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Government Medicine United States Science

FDA Approves Large Clinical Trial For Ecstasy As Relief For PTSD Patients (arstechnica.com) 151

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.
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FDA Approves Large Clinical Trial For Ecstasy As Relief For PTSD Patients

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  • by Scarletdown ( 886459 ) on Thursday December 01, 2016 @06:06AM (#53400207) Journal

    If this proves to be a success, then this treatment will definitely be something to rave about.

    • Here have a bottle of water
    • by Udom ( 978789 )
      PTSD... In the US Civil war affected soldiers would suddenly clasp their chests in pain and fall to the ground, unable to move. In WW1 some soldiers would develop dramatic spasmodic ticks and jerks that would persist for months, (videos of such patients on YouTube). Everyone is familiar with the modern symptoms... What we have is energy looking for expression and patients express according to their expectations. The energy is real, the expression is learned. PTSD is a psychosomatic illness.
  • by Anonymous Coward

    As long as I can CCW.

  • by catmistake ( 814204 ) on Thursday December 01, 2016 @06:22AM (#53400253) Journal

    Here's the ruling [erowid.org]

    Based upon this record it is the recommended decision of the administrative law judge that the substance 3, 4-
    methylenedioxymethamphetamine, also known as MDMA, should be placed in Schedule III.
    Dated: MAY 22 1986
    Francis L Young, Administrative Law Judge

    here is the story [norml.org]

    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.

    • by Rei ( 128717 ) on Thursday December 01, 2016 @06:58AM (#53400335) Homepage

      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.

      • Re: (Score:3, Funny)

        Comment removed based on user account deletion
        • Actually, their constitutional authority to exist is that the Executive Branch calls them into existence to execute the provisions of laws passed by the Legislative branch. Drugs are scheduled as different levels of controlled substances in different states (Florida's controlled substance schedule is hilarious--most food is illegal). In theory, the Federal Government doesn't have the power to enforce in a state which has passed law declining Federal enforcement; however, if the manufacture and sale of dr

          • Comment removed based on user account deletion
            • Actually, we could pass a constitutional amendment banning the private printing of United States money if we wanted. That doesn't mean the private printing of US money isn't already illegal or bannable under Federal law.

              Frequently, the role of a constitutional amendment is to establish the constitution of a country (surprising, that). For example: nothing in the U.S. Constitution establishes any sort of equal rights treatment for gay marriage--or any recognition of any marriage--and yet we had a short

      • by Anonymous Coward

        We have unelected bureaucrats effectively making laws outside the legislative process.

        And that's OK WHY?!?!?!

        But hey, remember to yell at (other) people to "PAY YOUR FAIR SHARE!!!" so we can get MORE of this bullshit from our overweening government.

      • by swb ( 14022 ) on Thursday December 01, 2016 @08:30AM (#53400583)

        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.

        • I doubt this issue will really come up. MDMA is an amphetamine that isn't really anymore dangerous or prone to abuse than methamphetamine. It will be classified as Schedule II, if it is approved.

        • 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.

          Cinch that tin foil hat down tight for this one...

          If you really want to dig deep on this, look how killers like cigarettes, alcohol, and opiates are all legal, while marijuana is not. Understand that the more harmless a drug is, the less of a chance it will be accepted legally.

          Sounds crazy, but here's why. Harm to humans not only helps manage finite resources via population control, but it also creates jobs, secures patents, and bolsters revenue.

          How many jobs have been created treating alcoholism and all

          • by swb ( 14022 )

            I'm on board with most of that, but if economics was a good enough explanation we wouldn't have seen the DEA making opiates much harder to obtain -- more intensive prescription databases to get doctor shoppers, more intensive audits of prescribing physicians, and the rescheduling of hydrocodone from III to II. The irony, of course, is that it has jacked up street prices and moved many low-level pill users accustomed to uniform dosing to street heroin, which despite DEA enforcement has become cheaper than m

    • The FDA decides if your manufactured drug is approved, and if the drug itself is approved for a use, and how to label it; the DEA decides if it's scheduled, and has to follow UN conventions--it can overschedule a drug (UN SCH3 means US SCH1-3), or schedule a non-UN-covered drug (UN uncontrolled = US SCH4 for some drugs).
    • With Trump and the republitards at the helm you can kiss your miracle drug goodbye.

