[HN Gopher] Psilocybin found safe in largest ever controlled study
___________________________________________________________________
Psilocybin found safe in largest ever controlled study
Author : pmoriarty
Score : 187 points
Date : 2020-01-02 20:47 UTC (2 hours ago)
(HTM) web link (www.independent.co.uk)
(TXT) w3m dump (www.independent.co.uk)
| sawyerjhood wrote:
| I'm personally excited to see what sorts of new treatments will
| come out of using psychedelics medically. I've always been on the
| skeptical side of medical marijuana usage in all but the most
| extreme cases, but I have a feeling that LSD and psilocybin can
| really provide mental turning points and help people break out of
| depression.
| iseedumbpeople wrote:
| Be warned the... the SF crazies are flagging anything critical
| of this article.
| mataug wrote:
| > I've always been on the skeptical side of medical marijuana
| usage in all but the most extreme cases
|
| Really? A friend of mine had a similar experience to what
| @ergothus described in their comments. The friend had a biking
| accident and got stitches. To ease the pain the doctor
| prescribed Aadvil / Tylenol, but those drugs just caused
| diarrhea. So he tried edible marijuana[in a legal state] and it
| helped him a lot through a few weeks of painful recovery
| without any side effects.
|
| I find miracle claims suspect as well, I don't think marijuana
| cures cancer.
| adamsea wrote:
| There's a great book by Michael Pollan, called "Change Your
| Mind", I think, which talks a lot about the history of
| psychedelic research in the US. Great read.
| freedomben wrote:
| I'm very optimistic as well. My family has hard-to-treat
| depression and there's a lot of reason to be optimistic about
| psilocybin. Michael Pollan's "How to Change Your Mind" was a
| fantastic read.
|
| It only makes me wonder what other possibilities have been out
| there but banned and therefore unavailable for study and
| experimentation. Luckily the days of censoring and hoarding
| information seem to be coming to an end.
|
| Of course as a society we love the pendulum effect. We'll swing
| it too far and then it will come back the opposite way too far
| (so much for my optimism :-P)
| tempsy wrote:
| From my experience it's incorrect to think of psilocybin as
| some magic pill that will magically make your depression go
| away.
|
| I'm in the camp that depression is rarely just some "chemical
| imbalance" in the brain that you were unlucky to be born
| with, and yet that is how we currently think of it and treat
| it.
|
| It's most often the case there is something in one's past,
| very often from one's childhood, that has been avoided, and
| creates a chronic sense of worry/anxiety/depression that
| lingers.
|
| Psilocybin has the effect of ego death - it feels as though
| the subconscious hold you have on your brain that pushes down
| uncomfortable feelings or memories just goes away. This
| paired with therapy can be very powerful because you
| naturally become much more open to talk through distressing
| things that you otherwise normally numb over and helps you
| process past traumas much more efficiently.
| iseedumbpeople wrote:
| Sad to see the censorship on this website flagging all
| critical thought. It's a good example of the dangers of
| censorship pushed by the so called "liberals" who are
| really just dangerous facists.
| [deleted]
| filoleg wrote:
| Agreed. Imo, psilocybin won't just magically fix a chemical
| imbalance in your head. But it can open you up (for the
| duration of its effect) to some thoughts and ideas that
| could help you resolve your internal issues causing you
| depression, and those thoughts and realizations are what
| can help with getting rid of depression, as those
| realizations can stay with you even after the trip is over.
|
| Which is somewhat similar to what i have read about the
| ketamine therapy, which essentially just makes certain
| areas of your brain more neuroplastic for a short duration,
| helping you get out of your routine thought patterns and
| help create new neural pathways and reshape the existing
| ones easier.
|
| Note: I am not a brain researcher myself at all, so what I
| said could totally be just some pseudoscientific bs, but
| that's what I got after reading a bunch on both of the
| topic in a lot of places, including other HN threads. If
| you want to correct some misunderstandings in my post,
| please feel free to reply. I will be very happy to correct
| my misunderstandings.
| tempsy wrote:
| yeah not sure why my comment was downvoted tbh. i guess
| there is a large segment of the population that thinks of
| illness as something that happens to them, and doesn't
| want to take responsibility in controlling or mitigating
| it without a so called magic pill.
| freedomben wrote:
| > _From my experience it 's incorrect to think of
| psilocybin as some magic pill that will magically make your
| depression go away._
|
| I don't think you are accusing me of saying that, but just
| to be clear I completely agree with this. Michael Pollan's
| book also doesn't paint it as a "magic pill." No doubt some
| people assume that, but I don't believe it exists.
