Ameisen's new paper

[bernard]

Title: Suppression of alcohol dependence using high-dose baclofen: An observational study
Published in the web version on 8 February 2010.
Link to abstract only

This reports the trial of 60 patients using the Ameisen protocol. 88% achieved at least a 50% reduction in alcohol intake. 20% had side effects that limited their dose, but it is not clear whether any quit baclofen completely due to side effects. The average switch dose was 145 mg/day, and two-thirds needed more than the FDA maximum of 80 mg/day, with min and (imposed) max of 15 and 300. The rate of titration was 30 mg/day/week. The location seems to be a suburb of Paris.

The body of the article is in French with no translation, but a machine translation makes it clear enough. The damn-that-baclofen crowd will deride it as not a controlled study, and yes it's not a controlled stud, but so what? That doesn't make it worthless. It is certainly of value, if only incremental.

Much of it is a rehash of what's in his book, but some of it strikes me as new:
1. He did a more thorough literature review on dosage safety, and writes of "suicide attempts of 23 consecutive patients with a baclofen doses (up to 2.5 grams)... Among them, some just needed to be observed or treated in intensive care. Not a single death has
occurred and all patients left the hospital without sequelae."

2. 180 mg/day is given to children with vertigo or balance disorder.

3. He argues that it is unethical to withhold baclofen above 80 mg/day "under the pretext that a drug did not receive AMM [French FDA, I gather] approval."

4. He makes a more pointed distinction between the efficacy of all other anti-craving candidates (nal, Campral, dopamax, and Zofram), which at best provide "reduction" in craving, and baclofen which offers complete "suppression" of craving.

[Lo0p]

I'll get it for us...

[bernard]

Originally Posted by OnTheWagon

Not a good sign if the French FDA will not approve the higher dose. That probably means there's no chance the US FDA will approve it?

I don't think it means that because there was no mention of any recent application to AMM for a higher dose, so the 80 is just the original approval from the 1960s. Just as no one will fund research, no one funds a new application. So Ameisen is just talking about the status quo both in France and the US.

[azuldog]

There are allot of talented, intelligent people on this forum and you are one of them. I am interested in up to date information and this is helpful. Thanks and keep up the good work.

azuldog

[eight days a week]

Many thanks from me too bernard, and the news that the average switch dose was 145mg a day is so encouraging

[Henrietta]

Thanks Bernard! It was interesting to read of the distinction between baclophen and the other meds. I tried topamax, naltrexone, campral --all with varying degrees of success. Nothing has come close to extinguishing my cravings like baclophen does. The 145 mg dose also sounds about right. I'm 110 lbs, so when I reached 130 mg per day it all just clicked into place. However I wouldn't want others to get discouraged by the average. The switch seems to happen within a huge range of doses. IMHO, I think there are a few factors that are just as important: 1) Tirate up slowly. Going slowly usually kept my side-effects manageable. I also found dropping back down 5 mg when things got to be too much did not harm my progress. 2) Read the wealth of experience on this site. I honestly don't know what I would have done with my sleep issues if I wasn't prepared by what I learned here (like being awake when my body was dead asleep!), and 3) Persevere. What has happened to me as a result of baclofen is so profoundly different than any of the other craving meds I tried, I give you my word this one is worth hanging in there for.

[Anna B]

thanks, Bernard, for finding this. I'm sure LoOp will get the full text (I could only find it in French). But for those of you who care, here's the English abstract (which is just what you summarized above):

Abstract
The present paper reports the results of an open 3-month trial of baclofen for the treatment of alcohol dependence. Baclofen was prescribed at escalating dose, with 300 mg/day as set upper limit, up to the point at which patients experienced a decrease or a suppression of their motivation to drink. The results show that, at 3 months, 88% of the patients had either totally stopped drinking, or had significantly decreased their alcohol intake and that many of them had become indifferent to alcohol, effortlessly. Efficacious doses were highly variable from patient to patient, ranging from 15 mg/day to 300 mg/day (average 145 mg/day). Approximatelaly 2/3 of the patients needed a dose higher than the approved 80 mg/day dose.

[bernard]

Originally Posted by Anna B

here's the English abstract (which is just what you summarized above)

Actually, you'll notice that I put more details into my summary than what appear in the abstract. The article is copyrighted and so we are not supposed to simply publish it. It's particularly unfortunate in this case because I've assembled a nifty pdf with a second layer containing the English translation that you can turn off or on. This translation is from Google Translate, which needed a lot of help with those damnable diacritical marks, plus my rewording of the often-twisted locution of machine translations.

[Greg]

Very positive news indeed! I'm pretty sure I have read about all the other trials of medication for the treatment of alcoholism, aswell as other forms of alcoholism treatment. This is by far the most promising and hopefully it will generate further interest even if it doesn't satisfy all the criteria of a full medication trial. Surely this is better than the quite low success rates mentioned in the literature for other medications used in alcoholism treatment (aswell as the low success rates for traditional treatment such as AA and rehab centres).