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        New Message Board Archives >> Medications, Treatments, Therapies 2004 >> Official Clinical Trial of ClusterBusters Underway
        
(Message started by: Flash on Mar 7^th, 2004, 10:30am)

Title: Official Clinical Trial of ClusterBusters Underway
Post by Flash on Mar 7^th, 2004, 10:30am

Bob Wold (pinkfloyd) of Clusterbusters.com has given PinkSharkMark and myself the honor of making a joint announcement of historic import to cluster headache sufferers.

Clinical studies on the effectiveness of psilocybin and LSD in the prevention and treatment of cluster headaches will soon take place!

Bob's tireless efforts have finally born fruit. Below is an excerpt from the confirmation letter received by Bob from Rick Doblin Ph.D., the president of the Multidisciplinary Association for Psychedelic Studies (MAPS):

Quote:

Dear Bob,

As the President of the Multidisciplinary Association for Psychedelic Studies (MAPS), I'm writing to confirm our agreement to work together to conduct FDA-approved research into the use of psilocybin and LSD in the treatment and prevention of cluster headaches. This research will be coordinated by MAPS and will be directed by Dr. John Halpern, McLean Hospital, Harvard Medical School, in association with Dr. Andrew Sewell.

Many of you have read on this board over the years of the spectacular successs clusterheads have achieved with psilocybin (the active compound in magic mushrooms) and of the equal success of the few LSD experimenters from whom we have reports. We express our heartfelt thanks to all those who had the courage to post their experiences with these controversial -- and in most countries, illegal -- substances in this public forum. Without the convincing evidence gathered from so many reports, there would have been no possibility whatsoever of enlisting any credible researcher -- let alone researchers connected with Harvard Medical School -- to embark upon a clinical study presenting as many challenges as this one does.

We would also like to thank DJ for allowing a full and frank discussion of this therapy to be carried out for so many years in this forum, and a special thanks to Ueli for investing countless hours in compiling his archive of links to every post ever made on this bulletin board regarding the use of psilocybin and LSD. Ueli's archive made the task of presenting convincing case histories to the interested parties a manageable one.

Bob will be releasing further details as the project unfolds, including posting additional information regarding time frames. He will also answer the question, "When & where do I sign up?"

Thanks also to PinkSharkMark for drafting the bulk of this posting.

HERE WE GO!

Flash

Title: Re: FDA has approved Clinical Trial of ClusterBust
Post by BobG on Mar 7^th, 2004, 11:09am

A big Thank You to Flash, pinkfloyd, PinkSharkMark, Ueli, the doctor's involved and of course DJ.

This has been a very controversial subject over he years. Thanks for sticking to your guns. Possibly the studies will lead to bigger and better treatments for all of us.

Title: Re: FDA has approved Clinical Trial of ClusterBust
Post by forgetfulnot on Mar 7^th, 2004, 4:19pm

WOW!!!!!!! David vs Goliath, as MOC would say, this is coolness. ;)

Lee

Title: Re: FDA has approved Clinical Trial of ClusterBust
Post by Simon on Mar 7^th, 2004, 4:30pm

Excellent news - I'd say sign me up, but the plane fares might be prohibitive.

Are you going to be able to take advantage of this, flash?

S

Title: Re: FDA has approved Clinical Trial of ClusterBust
Post by Edski_1 on Mar 7^th, 2004, 7:08pm

Does this have anything to do with Ashcroft being inthe hospotal? Maybe they slipped it by the justice department? :-/

Good work! :)

Title: Re: FDA has approved Clinical Trial of ClusterBust
Post by JDH on Mar 7^th, 2004, 8:23pm

Ya done good Pink, shine on!!!
This is very impressive guys and I thank all who are involved. Should only get better from here on.

Jim

Title: Re: FDA has approved Clinical Trial of ClusterBust
Post by Pinkfloyd on Mar 8^th, 2004, 2:29am

hello everyone!! ;;D

Yes, I am smiling. Thank you all.

There are a couple of things I'd like to make clear, and then add a few details.

First of all, the FDA still needs to approve the study design (protocol) before anyone checks into the hospital for this clinical study.

We, Clusterbusters, have been and will continue, to work with MAPS and Dr.s' Halpern and Sewell in designing this study. We will all be involved in working through each step that is required before anyone gets the first "legal" dose of psilocybin. But, it will be a legal dose.
We must do a lot more of work on the design of this study and then it must pass through the Harvard Medical School IRB (independant Review Board), the FDA and the DEA.

Much work has already been completed and we at Clusterbusters will continue to contribute throughout the process.

