YALE STUDY- Psilocybin for the Treatment of Cluster Headache

[FunTimes]

Heading back up for another round with this study. 

https://clinicaltrials.gov/ct2/show/NCT02981173

Might not help me much but it will make things a little better for the future. 

[Cast Iron]

And another Phase 2 trail on LSD.

MindMed CorpUpdate 7.2.2020

 

[xxx]

I know Dr. Emmanuelle Schindler, MD, is working hard to complete this Yale study using psilocybin as a CH intervention.

[Bejeeber]

Volunteering for a study like this is, knowing you may receive a placebo and be subject to some out of control attacks, is nothing short of a heroic act as far as I'm concerned, FunTimes - THANK YOU.

[kat_92]

@FunTimesyou are a true hero! Thank you for helping the future 

[Pebblesthecorgi]

This is a very well designed study by a researcher with great integrity.  The amount of work done to bring it to enrollment is beyond comprehension.  I am amazed recruitment has been so slow.  One would think with the paucity of effective preventative treatments for cluster headaches, the reach of organizations like clusterbusters and desperate souls the study would fill up fast.  Unfortunately I suspicion travel, time away from home and exclusion criteria (not much) play a role.   

I have often wondered if you could have a real placebo for a classic psychedelic if you were using perceptual level dosing.  Placebos are important in studies but gee whiz....   Paul Staments has been working on psilocybin micro dose supplement ideas for a while and has proposed adding niacin to discourage taking “too much”. Maybe a niacin effect type placebo is used. It does beg the question of placebo.

[jon019]

...yeah, would seem any placebo in this type of study would have to have some kind of psychoactive effect...and recruitment would have to defer to "inexperienced users" who would not be able to discern "type". have experienced the niacin effect...rather unpleasant but no psychoactivity....

[CHfather]

Some of the Yale non-CH psilocybin studies use niacin as a placebo, and say so explicitly (for example, https://clinicaltrials.gov/ct2/show/NCT03356483).  In the CH study, the placebo is listed as "Microcrystalline cellulose capsule."  (https://clinicaltrials.gov/ct2/show/NCT02981173)  Maybe you know what that means. I think it means that there is no active ingredient in it.

In the CH study, there are two different dosages being tested: essentially, a "high" dose of 10mg and a "low" dose of 1mg (these high and low doses can also be measured on the basis of body weight (see the link above)).  The high dose, 10 mg, is one hundredth of a gram. I have read that the psilo content of a dried shroom is between .5% and 2%.  So, assuming 1%, the 10mg high Yale dose would be roughly equal to what's in 1g of dried MM.  The low dose would roughly equal one-tenth of a gram of dried shroom.  So it seems like only the high dose has any "trip" potential at all. People with lower body weights might be taking less than that, but the weight-based option is, I assume, calibrated to bring about roughly the same trip risk.  Am I calculating this right, and/or is my assumption that pure ingested psilo has a similar effect to psilo in a dried shroom correct?

[Pebblesthecorgi]

As I understand 4 grams of dried mushrooms is equal to 20-25 mg active ingredient.  This being the case the max dose in the Yale study would be about the same as 2 grams dried fungus.  If i recall the study design included input from several folks with descent experience and influence with cluster busters.   

 

The safety studies with psilocybin done at UW Madison used an escalating weight adjusted model of doses from 23-30 mg/70 kg body weight.  Basically at the top end they received the equivalent of 5 plus grams dried which is often considered a "heroic dose".  I do not believe any participants had adverse physiological or psycho logic outcomes.  Many have participated in group discussions about the experience and have become actively involved in the psychedelic community.

[Bejeeber]

Glad they consulted with Cluster Busters regarding real world doses, lending all the more confidence in the study.

[FunTimes]

This is my second trip up for this study. I would think the travel expenses are what would be holding back the enrolment. Also most of us that already use MM for our own treatment have nothing to gain from this other then stopping home treatments, getting back to baseline hell then crossing your fingers on what you get from the study. I like to torture  myself from time to time so I figured why not try this again. No other vacations planned with this pandemic so sitting in a hotel room for 2 weeks cant be that bad. Give me new walls to stare at. 

In all reality I do sign up for studies whenever I can just to help get the science figured out by the smart people, It would kill me if one of my kids ever had to deal with this with nothing in the pipeline to ease the pain for them. 

[spiny]

Many cannot participate due to age as well.

Thanks for jumping in there again Fun Times!!!!