high-dose baclofen- clinical trial January 2011 Amsterdam University

[c0ffee]

I can't seem to find any information on the below taken off of wikipedia. I wonder if the trial has been started yet and if so, can you get any kind of results. Anyone know?

Inspired by reading Olivier Ameisen?s The End of My Addiction, a person who wishes to remain anonymous donated $750,000 to Amsterdam university in the Netherlands to initiate the clinical trial of high-dose baclofen Ameisen had called for since 2004. The trial is scheduled to start in January 2011 and will be led by the team of Pr. Dr. Reinout Wiers. Ameisen has been contacted by the team.

[TracyA]

high-dose baclofen- clinical trial January 2011 Amsterdam University

C0ffee, last I heard, it would be a couple years before results would be published. Maybe I'm wrong . . . but maybe they're after long-term effects.

[c0ffee]

high-dose baclofen- clinical trial January 2011 Amsterdam University

hmmm. maybe I'll shoot Dr. Ameisen an email and see what he says.

[bleep]

high-dose baclofen- clinical trial January 2011 Amsterdam University

That's the information I have as well, but it's second hand. I believe (not sure from where), that it's starting in October. I think LCM has a bit of information on the trial.

[I-want-to-be-sober]

high-dose baclofen- clinical trial January 2011 Amsterdam University

I heard it studies how baclofen helps subtypes of alcoholics and the study will go for four years, don't know if that's true. I can contact Prof. Wiers if you want.

[I-want-to-be-sober]

high-dose baclofen- clinical trial January 2011 Amsterdam University

Trial will start in september.

[foundhope]

high-dose baclofen- clinical trial January 2011 Amsterdam University

dr ameisen email

can someone give me Dr. Ameisen's email address?:thanks:

[redhead77]

high-dose baclofen- clinical trial January 2011 Amsterdam University

Hi

You can email him through his website. There should be a link there.

[Cassander]

high-dose baclofen- clinical trial January 2011 Amsterdam University

I-want-to-be-sober;1078556 wrote: Trial will start in september.

Anyone have any updated information about the status of the Amsterdam trials?

[gratitude]

high-dose baclofen- clinical trial January 2011 Amsterdam University

bump

[Cassander]

high-dose baclofen- clinical trial January 2011 Amsterdam University

No news on Amsterdam, but great news from France!

The very respected French newspaper Le Figaro reports that a bona fide (as in real) clinical trial has been scheduled to begin at the end of this year in France. This is apparently in addition to the Dutch trial.

Here's a link:

Le Figaro - Sant? : Alcoolisme*: le baclof?ne va ?tre officiellement test?*

And here's a Google translation:

It's a glimmer of hope for people suffering from alcoholism. Awaited by many patients and doctors, the first clinical trial to evaluate the efficacy of baclofen (Lioresal) in the treatment of alcohol dependence is expected to begin within a few months in France.

The drug, developed by the laboratory Novartis Pharma back nearly forty years to relieve muscle spasms, has no authorization in the market (AMM) to treat alcoholism. This does not prohibit doctors from prescribing it in this direction, but the practitioner takes the risk of being sued if something goes wrong.

For Professor Philippe Jaury, coordinator of the study, this trial represents a major step forward. "Currently, many doctors still refuse to prescribe baclofen for the treatment of alcohol dependence, lack of scientific evidence on its effectiveness," says the general practitioner, a teacher at the Faculty of Medicine Ren? Descartes in Paris. The study, which has long sought funding , finally received public funding, the amount is currently unknown. It should begin in December or January next, to the expected results in 2013.

The clinical trial will be conducted "in real life" - also known as pragmatic study - in the city, with 300 patients at eight centers. It will be conducted double blind, meaning that some participants will receive a placebo without knowing it. "Our hypothesis is that the placebo procedure to 20% and baclofen walk from 40 to 50%," said Prof. Jaury. A patient is considered cured if he stops drinking completely or if it adopts a so-called normal alcohol consumption, according to the standards of the World Health Organization (WHO).