|
| I do wonder about the accuracy of Freudian ideas, such as
| something in ones childhood being the cause or at least
| playing a role. It's certainly possible. Being raised by
| depressed people sucks, and there's a lot of scars that
| probably contribute to why depression seems to be
| inherited.
| yarg wrote:
| Magic mushrooms were the first substance to make me feel like
| myself after years and years of deep depression.
|
| But I didn't get quite the one hit, life changing state of
| mind that is often attributed to psychedelics.
|
| One thing that I have read is that the whole life-changing
| thing requires a transcendental experience - and that
| participants who failed to reach that echelon didn't
| experience long term improvement.
|
| I can't really comment on that - because I simply never
| reached that breakthrough dose.
|
| The biggest issue for me is that magic mushrooms taste kinda
| bad - it's rather hard to eat enough of them.
|
| Truffles on the other hand, are completely inoffensive -
| tasting (in some way) like a slightly off nut.
|
| I could quite happily snack on a big-ass bowl of those
| things, and watch enthralled as the world turned weird.
| pmoriarty wrote:
| _" Magic mushrooms were the first substance to make me feel
| like myself after years and years of deep depression. But I
| didn't get quite the one hit, life changing state of mind
| that is often attributed to psychedelics."_
|
| Did you take them under the supervision of a trained
| psychedelic therapist, with the appropriate dose, with the
| right intention, in a therapeutic context, over multiple
| sessions, using a protocol designed for maximum therapeutic
| effect (which usually includes talk therapy both before and
| after the sessions)?
|
| Having the right set and setting are both absolutely
| critical to get the most out of psychedelics.
| ergothus wrote:
| > I've always been on the skeptical side of medical marijuana
| usage in all but the most extreme cases,
|
| Really? I've always found the milder claims fairly believable
| (fighting nausea or chronic low level pain relief). As an
| anecdote, I can attest to dealing with kidney stone pain well
| (rather than stopping the pain it reduced how much I noticed
| it) and it ended up more effective and felt less dangerous than
| the opiods I had used in the past.
|
| Some of the more "miracle" claims, however, seem pretty suspect
| to me and I'd want some reliable reseach.
|
| What makes you skeptical of so many claims?
| yarg wrote:
| The treatment of Dravet syndrome with CBD seems to have
| genuine damned near miraculous results.
|
| And yes, the pain relief is very real.
| derefr wrote:
| Personally, I'm a skeptic that 1. CBD+THC offers any
| additional medical+ benefits over CBD used alone; 2. that it
| makes any medical sense to prescribe a (non-dose-
| controllable) plant over a pill, or at the very least an
| extract with tested dosage. I'm not skeptical of the medical
| benefits of (some of) the compounds _in_ marijuana; I 'm just
| a skeptic of prescribing _marijuana itself_ as a way of
| delivering those compounds. It 's like prescribing willow
| bark for a headache when aspirin exists.
|
| + For what it's being prescribed for, I mean--pain, nausea,
| anxiety, etc. THC, in its function as a psychedelic, _may_
| function as a treatment for certain psychiatric disorders
| (i.e. for much the same purpose LSD /MDMA/etc. are being
| investigated for.) But nobody's prescribing medical marijuana
| for this use-case right now; they're prescribing it for
| things where the presence of THC seems pretty irrelevant to
| the goal.
| oarabbus_ wrote:
| Hydroponic cannabis is grown in highly controlled
| environments and the dosage levels are tested to be within
| an acceptable range. There are also dozens (hundreds) of
| other cannabinoids found in marijuana which (may) have
| additional medical benefits.
|
| >It's like prescribing willow bark for a headache when
| aspirin exists.
|
| Willow bark contains salicin, not aspirin, while marijuana
| contains both THC and CBD. Willow bark also doesn't have
| the same blood-thinning effects of aspirin, which makes
| both viable pain relief choices for different populations.
|
| This really just sounds like "plants bad; pills good!"
| derefr wrote:
| My point was more, "measurement good; eating psychoactive
| things off the ground bad."
|
| The "key advancement of chemistry"--the thing that makes
| chemistry _chemistry_ , rather than alchemy (and as it
| happens, the thing that differentiates baking from
| cooking) is being able to measure the reactants we put
| into a beaker, and clean the product of the reaction of
| any side-products, such that we can then
| crystallize/distill/etc. out the product alone, weigh it,
| and thereby determine the exact potency of product. Once
| we know that, we can then do all sorts of things: dilute
| it to a controlled strength; create delivery vehicles
| that deliver it at particular speeds; put it straight
| into the body in ways that would just kill you if you put
| into the body all the _other_ stuff that you isolated the
| product out of; etc.
