© Katarzyna Białasiewicz | 123rf.com

Within an introductory “Note to the Reader,” to his book, The End of My Addiction, Olivier Ameisen said: “By completely suppressing my addiction, baclofen saved my life. I believe it can save and improve the lives of many others by completely suppressing their addictions, and I have written this book to that end.” He ended his note with a caution that his book was not a self-help manual or a guide to self-treatment. Baclofen, a prescription drug, “should be taken only as prescribed … and closely monitored by a licensed physician.” Yet his book is a detailed discussion of how he did exactly the opposite of everything he had just cautioned others not to do.

There had been some ongoing research into the potential of baclofen as a treatment for alcohol use disorders (see the References for Ameisen’s Alcohol and Alcoholism article) before Ameisen wrote his book. But Ameisen’s personal experimentation and its description in his book brought it to the attention of the public and sparked further interest in researching the potential of baclofen to treat addiction. “The End of Alcoholism? Part 1” looks in more detail at that story. Here I want to explore some of the research supportive of using baclofen in treating alcohol use disorders.

Giovanni Addolorato of the Catholic University of Rome was one of the initial baclofen researchers Ameisen read. Eventually they began to correspond and shared their interest its potential to treat alcoholism. A sampling of Addolorato’s published research studies looks at the ability of baclofen to reduce cravings and alcohol intake (2000); the suppression of alcohol withdrawal syndrome with baclofen (2002); a comparison of baclofen to diazepam in treating alcohol withdrawal (2006); the effectiveness of baclofen in maintaining abstinence with patients with cirrhosis of the liver (2007). Addolorato found baclofen to be effective in reducing craving and alcohol intake; it was comparable to diazepam in treating withdrawal; and it promoted abstinence—even in alcohol-dependent patients with cirrhosis of the liver.

Colombo et al. (2002) found that baclofen inhibited the drinking behavior of selectively bred alcohol-preferring rats. Baclofen is a known GABA(B) receptor and the results suggested that the GABA(B) receptor was involved in the disclosure and experience of the psychopharmacological effects of alcohol.

William Bucknam published a case study in 2007 to investigate whether baclofen-induced suppression to consume alcohol in animals could be transposed to humans. The patient, Mr. A., wanted to be able to control his drinking not establish and maintain abstinence. He “experienced a satisfactory response to high-dose baclofen that [was] sustained over ten months without significant side-effect.”

Lorenzo Leggio (2009) suggested that baclofen “represents a promising medication in the treatment of alcohol-dependent subjects.” It demonstrated an ability to reduce alcohol craving and intake. So it could be useful for promoting abstinence “as well as relieving alcohol withdrawal syndromes.”

In 2012 Renaud de Beaurepaire published a 2-year observational study of 100 individuals using baclofen. Initially 132 individuals were included in the study, but 32 were excluded for various reasons. These reasons included: not providing feedback after their first visit, stopping their use of baclofen because of adverse drug effects, and not being motivated to stop drinking. The effects of baclofen in the first three months were not included in the study, “because the effect of the treatment during this period does not represent the full potential of the drug.” (So what was going on in the initial three months that might give an unfavorable view of baclofen, I wonder?) The participants were evaluated before treatment with baclofen and then at 3, 6, 12 and 24 months to fit into three categories: low risk, medium risk and high risk.

In the “at low risk” category, patients experienced a suppression of craving, and their complete control over drinking was effortless. In the “at medium risk” category, patients experienced a clear decrease in craving but, for various reasons (in general, too strong an attachment to their drinking habits associated with an incomplete motivation to cease drinking), they were not able to control completely their drinking compulsions. In the “at high risk” category, patients either experienced an insufficient reduction of craving, or, although they experienced a significant decrease in craving, after a period of decrease in drinking, relapsed in their addiction. The risk category was defined according to the control over drinking during the last 4 weeks [before the evaluation].

Fifty-nine percent of the participants had one or more concomitant psychiatric disorders, including: 53% with anxiety disorder, 34% with depression, 18% with bipolar disorder, 42% with a sleep disorder, 11% with another addiction (mostly cannabis), 8% with psychosis, and 5% with an eating disorder.

