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New Alcohol Abuse Drugs Gaining Respect

New medications, when combined with therapy, are enabling some patients to cut back on alcohol intake or have fewer heavy drinking days
New Alcohol Abuse Drugs Gaining Respect
By Sana Siwolop
Published: April 6, 2016
Last updated: April 6, 2016
 

Do we have a game-changer for treating alcohol abuse? Several new medications, when combined with therapy and support, are enabling some patients to cut back on alcohol intake or have fewer heavy drinking days. Even established alcohol treatment centers are now using these drugs to help patients achieve or maintain sobriety while law enforcement agencies are using the medicines with DUI offenders to help them reach abstinence or at least cut back on their drinking.

A Drug Therapy Story

By the time Patricia Sams appeared before a Missouri drug court for drunken driving in the spring of 2010, alcohol was ruling her life. Unemployed and barely able to function, Sams, who is now 44, was drinking a fifth of whiskey a day (approximately 26 ounces) and sometimes more. Living in a rented room in Crane, Mo., she kept a bucket beside her bed.

Sams — a drinker since she was 11 — was pulled over for her first drunken driving arrest when she was 28. More arrests followed, and she spent 44 months in either jail or prison. After a December 2009 arrest, Sams completed a 28-day detox program the following April. The drug court judge then offered her an opportunity to try something new: monthly injections of a drug that might curb her powerful craving for alcohol.

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Three days after her first injection, Sams says she finally felt free of her cravings, and today, despite a family history of alcoholism, she continues to be alcohol-free. The drug she took for 8 months is Vivitrol, a once-a-month injectable form of naltrexone, approved by the Food and Drug Administration (FDA) in 2006 to help treat alcohol abuse. While the drug does not work for everyone, many addiction specialists say it addresses the compliance problems that are still common with the older drug on which Vivitrol is based. That drug, naltrexone, is a pill that has to be taken daily.

The Role of Drug Therapy

Alcohol addiction is what happens when a person — probably due to both genetic and environmental factors — is no longer capable of controlling the use of alcohol. What causes the addiction is often difficult to determine, although a  family history is widely thought to play a role in at leasthalf of all cases.

For years, drug treatment of alcohol addiction got short shrift from physicians and addiction specialists in favor of behavioral intervention services, counseling and social support groups like Alcoholics Anonymous (AA), which were widely considered to be more effective. But starting with the introduction of naltrexone in 1994, the number of drugs for treating alcohol abuse began to expand. Today’s medicines are more effective and often make it easier for drinkers to remain sober and comply with a treatment regimen.

The new drugs are not a cure for alcohol abuse, and so far, it’s not clear how long they remain effective. For many people, the drugs are most effective for reducing the intense craving that typically comes with alcohol addiction. More often than not, the drugs are prescribed only in conjunction with counseling and support services. The premise is that alcohol abuse is a condition that typically involves both physical and psychological components, which means that treating it effectively usually hinges on lifestyle changes.

Still, some physicians think drug therapy deserves far more attention than it’s gotten so far. In one recent study, published in the Journal of the American Medical Association, researchers at the University of North Carolina, Chapel Hill, looked at 120 previous studies, and, in an accompanying abstract, concluded that anti-alcohol medications are “considerably underused.”

At Hazelden, a nonprofit Minnesota-based institution with 15 treatment centers in 9 states, Marvin D. Seppala, MD, the chief medical officer, estimates that about a third of the center’s patients now leave with some type of medication that might reduce their craving for alcohol, and therefore, the likelihood of a relapse.

At Hazelden and Tarzana Treatment Centers — a Southern California-based organization with 9 offices — the current drug of choice is Vivitrol. “It’s been quite effective for us,” said Ken Bachrach, the clinical director at Tarzana. “We don’t believe that medications like Vivitrol are the answer to alcohol misuse, but we see it becoming another option. For some people, the effect is dramatic, and for some people, less so. In general, it seems to reduce the urge to drink in half, which means that people can focus on their recovery, they can pay attention in a group setting, and they can walk down the aisle of a store and not have as strong an urge [to drink].”