Current work being drafted for release by Clusterbusters, to the interested parties of this project includes, but is not limited to;
Organizing and distributing all of the case histories that have been posted here throughout the years (names have been changed to protect the innocent).

Critical data taken from these reports and additional reports on file at Clusterbusters.

A Quality of Life Questionaire for ALL cluster sufferers, whether they have used this treatment, have not used it yet and those that choose not to use this method. All information is just as important in this case. (so keep your eyes out for this one soon)

Scientific data and theories related to the efficacy of this treatment and why we feel it works.

The legal end of all that is involved.

Publicity to the press and additional Researchers and Doctors. (there are several that have not been named that will be participating)

Current updating of the website and FAQ

Modifying and "tweaking" of the treatment to find the most efficatious plan for the largest percentage of people.

Fundraising.
To clear up another point. MAPS has not donated any funds to this project as of this date.
We (Clusterbusters) had to fund the initial amount that was required to get this underway. Although Harvard "normally" doesn't consider at any project for under $250,000.00 up front, we have struck this deal for much less. All the initial funds are being put up by one member of Clusterbusters.

The total number of participants will be greatly influenced by the total dollars we supply. Each participant will cost money once the initial costs involved in getting all the approvals are met. Hospital stays in Harvard Medical School are slightly more expensive than the Red Roof Inn. ;-)

I will be supplying additional information as to where you can send any donations....soon.

At some point in the future, Clusterbusters will be supplying a list of possible participants that will be required to complete a questionaire to determine their qualification for the trials. We will be working closely with the researchers and MAPS in the design of this qualifiation process.
Don't worry, these criteria will not include, how many posts you've made here, who you have or have not, argued with here, or which organization you belong to or don't belong to. It will be based upon such things as: meeting the IHS criteria as being diagnosed with cluster headaches.

There is much more to report and I will do so as I can. Some information must wait to be released. Other information will be released as it becomes available.

Yes, there are MANY people to thank for all this. I will publicly do so at a later date....again, soon.

Hundreds of people have been involved since that first post by Flash, years ago.
There have been literally thousands of hours spent over the years (and thousands just in the last year).
There has also been thousands of dollars spent by individual ClusterBuster members (and I'm sure some non-members), over the last year and one-half, to get us here, not counting all the volunteered hours and efforts.

I want to thank everyone for all they have done. I will be more specific at a later date.

Our goal is not to make psilocybin or LSD legal. Our goal is to make this a legal treatment for all cluster sufferers.
Although there is much work left to be done, we are well underway. With the continued support of everyone willing to become involved, we will get there.

PF

Title: Re: FDA has approved Clinical Trial of ClusterBust
Post by Mark C on Mar 8^th, 2004, 2:55am

http://www.drfeller.com/Mark/clapping.gif

Title: Re: FDA has approved Clinical Trial of ClusterBust
Post by Eeyore on Mar 8^th, 2004, 3:12am

Ya'll have put a smile on my mothers face and more support for what I am about to do in my fathers eyes. You guys are my heroes!
- Eeyore -

Title: Re: FDA has approved Clinical Trial of ClusterBust
Post by ave on Mar 8^th, 2004, 4:26am

I am sitting at my puter and, drat it, tears are starting!
I don't know what to say.

Does this project have a Paypal connection?

Title: Re: FDA has approved Clinical Trial of ClusterBust
Post by ozzman on Mar 8^th, 2004, 9:02am

Bob, Flash, all of you at Clusterbusters, thank you. One step closer to the cure.

BTW, will report soon.

Ozzy

Title: Re: FDA has approved Clinical Trial of ClusterBust
Post by thomas on Mar 8^th, 2004, 11:01am

AWESOME!!!!!!!!!!!!! I haven't used this treatment, but I know countless people who have had success, and all I can say is WOW!!!!!!! Thank you guys for keeping the faith and fighting the good fight, you work has not gone unnoticed. ;;D

Title: Re: FDA has approved Clinical Trial of ClusterBust
Post by notseinfeld on Mar 8^th, 2004, 2:14pm

You guys Rock!

http://www.drfeller.com/Mark/clapping.gif

Title: Re: Official Clinical Trial of ClusterBusters Unde
Post by 9erfan on Mar 8^th, 2004, 2:33pm

darn! notseinfeld took my line... ;;D

But it's true, Pink, Pink, Flash, et al....YOU ROCK!!! This is SO EXCITING!

Title: Re: FDA has approved Clinical Trial of ClusterBust
Post by Pinkfloyd on Mar 8^th, 2004, 2:50pm

on 03/08/04 at 09:39:33, Bob P wrote:

Floyd,
Read your other post and just want to be clear.