  • But, (Score:4, Funny)

    by M0j0_j0j0 ( 1250800 ) on Thursday December 01, 2016 @06:57AM (#53400331)

    On the other hand, patients will suffer from low nutrition issues due to the Dragons in the kitchen.

  • IIRC Tim Ferriss mentioned throwing in his influence and leverage in the background to advance research and approval of unconventional medication in the area of PTSD treatment. IIRC he specifically mentioned this trial and it might even be prepared under his guidance. (It's in some Tim Ferriss Show podcast somewhere IIRC)

    AFAIK he has been doing some brain-drug experimentation himself, having owned a brain-drug company before his success as a bestseller author. He also covers brain drugs in his book "The 4-h

  • 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? I did see in the summary that this drug is reaching some patients who were not helped by other therapy (perhaps part of the 30-4

    • by Ol Olsoc ( 1175323 ) on Thursday December 01, 2016 @08:46AM (#53400645)

      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.

    • by cdrudge ( 68377 )

      What are the (projected) long-term side-effects? Is it worth the long-term costs?

      It's almost like they need to do a large clinical trial to actually find out. If only they'd do one...

      Someone else pointed out the difference between "improve" and "completely erased". But for someone who has a lot of mental disorders running through the family tree and with friends, there is vast differences for what works for one person but not another even for similar symptoms. I'd be extremely surprised if the 60-70% and tw

    • by torkus ( 1133985 )

      Assumptions not necessarily true:

      - that both groups are completely intersecting
      - existing treatment is as easy (or cheap/fast/etc.) as treatment with MDMA
      - that MDMA treatment is fully explored and mature so it's effectiveness is maximized
      - improving PTSD symptoms == erased all traces

      Now, I'm not one to believe any drug magically erases PTSD that easily. Nothing to date has proven to simply erase a mental illness (well, short of death.) Long term side effects I'm sure are being monitored, though you can a

  • The truth.... (Score:5, Informative)

    by beheaderaswp ( 549877 ) * on Thursday December 01, 2016 @08:40AM (#53400623)

    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.

    • You you have CPTSD? I would like to pick your brain on something, if I may.

      I am in my early thirties and I live with Asperger's Syndrome. I didn't know about Asperger's until my mid twenties. My entire childhood was spent being ostracised by other children for being different, and video games were my escape. Emotional abuse was just a part of life for me. I never considered myself a victim of PTSD, but I do remember a while back, I had a rather shocking flashback to repressed memories when my wife an

      • My experiences were twofold..

        At home I was severely physically and emotionally abused. At school I was ostracized and occasionally beaten.

        The school part of it was not the kid's fault... I did fine in school until 2nd grade- when home events escalated to levels that really screwed me up. I was a cultural American-Italian kid in a Jewish neighborhood. And probably appeared kinda of autistic or "off". The abuse and being a social outcast lasted until I was 17- when a state agency rescued me and force my paren

        • Thanks for the response. What I was getting at is that I suspect that things like CPTSD happen on a spectrum of severity. I was simply speculating that perhaps I've experienced a much milder form of what you endured. I think that there's a lot of grey area between being abused as a POW and living a normal, happy life.
    • Re: (Score:2, Interesting)

      by Anonymous Coward

      I too suffer from CPTSD or as it is known by the WHO ICD-10 F62.0 (Enduring personality change after catastrophic
      experience.) I was sexually and physically abused by my primary school principal when I was 10 (the perpetrator was criminally charged). Life is hell for me. Normal social interactions, trust in people and institutions, holding down jobs, participating in education, and keeping sane relationships is near impossible. I am constantly on my own suicide watch. I found a niche for myself being a lone

    • Truth, just a remark, it is not a disease, it did not happen by accident. Good luck on your recovery
    • Re: (Score:3, Interesting)

      by Anonymous Coward

      Totally believe it. A modest dose of shrooms can have a big impact on just about anyone. It allows/forces you to step outside of your normal patterns and thoughts and allows you to actually have a fresh approach to your reality. A key part that differentiates a trip from normally trying to evaluate your life is that you don't have a lot of choice in the matter, its a ride you can't just hop off of when it gets tense - even if you try to veg out and watch tv or just listen to music its still happening.