|
| Anyone can do this. People make THC tinctures and
| essential-oils all the time, in their kitchens. It
| doesn't matter to me whether you do it or someone else
| does it for you; but it seems irresponsible to me to tell
| someone to go eat the non-processed version for medical
| effect.
|
| > Hydroponic cannabis is grown in highly controlled
| environments and the dosage levels are tested to be
| within an acceptable range.
|
| Sure, you can control everything about the production of
| the marijuana itself. But the key to medical treatment is
| the last mile, and _specifically_ the ability to relate a
| patient 's response over time to a dosing
| schedule/pharmacodynamic profile for the drug. If you
| prescribe someone "medical marijuana", without fixing
| down _how_ they 're going to take it, they could very
| well do anything from eating the whole batch at once, to
| vaping it every three minutes, to just doing hits off a
| bong whenever they feel pain. These _are not the same
| thing_ , and medically they should be _different
| prescriptions_ if the doctor has any hope of knowing
| whether the treatment is _working_.
|
| Pills (or, really, anything more specific than "here's a
| plant, go to town") let a doctor say something more
| specific like "take one of these every two hours", and
| then from there know _exactly_ how much of the active
| ingredient should be in the patient 's bloodstream at any
| given time of the day, and so be able to measure effects
| (and side-effects!) against those that are normal, or
| abnormal, for that level of dose being in the patient's
| body for that period of time.
| heavyset_go wrote:
| > _CBD+THC offers any additional medical+ benefits over CBD
| used alone_
|
| You should because empirical evidence shows that there are.
|
| CBD's most overt therapeutic effect is mediated through
| action at 5HT1A autoreceptors and allosteric modulation of
| mu-opioid receptors, whereas THC's MoA is mediated through
| CB1 agonism, to a lesser extent CB2 agonism, and to a
| lesser extent than CBD, allosteric modulation of mu-opioid
| receptors.
|
| THC has anxiogenic (and paradoxical anxiolytic) and
| psychotomimetic properties, and has the property of
| inducing schizophrenia-related disorders in some people.
| CBD's action at 5HT1A receptors both induces an anxiolytic
| effect, and reduces the symptoms of psychotic disorders.
|
| A combination of CBD+THC can reduce the negative side-
| effects of THC used alone, and CBD alone does not have the
| same effects as THC or CBD+THC. There are studies that
| document the synergic effects of combined cannabinoids
| versus isolated cannabinoids.
| dbingham wrote:
| In the case of pain treatment, it seems likely that the
| psychoactive affects of THC may be a large contributor to
| its effectiveness. In that it distracts you from the pain.
|
| And there are a lot of people who are going to be more
| comfortable taking a plant in its natural state, than using
| an isolated compound that's been through a processing plant
| they have no control over, and which depends on a
| regulatory structure they have no faith in to tell them its
| safe (and what they are expecting).
|
| Basically, there are a lot of people very skeptical of the
| corporate drug system (for good reasons, frankly), and the
| availability of natural herbal medicines does (for the most
| part [aside 1.]) no harm to them, and actually can do quite
| a bit of good.
|
| If they don't trust aspirin, then let them use willow bark.
|
| 1. Obviously there are exceptions to this. There are some
| herbs that are considerably more dangerous and harmful than
| the useful compounds isolated from them. But there are also
| many herbs that are perfectly safe to use, and still
| effective to one degree or another. In some cases, they are
| every bit as effective, and even safer, than the isolated,
| concentrated alternatives (see St John's Wort).
| derefr wrote:
| I would argue that if they don't trust aspirin, they
| should buy a kit that lets them make aspirin (or salicin,
| rather) at home _from_ willow bark. Still safer than
| consuming arbitrary unknown amounts of salicin, together
| with whatever else is in the bark _besides_ salicin.
|
| Let me put it this way: the big-pharma drug manufacturing
| (and more generally, medical-equipment manufacturing)
| pipeline is set up such that the only thing about a drug
| that should be able to kill someone, is if the drug's
| active ingredient itself has a bad interaction with their
| body.
|
| Something like medical marijuana, meanwhile, can kill you
| by heavy-metal soil toxicity; by pesticides; by
| coincidental allergens in non-active-ingredient plant
| matter; etc.
|
| None of these things will be checked for when you get a
| dose of medical marijuana.
|
| An analogy: would you trust IV saline solution that's
| just salt that someone poured into "carefully collected
| rainwater" and then put into a bag? Even for an
| immunocompromised patient (i.e. exactly the kind who
| consumes medical marijuana for e.g. supportive cancer
| treatment)?
