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Re: Clinical Trial with Psilocybin in Los Angeles [Re: opensaysme]
    #7534635 -

It is more than likely synthesized psilocybin.

As far as the study population is concerned, it is much easier to pass a study through institutional review if you are administereing drug to "users".

All other parameters are up to the investigators. The experimental design will depend upon the outcome measures they are looking at. In this case, it appears to be standard psychiatric assessments of depression and anxiety.


--------------------
...the whole experience is (and is as) a profound piece of knowledge.  It is an indellible experience; it is forever known.  I have known myself in a way I doubt I would have ever occurred except as it did.

Smith, P.  Bull. Menninger Clinic (1959) 23:20-27; p. 27.

...most subjects find the experience valuable, some find it frightening, and many say that is it uniquely lovely.

Osmond, H.  Annals, NY Acad Science (1957) 66:418-434; p.436

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Re: Clinical Trial with Psilocybin in Los Angeles [Re: badchad]
    #7535904 -

wouldnt it be easier just to synthesize psilocin? seems like that would cut down on the variable of how quick the individuals dephosphorylate the psilocybin.

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Re: Clinical Trial with Psilocybin in Los Angeles [Re: SneezingPenis]
    #7536228 -

Yes.

More importantly (as someone mentioned earlier) it would allow standardized doing.


--------------------
...the whole experience is (and is as) a profound piece of knowledge.  It is an indellible experience; it is forever known.  I have known myself in a way I doubt I would have ever occurred except as it did.

Smith, P.  Bull. Menninger Clinic (1959) 23:20-27; p. 27.

...most subjects find the experience valuable, some find it frightening, and many say that is it uniquely lovely.

Osmond, H.  Annals, NY Acad Science (1957) 66:418-434; p.436

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Re: Clinical Trial with Psilocybin in Los Angeles [Re: badchad]
    #7536280 -

and we all know how important standardized doing it is.

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Re: Clinical Trial with Psilocybin in Los Angeles [Re: SneezingPenis]
    #7536395 -

STandardized dosing is very important in clinical trials. Especially when you are assessing largely subjective measures and using psychoactive substances.

It also facilitates the design of a placebo control.


--------------------
...the whole experience is (and is as) a profound piece of knowledge.  It is an indellible experience; it is forever known.  I have known myself in a way I doubt I would have ever occurred except as it did.

Smith, P.  Bull. Menninger Clinic (1959) 23:20-27; p. 27.

...most subjects find the experience valuable, some find it frightening, and many say that is it uniquely lovely.

Osmond, H.  Annals, NY Acad Science (1957) 66:418-434; p.436

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Re: Clinical Trial with Psilocybin in Los Angeles [Re: badchad]
    #7539200 -

What dose do you you think would be best for the clinical trials? I guess it would have to vary from person to person based on the sensitivety of the test subject. Right?


--------------------
"In god we trust..."


-I guess we're screwed.

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Re: Clinical Trial with Psilocybin in Los Angeles [Re: ThePyschonaut52]
    #7539222 -

I don't think so because if the doses would differ, the research wouldn't have a conclusive answer.
Something has to remain the constant, and the psychedelic experience itself always varies in intensity from person to person.


--------------------
:bunny::bunnyhug:
All this time I've loved you
And never known your face
All this time I've missed you
And searched this human race
Here is true peace
Here my heart knows calm
Safe in your soul
Bathed in your sighs
:bunnyhug: :yinyang2:

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Re: Clinical Trial with Psilocybin in Los Angeles [Re: MushroomTrip]
    #7539242 -

True.


--------------------
"In god we trust..."


-I guess we're screwed.

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Re: Clinical Trial with Psilocybin in Los Angeles [Re: ThePyschonaut52]
    #7539280 -

If i had to guess i would say that they would prob experiment with 2-3 different dosage levels, of course each person getting the same amount at each level. Probably a placebo once, a low dose once, and a high dose once; possibly with a moderate dose thrown in for good measure. My guess is the highest dose would go no more than the equivalent amount of psilocybin in around 3.5-4g cubes

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Re: Clinical Trial with Psilocybin in Los Angeles [Re: Thor]
    #7542402 -

Phred sure is, as I have had some PMs between the two of us regarding this. I can tell you from my personal experience, that mushies help me in an incalculable way, when it comes to squashing a severe migraine. I have the highest percentage of disability from the Department of Veteran Affairs due to migraines.


My friend of a friend does cultivate mushrooms for this purpose;since all the preventive medications I have taken: Imitex, Replax,Midrin,Zomig, Lithium...ETC....dont give me relief most of the time (at which I then proceed to puke in a bag)The only option at this point, is to kill the migraine by taking prescribed Percocet, which totally make it impossible for me to work. I find it quite trivial that Docs will prescribe me enough painkillers (deriving from opium, a plant) to take down a rhino , yet there are no legal medications coming from the sacred mushroom.


I hope that one day psilocybin in my possession, will not make me a criminal for trying to heal myself. Not to dramatize, but this aliment does make people lives a living HELL


--------------------
“I must not fear.
Fear is the mind-killer.
Fear is the little-death that brings total obliteration.
I will face my fear. I will permit it to pass over me and through me.
And when it has gone past I will turn the inner eye to see its path.
Where the fear has gone there will be nothing. Only I will remain.”

