of the wealthy elites, remember? 'Permanent revolution' has nothing to do with it.
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Any other useless lenses you suggest we look at the problem with?
Perhaps the 'dunces'?
The dunces where a dark age intellectual philosophy: Core belief. All knowledge and wisdom is already in The Bible and the works of the great greek philosophers. Seeking knowledge in any other place is foolish. They were about as right as the Marxists. Much lower megadeath count though.
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Very insightful observation. People are not supposed to be happy, at least not for very long. If people are happy they will not change anything to risk it going away. A ruling elite wants people to be unhappy and afraid.
I think it's the other way around. A complacent population is easier to handle. Never has there been a more drugged people than today's Americans - 70% take at least one prescription drug, plus a huge amount of over-the-counter and illicit drugs. As long as people function well enough to earn their wages, pay their taxes, and vote for those who speak in short enough sentences to understand, it's all good from a government point of view. Whether you shuffle to and from work as a zombie, and sit plastered
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Never has there been a more drugged people than today's Americans - 70% take at least one prescription drug, plus a huge amount of over-the-counter and illicit drugs.
"If you feel you are not properly sedated, call 348-844 immediately. Failure to do so may result in prosecution for criminal drug evasion."
Whether you shuffle to and from work as a zombie, and sit plastered in front of the TV or redtube all night doesn't matter, as long as you don't rock the boat.
Male voice (medicine cabinet): "What's wrong?"
Man: "I need something stronger."
Male voice (medicine cabinet): "Take four red capsules. In 10 minutes, take two more. Help is on the way."
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"70% take at least one prescription drug, plus a huge amount of over-the-counter and illicit drugs."
And almost all of these abused drugs are antibiotics, not anti-mental drugs.
Try again when you can be less disingenuous.
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And almost all of these abused drugs are antibiotics, not anti-mental drugs.
Try again when you can be less disingenuous.
Who said anything about abused?
Try again when you can be less disingenuous.
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How many of that 70% are taking a non-psychoactive drug--for high blood pressure, high cholesterol, or diabetes? Hardly an argument that we're a nation of drugged zombies.
The most common drug for hyptertension (high blood pressure) is lisinopril, which has a major common side effect of depression.
The most common drugs for high cholesterol are statins, which have a major common side effect of severe muscle pain, often leading to secondary prescriptions of opiates.
The most common drug for diabetes type II is metformin, which has a major common side effect of sleepiness.
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Very insightful observation. People are not supposed to be happy, at least not for very long. If people are happy they will not change anything to risk it going away. A ruling elite wants people to be unhappy and afraid.
.
If the FDA approves this, and doctors began prescribing it for PTSD and depression, the pearl-clutching catastrophists would start calling it "soma" and riddle the Internet with quotes from Brave New World
Let's require every global warming activist to take MDMA. Then we could actually sit down and start fixing the carbon problem.
Climate Activism (Score:2)
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.
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The so-called 'ruling elite' want people to be in a constant state of terror, because that effectively turns off their higher reasoning abilities, and in their perpetual panic, they look for someone, anyone, who appears to be able to 'save them'.
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The so-called 'ruling elite' want people to be in a constant state of terror, because that effectively turns off their higher reasoning abilities, and in their perpetual panic, they look for someone, anyone, who appears to be able to 'save them'.
That would explain the rash of scare articles that I have been scrolling by on my FB page solemnly warning about the extreme dangers of pretty much anything you may be dealing with every day out in the real world that we have to operate in.
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"If people are happy they will not change anything to risk it going away."
I'm happy as hell and I'd change anything just for some fucking monotony relief. Don't lump all people together, or you might find yourself with a friend planting a knife in your back when you least expect it.
Re:Also works great against depression (Score:5, Insightful)
Worse, it's not the FDA that is waging a war on drugs in the first place. The "war on drugs" is a political construct with no scientific evidence backing it. If the FDA were to be allowed to do studies to prove or disprove its effectiveness, the "war on drugs" would end pretty quickly. Ditto with the epidemiology of lack of gun control causing increased deaths..
Helping the "right" people (Score:5, Insightful)
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.
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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.
I don't disagree. But Americans are a very war-like people, so appealing to their militarism often works. It's how we got the interstate highway system, after all.
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Defacto? You realize that when the federal government of Mexico changed hands the federales basically stopped raiding Sinaloa and started raiding the other cartels. The Mexican drug war is a consequence of the national elections in Mexico. Power changed hands, it's going to take a while to change on the streets.
