Topiramate May Help Alcoholics Stop Drinking, Says Study

A new study that assesses the effectiveness of an antimigraine medication in treating alcohol dependence reports the drug shows promise for this indication. However, pharmaceutical interventions, while potentially effective, are not enough for these patients, warns a family physician who specializes in addiction medicine.

"Topiramate for Treating Alcohol Dependence," a 14-week, double-blind investigation published in the Oct. 10 Journal of the American Medical Association, or JAMA, was designed to determine whether topiramate, approved by the FDA to prevent migraines and sold as Topamax, presents a safe and efficacious pharmaceutical option for treating alcohol-dependent patients.

In the study, 371 individuals ages 18 to 65 years who had been diagnosed with alcohol dependence were randomized to receive up to 300 mg topiramate per day or placebo. The study included participants who drank 35 or more (for men) or 28 or more (for women) standard drinks (i.e., 0.5 ounce of absolute alcohol) per week during the 28-day period before they were screened.

Researchers excluded some participants based on certain factors, including

The researchers found that the treatment group showed a greater reduction in percentage of heavy drinking days from baseline to week 14 compared with controls, with a mean difference of 8.44 percent when imputing data for all study dropouts as relapse to baseline (the primary analytic approach). Using a prespecified mixed-model analysis, without imputing missing data for dropouts, topiramate again was shown to be more efficacious at improving the percentage of heavy drinking days, with a mean difference between the two groups of 16.19 percent. (The difference between the groups became statistically significant in week two of the study.) Topiramate also was superior to placebo on secondary measures of self-reported drinking and plasma gamma-glutamyl transpeptidase levels.

In addition, topiramate was associated with a significantly higher rate of achieving 28 or more days of continual nonheavy drinking and 28 or more days of continuous abstinence when either analytic approach was used.

Adverse events reported in more than 10 percent of all participants were paresthesia, headache, taste perversion, fatigue, anorexia, nausea, insomnia, difficulty with concentration and attention, nervousness, difficulty with memory, somnolence, diarrhea, sinusitis, dyspepsia, injury, dizziness, influenza-like symptoms, pruritus, and myalgia. With the exception of headache, nausea, sinusitis, dyspepsia, injury, influenza-like symptoms and myalgia, all occurred more frequently in the treatment than the placebo group.

Although the study results seem encouraging, Al Mooney, M.D., of Henderson, N.C., a board-certified family physician specializing in addiction medicine and co-author of The Recovery Book, warns that pharmaceutical treatments are not a substitute for traditional behavioral interventions for alcohol dependence.

According to Mooney, alcohol dependence is "the country's number one preventable cause of death." The JAMA study, he says, was well-designed and the results are interesting, but the authors' conclusion that topiramate represents "a 'promising treatment' for alcoholism is premature based on such a short-term trial with such small impact on sobriety and a significant incidence of side effects."

Meaningful outcomes in patients with addictive illness take much longer to assess, Mooney adds.

In addition, he notes, "The exclusionary criteria of this trial eliminated many patients with complicated or difficult problems who … would be most in need of physician involvement and possibly medication."

He stresses that pharmaceutical interventions may be useful to help addicted patients reach a point where they could commit to a proven long-term recovery program, such as Alcoholics Anonymous. He believes that a reduction in drinking days such as was shown in the topiramate study could have some benefits, but "it may have little correlation with long-term abstinence, meaningful recovery, improved productivity, enhanced family function, decreased alcoholism mortality and other morbidity recognized to result from addictions."

So what message does Mooney think FPs should take from this study? He says he hopes it will encourage family physicians to identify and help patients in their practices who have this deadly disease. The continuity of care that family physicians provide is unique and can have an important and substantial effect on long-term outcomes for these patients.