At Families Matter, a treatment center in Villas, N.J., alcohol abusers who come in for help now typically receive 6 monthly injections of Vivitrol, along with what director Patricia Campbell describes as “intensive” group counseling, as well as individual counseling. Her center was recently part of a pilot program administered by the New Jersey Division of Mental Health and Addiction Services to give Vivitrol to DUI offenders, or those found driving under the influence of alcohol.

In 2015, a study supported by the National Institute on Alcohol Abuse and Alcoholism suggested that as many as 1 in 7 American adults had alcohol use disorder (AUD) during the course of the previous year, and nearly a third of adults have had it at some point in their lives.  The institute defines AUD as either alcohol abuse or alcohol dependency (alcoholism).

Although alcohol abusers usually have some control over their drinking, they drink in a way that often harms their health, personal relationships, driving ability and ability to work. Alcohol dependence, on the other hand, is alcohol abuse that has progressed to the point where someone is not only unable to stop drinking, but has also developed a physical tolerance to high levels of alcohol. People who are alcohol-dependent typically suffer from withdrawal symptoms such as anxiety, trembling, sweating, nausea, insomnia and depression when they stop drinking.

It’s been estimated that only 20% to 30% of alcoholics ever receive any treatment for their condition, and less than 10% receive any of the medications available for treating alcohol dependency. Meanwhile, the social and health costs of alcohol use disorders continue to grow. According to a study released by the Centers for Disease Control and Prevention, 1 in 10 deaths among working-age adults between the ages of 20 and 64 is due to excessive alcohol use. Alcohol use disorders have been shown to increase a person’s risk of developing a number of medical problems, like  breast cancer, liver disease and heart disease.

Which Drug Treatments Are Available?

So far, the FDA has approved only 4 drugs for use in treating alcohol use disorders: disulfiram (Antabuse is one brand name), naltrexone (Revia), acamprosate (Campral) and Vivitrol. Nalmefene is now gaining regulatory approval abroad. (See 5 Meds Help Curb Alcohol Abuse .)

None of the drugs address all aspects of alcohol abuse or prove effective with all patients. Some are better at reducing the craving for alcohol, while others are more effective for reducing the number of heavy drinking days or lessening the chance that someone who is abstinent will drink again. There is no clear and convincing evidence that the drugs work well in combination therapy.

For example, at Hazelden, Dr. Seppala has found that Vivitrol helps only about 30% of those who take it. “These new drugs are the first to be based on understanding the neurochemistry of alcoholism, so in a way they’re like the first antibiotics,” he said. “I’m hoping we can eventually get better predictors of who should take them.”

Modern efforts to treat alcohol abuse with medication began in the late 1800s, when alcoholics and their physicians began turning to a grab bag of often widely hyped elixirs such as arsenic, opium, cocaine and strychnine. In 1951, the FDA approved the use of disulfiram, an “avoidance” drug that makes drinkers sick if they drink again. Because of the drug’s toxic side effects, it never really took off.  Its use was soon eclipsed by interest in behavioral interventions, including cognitive behavioral therapy, and the 12-step motivational programs offered by groups such as AA. More recently, researchers have started looking into digital solutions. There are promising results, for example, from a randomized trial of a smartphone app that helps heavy drinkers monitor themselves. A similar iPhone app, StepAway, is available for free from Apple’s App Store.

Disulfiram works by causing often intense side effects such as nausea, vomiting and palpitations if a user consumes even a small amount of alcohol; the effects may last a few hours, or in some cases, up to 2 weeks. While serious side effects are far less common, they do occur: liver failure, severe hepatitis, and even death has been seen when the dosage of the drug was not carefully monitored. Disulfiram should not be taken by anyone who has psychosis, severe heart disease, or a blocked artery to the heart. For someone who is not drinking, the drug’s most frequent side effect is drowsiness.

