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Psilocybin found safe for consumption in largest ever controlled study

independent.co.uk

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Re: Psilocybin found safe for consumption in largest ever controlled study

#61
post #28

Earlier quoted context omitted.

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…

>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?

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.

Re: Psilocybin found safe for consumption in largest ever controlled study

#62
post #37
post #8

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/…

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.

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.

Re: Psilocybin found safe for consumption in largest ever controlled study

#63
post #28

Earlier quoted context omitted.

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…

>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?

> 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.

Re: Psilocybin found safe for consumption in largest ever controlled study

#64
post #6

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.

> 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…

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.

Re: Psilocybin found safe for consumption in largest ever controlled study

#65
post #8

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/…

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 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…

It's not about toxicity, but tolerability limits and side-effect profile.

Re: Psilocybin found safe for consumption in largest ever controlled study

#66
post #28

Earlier quoted context omitted.

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…

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 t…

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.

Re: Psilocybin found safe for consumption in largest ever controlled study

#67
post #8

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/…

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.

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.

Re: Psilocybin found safe for consumption in largest ever controlled study

#68
post #8

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/…

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…

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...

Re: Psilocybin found safe for consumption in largest ever controlled study

#69
post #28
post #6

Earlier quoted context omitted.

> 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…

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…

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)

Re: Psilocybin found safe for consumption in largest ever controlled study

#70
post #21

Earlier quoted context omitted.

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.

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/

Personally I didn't notice any difference before or after or during going through a bottle of it.
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