New FDA approved usage of MDMA

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PanicManictroll
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I read somewhere that there is a new approved medicine, virtually the same as MDMA, being prescribed for PTSD. I can't remember the exact name of the medication although I think it starts with an F. Anyone else heard of this?

quincy
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Nope . . .

I get postings from an FDA site about newly approved meds but unless that one slipped by me I sure haven't seen it. They are doing extensive research on hallucinigens now that the 60's are far behind us and the stigma is off of the assorted drugs. They've had spectacular success with terminal cancer patients in tests using synthetic psilocybin, it seems to give them a better perspective on their imminent mortality. As I am a term. myself, when my time comes (That will be a long time away.) I hope that this is available for me and not just a few test subjects as it has not received FDA approval as of yet. Google FDA and search around their sites, you might find the info you want . . . Q

allgood
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re: PanicManic

I am on the same FDA email list as Q, and I haven’t heard of any new medication like you describe. If you know the specific chemical name I would be interested to know what it is, since I have read PiHKAL: A Chemical Love Story written by Dr. Alexander Shulgin and Ann Shulgin. Dr. Alexander Shulgin was the person who discovered and synthesized MDMA, and dozens of other similar psychoactive substances. He has written several books.

-------

I was watching a documentary on National Geographic Channel (or one of the similar channels) earlier this year or late last year where this guy was taking psilocybin to prevent his cluster headaches. He didn’t like taking them because of the temporary psychological effects, but they were the only thing that kept him free from cluster headaches for weeks at a time. It was also only necessary for him to eat them every couple of weeks to completely prevent his cluster headaches for weeks afterwards, and he was able to carry on a normal life and play with his kids. Prior to this he was more or less bed-ridden whenever the headaches started. If anyone reading this knows how debilitating cluster headaches can be and frequently are they would understand this father of 2 and husband's plight and willing to risk his freedom as opposed to possible end up as just another suicide statistic due to cluster headaches.

Cluster headaches are well known to cause people that have them to commit suicide (unfortunate but true, they have the nick-name suicide headaches for a reason). They are literally that painful and life destroying. Some people are able to "deal" with them by inhaling pure Oxygen, and they may go through up to 2 entire cylinders of Oxygen during the time that they are suffering from them, which is a massive amount of pure Oxygen to take in over a couple to several hours. They are not using a nasal cannula, like you see in hospitals where the oxygen tube splits into 2 and goes around the back of the patient's ears and the 2 tubes that were split prior to going up and around the back of the ears join at a junction that has 2 short half inch long rigid tubes that go in the patient's nostrils. These cluster headache sufferers are using a high flow mask that covers their mouth and nose allowing very large amounts of Oxygen to get to their respiratory tract, lungs, and subsequently red blood cells very quickly. Oxygen is pretty much the only medically approved solution for cluster headache sufferers that a doctor in the US can legally offer their patient. Although, Oxygen isn't always effective in stopping the cluster headaches.

- allgood

PanicManictroll
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Odd

I'm afraid i'm mistaken. It's being used by the VA to treat war veterans with PTSD. It's not FDA approved... at least not publicly or for civilians.

I know for sure it has a scientific clinical name and it can be prescribed by the VA... I just can't find it again! I remember when I did find the clinical name it even had a listing on nimh.nih.gov .

Trying to dig up more info...

flounder
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this?

I do not expect it to find widespread usage since it is schedule I rather than schedule III now because of neurotoxicity concerns. 

Is this the program you read about? http://www.maps.org/research/mdma/studies/mp8/

 

PanicManictroll
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well

I had read about the MAPS trials but this article was more recent and was a different undertaking. Like I said it actually gave the pharmaceutical name of the clinical drug.... for the life of me I can't remember it!! It's driving me crazy!

I understand it won't be a widespread or highly prescribed drug but from what i've gathered it's being widely used for Iraq/Afghan war veterans with PTSD. Sorry that all I have is hearsay... but i'm sure it's true.

After I had read about it I googled it and got the full description under:

www.nlm.nih.gov 

celticgreenman
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Clinical study

I agree with flounder.  The VA is under the same restrictions as any other physician, pharmacy, or medical facility in the US.  It cannot just prescribe anything it wants, nor go against the rules and regulations of the FDA/DEA.  They cannot just "experiement" on patients.

It is probably being studied within a research project in the treatment of PTSD. 

cgm

 

PanicManictroll
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LOL

The government itself can do any expirementation that is so pleases under the guise of "studying", "treatment", and "research".

I know what I saw. I should have written it down. It will come out sooner or later.

celticgreenman
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Studies

PanicManic,

Because of previous studies by the government and the current requirement for informed consent, the requirements for constructing a study (be it by the government, academics, or industrial) are very detailed and stringent. All studies have to be approved by an IRB (institutional review board), including studies which just do chart reviews (that have no actual patient contact).

