Baclofen Clinical Trials

[Zman]

I have read in a number of places that due to public pressure, clinical trials are underway on Baclofen's effect on addiction.

Does anyone have any info on these trials?

Thanks,

Zman

[bernard]

Baclofen Clinical Trials

From another thread:

the efficacy of any treatment can only be established through controled double blind clinical studies with statistically significant results. Otherwise, go ask Oprah.

This is not true. The double blind is the gold standard, but with that gold comes significant limitations on the richness of information that results. If evolution, physician's knowledge, or culture in general depended on double blind tests, we'd still be bacteria.

To wit and for example, in psychiatrist Stephen Stahl's Essential psychopharmacology of depression and bipolar disorder, 2000, which teaches the use of "rational polypharmacy" for patients unsatisfactorily treated by single drugs, he writes about two bases of treatments that have not been double blind tested. They are:

1) Conjecture based on "theoretical pharmacologic and molecular" mechanisms. In other words, he thinks it might work based on his (incomplete) understanding of the mechanisms.

2) Knowledge based on "anecdotal and empirical evidence of safety and efficacy from uncontrolled use in clinical practice."

Moreover, these are the bases for the common practice "off label" prescribing.

Furthermore, I will repeat here what has gone unnoticed on the veritas thread:

This "viral" flow of medical information will, I think, someday be reliable enough that physicians will use it openly rather than just lurk, as I suspect many psychiatrists are doing now to try and avoid becoming irrelevant due to knowing soooo much less than someone following this group. One step in that direction is to get at least some basic information from each person reporting so that an observer can start to see patterns and quote some numbers, such as numbers reporting any given symptom. It would be nice if one of the lurkers were a medical epidemiologist who might offer some rudimentary suggestions. As an amateur first draft, the list might include:

Gender, age, height and weight, detailed drinking history, other meds currently taking, other meds tried for alcohol dependence, response to alcohol, known bad reactions to drugs or foods, and so on.

I thought of this when I read more of veritas' story in which she explains that her standard response to many drugs, including excessive alcohol, moderate alcohol combined with baclofen, aspirin, codeine, certain antihistamines, and an epidural, is nausea and vomiting, sometimes quite severe, and sometimes in conjunction with other symptoms. In this context, her response to a combination of baclofen and alcohol--really bad nausea and vomiting, temporary paralysis, and overall horror--is not quite as big a red flag to other balofenists as it would have been without knowing this. (Of course I am not in the slightest belittling the suffering veritas went through.)

One other thought: Can any of you computer gurus figure out how to do a machine translation and consolidation into a single pdf of that 548-page thread in French on baclofen? It's at Alcool : forum E-sant?

[bernard]

Baclofen Clinical Trials

I forgot to add that Alkermes, the manufacturer of Naltrexone, is pipelining an extended release baclofen. I'm sure they figured out a long time ago that baclofen leaves Naltrexone in the dust (or leaves it at the bar). This drug will be on patent and will thus be marketed, so that dumbo physicians whose sole continuing education consists of sales seminars, will be willing to use it. Just google "Alkermes baclofen".

[Long Road]

Baclofen Clinical Trials

I threw a virgin down a well last week and my tinnitus improved. Based on this success I threw another down and it cleared completely! Killing virgins cures ringing in the ears QED. (once we run out of virgins we will all go deaf)

[veritas]

Baclofen Clinical Trials

Bernard, I think that baclofan is going to revolutionise not only the way addiction is treated, but also the way it is perceived.

In terms of my own reaction: I can only imagine that this must be what sea sickness feels like. The nausea and vomiting was not the gastric irritation from a night of too much wine, it was the feeling that the world was standing still while I was spinning in a circle. Now that I understand it I feel less paniced.

I remember in my early drinking days how I would have to fall asleep with my foot on the floor. It was exactly the same feeling.

[billyb]

Baclofen Clinical Trials

Bernard, you mentioned that Alkermes is producing a patented baclofen formula. I briefly looked at the information, and it seems they are combining an extended-release version of baclofen with some sort of opioid modulator for addiction treatment. Is the ER version alone patented, or is it only the combination with their opioid modulator? This could indeed be a cash cow for them if it is the baclofen ER alone, but if their only claim is on the hybrid baclofen/opioid modulator, then I don't see how this will be such a great drug, since baclofen therapy requires such big dosage increases. I could see a once-a-day 30mg pill being great, but if you have to also increase your doses of the opioid modulator along with it, that might get a little complicated. (I probably don't need to worry, I'm sure they have all the angles on this figured out...)

One of the most interesting things about Ameisen's discovery is the out-of-patent status of the drug. On the one hand it's frustrating that clinical trials are difficult to get funded, but on the other hand it's kind of nice to see a case where we don't need to rely on big pharma's corrupt marketing practices and questionable trial sponsorships where our own health and well-being is concerned...

[bernard]

Baclofen Clinical Trials

Alkermes is pipelining:

Baclofen ER, which is a straight baclofen packaged for a slow rate of release into the body. The clinical trial is described here: A Study of Baclofen Formulations in Healthy Adults - Full Text View - ClinicalTrials.gov

ALKS 29, a proposed mix of Baclofen ER and ALKS 33, described on Alkermes' website: http://www.alkermes.com/our-products.aspx
I don't see that it has been tested in humans yet, but the components are being tested separately.

and

ALKS 33, an opioid modulator, also described on Alkermes' site.

[Zman]

Baclofen Clinical Trials

Bernard,

I looked at the link for the Bac ER, and it says the study is complete, but no results are listed.

[bernard]

Baclofen Clinical Trials

Zman,
As I understand it, a drug pipeline consists of a long list of hurdles including numerous tests including various clinical trials. And it seems that the drug company is not required to publish the results until the drug is approved for sale. This particular test appears to just be measuring pharmacokinetics (concentration in the blood over the course of the day) and safety at 30 mg/day. It's like building an airplane; they do a lot of subsystem tests and checking before they speed down the runway.

The main point is that making baclofen extended release is method of making this off-patent product proprietary even though it's basically the same chemical. Being proprietary, then they have money to market it. (In places like Modern Drunkard Magazine. Modern Drunkard Magazine Online )

[billyb]

Baclofen Clinical Trials

bernard;670678 wrote: Alkermes is pipelining:

Baclofen ER, which is a straight baclofen packaged for a slow rate of release into the body. The clinical trial is described here: A Study of Baclofen Formulations in Healthy Adults - Full Text View - ClinicalTrials.gov

ALKS 29, a proposed mix of Baclofen ER and ALKS 33, described on Alkermes' website: http://www.alkermes.com/our-products.aspx
I don't see that it has been tested in humans yet, but the components are being tested separately.

and

ALKS 33, an opioid modulator, also described on Alkermes' site.

Thanks for pointing that out - I only saw references to ALKS 29, I didn't see the Baclofen ER stuff.