The FDA has not approved this research yet?

What you have is an agreement with MAPS to conduct this research if they can get the FDA to approve the protocol?

Seems to me we had this same agreement with MAPS a few years back, I think it was Rick who I was talking to then. They would conduct the trials and provide the psilocybin if we could cough up $20,000. It looks like you've found someone to front the money now but it is still a ways from being "FDA Approved Trials"?

Just don't want to see people get all worked up before it is warrented. Are my interpretations correct?

No Bob, we wouldn't want anyone to get the wrong idea.
I asked the author of these threads to please change the header as it is confusing, right after I saw it here.
That is why I tried to un-confuse it with my post.

You're right, there is still a long way to go. Its difficult to explain. The work on an FDA-approved study has begun.
The FDA will still have to approve the design of the study. As will the Harvard IRB. Approvals are needed at every step of the way. No, the FDA has not yet given it's go ahead to begin issuing psilocybin.

As far as being where we were two years ago, that couldn't be further from the truth. Unless of course you have a letter from the researchers that agreed to do the work. If you could send me the work done by these researchers I'd appreciate it greatly. Researchers that have gotten other hallucinognics approved for testing by the FDA (and every other level of approvals required).

After many (many hours and emails) of discussions with numerous people, organizations and researchers that we got interested in this project, it would be closer to the truth to state that Clusterbusters chose both MAPS and the researchers at Harvard, and agreed to let them be involved, than the other way around. There were other options available once we made our data available.

As to the 20K, yes I saw letters from several people from the past that broached the subject with MAPS and at least one doctor/researcher.
20K wouldn't have been enough to get us past the Harvard IRB let alone put people in the actual study.
(BTW, I also saw an old post that I've mentioned here before without any response about someone donating $2000.00 at one point. I'll ask again. Anyone have any idea if that money was ever received and where it might be?)
20K would never have gotten the ear of Dr. Halpern.

This is much further along than a letter from Rick at MAPS stating his interest in doing this project. Of course he would do it. Thats what they do....they coordinate trials.

The work that has been produced has greatly expedited this entire process and will continue to speed it along at a far greater speed than could have been expected by anyone.

Discussions have included the NIH, DEA and the FDA.
Discussions and preliminary work has begun on congressional hearings should they be required to speed things along.

There is a new department being formed as we speak, at Harvard medical school. This study will most likely be the first one they produce.

This are just some of the highlights.
Now, if people don't want to get excited just yet, thats fine. We'll let you all know when the pill is ready.

PF

If anyone would like to start a thread where everyone can list their contributions to this, thats fine. There are many people that were/are essential in this project. We can try to put everyone in an order of importance....
This is just a subject I don't have time to be a part of though.

Title: Re: Official Clinical Trial of ClusterBusters Unde
Post by Pinkfloyd on Mar 8^th, 2004, 3:01pm

BTW, If I sound like I'm not in a good mood, I'm not.
I just got back from root canal. >:(

PF

And now I just found out my father-in-law has bladder cancer so I will probably be in a bad mood for a while longer.

PF

Title: Re: Official Clinical Trial of ClusterBusters Unde
Post by jminmilwaukee on Mar 8^th, 2004, 3:48pm

Sorry bout the canal buddy bob! Hang in there man.

As far as starting a thread for recognition, I believe we all know who the major players are (Pink, Pink and Flash).

The rest of us Clusterbusters were mearly assisting in with your efforts in a manner that made this truelly a group effort.

I have to state publicly that I have never worked with a better group of unselfish persons willing to "step up" and fill in without question or even the need to ask.

Yes we have a long ways to go BUT we all (including those who supported from CH.com) deserve a huge pat on the back.

I must also add that those of you who are still pessamistic about this, we will be happy to share the pill form when it becomes available! ;;D

Major leaps and bounds have occured over the last few years by a handfull of dedicated individuals who will no longer be happy with the status quo of the "usual suspects" of sub par cluster treatments.

Thank you again to all.

Jmin <----stepping off of his high horse.

Title: Re: Official Clinical Trial of ClusterBusters Unde
Post by 1MajorPain on Mar 8^th, 2004, 3:48pm

Bob, I for one am proud of all the work you and the others have done to get us to this point! I'm sure peope have no idea of the hard work and countless unpaid hours ya'll have spent...it's easy to complain and be negative to some degree, which is what I've seen in some cases. But the fact remains the hard work you and others have done is what got us here. Hats off to the person that stepped up with the money to get things started!

Let's just all quit complaining and be grateful that an end just might be in site for all of us that suffer from this horrible beast.