The use of baclofen to treat alcohol dependence was popularized in France by a book, The Last Glass , published in 2008. Its author, Dr. Olivier Ameisen, a French cardiologist became an alcoholic, tells how he managed to suppress any desire to drink in this s'autoprescrivant muscle relaxant at high doses.

Narrow profile of patients

French practitioners were then reproduced the experience of patients by adjusting the dose on an individual basis, often with success. The forums of patients on this drug a "miracle" have quickly multiplied on the Internet to exchange contact information of doctors willing to prescribe treatment.

Jean-Pierre Couteron, president of the Federation Addiction which includes players alcoholism and addiction, this test is "welcome" because it will sharpen the profile of patients for whom the drug may be beneficial. "The evidence available are encouraging, but be aware that baclofen does not work for everyone," said he. And remember that there are of other means to fight against this disease , therapies such as group or community, like Alcoholics Anonymous, or cessation strategies practiced in conventional hospitals. "The care of a sick alcohol is always global, both medical, psychological and social, confirms Professor Jaury. The drug is only a crutch, although it may prove to be a very good stand. "

If the results of the clinical trial confirm the efficacy of baclofen, a laboratory working with the team of Pr Jaury should submit an application for marketing authorization for forms of the drug over-dose and extended-release (which allow the patient to take one tablet a day instead of multiplying the catch during the day). This would allow doctors to prescribe it to treat alcoholism in peace.

[Cassander]

high-dose baclofen- clinical trial January 2011 Amsterdam University

Nalmefene

More information from the French board:

The Danish pharma company Lundbeck reported in June continued positive results with testing of its compound Nalmefene.

Here's a summary:

Lundbeck has now completed the second 6-months efficacy study in the overall clinical phase III programme with nalmefene

Nalmefene has a significant potential for helping individuals with alcohol dependence in reducing their alcohol consumption and allowing individuals to be in control of their alcohol intake

The reduction in heavy drinking days and total alcohol consumption was seen within the first month of treatment in all three studies and was maintained throughout the 12-month safety study

Nalmefene was safe and well tolerated

Nalmefene is the first medicine aimed at regulatory approval in Europe for the reduction of alcohol consumption in patients with alcohol dependence consequently reducing the risk of alcohol related harm

Submission of an MAA for nalmefene in Europe is expected by the end of 2011

Here's a link:

http://www.lundbeck.com/investor/rel...1523497_EN.asp

[Murphyx]

high-dose baclofen- clinical trial January 2011 Amsterdam University

Cassander;1169371 wrote: More information from the French board:

The Danish pharma company Lundbeck reported in June continued positive results with testing of its compound Nalmefene.

Here's a summary:

Lundbeck has now completed the second 6-months efficacy study in the overall clinical phase III programme with nalmefene

Nalmefene has a significant potential for helping individuals with alcohol dependence in reducing their alcohol consumption and allowing individuals to be in control of their alcohol intake

The reduction in heavy drinking days and total alcohol consumption was seen within the first month of treatment in all three studies and was maintained throughout the 12-month safety study

Nalmefene was safe and well tolerated

Nalmefene is the first medicine aimed at regulatory approval in Europe for the reduction of alcohol consumption in patients with alcohol dependence consequently reducing the risk of alcohol related harm

Submission of an MAA for nalmefene in Europe is expected by the end of 2011

Here's a link:

http://www.lundbeck.com/investor/rel...1523497_EN.asp

Nalmefene is a version of Naltrexone. Interesting, but not bac related.

[Cassander]

high-dose baclofen- clinical trial January 2011 Amsterdam University

Here is a link to a German baclofen trial which is apparently under way:

Baclofen for the Treatment of Alcohol Dependence - Full Text View - ClinicalTrials.gov

[Murphyx]

high-dose baclofen- clinical trial January 2011 Amsterdam University

Unfortunately the German study is useless; they're only prescribing to a maximum of 90mg/day.

Cassander, I appear to be pouring cold water on your research news, that's certainly not my intention. I appreciate the work you put in here and always find your posts interesting.