Disulfiram is now typically prescribed only when the patient has stopped drinking for 12 hours, and it seems to work best in people who are already committed to abstinence. According to Dr. Seppala, Hazelden rarely prescribes the drug any more, but it has been helpful in 2 types of patients: “really impulsive” drinkers who have an inability to stay sober over time, and people who are new to recovery, but who are suddenly faced with a significant life event — such as a wedding — where the goal is to simply get through the party alcohol-free.

Naltrexone is the drug most commonly prescribed in the United States for treating alcohol abuse. It was approved by the FDA in 1994. It is FDA approved for use as a once-a-day pill (Revia) or for injection once a month (Vivitrol). Some addiction treatment centers, however, are also prescribing naltrexone implants, which are not FDA approved. Naltrexone implants are inserted under the skin, usually in the lower abdomen, causing the drug to be slowly released over a 6- to 12-week period.

Unlike disulfiram, naltrexone does not cause unpleasant side effects if a patient consumes alcohol. Instead, it works with the brain’s chemistry to reduce the pleasant “buzz” that comes with drinking. It can be effective for reducing the frequency and the severity of relapses that may occur during alcohol abstinence, as well as the risk of heavy drinking. Heavy drinking is now defined as more than 4 drinks a day for women and 5 drinks for men.

Goals Include Cutting Back and Abstinence

Although most addiction specialists advise drinkers to stop drinking before they begin taking naltrexone, some espouse another controversial approach: the so-called Sinclair method. Based on the work of American psychologist John David Sinclair, this approach is founded on the assumption that naltrexone works only if someone continues drinking. In his initial studies, and in his later interviews, Sinclair has said that the drug is 78% effective in either reducing drinking or producing complete abstinence after it’s been taken for 3 months or more.

Side effects can still be an issue with naltrexone. While the most common side effects are diarrhea and stomach cramping, the drug has been shown to cause liver damage if taken in large doses. Because naltrexone should be avoided by anyone who already has liver disease, it has limited usefulness for many people who already have a serious drinking problem. Moreover, compliance is a big problem with the pill form of naltrexone: some studies have shown that up to half of all oral naltrexone users stop taking their pills within just a few weeks of initiating use. Patients find it too difficult to take a pill daily and find that their craving for alcohol, while diminished, is still there.

Compliance is also a problem with acamprosate (Campral), which is taken in pill form 3 times a day. Unlike naltrexone, acamprosate doesn’t interfere with the “high” that comes with alcohol use. Instead, it is believed to somehow stabilize brain chemistry to lessen the chance that someone will drink again. The drug is believed to promote abstinence by alleviating the sleeping problems, sweating and anxiety that accompany abstinence.

Acamprosate has not been shown to work in people who haven’t stopped drinking, and its use must be monitored when a patient is also taking street drugs or certain prescription drugs such as antidepressants. While the drug is usually well tolerated, it can cause diarrhea, headache, flatulence and nausea. Less often, the drug causes serious side effects such as depression and suicidal thoughts. It should not be used by anyone with kidney problems.

Still, the research shows that drugs like acamprosate and naltrexone may be effective for some people in treating aspects of alcohol abuse. In their review, the University of North Carolina researchers found that  acamprosate and the pill form of naltrexone seem to be most effective for helping reduce alcohol use.

The researchers looked to see how many patients, on average, needed to be treated with a particular medication before a single patient saw some benefit. They found that, in order to prevent a return to any drinking, 12 patients needed to be treated with acamprosate and 20 for oral naltrexone. Naltrexone — in pill form —  also helped reduce the risk of a return to heavy drinking. By contrast, Vivitrol, the injectable form of naltrexone, was associated only with reducing the number of heavy drinking days, and not with abstinence.

Alkermes, Vivitrol’s manufacturer, says that its drug is aimed at people who can abstain from alcohol in an outpatient setting and who are also undergoing counseling. In a study published in the Journal of the American Medical Association in 2005, shortly before Vivitrol was approved by the FDA, the drug — depending on the dose — was found to reduce heavy drinking episodes by 17 to 25%.