Sorry to hear about your FIL and hopefully the pain from the root canal will be better soon.

I have expressed my thanks many times and will continue to do so in the future for the PF days I'm now able to enjoy...and for that I will always be gratefull.

Major

Title: Re: Official Clinical Trial of ClusterBusters Unde
Post by notseinfeld on Mar 9^th, 2004, 9:30am

Thanks nerfan for your line and MarK C. for the clapping hands. Looks like I'm just a little 'ol thief.

Alternative, Alternative therapy: Anyone ever take out a restraining order or harrassment lawsuit vs. the beast?

Title: Re: Official Clinical Trial of ClusterBusters Unde
Post by SommelierCH on Mar 10^th, 2004, 4:11am

I just dosed at 12:22 am PST, March 10, 2004. Someone at work heard me talking about this study and offered to donate to my research, she had them in her freezer, Chocolate Fudge squares. FINALLY. This town is knee deep in everything except this natural gift.

I should be a good subject: I’m in a weird Semi-Cluster cycle right now (last 3 weeks, it’s not TMJ). Alcohol sets it off within 15 mins. It comes every night 1 1/2 hours after I fall asleep. O2 can kill the Shadow creeping up during the day. But It attacks at night, just like my Clusters. But it’s not my Cluster. I kill this one easily with 1100mg aspirin, 650mg Acet., 70mg caffeine, i.e. 2 packets of Goodys Headache Powder. Go figure.

1:am Gotta go. I’ll be back.

The great work you have done, is already helping someone

1:12am Pink I just read your post on the other board, so I came over here to duplicate my reply. Thanks Everybody. Kicking in. Talk to you later

David J.

Title: Re: Official Clinical Trial of ClusterBusters Unde
Post by Giovanni on Mar 10^th, 2004, 10:11am

Hey PF, take care of yourself. We need a good mold for the bronzing act here. ;;D

Thanks so much for all of your hard work. Right now I'm happy, the wife is happy, the is dog happy. Really nice to be pf for the spring.

Thanks again,

John

Title: Re: Official Clinical Trial of ClusterBusters Unde
Post by Pinkfloyd on Mar 11^th, 2004, 1:51am

on 03/10/04 at 04:11:21, SommelierCH wrote:

1:12am Pink I just read your post on the other board, so I came over here to duplicate my reply. Thanks Everybody. Kicking in. Talk to you later

David J.

thanks for moving it here David.
Please keep us informed as to how things are going.
We'll help any way we can.

PF
And thank you to everyone else that has expressed such kind words. It is greatly appeciated. On behlaf of ALL the ClusterBusters...thank you.

Title: Re: Official Clinical Trial of ClusterBusters Unde
Post by Bob P on Mar 12^th, 2004, 11:04am

Pf,

Well I've searched a little but can't find any of the communications I had with MAPS. If I do have it, it's on one of the backup discs for my pooter (I only have a 40GB drive and do lots of video work so I need all the space I can get. I backup files to cd and then delete them from my drive). The year 2000 ch.com posts that you have on the busters site did refresh my memory a little.

I had spoken to Rick about shroom trials. He put me in touch with a research doc at the University of Arizona. That doc (don't recall his name) had said it would cost $30k to start trials. MAPS agreed to supply the psybin. Since there was no money to be had (I didn't persue it very far) everything came to a halt there.

So I can't produce the letters you ask for. Sounds like you have a much more concrete agreement with a prestigious outfit though. Good luck and I hope it all flows smoothly.

Folow-up: Did manage to find the guy at the MAPS site:
Psilocybin in the Treatment of Obsessive-Compulsive Disorder
Investigator: Francisco Moreno, MD
University of Arizona, Tucson, USA
Contact: Francisco Moreno, MD
Sponsor: Heffter/MAPS
This is the first FDA-approved study in more than 25 years to examine the use of psilocybin in a patient population. The principal investigators plan to study the use of psilocybin in 10 patients suffering from obsessive-compulsive disorder (OCD). They want to determine if they can replicate in a clinical study several published case reports of patients whose OCD symptoms were reduced after self- experimentation with psilocybin mushrooms. MAPS has paid $12,250 for the synthesis of one gram of psilocybin. Analytical data on this psilocybin has been submitted to FDA in March, 2001, with approval obtained from the FDA on May 9, 2001. DEA licenses received July 2, 2001. First patient was treated on November 27, 2001; eight subjects have been treated thus far, in a total of 29 sessions. Current news on this study, Study Protocol, Informed Consent Form
Last updated February 10, 2004

Title: Re: Official Clinical Trial of ClusterBusters Unde
Post by Pinkfloyd on Mar 12^th, 2004, 8:04pm

Thanks Bobp

I spoke with Dr. Moreno last year.

