Consolidated Baclofen Information Thread

[Ne/Neva Eva]

Consolidated Baclofen Information Thread

I find it a little ironic that this was posted 5 days ago and we haven't talked about it!
It looks as though OA has been busy with some research. I found the study very interesting, although the translation is rather burdensome. I can clearly see OA's hand in it, though! :H

We now have research on high-dose-bac on 60 people over 90 days with interesting results.
I've chosen the ones that struck me initially, but I'd be very interested in going through this point by point.

terryk;1102231 wrote: a Neuroscientists have also observed that to have a real impact, it was often give baclofen at doses well above those recommended (in the authorization of placing on the market or MA, France, the maximum doses are recommended 75 mg / d as outpatients and 120 mg / day in people hospitalized). Baclofen is prescribed by neurologists to increasing doses, until the antispasmodic effect. Gives neurologists and commonly long and baclofen at doses of 200 or 300 mg / day, without anyone find fault [14].
This is relevant to those of us on a maintenance dose. I would like to see the 1991 study in Neurology that they cite for the safety of high-dose-bac. I couldn't get anything except the abstract which doesn't really say anything. I do take comfort in the fact that it's there!

I don't know much about MS. What is the life expectancy? What are the cognitive ramifications of the disease? I ask because if the life expectancy is already short, and there is cognitive impairment associated with the disease itself, then the affects of long-term, high-dose-bac wouldn't be as much of an issue. I'm sure there are people on the forum who have experience with this disease...


terryk;1102231 wrote: The figures in our published study, which could therefore be fairly representative of larger series of patients, are as follows (three months). Close 90% of patients experienced the effects of suppressors baclofen on the desire to drink. Most have totally stopped drinking, or drink a glass of time time, usually without finishing the glass. However, a number of patients who said the experience clearly Suppressive effects of baclofen on their desire to drink, have been much more difficult to stop drinking, and some do not stop drinking, even if their consumption overall alcohol decreased significantly (decrease of more 50% compared with consumption before baclofen). We have a lot of thought and discussed the case of this group of patients we have termed "demigu?ris . It seems that these patients were unable to stop drinking for three main reasons: motivation inadequate, a concomitant psychiatric disorder and intolerance to side effects of baclofen.

90% of people experienced suppression of desire to drink.
There the actual numbers end. We're left with "most" stopped drinking, "a number of" them found it difficult to stop, and "some" do not stop drinking. In a study of only 60 people, well, it's hard to disseminate how many 'most', 'a number of' and 'some' actually are.
It would also be very interesting to see the breakdown of how many were "unmotivated", how many had other disorders, and how many had SEs that were just too great to overcome. (The 'unmotivated' category makes me smirk. How many people get into a study for a drug used off label and are unmotivated to see the promised result? I'm sure they exist, but, hmmm...)
There is also no mention of selection criteria, or did I miss it? With one profound exception: They allowed people in the study that had other psychiatric diagnoses. (depression and bipolar, for instance.) Most of the studies I've read (not many) wouldn't allow for people with other life-altering medical diagnoses.

Also, I would think that they chose people that didn't have high blood pressure, for instance. It would be interesting to know what they excluded and what they allowed. (smoking? cocaine use? etc...)

terryk;1102231 wrote: A real motivation to stop drinking appears as a prerequisite for the Baclofen is effective. A fairly large number of patients we cared we were "led", not say "pushed" by a spouse, or parent, or colleague or an employer or social services, while Just as the desire to stop drinking was not at all clear patients themselves.

This last is true in EVERY approach to sobriety, it seems to me. Unlike diabetes or cancer, for instance. In those two cases, willingness helps, but the bottom line is that the medicine does the job if one is willing to take the medicine as prescribed. Altering one's diet and lifestyle can have a profoundly positive effect, but isn't a requirement.

The willingness to change behavior and habits and in many cases (mine at least) one's very life has to be pretty profound in order to find sobriety. In my case, though, that willingness was never enough before baclofen.

These are just a few of my thoughts. Anyone else?
(Topic at hand, please.)
:goodjob: and thanks, Terry.

[Lo0p]

Consolidated Baclofen Information Thread

It's not a study NE, it's a paper. They cited the "study" they did back in 2010 which, frankly, was lacking in all the same ways that this paper is. On my droid all day, sorry I can't expand but you noted a lot of the shortcomings.

[Ne/Neva Eva]

Consolidated Baclofen Information Thread

HA! Now I understand why it all sounds so familiar. I was beginning to think that there was a standard introduction to everything written about this by the eminent doc...

You won't remember how confused and alarmed I was about the study... That's my recollection, anyway. I'd like to look at it again, but can't remember where it was. Do you?

Edit: And, ftr, that's pretty lame, isn't it???

[terryk]

Consolidated Baclofen Information Thread

High-dose baclofen studies

[terryk]

Consolidated Baclofen Information Thread

[Lo0p]

Consolidated Baclofen Information Thread

THANK YOU!!!

