for treating alcohol dependence, a study shows. But use of the drug for this
purpose is not without controversy.
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
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
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
Kara Russell of Ortho-McNeill tells WebMD that the company knew nothing
about the question-and-answer sheet until the Public Citizen letter became
"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.
(What approaches have you tried to
quit drinking ? What has worked best? Discuss it with others on WebMD's
Addiction and Substance Abuse: Support Group board.)
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
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
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
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 o 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
"Some people will do fine with drug treatments alone, but others may
need more intensive interventions," he says.
By Salynn Boyles
Reviewed by Louise Chang
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