The consent forms that possible study participants are given and have to read are extremely detailed and thorough. Often, these consents are multiple pages long, some reaching up around 50 to 60 pages. The participant has to be given as much time as he/she wishes to ask questions. Many times, participants are required to come back a few times, so that theycan discuss the study with family and ask questions, before signing the consent form.  And, the participant can withdraw from a study at any time.

So, no participants should ever say that they did not know what they were getting into. This is one reason that many of the "gold standard" (randomly selected, double blinded studies) are so difficult to do. The amount of time, money, and effort that goes into setting up a proper study project and seeing it through to fruition is extensive.

Thus, the government, or anyone else, cannot just do any experimentation it wants. And, again, the VA and the military cannot prescribe any substance they want. Their formularies are regulated by the FDA just like the civilian sector.

cgm

 

PanicManictroll
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Fair enough

1. I never stated that any of the veterans were given this medication (containing 100% pure MDMA) unwittingly. Despite that; does the doctor tell me the chemical compound of alprazolam in laymen's terms prior to writing out a script? No. (I know the base source of MDMA is Safrole... and it's illegal. I have no idea what the base extract of Alprazolam is and i've been taking it legally for years.) Yet does the doctor even bother to "warn" of the potentially life threatening withdrawal syndrome? No. Has there been enough research done on alprazolam and other potentially neurotoxic benzodiazipines, SSRI, and SNRI? No. Your point is MOOT.

Forgive me.. i'm not trying to sound rude..  but you're coming across as either naive or an apologist.

Everything that has been done under the guise of "psychiatric" medicine has been done, for years, covertly. If you truly believe that all this has changed due to some type of internal house cleaning I would beg you to reconsider.

MDMA is currently being used to treat veterans with PTSD.

My grandmother spent years as a "guinea pig" in a mental hospital. We're all (any of us who take these medications) guinea pigs. It's not a conspiracy. There is no stringent standard that is followed by the letter of the law or some board of lobbyist'.

Period.

celticgreenman
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US pharmacopeia

If we are getting into a discussion, then I will also put in my two cents worth.

I. Veterans, in general, are not being treated with MDMA. A physician at the VA cannot get on the computer and prescribe it for a patient with PTSD. There are a few, very controlled, studies being conducted.  Veterans may participate in the study, if they so wish, in which the efficacy of MDMA is being investigated as a possible treatment for PTSD. This does not mean that it will ever become a treatment in the future.

2. I am speaking of medications which have already been through the extensive approval process by the FDA, to become an approved medication within the US pharmacopeia. If you wish to know the chemical structure or any other information of any of your medications, pick up the package insert and read it to your heart's content.   These medications have gone through the multi-stage approval and trial processes to assess their efficacy and safety.  However, all medications are chemical substances which interact with the human body.  There is a fine line between a substance providing a useful service and being a poison.  I take rat poison every day.  I am on Coumadin (warfarin), which is the active ingredient in D-Con rat poison.  But, when taken at the appropriate dose, for an appropriate indication, it provides a life saving service.  Take too much of it and it will kill you.  So, every patient has to make the decision as to whether or not to take a specific medication.  Is it worth possible side effects and long term consequences, to treat a problem that is affecting your life at the present time?  That is your decision.  If you think that the medication safety profile is not to your liking, don’t take it, live with your condition as it is.  That is one of your rights as a patient.  No one is forcing you to take a specific medication.

3. Don't know about your physicians, but when I was placed on a benzodiazepine medication, I was told to take it exactly as directed, not to exceed the prescribed dose, and to not stop it abruptly as that could cause problems. Again, as to what happens to patients being treated for mental health problems is between them and their physicians. Every psychiatrist and patient is different. Some patients want to know everything about their medications, while others don't really care. If an individual patient desires specific information, above just the usual brief explanation of "this is for this and take it like this", then they have to ask.  If patients are not mentally capable of asking, then their family or appointed guardian should ask about the medications which the patient is placed on.  But, again, these medications have been through extensive trials and approval processes.

4. I just get real tired of people bashing the government, the VA, and the military as being substandard medical systems and that they "experiment" on patients without the patient's permission. Sure, tragic incidences occurred in the past, which is why any study done now (civilian or government) has to be so open and provide any and all participants with all the information on the study.  You stated, “The government itself can do any expirementation that is so pleases under the guise of "studying", "treatment", and "research".”  Sorry, but that is just not correct.

5.  Since you are interested, the chemical name of alprazolam is 8-Chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-α] [1,4] benzodiazepine.  Physicians are not taught the chemical structures of the medications they prescribe.  Sure, they studied pharmacology in medical school, but the basic science is not routinely used by physicians in clinical practice.  Researchers use the chemical names, but that’s about it.  Physicians are basically interested in the indications, outcomes, side effects, some basic physiology involving the medicine, and that is about all they need.

cgm