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        Cluster Headache Help and Support >> Cluster Headache Specific >> Harvard?
        
(Message started by: Bob P on Aug 1^st, 2007, 6:43pm)

Title: Harvard?
Post by Bob P on Aug 1^st, 2007, 6:43pm

Any new info on the status fo the Harvard/Sewell/MAPS shroomsearch?

Title: Re: Harvard?
Post by Pinkfloyd on Aug 3^rd, 2007, 1:28am

on 08/01/07 at 18:43:43, Bob P wrote:

Any new info on the status fo the Harvard/Sewell/MAPS shroomsearch?

I'm not ignoring you Bob....(I only attempt the impossible once a week).

I could answer with a simple...yes, or no, but this deserves a detailed answer that'll take a while to write.
It is time for a good update to everyone. I'll try to do that early next week. I'm up to my neck with stuff I'm trying to get done so I get go away for the weekend...but I'll do this asap.

The short answer is Yes, btw.

Bobw

Title: Re: Harvard?
Post by Bob P on Aug 3^rd, 2007, 8:44am

Thanks Bob. A supporter posted about starting a NPO to fund research and it brought this to mind. No hurry. Appreciate the response.

Title: Re: Harvard?
Post by Jonny on Aug 20^th, 2007, 7:32pm

And? ;;D

Title: Re: Harvard?
Post by Jonny on Aug 20^th, 2007, 9:23pm

And? ;)

Title: Re: Harvard?
Post by Pinkfloyd on Aug 20^th, 2007, 9:54pm

on 08/20/07 at 21:23:25, Jonny wrote:

And? ;)

And the Bears are on and I'll be back later tonite.

Title: Re: Harvard?
Post by Pinkfloyd on Aug 21^st, 2007, 1:56am

on 08/01/07 at 18:43:43, Bob P wrote:

Any new info on the status fo the Harvard/Sewell/MAPS shroomsearch?

Bob, and all interested parties,

There have been a lot of developments over the past year. Here is the latest rundown.

The protocol has gone through several different versions and the latest version is again nearing completion. Changes have been made along the way and I imagine it will be an evolving project all the way until it's final approval by the FDA/DEA.

As it stands now, the main trial design is for studying Episodic cluster patients with psilocybin. The number of patients is currently at 18 people. 9 with psilocybin and 9 placebo. There is also a planned separate arm of the study that would study treating 4 Chronic Cluster patients with LSD.
It is our hope and it is believed that people will be accepted into the study and begin receiving psilocybin/LSD to treat their clusters, in 2008.

Preliminary budget numbers have been submitted to McLean.

Mass. General will also likely be involved.

MAPS is no longer working directly with McLean. Clusterbusters is in direct contact with McLean and MAPS is supporting Clusterbusters.

We have found that this is a very long and drawn out affair but are all still determined to see it come to fruition. Currently, we are in the middle of designing the headache diary needed for the study participants. Its not as easy as it sounds ;-)

The psilocybin/lsd study is being handled by Dr. Halpern at McLean.

Dr. Andrew Sewell left McLean this year and is no longer involved in the psilocybin/lsd work.

Dr. Sewell is though, currently working independently, though an independent IRB, on a case series on LSA such as the one he did for us on psilocybin that was published in Neurology. This work is being done under a contract between Clusterbusters, MAPS and Dr. Sewell. This is scheduled to be completed in September. Not sure when it may make publication as that also takes time and efforts after the results are known.

Although I can't give too many details on the following, because it is currently in progress....I can say:
There are cluster patients in Europe currently being treated with a modified LSD. Clusterbusters, Dr. John Halpern, MAPS and McLean are involved from the States and a highly respected research doctor(s) and lab in Europe, are involved in this International effort. We are awaiting the results. As soon as the study has closed and results are reported to us, I can give more details.

We have had a great deal of press coverage over the last couple of years. I think tommy may have a better idea but I believe that most likely the number is over 500 people now that have tried psychedelics to treat their clusters....unofficially of course.
We have gotten to the point that when people bring up the subject to their doctors, many of the docs know about the work being done and are supportive of people giving it a try.....unofficially of course. Some doctrs are actually bringing it up to their patients and explaining the similarities of psychedelics to both sansert and the triptans. I believe our presentation at the Headache Summit, along with the article in Neurology have made this a topic of discussion within the headache community.

If you have any questions, I'd be happy to try and answer them.

If you have any money you'd like to donate, send it to MAPS and mark it for the cluster headache study.

Bob

Title: Re: Harvard?
Post by fiftyamp on Aug 21^st, 2007, 2:43am

Does anyone know where to make a private donation to this study?

Title: Re: Harvard?
Post by southwalessunshine on Aug 21^st, 2007, 6:15am

Pinkfloyd, you mentioned the the trials were involving episodic CH patients. Does that mean psychedelics don't work on chronic patients or they just haven't tested them yet?

Title: Re: Harvard?
Post by Lotus on Aug 21^st, 2007, 9:06am

Thanks for the info, that is interesting.

Do you know what is the selecting criteria for the study? Would it be episodic CHers who have never tried psychedelic substance before or people who have had some experience with them? Would they have to go through a psych evaluation prior to be accepted to the study?

Since the treatment must be taken while in cycle, how do the researchers manage to get all subjects to have cycles at the same time? Or will the data be collected individually throughout the year? And for the people given placebo, how will they cope without any meds through the cycle? How long are the treatments given, is it done over days, weeks or months or just until the cycle ends?

