Treating alcoholism with a pill?

By Hilary Waldman
The Hartford Courant

KRISTOPHER LEE / THE SEATTLE TIMES

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Medication that alters the brain's response to alcohol could change the treatment of problem drinking so that it more closely resembles the type of care now routine for diabetes, high cholesterol and depression.

Researchers say the medications — some already available, others nearing FDA approval — could help lift the social stigma that prevents many problem drinkers from seeking help.

The availability of a pill or a shot could bring alcoholism out of the national closet in the same way that drugs in the Prozac family have made depression a legitimate and treatable disease for millions of people in the U.S.

With the revolution in antidepressants, "people are much less likely to view depression as the fault of the person like alcoholism is now," said Dr. Henry R. Kranzler, professor of psychiatry and an alcoholism researcher at the University of Connecticut Health Center in Farmington.

A pill available today

Though several drug companies are working to develop new medications for alcoholism, at least one has been available for 10 years. Naltrexone is a pill that appears to work by blocking chemicals in the brain that make people feel good when they drink alcohol. Because it blunts the pleasure sensation in people with alcohol addictions, it may reduce their urge to drink.

Naltrexone works well for at least some patients, but doctors have been slow to prescribe it.

In a survey published last year in the journal Addiction, Kranzler and his colleagues asked 1,388 physicians who treat substance abusers about their prescribing habits. On average, the doctors prescribed naltrexone to only 13 percent of their patients.

The doctors cited insufficient understanding about alcoholism medications but also said studies showing that naltrexone works only for certain alcoholics made them reluctant to prescribe it.

Kranzler and others acknowledged that naltrexone is not for everyone. But for people in whom it works, the effect can be dramatic.

"Believe me, naltrexone has changed the lives of some alcoholics," said Dr. Charles O'Brien, vice chairman of psychiatry and director of the Center for Studies of Addiction at the University of Pennsylvania School of Medicine.

One problem is nobody's certain about whom it will help. There's evidence naltrexone is most effective for people with a certain genetic blueprint. It also seems to help men more than women.

But a new study by a biotechnology company developing a once-a-month naltrexone injection found that a high-dose of the drug reduced the rate of heavy drinking dramatically in most of the patients who tested it.

In the month before the first naltrexone injection, the average man in the study reported having 19 heavy drinking days a month. Consuming five or more alcoholic beverages in a day is considered a heavy drinking day. After six months on 380 milligrams of once-a-month naltrexone, the number of monthly heavy drinking days for average men in the study dropped to two.

Women, who make up about a third of the people in the U.S. with alcohol problems, reported drinking less while on naltrexone shots.

But the improvement was not statistically significant, according to the study, conducted by Alkermes, a Massachusetts company testing Vivitrex, a once-a-month naltrexone shot.

"We really do see an effect across the board" in men, said Bernard Silverman, director of clinical development for Alkermes.

Early next year, the company plans to apply to the U.S. Food and Drug Administration (FDA) for approval to market Vivitrex.

Other promising drugs

Naltrexone will not help all of the estimated 17 million Americans who battle problem drinking, Kranzler and others said.

Several companies are testing new formulations that could alter the brain's reaction to alcohol.

Two of the drugs are approved for treating other conditions but also show promise for alcohol addiction. Topiramate is an anti-seizure drug, and aripiprazole is an anti-psychotic that regulates the release of dopamine, the brain chemical affected by alcohol.

Another drug, acamprosate, which is widely used in Europe to help calm alcohol cravings in newly sober people, is under review by the FDA. In addition, at least one completely new drug is on the drawing board.

"We are really on the verge of a kind of expansion in the kinds of medications available for patients," said Stephanie O'Malley, director of the Division of Substance Abuse in the psychiatry department at the Yale School of Medicine in New Haven.

As new drugs become available, they could be tried alone or in combination with naltrexone.

For example, O'Malley and colleagues are wrapping up a study on combining naltrexone and acamprosate. The results could be published within a year.

A variety of medications that work in different ways will give therapists an option to mix and match to find combinations to help more people, Kranzler said.

"A reasonable strategy right now is giving everybody naltrexone, these 17 million people, all of them, and seeing for whom it works and stopping for whom it does not work," Kranzler said.

Kranzler said he would like alcoholism to be regarded in the same way diabetes is seen — as a condition in which genes, lifestyle choices and biochemistry play a role in causing disease.

Boost to 12-step programs

Researchers agree that medication alone cannot cure alcoholism. But they can be a boost to 12-step programs such as Alcoholics Anonymous and to traditional psychotherapy, which for generations have been the backbones of treatment for heavy drinkers.

Because only about 10 to 20 percent of people with drinking problems seek any kind of help, the drugs could begin to put a dent in the number of untreated problem drinkers who continue to drive drunk and cause havoc at home and at work, researchers said.

"The good thing about medication is it could augment these treatments," said O'Malley, speaking about traditional psychosocial approaches.

"But they could also open the door for people to be managed by their primary-care physician."

Copyright © 2004 The Seattle Times Company

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