I've wanted this for a long time now!!

[Florieanne]

Consolidated Baclofen Information Thread

Hey there

A link to an article published ( in English) on May, 6th.
http://www.baclofene-alcool.fr/index...ownload&id=103
Florie

[bleep]

Consolidated Baclofen Information Thread

Thank a lot for all the articles Terry, very interesting stuff.

[Ne/Neva Eva]

Consolidated Baclofen Information Thread

I haven't yet worked my way through the studies you posted, Terryk, but thank you so much for finding them, scanning them and putting them up for all. I'm very much looking forward to discussing them here.

Thanks for the article, Florie. As ever, you are such a valuable resource.

Someone needs to lay off the keyboard and work on interpersonal skills. Yep. I said it. Hope he's listening. You need a PR person, a marketing person and a secretary. We're here.

Ne

[ignominious]

Consolidated Baclofen Information Thread

Yeah, thanks for posting that Flori.

The main thing I came away with is that they are considering capping the test at 200mg or less. WHY for gawds sake. Urghh. If it was me I would have been a mere 20% away from the dose I switched at. I'd be hopping mad.

Still its better than nothing but one can get the idea why baclofen is still some while away from becoming a mainstream treatment. Do the study already, I want to see the results. However much they fuck with the protocol I expect the efficacy will be indisputable.

[SassyLassy]

Consolidated Baclofen Information Thread

Thanks, TerryK and Florie...it's articles like this that I save and will eventually use when I'm switched to explain to my husband and those around me what I did and why...250mg now, not switched, but 1 AF day yesterday - yeah!

[terryk]

Consolidated Baclofen Information Thread

Some extracts (and commentary by me) from Clinical and pharmacokinetic aspects of high dose oral baclofen therapy (emphasis mine):

On the safety and possible side effects of high-dose (up to 300mg /day) baclofen:


“A recent trend among clinicians is the use of high-dose baclofen (80 to 300 mg/day) to control severe spasticity in patients with multiple sclerosis (MS) or spinal cord injury (SCI) when it does not respond to conventional dosages.”

“Side effects presumably due to baclofen were reported by five patients. These included transient muscle fatigue, hypotension, mild sedation, lightheadedness, and nausea. In most cases, symptoms resolved without change in baclofen dose. Although no toxic level applicable to all patients was found, levels beyond the tolerance of individuals were defined.”

“There was a strong correlation […] between incidence of possible side effects and patient age.”

“In this study, ten of eleven patients received higher doses of baclofen than the 80 mg daily maximum recommended in the 1992 Physicians’ Desk Reference. […]. Although side effects occurred in five patients, they tended to be mild, developing most often in older patients.”

“Clinical experience has shown wide variations in effective baclofen dosages among individuals, and it is often necessary to use doses that signigicantly exceed 80mg/day to achieve adequate symptomatic relief of spasticity. In our study, such doses were generally safe and effective, with a tendency for side effects to occur in older patients.”



On large individual doses of baclofen (like a whole handful or day’s worth of pills at once):

“Baclofen has been demonstrated to stimulate gastric motility in the rat, suggesting that larger doses of baclofen may be less well absorbed.”



On the sometimes unexpected non-linear blood levels of baclofen in patients:

“An earlier study suggests that baclofen levels can diminish with time on a stable dose. Our data demonstrated increasing blood levels over time in three of five patients on a stable regimen which ranging [sic] from 120 to 240mg/day.”

A large part of the article discusses the phenomenon observed in this study of a non-linear relationship with baclofen dosing and baclofen blood levels, in several patients. To put it in simple terms, one would expect that after ingesting a drug, the drug would be absorbed in to the body, achieve a peak blood level, and then that level would diminish as time went on and the body metabolized/excreted the drug. The process would repeat with each successive dose. It was observed in this study, however, that this did not always happen. In one case, a patient’s kidneys did not excrete the baclofen as efficiently as they should have. The patient’s baclofen-blood level kept increasing (and she actually enjoyed the benefit of increased relief from spasticity) until it caused her blood pressure to drop too low. The article goes on to explain other aspects of , and possible reasons for, this phenomenon. It gives me food for thought as to why folks here are reporting all kinds of differences in ability to titrate up and present/cope with side effects.





And finally for your amusement…

“The major portion of a dose is recovered in the urine in amounts ranging from 50 to 80 percent.”

Yup, I knew that most of the baclofen dose that you take leaves the body unchanged (15% is metabolized by the liver the other 85% is filtered by your kidneys), but it wasn’t until I read that sentence that a light-bulb went off in my head.

You could theoretically drink your own (baclofen-fortified) urine to stave off withdrawal in emergency baclofen shortages. (I had a funny side note here, but I edited it out on second thought).
-tk

[bleep]

Consolidated Baclofen Information Thread

Jesus, I wish you had never posted that Terry! I just know I'm going to be in that situation one day, stuck on a island somewhere.

I suppose it's the perfect tapering method, really, take no more baclofen, just drink all your urine for a month, as the concentration slowly gets less.

