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Topic: Official Clinical Trial of ClusterBusters Underway (Read 1691 times) |
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Flash
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Official Clinical Trial of ClusterBusters Underway
« on: Mar 7th, 2004, 10:30am » |
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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. |
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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
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| « Last Edit: Mar 8th, 2004, 2:16pm by Flash » |
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BobG
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Re: FDA has approved Clinical Trial of ClusterBust
« Reply #1 on: Mar 7th, 2004, 11:09am » |
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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.
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forgetfulnot
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Re: FDA has approved Clinical Trial of ClusterBust
« Reply #2 on: Mar 7th, 2004, 4:19pm » |
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WOW!!!!!!! David vs Goliath, as MOC would say, this is coolness. 
Lee
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Simon
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Re: FDA has approved Clinical Trial of ClusterBust
« Reply #3 on: Mar 7th, 2004, 4:30pm » |
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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
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Edski_1
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Re: FDA has approved Clinical Trial of ClusterBust
« Reply #4 on: Mar 7th, 2004, 7:08pm » |
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Does this have anything to do with Ashcroft being inthe hospotal? Maybe they slipped it by the justice department? 
Good work! 
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JDH
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Re: FDA has approved Clinical Trial of ClusterBust
« Reply #5 on: Mar 7th, 2004, 8:23pm » |
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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
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Pinkfloyd
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Re: FDA has approved Clinical Trial of ClusterBust
« Reply #6 on: Mar 8th, 2004, 2:29am » |
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hello everyone!! 
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
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Mark C
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Re: FDA has approved Clinical Trial of ClusterBust
« Reply #7 on: Mar 8th, 2004, 2:55am » |
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Eeyore
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Re: FDA has approved Clinical Trial of ClusterBust
« Reply #8 on: Mar 8th, 2004, 3:12am » |
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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 -
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| « Last Edit: Mar 8th, 2004, 3:13am by Eeyore » |
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ave
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Re: FDA has approved Clinical Trial of ClusterBust
« Reply #9 on: Mar 8th, 2004, 4:26am » |
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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?
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ozzman
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Re: FDA has approved Clinical Trial of ClusterBust
« Reply #10 on: Mar 8th, 2004, 9:02am » |
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Bob, Flash, all of you at Clusterbusters, thank you. One step closer to the cure.
BTW, will report soon.
Ozzy
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| « Last Edit: Mar 8th, 2004, 3:08pm by ozzman » |
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thomas
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Re: FDA has approved Clinical Trial of ClusterBust
« Reply #11 on: Mar 8th, 2004, 11:01am » |
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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.
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notseinfeld
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Re: FDA has approved Clinical Trial of ClusterBust
« Reply #12 on: Mar 8th, 2004, 2:14pm » |
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You guys Rock!
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| « Last Edit: Mar 8th, 2004, 2:15pm by notseinfeld » |
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Virginia
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Re: Official Clinical Trial of ClusterBusters Unde
« Reply #13 on: Mar 8th, 2004, 2:33pm » |
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darn! notseinfeld took my line...
But it's true, Pink, Pink, Flash, et al....YOU ROCK!!! This is SO EXCITING!
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The Clusterhead formerly known as 9erfan.
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Pinkfloyd
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Re: FDA has approved Clinical Trial of ClusterBust
« Reply #14 on: Mar 8th, 2004, 2:50pm » |
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on Mar 8th, 2004, 9:39am, 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? |
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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.
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Pinkfloyd
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Re: Official Clinical Trial of ClusterBusters Unde
« Reply #15 on: Mar 8th, 2004, 3:01pm » |
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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
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| « Last Edit: Mar 8th, 2004, 3:32pm by Pinkfloyd » |
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"Nothing is so firmly believed as what we least know."
"There is no passion so contagious as that of fear."
[Michel de Montaigne
www.clusterbusters.com
www.obscuredview.blogspot.com
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jminmilwaukee
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Re: Official Clinical Trial of ClusterBusters Unde
« Reply #16 on: Mar 8th, 2004, 3:48pm » |
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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!
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.
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1MajorPain
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Re: Official Clinical Trial of ClusterBusters Unde
« Reply #17 on: Mar 8th, 2004, 3:48pm » |
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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
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notseinfeld
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Re: Official Clinical Trial of ClusterBusters Unde
« Reply #18 on: Mar 9th, 2004, 9:30am » |
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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?
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SommelierCH
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Re: Official Clinical Trial of ClusterBusters Unde
« Reply #19 on: Mar 10th, 2004, 4:11am » |
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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.
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| « Last Edit: Mar 10th, 2004, 4:21am by SommelierCH » |
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Giovanni
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Re: Official Clinical Trial of ClusterBusters Unde
« Reply #20 on: Mar 10th, 2004, 10:11am » |
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Hey PF, take care of yourself. We need a good mold for the bronzing act here.
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
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Pinkfloyd
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Re: Official Clinical Trial of ClusterBusters Unde
« Reply #21 on: Mar 11th, 2004, 1:51am » |
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on Mar 10th, 2004, 4:11am, 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. |
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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.
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"Nothing is so firmly believed as what we least know."
"There is no passion so contagious as that of fear."
[Michel de Montaigne
www.clusterbusters.com
www.obscuredview.blogspot.com
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Bob P
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Re: Official Clinical Trial of ClusterBusters Unde
« Reply #22 on: Mar 12th, 2004, 11:04am » |
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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
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| « Last Edit: Mar 12th, 2004, 4:39pm by Bob P » |
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Pinkfloyd
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Re: Official Clinical Trial of ClusterBusters Unde
« Reply #23 on: Mar 12th, 2004, 8:04pm » |
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Thanks Bobp
I spoke with Dr. Moreno last year.
I appreciate you looking to see what you had.
PF
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"Nothing is so firmly believed as what we least know."
"There is no passion so contagious as that of fear."
[Michel de Montaigne
www.clusterbusters.com
www.obscuredview.blogspot.com
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pinksharkmark
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Re: Official Clinical Trial of ClusterBusters Unde
« Reply #24 on: Mar 13th, 2004, 4:18am » |
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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
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| « Last Edit: Mar 13th, 2004, 4:19am by pinksharkmark » |
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