I appreciate you looking to see what you had.

PF

Title: Re: Official Clinical Trial of ClusterBusters Unde
Post by pinksharkmark on Mar 13^th, 2004, 4:18am

Thanks to all who have expressed their congratulations.

This study will be a milestone, for sure.

I have already thanked DJ in the mirrored thread in the "General Posts" forum. The problem with thanking people for their contributions by name is that almost inevitably some names are overlooked. Let me attempt to correct (at least partially) that oversight now.

The first posts I ever read on this subject -- the ones that made me sit up and take notice -- were from Monique and Margi, detailing the successes their husbands (Greg and Mike) had had with mushrooms. It was their posts which led me to comb through the archives and eventually come across Flash's original posts -- waaaay back when the board was brand new.

And the discovery of Flash's original posts led me to Bob Pahlow's (Bob P) intriguing posts on serotonin (5-HT) and compounds (including the hallucinogens) whose effects appear to be caused through serotonin "mimicry". Bob P was the first (to my knowledge) to take Flash's posts seriously and to post here the results of his research into the serotonin connection. Bob P was the earliest supporter of Flash's discovery, and the first to contact MAPS (and others, if I'm not mistaken) in the hopes of finding researchers interested in pursuing clinical studies. Bob P also provided needed support and assistance to some sufferers at one of the OUCH conventions.

I have always considered it the very cruelest of ironies that Bob P turned out to be one of the few who had no personal success with mushrooms. It just doesn't seem fair, somehow.

And then there's Stavi. Although I had already made a few posts on hallucinogens as a treatment for cluster headaches by the time she made her first post...

http://www.clusterheadaches.com/wwwboard/messages/57787.html

...it was her post that really lit the fire under my ass and prompted me to provide the first information on home mushroom cultivation which eventually resulted in the rash of clusterhead "fungus farmers for freedom" (hee hee hee!) She hasn't posted here in years now, but in the last e-mail I received from her she reported that she remains pain free through periodic maintenance doses of mushrooms.

Those interested in the early days of discussion here at clusterheadaches.com really should take the time to check out "Ueli's Archives". I review them from time to time, even though I remain embarassed at some of the misinformation I so confidently disseminated back then -- specifically my erroneous claim that these mushrooms were legal in most of the countries in the world. Doh!

Here's a link to the section of Ueli's Archives which provides links to the posts at clusterheadaches.com from Flash's first post in July of 98 (message number 1613!) till the end of December 2000 --

http://www.clusterbusters.com/2000.html

They really make for some fascinating reading.

pinky

Title: Re: Official Clinical Trial of ClusterBusters Unde
Post by Bob P on Mar 13^th, 2004, 8:34am

Quote:

I have always considered it the very cruelest of ironies that Bob P turned out to be one of the few who had no personal success with mushrooms. It just doesn't seem fair, somehow.

Pink, I haven't given up yet. You coached me to print some of that first crop. Those prints recently yeilded fruit. I am due for a cluster this summer and will go at it again. Tea this time instead of OJ smoothies. I can't let you guys have all the fun.

Again, hope the current beginnings yeild solid clinical results. I do appreciate the recognition of past efforts also but my real purpose in joining this thread was to make sure everyone was getting an accurate picture of what was happening. That was taken care fo when Flash changed the title of the thread.

Best of luck in your continued efforts 'busters'.

Quote:

Bob P also provided needed support and assistance to some sufferers at one of the OUCH conventions.

Is it illegal to transport that stuff across 7 state lines?

Title: Re: Official Clinical Trial of ClusterBusters Unde
Post by Flash on Mar 15^th, 2004, 6:37am

BobP,

As I recall the mushrooms initially had some impact on your headaches, disrupting them to some extent but quite early in the episode (I think it was during the 1st or 2nd week) you started taking pred. At that time we had no reason to suspect that pred would interfere with the treatment, although now we no that it does.

Possibly without the pred you might have certainly seen more disruptive activity from the shrooms.

Your episodes are fairly regular, like once every 3 years. This time it might be worth taking a preventative dose and then waiting to see if your episode arrives on schedule. In the event that the episode does trigger you could then try the shrooms again at an early stage.

As always my advice is to keep the doses low.

What do you think?