|
| No; you'd distill the water, wash and recrystallize the
| salt, and basically do everything else you can to ensure
| that "salt and water" is _all_ that 's in the "bag of
| salt and water" you're putting into the patient's
| bloodstream. Because that's how you ensure that some
| random variable doesn't creep in and mysteriously make
| them sick in a way that's impossible to diagnose.
| monkmartinez wrote:
| >Let me put it this way: the big-pharma drug
| manufacturing (and more generally, medical-equipment
| manufacturing) pipeline is set up such that the only
| thing about a drug that should be able to kill someone,
| is if the drug's active ingredient itself has a bad
| interaction with their body.
|
| "Should be" is a giant risk factor... "Don't worry Mrs.
| Jones, this drug shouldn't be able to kill you unless you
| have a terrible allergic reaction!"
|
| Big-pharma has shown, repeatedly, that their sole
| motivation is not altruistic treatments of human
| aliments... it is that of any other corporate entity.
| Profit. I don't think that is inherently evil either.
|
| Medical cannabis could kill you... you are right, but I
| would argue that you are much more likely to be killed
| from alcohol or tobacco related events.
|
| For just one data point: I've worked in EMS for 14 years
| and I have never seen a cause of death that was directly
| the result of using cannabis. Unfortunately, I have lost
| track of how many people I have seen die that were the
| direct result of alcohol ingestion. Same for Oxycotin and
| other opioid based "medicine" prior to everyone and their
| brothers walking around with narcan.
| DennisP wrote:
| > heavy-metal soil toxicity; by pesticides; by
| coincidental allergens in non-active-ingredient plant
| matter
|
| The exact same risks are in your grocery store produce
| aisle.
|
| I'll grant that _illegal_ marijuana has higher risk, but
| if it 's regulated like any legal food crop I don't see
| the difference; in fact, I'd say there's less, since
| people consume it in relatively low quantities.
| dbingham wrote:
| IV Saline Solution is not a good analogy, that's a very
| different case from herbal medicine.
|
| People have been using willow bark for pain relief for
| hundreds if not thousands of years. They have not been
| injecting saline solution.
|
| There's reason to believe that, in some cases, it is
| better to get medicines in their tried and true forms
| (those used for hundreds or thousands of years) rather
| than their more recent isolated forms (which only have a
| few decades of use). There could be beneficial
| interactions between all those unknown substances. In
| some cases - again see St John's Wort - the natural herbs
| are more effective, safer, and with fewer side effects
| than the concentrated drugs. And they are infinitely more
| available, since they can be grown right in your back
| yard.
|
| There are of course exceptions to this - there was the
| very popular Chinese herb that had been used for a
| thousand years that turned out to give you throat cancer.
|
| Don't get me wrong, I use the medical system. I also
| sometimes use herbal medicine, but I'm much, much more
| likely to reach for Advil than I am for willow bark. But
| I understand those who reach for willow bark, and
| recognize the validity of their reasoning.
|
| Personally, I want to see these herbs tested in proper
| trials so we can determine which are pure placebo, which
| are effective the way St John's Wort is, and which are
| dangerous the way that Chinese herb was. If we can
| identify the ones that are actually effective, then that
| opens up a ton of room for people to self medicate and
| frees up resources in the medical system for those who
| really need them.
| taxidump wrote:
| >Personally, I'm a skeptic that 1. CBD+THC offers any
| additional medical+ benefits over CBD used alone;
|
| Why?
|
| >2. that it makes any medical sense to prescribe a (non-
| dose-controllable) plant over a pill,
|
| Some medication, in pill form, is highly toxic.. see
| opiates which is a common alternative to thc for pain
| relief.
|
| How did your comment reach the top?
| tsimionescu wrote:
| The point of 2 was that you could synthesize a drug
| starting from Marijuana instead of prescribing it
| directly. It wasn't about prescribing opioids instead of
| Marijuana.
| derefr wrote:
| > Why?
|
| Because there are no studies proving it has any benefit?
| Because, from clinical anecdote (i.e. stories from my
| doctor friends) CBD alone seems to work perfectly as a
| treatment for every problem where "try medical marijuana"
| is the current line on the treatment flowchart?
|
| I mean, admittedly, I'm not friends with _every_ kind of
| doctor. I don 't know whether THC has any added benefit
| in cancer treatment, for example. That's why I'm not
| _denying_ the benefits of THC; I 'm just _skeptical_ of
| them. I 'd like to see some supporting evidence!
|
| > Some medication, in pill form, is highly toxic.. see
| opiates which is a common alternative to thc for pain
| relief.
|
| Opiates in pills are no more or less toxic in pill form
| than in their "native" form (e.g. the opium poppy.) There
| are even animal nerve toxins that are classified as
| opiates. It is the molecule itself--and the dose--that
| makes something toxic, not the delivery mechanism.