      It

    • by dj245 ( 732906 )

      Research into cannabis, MDMA, LSD, etc was the most promising area of psychiatric research in the 1950s. A mental health revolution was on the horizon until a bunch of non-scientists got involved and shut the whole thing down.

      • by GuB-42 ( 2483988 )

        From what I understood, it was indeed promising but it never went beyond that.
        The problem with psychedelics is that while we did have some very good results, it was too unpredictable. You talk about non-scientists but there is nothing scientists hate more than unpredictability.
        When a psychiatrist gives a drug to a patient, he wants to know the effects beforehand, he wants to know how things can go wrong, what to do next, etc.. You can't have it with LSD. I don't think we went passed the point of throwing it

        • by dj245 ( 732906 )

          From what I understood, it was indeed promising but it never went beyond that. The problem with psychedelics is that while we did have some very good results, it was too unpredictable. You talk about non-scientists but there is nothing scientists hate more than unpredictability. When a psychiatrist gives a drug to a patient, he wants to know the effects beforehand, he wants to know how things can go wrong, what to do next, etc.. You can't have it with LSD. I don't think we went passed the point of throwing it at a patient and see how it sticks.

          One of the last potential use of psychedelics is for treating cluster headaches. A benign but extremely painful condition. Interestingly, the most effective treatments are all hit-or-miss repurposed drugs, psychedelics are of these.

          Every drug has potential side effects and some level of unpredictability. If you were to measure the negative side effects and the benefits of commercial prescription antidepressants and mood disorder drugs, the net gain is very small or even negative in some cases. Some antidepressants on the market actually perform worse than a placebo. That's not a particularly high bar for these drugs to clear.

          The only reason these drugs weren't fully researched is because they were made very difficult to study,

  • Coming soon: a sudden change of heart on allowing imports of those generic medications that keep being shkrelied.

  • by SCPaPaJoe ( 767952 ) on Thursday December 01, 2016 @09:58AM (#53401009)
    The army's on ecstasy, so they say I read all about it in "USA Today" They stepped up urine testing to make it go away 'Cause it's hard to kill the enemy on ol' mdma! Oysterhead
  • So are patients going to be trading one form of delusions for another? That really makes no sense to me but perhaps I'm simply looking at it from an engineering standpoint.

    • by Anonymous Coward

      MDMA helps to turn off the fear center of your brain. Once a sufferer can get past the fear, normal psycho-therapy techniques can be used to help a patient to basically "re-program" themselves to overcome their problems. There is no delusional trade off. Re-program means that it allows them to see what is causing their chronic stress and come to terms with it and put it behind them. The inability to overcome fear is stopping them getting to that point like most people do when they encounter anything traumat

    • So are patients going to be trading one form of delusions for another?

      "Delusion" isn't the right word for people suffering from PTSD. I haven't experienced it myself, but as a former member of the US military, I have seen what the effects are; they vary widely from what people can mistake for delusions, to what people can mistake for "ordinary" depression/withdrawal.

      I don't do drugs quite as often as I used to, but if I had to pick one to do right now, it would be mushrooms. The effects of that drug, I think, can be fairly referred to as delusions. The symptoms of PTSD vary m

  • FYI The dosing is important, it is for talk therapy. I saw a lecture from one of the main doctors who does this research⦠There are formal quantifiable skills for evaluating PTSD. The highest success rate is finding the dose of the drug that allows you to have extremely effective talk therapy, the drug that helps you process information about traumatic events without your system going wild and then shutting down . But too much of the drug and you're having a good time but you are not verbal in

  • Got some powder. I just did smaller amounts to get a nice feeling. I know from past experience you can get cranky as hell a few days after E but with small amounts if was interesting how clear my head was for a few days after wards but there was a issue. If I did enough to really start feeling it my heart would race and get some crazy palpations once in a while. When you're 20 you don't care but at 42 lol the irregular heart beats are noticed more.

  • Is this the erase and rebuild method applied to brain dysfunction?

If you have a procedure with 10 parameters, you probably missed some.

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