Migraine drug Topamax tested on alcoholics

Researchers in the United States say a drug used to prevent migraines has been effective in reducing the number of days alcoholics spend binge drinking.

The drug Topamax (topiramate) is made by drug giant Johnson & Johnson and also has approval to treat seizures.

In a study funded by the drug company, Topamax was tested on 371 men and women aged 18 to 65 with alcohol dependence.

The individuals from 17 cities in the States were treated after reaching a point of maximum crisis, when they were drinking severely, says study author Dr. Bankole Johnson of the University of Virginia in Charlottesville.

Of those participating in the study the men drank 35 or more standard drinks per week and women 28 or more standard drinks per week in the 28-day period prior to being screened.

The study took place between January 2004 and August 2006 and covered 14 week periods.

A standard drink was defined as a half ounce of absolute alcohol, or the equivalent of a 10-ounce beer or a 4-ounce glass of wine.

All the participants received a weekly counseling session of 15 minutes and half of the patients were given Topamax while the others were given a placebo.

The researchers found the percentage of heavy drinking days fell in both the groups by the 14th week of the study, but the reduction was greater in the Topamax group, where heavy drinking days fell from 81.9 percent to 43.8 percent.

The percentage of heavy drinking days in the placebo group fell from 82 percent to 51.8 percent and there were more days of continuous abstinence.

A heavy drinking day was defined as five or more drinks for men and four or more for women.

However the drug was found to cause side effects in half those took it, such as abnormal skin sensations of tingling and numbness, taste perversion, and difficulty concentrating.

This compared with about 10 percent in the placebo group.

Dr. Johnson says 30 percent of study participants withdrew, mainly because of the side effects.

An analysis which excluded the dropouts showed a 16 percent reduction in binge drinking among those who took Topamax compared with the placebo group.

Johnson said the drug shows promise given that current treatments require alcoholics to stop drinking before they can access a drug to keep them sober.

However the consumer watchdog group Public Citizen says the benefit was modest and suggests that promotional materials accompanying the study suggest doctors could prescribe the drug to alcoholics as a so-called off-label treatment.

Public Citizen has written to the U.S. Food and Drug Administration Commissioner Dr. Andrew von Eschenbach, saying that background materials issued by the University of Virginia suggest the drug "is available to your doctor to prescribe it to you off-label."

J&J say they have not seen the material and are not marketing Topamax as a treatment for alcoholism.

The study appears in the Journal of the American Medical Association.