|
| The point of putting something in a pill--or even more
| simply, of extracting and distilling an active ingredient
| into an essence--is to make the dose measurable and to
| control for any unknown variables (the other stuff
| besides the active ingredient), so that dosing can be
| done precisely.
|
| Without first isolating and measuring the active
| ingredient(s), there is no way to, for example, make
| "extended release" or "immediate relief" forms of medical
| marijuana, because you both don't know how much THC+CBD
| is entering your body, and (with edibles or anything
| besides smoking) don't even control how quickly your own
| metabolism takes up the active ingredient from the plant
| matter.
| jcims wrote:
| Not that you're looking for anecdotes but I've noticed a
| broader spectrum of effect when THC is in the mix.
|
| For point 2, I couldn't agree more. I think it's just an
| industry maturity thing. My wife is using it for
| appetite/anti-emetic effects and trying to 'dose' with dry
| herb or pen vaporizing is a joke, and most of the
| oils/edibles are administered in a way that has pretty
| gnarly taste/aftertaste that has been counter-productive
| for her. (I've started making my own tablets but it still
| feels like a crap shoot)
| vmchale wrote:
| There are other anti-nausea drugs lol.
|
| Maybe it's useful if nothing else works but come on.
| cmrdporcupine wrote:
| For myself cannabis literally has the opposite effects --
| increases inflammation and pain (I have chronic back pain).
| So I think it's right to be skeptical because the compounds
| themselves have extremely variable results.
| tudelo wrote:
| This is very surprising to me -- have you done any research
| in to this? I would be interested to go down the rabbit
| hole but if you did some of the research already maybe we
| can be efficient humans :D
| sawyerjhood wrote:
| I tend to agree with grawprog. I think it is powerful in
| cases like chemo (I had a friend who used MM on chemo and it
| curbed his nausea like no other drug could). For chronic pain
| I think it is better than opiates, but I'm not sure that the
| side-effects out-weigh the benefits. My mother has knee
| issues and is a MM user, but the marijuana is not helping at
| all with the root cause (she is severely overweight at 5ft
| 4in and over 300lb). Mainly I think that I see medical
| marijuana as being over-prescribed where there are better
| solutions. I personally don't have any problems with
| marijuana overall as I am a recreational user.
| grawprog wrote:
| I've definitely experienced the anti-inflammatory properties
| and the anti-nausea effects allowed my mom to keep food down
| while going through chemo. It was the only thing that would
| take away her nausea.
|
| I do agree with the parent poster about the more miraculous
| claims though and I think, personally those more miraculous
| claims create skepticism for the actual benefits.
|
| I kind of wish everyone took a more level headed approach to
| drugs in general. Every drug out there has some benefits and
| drawbacks. Without proper study, we're potentially missing
| many benefits and won't fully understand all the drawbacks.
|
| This includes approved pharmaceutical drugs too. Too many
| drugs get rushed out without fully understanding the side
| effects until people start suffering or dying.
| ArtWomb wrote:
| Low hanging fruit here may be ayahuasca / ibogaine treatment
| for symptoms of withdrawal from chronic opioid abuse.
|
| It sort of makes sense intuitively. If you you can just make it
| through the agony of junk sickness. You are in the clear. A
| 36-hour dose seems preternaturally suited.
|
| https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5773453/
| iseedumbpeople wrote:
| Oh please this is pure propaganda. Even the great Terrance
| McKenna had to stop doing shrooms later in life because a bad
| trip fucked him up so badly. The potential for misuse and serious
| psychological dissociation is huge for anyone who is depressed
| and abusee psilocybin. Micro dosing and/orhaving a few wondrous
| trips is great if you come at it with a good headspace. Use it as
| a crutch after a break up or while surrounded by toxic people and
| you are most likely in for a very bad time that many may not be
| equipped to deal wih.
| cityzen wrote:
| Awesome! Can't wait until 2030 when it is legal in a handful of
| states in the US.
| iseedumbpeople wrote:
| Why is critical discussion being flagged?
| kasperni wrote:
| Now that mainstream club drugs such as MDMA, Ketamine, and
| LSD/Magic Mushrooms are finding their way into therapeutic usage.
| I'm wondering if and how governments will change the current
| narrative about "all drugs are bad for you".
|
| Edit: I'm not advocating recreational drug usage. Just saying,
| that if mum is on magic mushrooms and studies like these have
| established safety dosage and clear therapeutic benefits. You
| can't really tell your teenager that they are going to go crazy
| if they try some.
| tempsy wrote:
| Uhh would definitely never recommend taking LSD or shrooms to
| go clubbing.
