Announcement

**Lostinspace** · April 15, 2015, 04:06 PM

Thanks so much for the info, tk. This was a very nice thing to come home to in the midst of all the bs chaos on this site recently

Hopefully, other countries will soon follow suit.

**neophyte** · April 15, 2015, 04:19 PM

Thanks for this TK

**Stevo** · April 15, 2015, 08:28 PM

Thanks for this TK,this is great news and also a wonderful thing to open the forum up to this morning.

**Cassander** · April 16, 2015, 08:56 PM

Originally posted by terryk

...

In any case, it's official now...Baclofen works.

...

:happy2:

And, of course, as we knew.

**terryk** · April 19, 2015, 08:10 PM

From the full-text:

"The first patient was recruited in March 2011, and the last visit was completed in May 2014. Inclusion criteria for men and women were: a) age of 18 and < 65 years; b) diagnosis of alcohol dependence according to ICD-10 (WHO, 1994) and DSM-IVTR ((APA), 2000); c) an alcohol consumption of at least 2 heavy drinking days per week on average (men 5 drinks per day; women 4 drinks per day; 1 standard drink is equal to 12 g absolute alcohol) and an average overall alcohol intake of 21 drinks per week or more for men and 14 drinks per week or more for women during the 4 weeks before detoxification."

"The 24-week trial consisted of four intervals [...] For the first 3 days, patients received baclofen or placebo in identical capsules in a dose of 5 mg t.i.d.; subsequently, the daily dose of baclofen/placebo was increased to a maximum of 90 mg t.i.d. within 4 weeks (titration phase). In case of intolerance, the dosage could be reduced to a minimum of 10 mg t.i.d. Patients received the maximum tolerated dosage of baclofen or placebo for 12 consecutive weeks (high-dose phase). Medication was then gradually tapered over a maximum of 4 weeks (tapering phase)."

"Tolerability of the study medication was fair in all study participants, and no deaths or drugrelated serious adverse events occurred.[...]Two patients of the baclofen group terminated treatment due to side effects (fatigue). [...] No reports of euphoric or stimulating effects of baclofen were recorded, and no patients receiving baclofen reported craving for the study medication after drug discontinuation."

"During the 12-week high-dose phase, significantly more patients assigned to baclofen remained abstinent compared to those assigned to placebo (15/22, 68.2 % vs. 5/21, 23.8 %, ?_ = 8.6, df = 2, p = 0.014). Cumulative abstinence duration during the high-dose phase was significantly higher in the group of patients allocated to baclofen, showing an increase of 30.9% compared to patients receiving placebo (mean 67.8 (SD 30) vs. 51.8 (SD 29.6) days; U =150, p = 0.047). The number of drop-outs during this interval did not differ between the baclofen and placebo groups (3/22, 13.6 % vs. 5/21, 23.8 %; ?_ = 0.83, df = 2, p = 0.743). Analysis of the whole medication phase (i.e., titration phase, high-dose phase and tapering phase) revealed that significantly more patients also maintained alcohol abstinence in the baclofen group compared to placebo (12/28, 42.9 % vs. 4/28, 14.3 %; ?_ = 5.6, df = 1, p =0.037). Cumulative abstinence duration during the complete medication phase was higher in the baclofen group (mean 82.9 (SD 49) vs. 66.8 (SD 41.9) days), but fell short of statistical significance (U = 320.5, p = 0.241). The number of drop-outs did not differ between the baclofen and placebo groups during this interval (6/28, 21.4 % of each group)."

"Compared to previous studies, the mean dosage of baclofen was relatively high in the present study (180 mg/d), possibly contributing to the superiority of baclofen compared to placebo, which was not found in a larger trial using lower dosages (30 mg/d) (Garbutt et al., 2010)."

