Friday, October 07, 2005

Cutting into alcoholism

Kick the habit. Drugs could hold the key to sobriety

By Darla Carter ~ Thursday, October 6, 2005 ~ The Courier-Journal

In an ideal world, there would be a way to make all alcoholics stop drinking and never go back to hitting the bottle.

No one has discovered such a cure-all, but that hasn't kept researchers from trying to find effective therapies.

The result is a small but growing cadre of drugs to treat alcohol-dependent people, who sometimes need more than a 12-step program to achieve success, said Raye Litten of the National Institute on Alcohol Abuse and Alcoholism.

The institute, which is part of the National Institutes of Health, is fostering medication development by funding research.

"We'd like to get a menu of treatments out to practitioners that they could use, that if one treatment strategy doesn't work, then they can rely on another one," said Litten, associate director of the Division of Treatment and Recovery Research at the institute also known as NIAAA.

Although drugs have been available to treat alcohol-dependent people for more than 50 years, many people, including some doctors, don't know about them despite recent advancements in the field, Litten said.

The drugs on the market are disulfiram (Antabuse), naltrexone (ReVia) and the latest, acamprosate (Campral), which was approved by the U.S. Food and Drug Administration last year. They're often used in combination with other assistance, such as counseling.

For some people, medication has a really "big impact," Litten said. For others, "it doesn't do anything."

That's a potential deterrent to getting physicians to prescribe the medication.

Doctors "may feel that because it doesn't work for everybody that it doesn't work at all," although in some cases they're just not aware of the drugs, Litten said.

Recently, the NIAAA, pharmaceutical companies and other interested parties have taken steps to bring attention to the drugs, and the increased visibility may help to draw more alcoholics in for treatment and get more physicians active in treating alcoholics.

Last week at a media briefing by the Community Anti-Drug Coalitions of America, former FDA Commissioner Dr. David Kessler noted, "There's a large population of persons with alcohol-use disorders in this country -- some 18 million; the majority never receive any kind of help and only a minority are successful in resolving their drinking problems."

If patients become aware that medication is available, "they may go and ask their primary-care physician about it," Litten said in a phone interview.
A revised guide

To educate doctors and mental-health clinicians, the institute recently issued a revised guide for handling drinking problems in patients that includes more substantial information about drug options. It also addresses other issues, such as how to screen patients and how to handle those who don't follow through on referrals.

"In updating this guide, we wanted to make it easier for clinicians to screen patients," NIAAA Director Dr. Ting-Kai Li said in a July news release.

The guide also discusses how the available drugs work and their positive and negative effects.

Antabuse, the oldest of the approved drugs, is designed to deter people from drinking by making them sick. But newer drugs use different powers of persuasion.

A new generation of medications has been researched over the past 15 years or so that reduces people's "urge or craving or desire to drink" instead of making them ill, Litten said.

They include Campral, which is the first treatment to hit the market in about a decade. It was approved by the FDA in July 2004 and is used to help prevent relapses. In three trials, "Campral increased abstinence rates when used with psychosocial support or counseling," according to Forest Laboratories, which markets the drug in the United States. "Abstinence rates were up to three times higher in Campral-treated patients than in placebo-treated patients."

Naltrexone, which is used to maintain sobriety, is said to reduce alcohol craving and consumption and block the euphoria associated with drinking. It is available as a daily pill, but may be sold in a once-a-month injectable form called Vivitrex soon. The injectable form is under FDA review with a decision expected by year's end, Litten said.
Complexity of alcoholism

Several other drugs, including the anticonvulsant topiramate and another drug called baclofen, also are being studied for their potential to help the alcohol-dependent.

Greater understanding of the brain and its circuitry is helping to fuel the search for new therapies. "There are exciting new findings in (the) basic neuroscience of addiction," said Kessler, dean of the School of Medicine at University of California, San Francisco. There's an "increasing number of molecular targets to aim at" and increased potential for drug treatments.

The fact that no super cure has been found speaks to the complexity of alcoholism, Litten said.

There are biological, psychological, social and cultural components to the condition, and everybody who suffers from alcohol dependence is different, "which is probably one of the reasons why we don't have a magic bullet or magic cure for alcoholism," he said.

The latest drugs provide an alternative to Antabuse, which has had a less-than-perfect track record.

In the past, "several studies (on Antabuse) have really questioned whether or not it's more effective than a placebo, so it's not widely prescribed anymore at all," said Dr. Robert Anthenelli, an associate professor in the psychiatry department at the University of Cincinnati and director of the Tri-State Tobacco and Alcohol Research Center.
'Two big old pills'

Louisville psychiatrist Dr. Bill Barclay, who is affiliated with the University of Louisville and Norton Psychiatric Center, said he's seen people play with Antabuse, stopping at times so that they can drink. Also, "I had a patient many years ago who was proud of the fact that he had developed a tolerance and had worked his way up to drinking six beers a day while he was taking it."

Though Barclay has only been prescribing Campral since the spring, he said he's had some "striking successes with it," but noted "you've got to take two big old pills three times a day."

Barclay said he's pleased to have such drugs among his options for helping patients, and he hopes to see additional ones become available.

The NIAAA is funding about 50 clinical trials on medications, Litten said, and that could help lead the way to new and possibly better drugs to help alcoholics and special populations, which include those who have a second condition, such as schizophrenia, depression or cocaine dependence.

Researchers also are trying to figure out who will best benefit from these kinds of drugs.
Ideal candidates

Anthenelli is leading a NIAAA-funded trial involving the antidepressant citalopram.

"We're using it off-label for the treatment of alcoholism," and "looking at a particular gene that regulates serotonin function … and wondering or questioning whether or not this gene influences how people respond to the citalopram," said Anthenelli, who's affiliated with the Cincinnati Veterans Affairs Medical Center. It may affect whether the drug works on a person and what side effects are experienced.

Such trials are needed because right now, "It's very difficult for us to determine who's going to respond to a drug," Litten said.

Barclay said he's found that a person's mindset is important in achieving success when taking a drug for alcohol dependence.

The person has to be "motivated to change," he said, meaning "they've contemplated the fact that they need to make changes and they're ready to act."

But "nothing works for everybody," he said. "AA (Alcoholics Anonymous) is wonderfully successful for some people. Individual counseling and various approaches have been used successfully" and these drugs "also have benefit and are useful for some people."

Jay Davidson, president and chief executive officer of The Healing Place, a Louisville program for overcoming alcohol and drug addiction, said he sees the FDA-approved drugs as "good tools" for people who've been abusing alcohol briefly, such as less than a year or two.

But The Healing Place serves longtime users, and "we don't use any drugs" because "even if it did stop them from using alcohol and drugs, it would not resolve the problem because we would not be addressing the (person's) underlying behavioral issues," Davidson said.

Through approaches, such as peer role modeling, his program helps people "learn what behaviors are causing them to be restless, irritable and discontent" and motivates them to change.