| yellow_lead wrote:
| After Snowden's revelations, I also wondered if the government
| would change it's practices.
| JumpCrisscross wrote:
| > _I 'm wondering if and how governments will change the
| current narrative about "all drugs are bad for you"._
|
| Caffeine and alcohol are "drugs". But they aren't drugs. In the
| same way, I think we'll the label released from accepted
| substances, while remaining attached to unacceptable ones.
| mikelyons wrote:
| MDMA, Ketamine and LSD sure, but mushrooms have been in use for
| spirituality far longer than mainstream clubs have even been a
| concept.
| kasperni wrote:
| Right, but they haven't been classified as an illegal drug in
| most countries until recently.
| warent wrote:
| As long as it's popular understand and opinion of drugs, then
| ultimately democratic/representative governments are going to
| have to start changing the narrative if they want to stay in
| office
| vmchale wrote:
| I don't think Psilocybin mushrooms or LSD are used as a club
| drug.
| kasperni wrote:
| I think it depends on the definition,
| https://en.wikipedia.org/wiki/Club_drug includes them
| robertfw wrote:
| Perhaps not club, but most definitely festival
| trekrich wrote:
| They wont change it, as they will be paid lots of lobbying
| money to not change it.
| globular-toast wrote:
| Yes. Unlike alcohol, there is very little money in those
| drugs. Most of them aren't even addictive!
| teslaberry wrote:
| everything is safe or unsafe depending on dose-age and frequency
| of use. click-bait stupid analysis / catchphrases /headlines
| about drugs are why the average conservative is quite rational in
| their approach to just thinking that the better advice for
| younger people is to simply abstain.
|
| the same applies to coffee.
|
| if you don't know how to use a drug properly you shouldn't use
| it.
|
| saying it 'is safe' is nonsense. TOTAL ABSURD NONSENSE.
|
| morphine is safe. it is used tens' of thousands of times a day by
| people in intensive care units around the u.s. , maybe millions.
|
| 'safe'.
|
| nothing is safe. everything is safe. what isn't safe is listening
| to nonsense.
| aargh_aargh wrote:
| The study seems to be this one:
|
| https://doi.org/10.3389/fphar.2017.00974
|
| Would it kill the PopSci article to include the DOI to the actual
| study?
| iseedumbpeople wrote:
| There is a dangerous pro drug agenda being pushed here. The
| owners of this website are not good people.
| MobileVet wrote:
| This could dramatically improve my family's life.
|
| Been following and supporting the research at Johns Hopkins since
| Tim Ferris brought attention to it.
| every wrote:
| I was performing my own informal tests on various psychoactive
| agents in the late 60's and early 70's and can attest to the
| efficacy of psilocybin, as best as I can remember...
| internet_user wrote:
| Some charts and data:
|
| https://compasspathways.com/wp-content/uploads/2019/12/poste...
|
| "Psilocybin administration to healthy participants: safety and
| feasibility in a placebo-controlled study"
|
| "Poster presented at the 58th Annual Meeting of The American
| College of Neuropsychopharmacology, Orlando, FL, USA, 8-11
| December 2019"
| arkades wrote:
| This is NOT a trial that was designed to assess the safety of
| psilocybin. This was a trial meant to show that a particular
| dosage of psilocybin is /safe enough/ to pursue further research
| in that dose range.
|
| This was a /phase one/ clinical trial.
|
| Phase One: administer small doses under very close supervision in
| a tiny number of people to determine whether it's immediately
| dangerous, or safe enough /for further study/. They used 89 -
| initial randomization of 30 each to placebo, 10mg, and 25mg.
| That's a good number for a phase one trial. But when we look at
| the sort of things that start hurting people when released to
| market, they're the sort of adverse effects that go undetected in
| trials with thousands of participants, and would need an
| infeasible large trial (>10k patients) to detect.
|
| This trial does not prove safety. This trial is meant to
| establish a dosing range that is /safe enough/ to participants to
| allow for further study. They found no "serious" adverse effects,
| in healthy volunteers - that is, not depressed patients. Can
| drugs like this have different effects in people w and without
| depression? Yes they most certainly can, in particular if those
| people are on concurrent medications (which they will be, since
| this is being developed for treatment-resistant depression).
|
| "We wanted to look at the safety and tolerability profile of our
| psilocybin, and to look at the feasibility of a model where up to
| six one-to-one sessions are held at the same time." No they
| didn't /want/ to - they /had/ to. This is article is just a press
| release.
|
| Phase 2 is generally a range of doses, within the range
| established in phase one, wherein we attempt to determine, to a
| rough level of accuracy, which doses show toxicity, which show
| therapeutic benefit, and at roughly what proportions. This phase
| is meant to determine what dose will be used in a phase 3 trial,
| if any dose exists with an appropriate proportion of therapeutic
| benefit to side effect.