Flash

Title: Re: Official Clinical Trial of ClusterBusters Unde
Post by Margi on Mar 15^th, 2004, 10:00am

Flash, I think you may be confusing Bob with my Mike. Two cycles ago, he dosed while being totally med free - 3 times over a period of 3 weeks and then, a month later had to do the pred burst. That truly was his worst cycle ever, although I doubt we can blame that on the shrooms. It was a full month after his last dose though that he started the prednisone (I remember clearly because he was dosing during the month of Nov/Dec and didn't start meds until late January). I'm not sure, but I don't think Bob did the pred, although both Bob and Mike were in cycle at the same time that year. For some reason the treatment didn't work for Mike (or Bob) and he ended up having to go the med route. Rough cycle. He's just been through another 5 month cycle and didn't dose this time.

Update on Greg though (Monique's hubby) - he is still cluster free and does a pencil eraser size dose whenever he feels the twinge - it's still working well for him. He doesn't always wait the 5 days and, (maybe because of the size of the dose - he just puts it under his tongue), it's keeping him in remission.

Title: Re: Official Clinical Trial of ClusterBusters Unde
Post by Bob P on Mar 15^th, 2004, 10:16am

Last time I dosed 3 or 4 days into the cycle. I was med free at the time. Tripped pretty good for 4 or 5 hours so it was a big dose. My attacks stayed right on schedule. The treatment didn't make a dent in them. I did dose 3 more times over the following weeks but I was also taking meds. No way I'm going to sit through full blown attacks when there are meds that will abort them. During that 15 week long cluster, I did do a couple of pred bursts (Medrol dosepak).

Quote:

At that time we had no reason to suspect that pred would interfere with the treatment, although now we no that it does.

Flash, I'm curious as to how you know this? Seems strange since I don't think the pred does anything with the 5HT receptor sites (pred is a steroidal anti-inflamatory) which is where the fungi does it's magic.

Title: Re: Official Clinical Trial of ClusterBusters Unde
Post by Flash on Mar 15^th, 2004, 10:50am

People taking pred have much less success with this treatment. In several cases where the shrooms have done zip the person has been on pred.

Although pred may not act on those receptors it does affect CH so it's no surprise if there is an interaction at some level.

Although shrooms do act on those receptors we have no way of knowing whether this is the specific mechanism that causes them to act against CH.

Personally I think it all has something to do with DMT.

Title: Re: Official Clinical Trial of ClusterBusters Unde
Post by pinksharkmark on Mar 15^th, 2004, 10:51am

on 03/15/04 at 10:16:57, Bob P wrote:

No way I'm going to sit through full blown attacks when there are meds that will abort them.

Can't blame you for that. I did the same when I was caught shroomless at the beginning of a cycle. By the time I had grown sufficient replacements to start using them, my cycle was very firmly established. I was unable to "detox" entirely before taking my first dose of shrooms -- it just hurt too damn much. It took about six doses to finally terminate the cycle.

It's entirely possible I would have required fewer doses to terminate the cycle had I been completely med free. I have no way of knowing for sure one way or the other.

Quote:

We have anecdotal evidence now from quite a few people (myself included) to indicate a correlation between prednisone use and decreased psilocin efficiency in terminating cluster cycles.

Like you, I couldn't imagine any mechanism by which pred would bind to the same receptors as psilocin, so I felt if I had to fend off my CH with something while waiting to harvest my crop, pred was my best bet. I was wrong. My first two doses were taken while still tapering from pred. The beneficial effects, while noticeable, were shall we say less than spectacular. The subsequent doses were taken while pred free, and each of these doses led to greater improvements.

As I say, there are others (several posters at Clusterbusters) who have reported the same thing.

My only hypothesis on this is a fuzzy one -- prednisone affects hormone production (through its action on the adrenal cortex), and hormones are known to alter the operation of several different body mechanisms simultaneously. I would imagine this is why prednisone is prescribed for dozens of various (often seemingly unrelated) conditions. As well, look at the reported correlation between Synthroid and CH, or the reports we have had regarding some female clusterheads and hormonal changes during pregnancy which have altered their regular CH patterns.

Whatever the mechanism may be, I have now seen enough reports from pred users complaining about lack of success with psilocin (and of course my own experience) to conclude there is a good chance there is some kind of interaction going on there.

pinky

Title: Corticosteroids impair serotonin response
Post by floridian on Mar 15^th, 2004, 11:34am

Long term (but not short term) use of corticosteroids like prednisone can make the serotonin receptors less effective. Lots of research on this effect and the 5-ht1 receptors, less research on the 5-ht2 receptors and cortisone, although the 5-ht2 receptors do seem to be involved. And clusterbusters influence both 5-ht1 and 5-ht2 receptors, although they are especially active on the 5-ht2 while other meds (ie triptans) are not.
Corticosteroids affect the HPA (hypothalamus-pituitary-adrenal) axis in many ways. Conversely, 5-htp down regulates corticosteroid receptors via 5-ht2 activity.