Most reporters are too scared to write about it. The economist, being in England, did. Bet the reporter (who's name escapes me) isn't going anywhere near Mexico, ever.
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"The "war on drugs" is a political construct with no scientific evidence backing it."
Yea, lemme tell you about the studies done on meth users... right down to the fact i have a drug treatment hospital not even 40 yards from my property.
When they 'escape' they just fuck it all up around our area. (I say 'escape because they have shitty security protocols, we've had to deal with escapees on our block more than once.)
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We had a sober living house open about a mile away. It lasted four years. After the _third_ tweak nutted up and was shot by the local police they converted it into an old folks assisted living house.
The main day to day problem was the junkies wheeling off the county recycle bins on pickup day. You never knew where to find them.
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4-10% is the general percentage in crime statistics, the UCR fucks it up though. That's not even touching on secondary things.
Old news (Score:5, Insightful)
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.
Re: Old news (Score:5, Informative)
In the 70s it was used for exactly this purpose and with great success. Then it got banned. "Breakthrough", lol, morons.
Re: Old news (Score:4, Insightful)
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.
Re: Old news (Score:5, Informative)
The history of MDMA isn't one of patent abuse, but malfeasance by the DEA [wikipedia.org]. The first MDMA synthesis patent was filed in 1912.
MDMA was put on schedule I by the DEA against the guidance of the medical community, who sued to have it rescheduled. After a judge ruled that it had valid medical uses and should be rescheduled, the DEA unilaterally declared that it has no medical uses again and banned it.
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The history of "drugs" in general is one of abuse. The only thing people can't agree on is who is abusing what or whom.
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By those standards both nicotine and alcohol should be outlawed; Both have limited medicinal use but both are as addictive as heroin and kill far more people than they safe. nicotine in particular is abused by nearly every single cigarette smoker, with only extremely few people limiting it to medicinal use (and for the few medicinal uses nicotine has (stress reduction, treating IBS, limited migraine reduction effects), there are far better alternatives, including cannabis).
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You might want to read my comment again, you'll get it eventually. ;)
Re: Old news (Score:5, Insightful)
Personally, I think that the entire pharmaceutical and medical industries should be mandated to be not-for-profit. With no motivation for the Few to get rich off the suffering of others, we'd see a big change in healthcare in this country.
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There's plenty of money in a cure. Yes, they remove whatever condition a person has, but who says that it stays removed. If anything, with people no longer having to avoid contracting it because they know they can get rid of it again, people will get careless and then beg you to sell them your cure.
Re: medicament (Score:2, Funny)
A medical predicament, duh!
Re:medicament (Score:5, Informative)
https://www.merriam-webster.co... [merriam-webster.com]
It's not that often that a non-native speaker gets to teach a native speaker a new word, I guess.
Re: medicament (Score:4)
It's easier than that. Medikament is German for medicine, and I'm a German native speaker. What happened here is me being out of caffeine and not translating a term properly.
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There's no need to apologize. Medicament is a perfectly usable English word.
Although seldom seen in US street English, it's still very much alive [google.com].
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Wasn't supposed to be an apology, more an explanation before people start to interpret more into something than there is.
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Wtf is a "medicament"?
A good word that has fallen out of common use in the US, but is still part of English, and should be known by everyone. Note that your spell checker accepted it when you typed it in - that should have been a clue to look it up before jerk posting.
A medicament is a healing substance, curative or remedy. It's a noun that describes a larger group partially overlapping medicine and medication. Vaseline on skin is a medicament. So are antibiotics. But a pure symptom suppressor is not necessarily a medicamen
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The difference between most concepts is a subtle, but significant differentions.
It is what allows language to evolve to convey context and nuance.
Medication, is a very broad term.
Medicament is that used in therapy.
The Chinese had it correct by giving each lemma a new character, even though the pronunciation was the same. That practise has died, but the impact on society was great.
If users of English were able to construct new words and better convey its semantics through visual representation in addition t
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Wtf is a "medicament"?
"It is a damn poor mind indeed which can't think of at least two ways to spell any word."
-- Andrew Jackson
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My therapist worked on the trials back in the 70s, and said the results were amazing when treating PTSD and anxiety. I have long hoped that this could happen, but am surprised it actually has.
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This is what happens when you have governments making policy which isn't evidence/science based, so they can pander to idiots who think their holy book has told us everything we need to know about the universe and wish to impose their idiocy on the rest of the world.
