Seizure Drug May Treat Alcoholism

Study Shows Fewer Heavy Drinking Days For Patients Treated With Topamax

(WebMD)  The seizure and migraine medication Topamax shows promise 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 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.

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 percent of the Topamax users and 2.7 percent of the placebo users reported attending Alcoholics Anonymous meetings during the study.

Compared with placebo treatment, treatment with Topamax was associated with an 8 percent greater reduction in the percentage of heavy drinking days during the trial, the researchers reported.

Researcher Bankole Johnson, MD, 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 percent 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 percent to 20 percent of people with alcohol dependence develop the most severe form of the illness, and only about 12 percent 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.


(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.)

[beachgirl22-2009]

Well,snidegrass, alcohol isn''t illegal and never will be. It''s everywhere!!! And yes drinuk, big pharma will stop at nothing to sell their junk. However, thank God, my Dr. was smart enough to get me off the stupid antidepressants that my obgyn gave me after post partum. They actually made me crave alcohol. I went to a Phcyciatrist, she prescribed Topomax 2 years ago. I haven''t had a drink since. I lost 10 lbs. Only had to take the pills for three months. And she gave me samples. Now that''s a good doctor!! I hope you''re never in a position where you or a family member need meds and get a bad Doctor.

This sounds like Big Pharma. Treating drugs with drugs, very profitable.

[gordon.couger]

Topamax is no magic drug. It''s difficult for me to get up to dose on. I go half as fast as the prescribed dose. It changes the taste of food and carbonated beverages. Many people find this intolerable.

I have a hard time remembering to eat and drink enough. Evidently I get plenty to eat as I am not as I am still over weight. I do have times I go to long with out eating an get low blood sugar. I lost over 14% of my 270 pounds done 218 for a while. As I cut the dose back and took other drugs it has crept up some but it still is a great drug for controlling weight. They haven''t published the weight loss study for fear of the off label suits and problems with FDA but it one of the best weight loss drugs there is.

I have to make an effort to remember to drink water some of the time.

I take it as a mood stabilizer[anger control], nerve protector in case of an MS episode and to keep my weight down. My problems fit its side effects well.

My Neurologist became a true believer when his daughter started having seizures at 13 and he looked for a drug to protect her brain from seizure induced neuron death.

My neurologist was taking a small dose for the neuron-protection and weight control effects of the drug. He got dehydrated he had a kidney stone attack. They found a very small cancer on his kidney that would have gone undetected until it was too late had he not had the kidney stone. So Topamax''s undesirable side effect saved his life.

I too am a true believer.

GC

[jmann27273]

Even if this is true, many of the people who really need it cannot afford to go to a Dr. and get a prescription as a result of their alcoholism.

[reel-crazy]

I am an alcoholic in recovery (2 years sober) from a 35 year day to day addiction and I will tell you there is NO miracle pill to EVER cure alcoholism. This is more pharmaceutical corporate propaganda to increase profitability by selling pills for people looking for the pipedream of future sobriety.

I suggest that any of you slaves to the pharmaceutical industry or the court system read a book written by Dr. William D. Silkworth before gobbling down or pushing Ortho''s little yellow pills in the hope of a cure for alcoholism.

Sobriety doesn''t come from one pill at a time....

[incog-nito]

If you''re an alcoholic who is prone to seizures, THIS is the drug to get.

[tnt1954]

thanks drinuk. i was hit broadside by a drunk
and stoned driver fleeing the police going about 75 mph when i was 16.
the three of us up front were miraculously spared.
it altered all three of our lives in a split second.
yes, it is true, many of us have axes to grind. if
you''re a drunk, don''t drive.

[drinuk]

Big Pharma will stop at nothing to sell their junk, I''ve heard it all now, get ''em off the booze and turn ''em into junkies. They must be real evil to target drunks.

[tnt1954]

if you can take it or leave it alone, you won''t
miss it when alcohol becomes illegal. only
alcoholics will really miss it. did you know
that 50% of the world are teetotallers, never
touch the stuff? did you know that alcoholism
is caused by alcohol? did you know that if there
was no alcohol there would be no alcoholism? lol.