Well, if the time ever comes, you can bet who I'll be raising the first glass to...

On large individual doses of baclofen (like a whole handful or day’s worth of pills at once):

“Baclofen has been demonstrated to stimulate gastric motility in the rat, suggesting that larger doses of baclofen may be less well absorbed.”

This explains why I never had any joy in reducing the number of doses, but increasing the number of pills.

[Ne/Neva Eva]

Consolidated Baclofen Information Thread

Thanks so much for boiling it all down and coming up with bac-laced-urine, TK! whew. It's a relief that I am not the only one who has ship-wrecked scenarios going on about this.

Forgive, please, that I'm going to go off on a bit of a tangent here. I've really been struggling with the fact that there is such a dearth of information about baclofen. This innocuous and extremely powerful little chemical compound that we are all betting will save our lives.

What I realized last night, after reading your thoughts, is that this medication came out when placebo-controlled, double-blind studies were in the dark ages. No CAT scans, much less MRIs. Hell, it was even before there were regulations in place to protect people from unwanted and unwarranted 'research'.

A study consisting of 11 people taking more than 80mg/day might be all we've got. And glad to have that, frankly.

I have often wondered, too, why it is that it affects each of us so differently. That doesn't seem very effective or reliable, does it? But there are plenty of life-altering meds (most of them) that have that result. That's why there are so many meds to deal with depression, for instance, right? (How well and to what extent and in what ways your kidneys work simplifies that understanding. It varies in each of us, of course, so of course blood levels etc wouldn't be constant for each of us.)

Alright, that's all I've got in the way of digression this morning. Thanks again, Terry. Hope you'll keep it up and find the information, then disseminate and elaborate on it so I don't have to do much work!

[terryk]

Consolidated Baclofen Information Thread

Ne/Neva Eva;1115530 wrote:
Forgive, please, that I'm going to go off on a bit of a tangent here. I've really been struggling with the fact that there is such a dearth of information about baclofen. This innocuous and extremely powerful little chemical compound that we are all betting will save our lives.
I'm not done yet. The other article (and the two more it makes reference to) tell(s) a little more.

Ne/Neva Eva;1115530 wrote:
What I realized last night, after reading your thoughts, is that this medication came out when placebo-controlled, double-blind studies were in the dark ages. No CAT scans, much less MRIs. Hell, it was even before there were regulations in place to protect people from unwanted and unwarranted 'research'.
I think that the studies and trials began in the 70's. These articles are from the 90's. I'm sure SCI patients and many MS patient are given MRI's and probably CAT scans (maybe not the appropriate ones, you might say, but maybe). The YouTube video that's been posted on this forum demonstrating baclofen's effect on cocaine craving is *definiely* some kind of brain scan (no one seemed alarmed in it in the video, quite the opposite). I wouldn't bet that there is no unwanted and unwarranted 'research' going on currently in the American prison industrial complex, much less internationally.

Ne/Neva Eva;1115530 wrote:
A study consisting of 11 people taking more than 80mg/day might be all we've got. And glad to have that, frankly.

There are (will be when I post a follow-up to #2) *4* studies mentioned here, I think both of the scanned studies I posted take random samples (10%) from a larger population of subjects. I'm not sure about scientific method and how statistically valid the results are. Again, the second article has a bigger population, 112 (with some caveats), and it refers to 2 other studies were the safety and efficacy of baclofen was confirmed at doses up to 225mg/day in larger populations for a duration of 6 years. Many of the participants here spinal cord injury victims, so it is fair to say that they wouldn't experience declining mental faculties as a result of their illness, so if it happened with baclofen, you'd think that someone would've noticed and reported it. OA has reported that doctors use baclofen in doses up to 300mg/day safely. These articles do a lot to back that up. I'm still concerned about the safety of long-term safety of high-dose baclofen and I don't have a lot of blind faith for what doctors and drug companies tell me. But then again, I can't find *anything* anywhere suggesting that baclofen is damaging peoples' brains or bodies in someway. Not definitive proof, by far, but it *is* a good track record. I'm still concerned.


Ne/Neva Eva;1115530 wrote:
I have often wondered, too, why it is that it affects each of us so differently. That doesn't seem very effective or reliable, does it? But there are plenty of life-altering meds (most of them) that have that result. That's why there are so many meds to deal with depression, for instance, right? (How well and to what extent and in what ways your kidneys work simplifies that understanding. It varies in each of us, of course, so of course blood levels etc wouldn't be constant for each of us.)

*This* article really fleshes out the phenomenon of baclofen affecting everyone differently. All along (especially during my titration) I've wondered why the fuck OA said he didn't have side effects (as some have also reported here). Mostly I call bullshit, but many of these studies too, reflect mild (or no) side effects among participants. Could it be that years of physical dependency on alcohol and the subsequent changes it brings to our brains (and GABA receptors) makes some/most/all of us especially susceptible to side effects from the drug that remediates that damage?

-tk