Quote:

Neuropharmacology. 2003 Dec;45(7):925-34. Acute and chronic effects of corticosterone on 5-HT1A receptor-mediated autoinhibition in the rat dorsal raphe nucleus.

Fairchild G, Leitch MM, Ingram CD.

...
For chronic treatment, rats were supplied with drinking water containing corticosterone (50 microg/ml) or ethanol vehicle (0.5%) for 25-31 days. The autoinhibitory response to 5-HT was significantly attenuated in the corticosterone-treated group; vehicle EC(50)=48+/-8 microM vs. corticosterone EC(50)=121+/-20 microM. Furthermore a subpopulation of 5-HT neurones from corticosterone-treated animals exhibited marked insensitivity to 5-HT. ... Thus, 5-HT(1A) autoreceptor function in the DRN is attenuated following chronic, but not acute, exposure to elevated corticosterone levels, and this effect may involve changes to the receptor-effector coupling mechanism.

Quote:

Neuropsychopharmacology. 2003 Jul;28(7):1300-10. Epub 2003 Apr 09.

8-OHDPAT-induced disruption of prepulse inhibition in rats is attenuated by prolonged corticosterone treatment.

Czyrak A, Mackowiak M, Chocyk A, Fijal K, Gadek-Michalska A, Wedzony K.

The present study investigated the impact of acute and repeated administrations of corticosterone (10 mg/kg, twice daily, for 7 days) on serotonin (5-HT)(1A) receptor function, density and expression.
...
It is concluded that chronically elevated corticosterone level is capable of inducing functional desensitization of 5-HT(1A) receptors which is paralleled by decreases in the 5-HT(1A) receptor binding in the ventral hippocampus and entorhinal cortex, the brain structures shown to be engaged in the regulation of PPI. Alterations in 5-HT(1A) receptors may be one of important mechanisms by which glucocorticoids/stress influence various psychiatric conditions.

Quote:

J Neuroendocrinol. 2000 Aug;12(8):736-44.
Regulation of central corticosteroid receptors following short-term activation of serotonin transmission by 5-hydroxy-L-tryptophan or fluoxetine.

Semont A, Fache M, Hery F, Faudon M, Youssouf F, Hery M.

Alterations of the hypothalamic-pituitary-adrenal (HPA) axis function characterized by a decreased negative feedback capacity are often associated with affective disorders and are corrected by treatment with antidepressant drugs. To gain a better understanding of the effects of the antidepressant drug fluoxetine, a specific serotonin (5-HT) reuptake inhibitor, on central corticosteroid receptors, the effects of short-term activation of serotonin transmission on central corticosteroid receptor expression were analysed in adrenalectomized (ADX) rats either supplemented or not with corticosterone. Serotonin transmission was stimulated either by a single injection of the 5-HT precursor, 5-hydroxy-L-tryptophan (5-HTP), or by a 2-day treatment with fluoxetine. In ADX rats, administration of 5-HTP decreased hippocampal mineralocorticoid (MR) and glucocorticoid (GR) receptor numbers 24 h later, while their respective mRNAs were unchanged and these effects of 5-HTP were mediated by 5-HT2 receptors. In the hypothalamus, GR mRNAs and binding sites decreased 3 h and 24 h after 5-HTP, respectively. By contrast, fluoxetine treatment increased hippocampal MR and GR mRNAs and MR binding sites while GR number remained unchanged. In ADX rats supplemented with corticosterone, 5-HTP and fluoxetine treatment had the same effects on corticosteroid receptors compared to those observed in non supplemented ADX rats: 5-HTP decreased hippocampal MR and GR and hypothalamic GR while fluoxetine treatment increased hippocampal MR. These results show that short-term stimulation of 5-HT transmission by 5-HTP decreases hippocampal and hypothalamic corticosteroid receptor numbers through a corticosterone-independent mechanism. It is hypothesized that the delayed maximal increase in extracellular 5-HT contents after fluoxetine treatment, due to negative feedback regulations induced by the activation of 5-HT1A and 5-HT1B autoreceptors, is not the primary cause for the delayed normalization of corticosteroid receptor numbers that regulates the HPA axis functioning.

Title: Re: Official Clinical Trial of ClusterBusters Unde
Post by floridian on Mar 15^th, 2004, 11:51am

Cortisol / Stress affects serotonin transport.

Quote:

Cogn Affect Behav Neurosci. 2001 Dec;1(4):388-93.

