Prescribing of baclofen for alcohol dependence 'should be reconsidered'

November 30, 2016

The drug baclofen has received high visibility as a possible breakthrough treatment for alcohol dependence*. Now a new randomised controlled trial from the University of Amsterdam found no evidence for the usefulness of high-dose baclofen in treating alcoholism when added to psychosocial treatments.

Recent trials have suggested high doses of the GABA-b agonist baclofen can be effective in the treatment of alcohol dependent patients. These studies, coupled with individual patient testimonies, have given baclofen a high public profile, prompting the French authorities in 2014 to give permission to physicians to prescribe high doses baclofen for alcohol-dependent patients, pending results from ongoing randomized clinical trials. Even before that permission, more than 200,000 persons had used baclofen "off label" in France alone. Baclofen is licenced for use as a skeletal muscle relaxant for spasms (spasticity).

Now researchers from the Netherlands have carried out the largest randomised controlled trial (RCT) on baclofen for alcohol dependence so far. Their report, published in the peer-reviewed journal European Neuropsychopharmacology (December 2016), indicates that the effects of the drug may add little to the effect provided by psychosocial treatment.

151 alcoholic patients took part in the 16 week trial. 58 were given high-dose baclofen (starting with low dose, with the dose rising to up to 150 mg/day), low dose baclofen (31 patients, 30 mg/day), or placebo (62 patients). At the end of the trial the researchers found no differences in relapse rates (measured as the time to the first heavy drinking day post-treatment) between the groups: about 25% relapsed in each group.

Lead researcher, Professor Reinout Wiers (University of Amsterdam), said:"This came as a surprise to us. In August 2015 a small German RCT** had indicated that high dose baclofen showed good results, but their control group did not receive any treatment, whereas all our patients, including the placebo group, received psychosocial treatment. Together these studies indicate that baclofen may be as effective as psychosocial care, but does not seem to increase effectiveness further. This means that we may have to further study the effectiveness of baclofen before we can recommend it for use. For example, perhaps it can help a subgroup of alcohol-dependent patients who do not respond to psychosocial treatment. We believe that prescribing baclofen widely, as currently happens in France, might be premature and should be reconsidered".

Professor Wiers continued:"We are planning a new RCT, where we will test high dose Baclofen, up to 330 mg per day, in alcohol-dependent patients who have not responded to regular psychological treatment. For comparison, the maximum recommended adult dose of baclofen for its normal (spasticity) use is 80 mg/day. We need to consider safety and side-effects. We are not closing the door on baclofen, but we are saying that we need more research".

Commenting, Professor Jonathan Chick, Medical Director, Castle Craig Hospital, Edinburgh, Scotland said:"Baclofen showed promise in the original trials in Italian liver clinics where patients did not receive intensive psychosocial treatment. The new Dutch study recruited patients from 4 and 6 week residential programmes, one of which was based on the 12-step model. Intensive treatment, especially with 12-step aftercare, is known to be powerful as shown here - all groups had better outcomes than usual in European studies. Given that such good results are obtained with psychosocial treatment, any additional effects of baclofen probably wouldn't reach statistical significance in a group of this size".

The use of Baclofen for alcohol dependence was stimulated by the book 'The end of my addiction', written by the French physician Olivier Ameisen, who claimed to have cured his own alcohol dependence by self-administering a high dose of Baclofen. Until then, Baclofen had been used in a much lower dose as a muscle relaxant for spasms (spasticity).
-end-
See paper, http://www.europeanneuropsychopharmacology.com/article/S0924-977X(16)31968-X/fulltext

*See for example, "Baclofen: the controversial pill that could 'cure' alcoholism", https://www.theguardian.com/society/2016/sep/16/baclofen-controversial-pill-cure-alcoholism

**The 2015 German study had followed 56 alcohol-dependent patients, who either received a high dose of baclofen (up to 270 mg/day) or placebo. It found that 68 % of the patients on baclofen remained abstinent compared to only 24% of the patients on placebo. Ref; High-dose baclofen for the treatment of alcohol dependence (BACLAD study): A randomized, placebo-controlled trial Mueller et al., European Neuropsychopharmacology, Volume 25, Issue 8, August 2015, Pages 1167-1177

Funding for this study was provided by a private donation through the University of Amsterdam Fund.

European College of Neuropsychopharmacology

Related Alcohol Articles from Brightsurf:

Alcohol use changed right after COVID-19 lockdown
One in four adults reported a change in alcohol use almost immediately after stay-at-home orders were issued: 14% reported drinking more alcohol and reported higher levels of stress and anxiety than those who did not drink and those whose use stayed the same.

Changes in hospitalizations for alcohol use disorder in US
Changes over nearly two decades in the rate of hospitalizations and in-hospital deaths from alcohol use disorder in the US were examined in this study.

Associations of alcohol consumption, alcohol-induced passing out with risk of dementia
The risk of future dementia associated with overall alcohol consumption and alcohol-induced loss of consciousness in a population of current drinkers was examined in this observational study with more than 131,000 adults.

New alcohol genes uncovered
Do you have what is known as problematic alcohol use?

Does estrogen influence alcohol use disorder?
A new study from researchers at the University of Illinois at Chicago shows that high estrogen levels may make alcohol more rewarding to female mice.

Sobering new data on drinking and driving: 15% of US alcohol-related motor vehicle fatalities involve alcohol under the legal limit
A new study in the American Journal of Preventive Medicine, published by Elsevier, found that motor vehicle crashes involving drivers with blood alcohol concentrations (BACs) below the legal limit of 0.08 percent accounted for 15% of alcohol-involved crash deaths in the United States.

Alcohol-induced deaths in US
National vital statistics data from 2000 to 2016 were used to examine how rates of alcohol-induced deaths (defined as those deaths due to alcohol consumption that could be avoided if alcohol weren't involved) have changed in the US and to compare the results by demographic groups including sex, race/ethnicity, age, socioeconomic status and geographic location.

Cuts in alcohol duty linked to 2000 more alcohol-related deaths in England
Government cuts to alcohol taxes have had dramatic consequences for public health, including nearly 2000 more alcohol-related deaths in England since 2012, according to new research from the University of Sheffield's School of Health and Related Research (ScHARR).

Integrated stepped alcohol treatment for people in HIV care improves both HIV & alcohol outcomes
Increasing the intensity of treatment for alcohol use disorder (AUD) over time improves alcohol-related outcomes among people with HIV, according to new clinical research supported by the National Institutes of Health.

The Lancet:Targets to reduce harmful alcohol use are likely to be missed as global alcohol intake increases
Increasing rates of alcohol use suggest that the world is not on track to achieve targets against harmful alcohol use, according to a study of 189 countries' alcohol intake between 1990-2017 and estimated intake up to 2030, published in The Lancet.

Read More: Alcohol News and Alcohol Current Events
Brightsurf.com is a participant in the Amazon Services LLC Associates Program, an affiliate advertising program designed to provide a means for sites to earn advertising fees by advertising and linking to Amazon.com.