|
| Phase 3 - a dose (or couple of doses) of a drug in a regimen
| meant to reflect real-world proposed usage is distributed and
| compared against either a currently used drug or a placebo.
| Depending on how big an effect is expected, how common the
| disease, etc. we'd look at trials of hundreds to thousands of
| patients. This is the trial where we get a real sense of safety,
| side effect profiles, efficacy, etc. This is the make-or-break
| line for getting your drug to market.
|
| Phase 4 "trial" - aftermarket surveillance. Goes on for years
| after a drug hits market, because there's no trial that comes to
| close to capturing the rare side effects that may be visible when
| applied to the general population.
|
| This was, also, presented to a neuropsychopharm conference, not
| published data. Which is to say, they're ready to brag about it,
| but they're not ready to submit themselves to close scrutiny.
| mikefivedeuce wrote:
| Thanks for this breakdown. Any thoughts on how this process
| might unfold for psilocybin as opposed to a drug that's subject
| to a chemical patent? Funding, timing, etc.
| arkades wrote:
| I'm not familiar with the company running this trial, but I
| can basically guarantee you they have found a way to patent
| this. Their intention is to come to market in 5 to 10 years,
| and there's no way they're bearing the expense of phase 3
| trials just to become a generic manufacturer. Psilocybin
| isn't hard enough to manufacture (as opposed to say,
| propofol) to provide any sort of moat. They'll probably try
| to patent either an extended-release form or a particular
| administration device (e.g., inhaler).
|
| E.g., the company that did the major trials for ketamine
| actually studied the s-enantiomer of ketamine using a nasal
| spray, which is quite distinct from the years of data we've
| accumulated on racemic ketamine with prolonged IV infusion.
| But this let them get a patentable version of ketamine on the
| market.
| derefr wrote:
| Still big news that anyone is even doing phase 1 trials, since
| you wouldn't tend to bother if you didn't intend to follow up
| with further phases. I.e. "X is safe in a phase 1 trial" is
| never a useful terminal fact that you set out to prove and
| then, having proven it, do nothing more.
| arkades wrote:
| The vast majority of drugs don't make it through phase 3.
| Most will fail by the end of phase 2. If we trumpeted every
| time a prospective intervention underwent the earliest phases
| of study... well, I guess we'd have what we have had for
| years. Constant claims of miracle drugs on the way, with
| almost no subsequent impact on human lives.
|
| If you find the endless hype a source of optimism and hope,
| then ... well, I guess I /am/ glad you have another source of
| optimism and hope. I don't share it, though.
| derefr wrote:
| Oh, to be clear, I'm not excited by the prospect of
| psilocybin making it all the way to FDA approval. What
| excites me is that this is more evidence of a pattern of
| change in what medical research is being conducted. There
| were many drugs that we were "leaving on the table" before,
| that we're actually bothering to look into now. Whether or
| not they turn out to _work_ for anything, at least we 'll
| know, instead of pretending they don't exist!
| dmurray wrote:
| Are controlled experiments necessary for proving safety?
| Intuitively, there shouldn't be a placebo effect, and you could
| get twice as powerful a study by giving twice as many people
| the drug and using statistics for the general population as the
| control group.
| arkades wrote:
| No. For phase 1, it's generally sufficient to show that few
| or no people had life-threatening adverse effects, that none
| of the life threatening effects were plausibly related to the
| drug, and there were no meaningful hiccups in CNS, pulmonary,
| or cardiac function.
|
| In this case, they went for a placebo set-up because they
| were also trying to grab a little data to show whether 25 mg
| was significantly distinct from 10mg. The comparison to
| placebo was not needed, but is winning them a little extra
| publicity.
| semi-extrinsic wrote:
| Why shouldn't there be a placebo effect? It's well documented
| for basically any drug, even for alcohol. Serve people non-
| alcoholic drinks but tell them otherwise, and they get drunk.
| dmurray wrote:
| Because the trial wasn't about finding the expected effect
| (drunkenness) but the secondary effects. People don't get
| heart disease or cirrhosis from non-alcoholic drinks, or at
| least, I'd be interested in reading the study where they
| do.
| endorphone wrote:
| It's worth noting that they were testing with 10mg and 25mg,
| which is equivalent to about 2g and 4.5g of dried mushrooms
| which are significant doses (e.g. far from microdosing). They
| reported no significant negative effects on cognitive and
| emotional functioning which is surprisingly positive for such
| an experience. Instead it is just the expected psychedelic
| experience.