At the end of the first visit, participants were told they could drink as usual. Using baclofen was expected to suppress the motivation to drink. No additional therapeutic intervention other than baclofen was given or suggested.

The doses ranged from 20 mg to 330 mg, with an average dose of 147 mg. Eighty-eight percent of the participants reported at least one undesirable side effect. The five most frequently reported were: fatigue or sleepiness (64%); insomnia (31%); dizziness (21%); tingling or abnormal sensations (18%); nausea or vomiting (17%).  There were several others, including: weight loss, memory loss, mental confusion, hypomania, dysphoria (a state of profound unease or dissatisfaction). De Beaurepaire assessed these side effects as “always benign.” However, eleven individuals discontinued treatment because they could not tolerate the side effects. And 20 participants did not reach an optimum dose because of the worsening of side effects.

The study reported that 92% reported a decrease in their motivation to drink at one time or another during the follow up time period. About half reported that at sufficient doses of baclofen, they had “a complete and effortless control” of alcohol craving. All participants were rated “at high risk” initially, but about half were rated “at low risk” at 3, 6, 12, and 24 months of follow up.

De Beaurepaire concluded that baclofen was very effective in treating alcohol dependence, particularly in reducing the motivation to drink. High doses were often necessary to obtain an optimum effect. The principle limitations seemed to be the side effects, the absence of a strong willingness in some to stop drinking, and co-occurring psychiatric illness—with the possibility that the concomitant use of psychotropic medications was a factor. “Baclofen should be considered a major help for drinking cessation, but other factors (psychological and environmental) are likely to play an important role with many patients.”

Ameisen sees baclofen as essentially a miracle cure for alcoholism. “So far it seems to work in all types except for one … and that’s people who turn up once and don’t come again.” He admits that no medication works effectively for everyone, and that includes baclofen. It’s not one size fits all; “you have to refine it.” There is a parallel here to methadone maintenance for opioid addiction. Ameisen’s “threshold dose,” refining the dosage until it’s high enough to eliminate cravings, sounds like raising a person’s methadone dose until they don’t want to get high anymore.

But the miracle cure claims of his treatment have provoked skepticism. Dr. Nicholas Pace, a clinical professor of medicine at New York University said: “I have studied alcoholism for the past 40 years, and there is no single magic bullet. This is a complex disease, and you can’t just flip one switch. The idea that an alcoholic can drink socially is simply a lot of bull.”

Ameisen said this kind of reaction from addiction professionals is because they feel threatened. “If baclofen works, then their specialism is going to fall apart.” But James Medd, writing for The Guardian suggested there could be another reason. This isn’t the first time someone claimed they found a cure for alcoholism. Barbiturates, benzodiazepines like Valium and antidepressants such as Prozac were hyped at one time as an end to addiction. Naltrexone has also been proposed as a “cure” for alcoholism in the Sinclair Method (See A “Cure” for Alcoholism).

At least for Ameisen, baclofen seems to have turned his life around. He reportedly had over nine years without drinking compulsively. There are several studies being done to investigate the treatment potential of baclofen. Here is sample a of some of those listed on clinicaltrials.gov. Assistance Publique – Hôpitaux de Paris (study 8) is completing a study to show the effectiveness of a year of baclofen treatment to that of a placebo. It was planned to increase the dose to a maximum of 300mg daily. In case of intolerance, the dosage would be decreased.  Essentia Health (study 9) is investingating the use of baclofen to prevent the symptoms of Alcohol Withdrawal Syndrome. The University of North Carolina at Chapel Hill (study 14) is investigating whether a 90mg dose of baclofen is effective and safe with individuals with alcohol dependence.

While there are some potential benefits with baclofen in treating alcohol use disorders, there are some clear adverse effects as well. We will look closer at those side effects in Part 3. Amiesen did not describe or dwell on the adverse effects with baclofen. Perhaps this was because he came to it when his own fight against alcoholism was at the point that he thought he was going to die from it. He had a blind spot to its negative effects because baclofen became the miracle drug that saved his life. As a physician writing a book on baclofen he cautioned his readers to not self-treat with baclofen. As an active binge drinker he was desperate to find something—anything—that would put an end to his addiction and did it anyway.