Thanks again

Annette

Title: Re: Harvard?
Post by Kevin_M on Aug 21^st, 2007, 10:04am

Thanks Bob. Good to know of this continued, and accelerated progress with something so important for us. Great work!

thanks again. :)

on 08/21/07 at 01:56:05, Pinkfloyd wrote:

Preliminary budget numbers have been submitted to McLean.

fingers crossed.

Title: Re: Harvard?
Post by pattik on Aug 21^st, 2007, 10:35am

Quote:

Do you know what is the selecting criteria for the study? Would it be episodic CHers who have never tried psychedelic substance before or people who have had some experience with them? Would they have to go through a psych evaluation prior to be accepted to the study?

The protocol is not yet completed, but it's close to being finished. That's why I don't have a definitive answer to all of your questions. All subjects will go through a psychological evaluation before and after treatment, and will be monitored during.

Quote:

Since the treatment must be taken while in cycle, how do the researchers manage to get all subjects to have cycles at the same time?

Finding enough subjects in cycle at the same time will not be difficult to do. Oxygen will be available for all subjects, until their cycles have ended. Until the protocol is finished and has gained official approval and becomes public knowledge, accurate answers to your questions will have to wait.

To fiftyamp: Below is a link to make a contribution through MAPS. There are links on this page to guide you.
http://www.maps.org/research/cluster/psilo-lsd/

Patti

Title: Re: Harvard?
Post by Lotus on Aug 21^st, 2007, 5:18pm

Thanks Patti.

Wouldnt this be the first ( formal ) study of its kind into the efficacy of psilocybin in cluster headaches?

Eagerly await results.

Title: Re: Harvard?
Post by Pinkfloyd on Aug 21^st, 2007, 5:41pm

on 08/21/07 at 09:06:14, Lotus wrote:

Thanks for the info, that is interesting.

All good questions. I'll answer what I can.

Do you know what is the selecting criteria for the study?

Yes, I do know what currently the inclusion and exclusion criteria are, but until the protocol is finalized, these things may change. This is a topic that is scrutinized and often modified by the IRBs, and others. I probably wouldn't want them public until they are "finally" finalized. No reason to make people think they couldn't get in if they can, later due to a change, or vice-versa.
At this point they are pretty simple and straight forward.

Would it be episodic CHers who have never tried psychedelic substance before or people who have had some experience with them?

This is one of the more fluid factors that is likely to change again. One thing is most certain that having to have some experience with psychedelics will NOT be necessary for inclusion.
To make that more clear...people will not have to have experience with psychedelics to get in.

Would they have to go through a psych evaluation prior to be accepted to the study?

Yes

Since the treatment must be taken while in cycle, how do the researchers manage to get all subjects to have cycles at the same time? Or will the data be collected individually throughout the year?

We do not need to have everyone there at the same time.

And for the people given placebo, how will they cope without any meds through the cycle?

Another point being considered and modified as needed. Rescue meds are one of the many points under consideration. It is laid out now but this is again, an area that many people/agencies/interested parties, will have input as we follow the approval process.

How long are the treatments given, is it done over days, weeks or months or just until the cycle ends?

[b]Currently....3 treatments over a 10 day span. Its a little more complicated than that, but....At this point, that is the crux of the matter.

You're welcome
Bobw[/b]

Thanks again

Annette

Title: Re: Harvard?
Post by Pinkfloyd on Aug 21^st, 2007, 5:47pm

on 08/21/07 at 17:18:43, Lotus wrote:

Wouldnt this be the first ( formal ) study of its kind into the efficacy of psilocybin in cluster headaches?

Yes. As a matter of fact, it will be the first study of it's kind into the use of psychedelics to treat ANY physical ailment in the US in over 40 years.

Bobw

Title: Re: Harvard?
Post by Pinkfloyd on Aug 21^st, 2007, 5:52pm

on 08/21/07 at 06:15:53, southwalessunshine wrote:

Pinkfloyd, you mentioned the the trials were involving episodic CH patients. Does that mean psychedelics don't work on chronic patients or they just haven't tested them yet?

There is a small arm of the study involving chronic clusters.

Psychedelics do work for chronic patients, although they have not yet been officially tested in a clinical setting, yet.
There are quite a few chronics here, and elsewhere that can attest to the fact that they are no longer chronic, due to the use of psychedelics.

Bobw

Title: Re: Harvard?
Post by Bob P on Aug 21^st, 2007, 6:45pm

Thanks Bob.

Title: Re: Harvard?
Post by Pinkfloyd on Aug 21^st, 2007, 11:45pm

on 08/21/07 at 18:45:38, Bob P wrote:

Thanks Bob.

You're welcome Bob

Title: Re: Harvard?
Post by LeeS on Aug 22^nd, 2007, 11:57am

on 08/21/07 at 17:52:43, Pinkfloyd wrote:

There are quite a few chronics here, and elsewhere that can attest to the fact that they are no longer chronic, due to the use of psychedelics.

I be one 8)

Thanks for the update Bob.

-Lee

Title: Re: Harvard?
Post by nani on Aug 22^nd, 2007, 12:08pm

on 08/22/07 at 11:57:58, LeeS wrote:

I be one 8)

I be one, too!
Broke a 5 year cycle with busting. Technically, I'm chronic again in that I don't go 30 days without acitvity... but I've gone longer than that without an attack... just occasional twinges and easy shadows. 8)