Comment on:

* Cogn Affect Behav Neurosci. 2001 Mar;1(1):96-104.

Correlation between cortisol level and serotonin uptake in patients with chronic stress and depression.

Tafet GE, Idoyaga-Vargas VP, Abulafia DP, Calandria JM, Roffman SS, Chiovetta A, Shinitzky M.

In a recent study (Tafet, Toister-Achituv, & Shinitzky, 2001), we demonstrated that cortisol induces an increase in the expression of the gene coding for the serotonin transporter, associated with a subsequent elevation in the uptake of serotonin. This stimulatory effect, produced upon incubation with cortisol in vitro, was observed in peripheral blood lymphocytes from normal subjects. In the present work we investigated the cortisol-induced increase in serotonin uptake in lymphocytes from hypercortisolemic patients, including subjects with major depressive disorder (n = 8), and subjects with generalized anxiety disorder (n = 12), in comparison with a control group of normal healthy subjects (n = 8). A significant increase in serotonin uptake (+37% + 14, M + SD) was observed in the control group, whereas neither the generalized anxiety disorder nor the major depression group exhibited changes in serotonin uptake upon incubation with cortisol. It is likely that under chronic stress or depression, the capacity for increase in serotonin transporter has reached its limit due to the chronically elevated blood cortisol level. The physiological and diagnostic implications of this observation are discussed.

Title: Re: Official Clinical Trial of ClusterBusters Unde
Post by Bob P on Mar 15^th, 2004, 5:13pm

So check me on this:

Article 1 says 5-HT(1A) autoreceptor function is weakened by chronic use of corticosterone (25-31 days) but not acute usage.

Article 2 says chronically elevated corticosterone decreases 5-HT(1A) receptor binding.

Article 3 says corticosteroid receptor #s are decreased by 5-HTP or flouxetine.

Article 4 says cortisol increases 5-HT uptake. However, chronic stress or depression will also increase the 5-HT transporter to it's max.

All of these articles deal with 5-HT(1A) receptors. You say that fungi act on 5HT(2A) receptors. I guess I'm wondering if you posted these abstracts to prove or disprove that steroids effect the working of the fungi or if this was a just for information post and we can draw our own conclusions?

Title: Re: Official Clinical Trial of ClusterBusters Unde
Post by floridian on Mar 15^th, 2004, 11:56pm

Quote:

All of these articles deal with 5-HT(1A) receptors. You say that fungi act on 5HT(2A) receptors. I guess I'm wondering if you posted these abstracts to prove or disprove that steroids effect the working of the fungi or if this was a just for information post and we can draw our own conclusions?

You are correct on the article by article analysis.

One disagreement - I didn't say that fungi acts just on the 2a/2c receptors. While clusterbusters all seem to involve 2a/2c, they are not limited to that. LSD also affects the 5-ht1a, 5-ht6, 5-ht7, dopamine D1 and D2, the adrenergic, and probably other less studied receptors. (http://www.heffter.org/review/Review2/chap5.pdf) I don't know if that is also true of the fungi, but I assume it is. (The two molecules are functionally similar but not identical, and there is more research on the lysergic compounds).

My purpose in posting was to start to establish the effects of prednisone on serotonin receptors. I am assuming (based on reports from others) that such steroids might reduce the effectiveness of clusterbusters. Clearly, corticosteroids affect some serotonin receptors, and serotonin affects steroid receptors. The impairment of 5-ht1a receptors might be involved, or a similar process might be occuring with other receptors. Very preliminary, theoretical, but it might explain the interaction.

Title: Re: Official Clinical Trial of ClusterBusters Unde
Post by Edski_1 on Mar 16^th, 2004, 7:54am

Certainly seems to point to an interaction. A lot more substantial than a huntch, but we should never discount the value of such.

Good work, as usual, Floridian! :) Good to see your posts here again! Challenging reading (especially this early in the morning! :P), but well worth the effort!

All this discussion is fascinating...I'm hoping that eventually some eyes in the general public are opened. Personally I don't think I am leaning toward trying this treatment, although as a youth I have had my share of recreational use with 'shrooms and LSD in college...

Funny, I sort of remeber it was around that time my CH started, but I can't remeber any sort of patterns...it's not like I was habitual or anything or could even guess if there was any effects. But just learnign that the chemistry of Imitrex and psylicibin are remarkably similar gives me pause.

And then there are some family members, who are virulently anti-drug...and can't see the forest through the trees. Can't see that many of the meds for CH and migraine already derive from hallucinogens, and this idea is not so far fetched...

Just re-inforces my belief that GOOD SCIENCE RESULTS FROM GOOD COMMUNICATION. :)