Alcohol-dependent patients in the University of Virginia study who took Topamax for three and a half months averaged fewer heavy drinking days overall, fewer drinks per day, and more days of continuous abstinence from drinking than patients given placebo treatments.
The study was paid for by Topamax manufacturer Ortho-McNeil Neurologics, and it appears in the Oct. 10 issue of TheJournal of the American Medical Association.
A spokeswoman for Ortho-McNeil tells WebMD that the company will not be pursuing FDA approval for the drug as a treatment for alcohol dependence.
But in a letter to the FDA, the consumer interest group Public Citizen accused the company of illegally promoting use of the drug for this purpose.
While doctors can legally prescribe FDA-approved drugs for nonapproved conditions, it is illegal for the companies that market the drugs to promote these so-called "off label" uses.
The Public Citizen complaint involved a question-and-answer sheet distributed to the media before publication of the study, which specifically discussed the drug's potential "off label" use for alcohol dependence.
Kara Russell of Ortho-McNeill tells WebMD that the company knew nothing about the question-and-answer sheet until the Public Citizen letter became public.
"Ortho-McNeil Neurologics does not support any reference to off label use of its products and only promotes the use of Topamax in the approved indication of migraine and epilepsy treatment," Russell says.
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Fewer Drinks and Drinking Days
The study included 371 men and women with alcohol dependence. The men drank 35 or more standard alcoholic drinks per week prior to enrollment; the women had 28 or more drinks. Participants' ages ranged from 18 to 65 with an average of around 47.
A standard alcoholic drink was defined as one containing 0.5 ounces of alcohol, which is found in a 10-ounce regular beer, a 4-ounce glass of wine, or 1 ounce of 100-proof liquor.
Study participants were treated with up to 300 milligrams of Topamax a day or a placebo during the 14-week trial. Both groups had a weekly, 15-minute session with a health care provider designed to promote adherence to treatment.
Only 5% of the Topamax users and 2.7% of the placebo users reported attending Alcoholics Anonymous meetings during the study.
Compared with placebo treatment, treatment with Topamax was associated with an 8% greater reduction in the percentage of heavy drinking days during the trial, the researchers reported.
Researcher Bankole Johnson, MD, PhD, tells WebMD that alcoholics in the trial who took Topamax went from the equivalent of drinking a bottle and a half of wine a day to about 3 1/2 glasses of wine.
"I think that is a big difference," he says. "Most people can manage that amount of alcohol without getting into too much trouble."
The researchers reported that Topamax users had a greater rate of achieving 28 or more days of continuous nonheavy drinking during the study and 28 days of continuous abstinence.
But they were also more likely to drop out of the trials due to side effects, with 34 doing so in the Topamax group compared with just eight in the placebo group.
Half of the Topamax users experienced burning or prickling sensations in their extremities, compared with 20% of placebo-treated patients. Concentration problems, loss of appetite, and a distorted sense of taste were also more common compared with those taking placebo.
But Johnson says most of these side effects disappear over time. Some of his alcohol-dependent patients have been taking Topamax for as long as two years, and he says they will likely stay on it.
"I think we are about to see a paradigm shift in the treatment of alcohol dependence," he says. "This treatment and the other drug treatments offer people an alternative that they haven't had before."
Drugs to Stop Drinking
Addiction treatment expert Mark L. Willenbring, MD, agrees, but adds that drugs should not be seen as a replacement for today's most widely used nondrug treatments like rehab and Alcoholics Anonymous.
He points out that only 10% to 20% of people with alcohol dependence develop the most severe form of the illness, and only about 12% of all alcohol-dependent people ever receive professional treatment.
Willenbring is director of the treatment and recovery research division of the National Institute on Alcohol Abuse and Alcoholism.
"One of the goals of the Institute is to promote research into treatments for earlier and less severe stages of alcohol dependence," he says. "These people are struggling, but they don't seek treatment."
The hope, he says, is that within five to 10 years drug treatments will become common for the treatment of alcohol dependence, in the same way that selective serotonin reuptake inhibitor (SSRI) antidepressants are now used to treat depression.
"Some people will do fine with drug treatments alone, but others may need more intensive interventions," he says.