"To the best of our knowledge, this is the first randomized, placebo-controlled trial assessing the efficacy and safety of individually titrated high-dose baclofen (30-270 mg/d) in alcohol-dependent patients. We found that baclofen supported patients in maintaining abstinence more effectively than placebo during the 12-week high-dose phase as well as during the complete medication phase (including titration and tapering). Thus, our study adds further evidence for the efficacy of baclofen in the treatment of alcohol dependence shown in previous clinical trials (Addolorato et al., 2002; Addolorato et al., 2007)."

This study was completed almost a year ago, so it took 11 months to go from analysis/write-up to being published. The French trials (Bacloville and Alpadir) concluded in the fall of 2014, so it still may be a few months before we see those results. In anycase, it's official now...Baclofen works.

-tk

**Spiritfree** · April 20, 2015, 08:49 AM

Efficacy and Safety of High Dose Baclofen for Alcohol Dependence-NIH

Hi Terry. This really is great news in support of Baclofen.

As I was reviewing clinical trial information regarding Baclofen/Alcoholism on the NIH site, I came across this one:

ClinicalTrials.gov

https://clinicaltrials.gov/ct2/show/NCT01980706?term=baclofen+alcoholism&rank=2

Terry, this study pales in comparison to the Germany study. If you cared to or wanted to take the time to write them, I would really enjoy reading a response that they give to you for not exceeding the 90mg. It is interesting to me that Dr. Koob did tell us all to keep and eye on the study in France. I am really curious as to why the US is not trying to simulate their study (or Germany's).

THE STUDY
"The proposed study will carefully test the hypothesis that a robust dose of baclofen (90 mg/day) has efficacy and is safe in individuals with alcohol dependence. Furthermore, the proposal will test whether an indicator of physical dependence, i.e. drinks/drinking day, predicts response to baclofen. Additionally, the proposal will examine the anti-anxiety effects of baclofen within an alcohol dependent population and ascertain whether baseline levels of anxiety predict response to baclofen."

Sponsor:
University of North Carolina, Chapel Hill
Information provided by (Responsible Party):
James Garbutt, MD, University of North Carolina, Chapel Hill

University of North Carolina at Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Melissa Stansbury 919-966-0011 mstansbu@med.unc.edu
Principal Investigator: James C Garbutt, MD

-SF-

**Bac4Canada** · April 20, 2015, 10:23 PM

Hi all - I am a new/old member here. I was on this forum in 2010 and was then known as Susanna (I can't seem to log on to that profile so now have a new identity here!). I wonder if anyone knows what the result of the Rotterdam trials are/were? I have not been able to find anything on it. This is the trial the Dr. Amiesen was able to get funded via a private donor.

**terryk** · April 20, 2015, 10:50 PM

Hi Susanna - nice to see you again, how are you and Paulslice these days?

I don't recall the details, but I don't think that that study ever got off the ground, and maybe the money was paid forward to one or both of the French studies? Both of those (Bacloville and Alpadir) concluded in the fall of 2014, we are expecting to see the results soon.

-tk

EDIT: ok, I did some research - I think the trial location is actually Amsterdam, and MWO member Xadrian (who is Dutch) posted this update last year: https://www.mywayout.org/community/sh...y-of-Amsterdam

**Bac4Canada** · April 21, 2015, 09:02 AM

Hello Terryk - nice to see you too! We are good - it's hard to believe this much time has passed. I have been an advocate for baclofen in Canada - and have pointed many people to it as a possible treatment for them or loved ones. Many have had success with it. I just want to look into what more I can do to spread the word and of course any clinical trial information certainly helps. I was interested to read about The Home Clinic - such a humane way to provide support to people getting treatment! I would like to see if I can get something like that in going in Toronto.

More later, nice to see some of the 'old faces' and many new names here on this site.

S

**terryk** · December 26, 2015, 02:12 PM

Bump

**_serenity_** · August 31, 2016, 06:47 PM

bump

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Announcement

April 2015 - High Dose Baclofen proven efficacious versus placebo in German RCT

April 2015 - High Dose Baclofen proven efficacious versus placebo in German RCT

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