Whiny Christians, Islamc fundamentalists, Orthodox Je
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all drugs are bad no matter what, especially if people might also use them for fun
No, the problem with drugs is that they aren't any fun after addiction and tolerance set in. The Christian Right doesn't care that cocaine can be prescribed by a physician - they're more concerned that it's addictive properties will be used to exploit the weak and suffering. Which is why it can be legally prescribed by a physician, but not the corner drugstore sales associate.
Perhaps someone on the Left can answer thi
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Perhaps someone on the Left can answer this for me, but why is it that the Left objects so strongly to the exploitation of the weak by corporations, but considers exploitation by drug dealers to be a positive social good?
As a member of the Left, I'd like to know where you got the notion that anyone on the Left thinks that way. Please point out where a person has said that exploitation by drug dealers is a social good, or admit this is a strawman.
People in general think the war on drugs is bad because the supposed cure is worse that the disease. I would much rather be addicted to heroin than serving time on a 20 year prison sentence. I can kick the smack, but I can never get rid of a felony record.
Perhaps someone on the R
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Right, because drugs themselves haven't condemned MILLIONS of people to decades of suffering either?
Look, I understand your point: the 'war on drugs' is stupid. I agree. But to assert that the absence of MDMA as a theraputic resources is even within what, four? five? more? orders of magnitude the overall hurtful impact of class 1 substances generally is just silly.
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Right, because drugs themselves haven't condemned MILLIONS of people to decades of suffering either?
Look, I understand your point: the 'war on drugs' is stupid. I agree. But to assert that the absence of MDMA as a theraputic resources is even within what, four? five? more? orders of magnitude the overall hurtful impact of class 1 substances generally is just silly.
Class 1 substances like marijuana, LSD and Peyote? These drugs do not cause suffering.
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https://erowid.org/library/boo... [erowid.org]
What about the Side effects? (Score:4, Funny)
Side effects include getting into trance music, edm and attending raves. ðY
Re:What about the Side effects? (Score:5, Insightful)
I'd be willing to take that risk. PTSD isn't fun, hell, if it would make me like dubstep or country, I'd still do it.
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I think it would take at least heroin to numb the pain from having my eardrums pierced.
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I think you only start liking country if you do a lot of meth.
That's ok, we play both types of music here, Country and Western!
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Raves (Score:2)
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.
Please provide link to official FDA release (Score:5, Interesting)
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
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Re:Please provide link to official FDA release (Score:5, Funny)
Merck held the original patent for MDMA - marketed as a weight loss drug for ladies with interesting side effects.
But the studies were cut short when they ran out of ladies with interesting side effects.
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FDA doesn't issue press releases about the status of drug applications (NDAs). Those are under confidentiality agreements due to trade secrets, etc. However, the NDA sponsor can release any information they want about their application.
So, yes, it could be hype. But I would bet any investors/donors want to see evidence that it is truly fast tracked, and could sue for fraud if not.
fda site (Score:2)
In other words (Score:2)
Nightclubs are full of people with PTSD.
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Nightclubs are full of people with PTSD.
That's because they all saw the morbidly obese woman in the club dance topless after taking ecstasy,
Great News (Score:4, Funny)
X used to be legal (Score:2)
Comment removed (Score:3)
As opposed to say DMT or LSD? (Score:2)
Therapy for the PTSD ... (Score:2)
MAPS (Score:5, Informative)
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.
Psilocybin also proving effective for anxiety (Score:2)
https://www.nhs.uk/news/mental... [www.nhs.uk]
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Only for long term users [wikipedia.org]. This therapy is short term.
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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.
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Even safe antidepressants can cause permanent changes in the brain, what do you expect from a substance than is much more potent?
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Well, what I'd expect from a more potent drug is lower dosage and shorter use.
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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.
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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.
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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)
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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?
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I'd suggest you take a look at this university's page [imperial.ac.uk] 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 t
Re:Lies (Score:5, Informative)
"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."
Re: Lies (Score:2, Insightful)
Show me another placebo with 60+% efficacy in a double blind trial and get back to me.
Re: Lies (Score:2, Insightful)
Cinnamon Toast Crunch.
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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
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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.
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MDMA:
https://erowid.org/library/boo... [erowid.org]
MDA:
https://erowid.org/library/boo... [erowid.org]
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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
Re: don't know how "disease" or drug works,try it! (Score:2, Informative)
"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?
Re: don't know how "disease" or drug works,try it! (Score:2, Informative)
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.
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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
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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!
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While war may be the most famous cause, PTSD has a lot of non-war causes as well.
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