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Re: Clinical Trial with Psilocybin in Los Angeles [Re: figgusfiddus]
    #7549772 -

As for the deeeeeetails....

This is the coordinator of the trial in LA chiming in with a few bits of information that may be of interest. In no particular order:

- We are using synthesized psilocybin. I'll have to get back to you regarding the question of why we don't simply synthesize psilocin instead.
- For our trial, we're dosing at .2mg/kg body weight. The Hopkins trial used a higher dose.
- We are using a mild/moderate dose for several reasons. Namely, we aim to induce an analytical experience instead of a "knock your socks off" mystical dose due to the psychotherapeutic nature of the work.
- I arrive prior to the participant's admission to decorate the room and make it as "unhospitalish" as possible. (I decorate the room the same way each time to minimize variability.)
- Everyone who participates has one active session and one placebo session. Both are blinded. (Yes, we usually have a good idea which was which, but we don't know for sure.) We've spent endless hours contemplating how to address the placebo issue in psychedelic trials. The Hopkins study used Ritalin. We use niacin. I am beginning to think that the whole notion is ridiculous. People tend to know when they are in an altered state of consciousness. I think the analogy with trials looking at the effects of exercise is applicable. You can't have a true control group in that case; people know if they are exercising or not. We can't use another antianxiolytic because then we wouldn't know which substance influenced the respondents' follow-up data. I like this debate, so I'm curious what others think. (They did see some interesting placebo effects on the Hopkins trial.)
- Each participant serves as his or her own control because random selection to a group that received only a placebo would be unethical in a trial for people who have advanced cancer.
- I agree wholeheartedly with the criticism that it's poor science to be contacting obviously-partisan groups. My intention by posting here was to raise awareness of the trial in general. I wasn't really expecting to find participants in this forum... but you never know where a lead will pop up. This small pilot is primarily a safety and feasibility study. Our population isn't large enough to tell us much about efficacy. Subsequent larger phases will adhere to stricter scientific rigor when it comes to recruiting. It has been far more difficult to find participants than we'd ever imagined. If there's interest in this topic, I'll be happy to go into more detail in future posts.
- We are not a MAPS-funded trial. The non-profit Heffter Research Institute is our sponsor. (www.heffter.org)

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Re: Clinical Trial with Psilocybin in Los Angeles [Re: Dan4th]
    #7550155 -

Best wishes to you and to your study (and to the participants, who will undoubtably be back looking for another go at it!).


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Re: Clinical Trial with Psilocybin in Los Angeles [Re: suzie_girl]
    #7550371 -

Yes, undoubtedly! One of the hardest aspects of working on this trial is not being able to provide booster sessions, especially when participants express a desire to have another go at it. We are discussing the possibility of adding booster sessions to future protocols.

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Re: Clinical Trial with Psilocybin in Los Angeles [Re: Dan4th]
    #7551920 -

The new LSD study in Switzerland uses a low dose (20ug?) of LSD as the active placebo. That seemed to be the best placebo approach I've heard of.

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Re: Clinical Trial with Psilocybin in Los Angeles [Re: Freedom]
    #7553550 -

I really don't suppose finding participants for this "survey" is really much of a problem.

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Re: Clinical Trial with Psilocybin in Los Angeles [Re: SneezingPenis]
    #7556432 -

So, I checked in with our principal investigator regarding the psilocin (a metabolite of psilocybin) question. The reason we are working with psilocybin is because we could get FDA approval to do so. In order to work with human subjects, especially a population with advanced-cancer, animal studies are generally a required prerequisite. There have been animal studies and prior trials with humans for psilocybin, so that determined the choice of which substance to synthesize. Over time, it may be possible to do research with psilocin as well.

Next question? :wink:

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Re: Clinical Trial with Psilocybin in Los Angeles [Re: Dan4th]
    #7557852 -

even if you get the best results you could wish for, what will this study accomplish?

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Re: Clinical Trial with Psilocybin in Los Angeles [Re: SneezingPenis]
    #7559218 -

Per my earlier post, this is primarily a safety and feasibility pilot. Several years ago when the team was drafting the protocol, they had an uphill battle to fight to get permission to work with a Schedule I substance. Therefore, baby steps were in order. By starting small, we could establish that the treatment model is feasible and safe in order to open more possibilities for future research.

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Re: Clinical Trial with Psilocybin in Los Angeles [Re: Dan4th]
    #7559645 -

fair enough.

the other side of the coin: if something goes wrong, is it possible that it could be a setback for all future psilocybin studies?

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Re: Clinical Trial with Psilocybin in Los Angeles [Re: SneezingPenis]
    #7559812 -

The team was exceptionally mindful of safety protocols from the start for that very reason. To give you an example, we require a recent MRI of the brain to rule out brain or CNS metastases. We take blood pressure and temperature measurements every hour during the treatment sessions, too. You might also be interested to learn that we're not seeing the typical nausea and GI effects that can result from mushroom ingestion. Participants have reported gentle physical experiences so far with the pure psilocybin. As for the potential for a "freak out" during or following treatment, we are unlikely to see that outcome with the mild/moderate dose we're providing -- even among those who have no prior psychedelic experiences. For more info on the inclusion/exclusion criteria, you can check here: www.canceranxietystudy.org. Believe me, we're the last ones who would want anything to go wrong. With only one more participant to go and no adverse events related to treatment to report, we in good shape at this point. Rest assured, we take risk mitigation seriously.

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