|
| As to safety, the LD50 of psilocybin is pretty well established
| at very high levels, with physical effects being unreported
| below that.
| arkades wrote:
| The press release noted no negative effects. The poster they
| presented to the neuropsychopharm folk the other night noted
| a few hundred, but none life-threatening.
|
| Poster: https://compasspathways.com/wp-
| content/uploads/2019/12/poste...
| JackRabbitSlim wrote:
| https://www.caymanchem.com/msdss/14041m.pdf
|
| Acute toxicity level 4 for Oral ingestion
|
| https://www.ilo.org/legacy/english/protection/safework/ghs/g...
|
| Defines Toxicity level 4 as ~ 2000 to < 5000 mg/kg
|
| The most potent strain of "magic mushrooms" are at most ~2% by
| weight(Psilocybe azurescens)[0]. So according to all the de
| facto standard literature, a _potentially_ fatal dose of magic
| mushrooms is over 3 ounces of dried mushroom per kilogram of
| body weight. At 68 kg I would need to ingest over 5 kg to come
| up to the _lower_ bound of the LD50.
|
| No one without an axe to grind could realistically argue
| toxicity is a real valid concern.
|
| [0]https://www.shroomery.org/8700/Psilocybe-azurescens-
| taxonomy...
| arkades wrote:
| Acute toxicity and LD50/fatal dosages are fine when you're
| worried about acute overdoses or unintentional ingestions.
|
| Those are not the measures we are concerned with when we're
| talking about uncommon or rare effects (which, like the Vioxx
| deaths, had an incidence of one in /thousands/ at standard
| dosages), or effects that manifest with /chronic/ usage
| (e.g., over years of use, as is common with anti-depressant
| therapy).
|
| What you're discussing is apples to oranges.
| internet_user wrote:
| It's not about toxicity, but tolerability limits and side-
| effect profile.
| mothsonasloth wrote:
| I'm gonna sound really cliched but I have become really
| fascinated with Psychedelics thanks to the Joe Rogan podcast.
|
| I wouldn't say I am depressed but as someone who doesn't drink,
| smoke, drugs or take caffeine. I really want to try them.
|
| The fact that mushrooms have been used by shamans all around the
| world since neolithic times, is truly fascinating.
|
| I hope to try them at some point although at the moment I have
| been trying Sensory Deprivation Tanks and it really has reset my
| mind and emotions.
| ianai wrote:
| I'd steer you toward kava kava as a legal and otc way to change
| your mind and emotions for the better or more open. Also St.
| John's wort.
| r00fus wrote:
| What source would you recommend? I've tried some name-brand
| kava tea and it didn't seem to do much.
| ianai wrote:
| I've had extracts that didn't do much. Pills of the powder
| have helped. The biggest experience I had was with the full
| on blending of the powder in a blender following a YouTube
| recipe video-wakacon from amazon.
| mothsonasloth wrote:
| After googling, it appears that kava causes liver damage,
| thanks but no thanks
| LinuxBender wrote:
| Yes you probably would not want to take it for an extended
| period of time [1] There is not a direct causation link to
| liver damage as of yet. It may be that people have a
| preexisting issue that is exacerbated by kava.
|
| [1] - https://examine.com/supplements/kava/
| ianai wrote:
| There was something of a hit campaign against it at one
| point. I forget the specifics, but it's safe if you do
| your homework and buy from proven sources.
| LinuxBender wrote:
| That's happened to several food compounds. Scientists
| don't spend time on a compound unless there is a
| compelling medical need to do the research. There just
| isn't much money in supplements / foods as compared to
| prescription drugs and the risk of litigation is really
| high, according to a few of my favorite scientists that I
| follow.
| LinuxBender wrote:
| I would add in the non essential amino acid L-Theanine [1].
| Has a nice calming and focusing effect.
|
| [1] - https://examine.com/supplements/theanine/
| ianai wrote:
| I get that from matcha in the morning. Very focused, almost
| driven sort of energy. Definitely a nootropic for my
| purposes.
| redisman wrote:
| Personally I didn't notice any difference before or after
| or during going through a bottle of it.
| LinuxBender wrote:
| I am not a neurologist nor a doctor and I am entirely
| guessing, so I should not even comment, but some people
| may not be affected by small amounts of amino acids like
| this depending on their diet, gaba receptors, existing
| amino acid intake such as already drinking green tea or
| using arginine or citruline, or other medications. It is
| entirely possible that your a waves are already elevated
| from something else or that this amino acid isn't
| metabolized correctly.
| maxkwallace wrote:
| Related: How To Change Your Mind is worth reading. It covers the
| history of psilocybin & LSD research including the early parts of
| this recent resurgence in interest.
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