Because Vivitrol is injected in the buttocks with a special needle, its use requires regular medical visits. Its most common side effects are nausea, headache, vomiting and reactions such as tenderness and swelling at the injection site. Dosage changes can sometimes help alleviate certain symptoms, like nausea. More serious side effects are rare, but they include severe injection-site reactions that may lead to tissue death, a type of severe allergic pneumonia, depression, suicidal thoughts and a greater risk of overdosing (perhaps fatally) if someone is also taking opiates such as heroin or prescription pain medicines.

Like the pill form of naltrexone, Vivitrol can cause liver damage or hepatitis. It should not be used by anyone who has acute hepatitis or liver failure, or who is either dependent on opiates, taking prescription painkillers, taking cough, cold or diarrhea medicines that contain opiates, or who is going through active opiate withdrawal.

Despite its limitations, Vivitrol has attracted attention from a number of publicly funded addiction treatment programs, including in Los Angeles County, where the drug has been shown to help alcohol abusers stay in treatment longer. Alkermes estimates that the drug is now in use in more than 55 criminal-justice programs (including those offered by drug courts) in 21 states. While each injection costs $1,100, the drug is now covered by more than 90 percent of insurance plans, as well as by every state Medicaid plan. Meanwhile, for private payers, Alkermes has set up a $500 per injection co-pay program for patients who are taking the drug for an FDA-approved use. In 2010, Vivitrol was approved for treating opiate addiction as well.

Addiction specialists are continuing to analyze the data for clues as to why some anti-alcohol medications, such as Vivitrol, work better in certain people. “Anecdotally, my experience with it has been that it’s more effective for people who have a long family history of alcohol issues,” said Ken Bachrach at Tarzana Treatment Centers. “But then I also find that these people have higher cravings to begin with.”

New Drugs on the Horizon

Despite ongoing physician and patient resistance to using medications to treat alcohol abuse, more drugs may be in the offing. Some researchers have reported encouraging results with the anti-epilepsy drug topiramate (Topamax) in individuals who are still actively drinking, even though that medication can produce troublesome side effects —  such as memory and cognitive problems —  if its use isn’t monitored properly. Gabapentin (Neurontin), a drug widely used to treat epilepsy and neuropathic pain, has also been getting attention because it appears to improve sleep and mood in people who are trying to quit drinking.

In the fall of 2013, Scotland became the first country in Europe to approve the use of a drug for treating people who are heavy drinkers, but who don’t have the same kind of physical dependence as alcoholics. The drug, nalmefene, is similar to naltrexone, but it appears to be less toxic to the liver. Like naltrexone, it reduces the craving for alcohol. Nalmefene is designed to be taken as a pill 1 or 2 hours before drinking, however, and not every day. Studies suggest that it may cut the number of heavy drinking days roughly in half.

Despite the promise of drug therapy, some former alcohol abusers emphasize that there is far more to staying sober, particularly after a medication regimen ends. Patricia Sams, for example, experienced a year of sometimes intense withdrawal symptoms after she finished 8 months of Vivitrol injections. During that time, Sams often found it difficult to focus, write steadily, and taste and smell food.

Sams is now helping to run a faith-based recovery center in Branson, Mo. She continues to seek counseling — including at AA meetings — when she needs help herself. “I’m free of the cravings, but once in a while my brain tells me that a drink would be nice,” she said. “Alcohol is all around us, but I’m very, very aware of it.”

For More Information

National Institute on Alcohol Abuse and Alcoholism

National Council of Alcoholism and Drug Dependence

Advances in Alcohol Treatment (National Institute on Alcohol Abuse and Alcoholism)

This feature is an update of an article published September 4, 2015.

Sana Siwolop

Sana Siwolop

Sana is a New York-based science and business journalist who has written for national publications, including The New York Times, Business Week and Discover. She teaches journalism at St. John’s University in New York City.

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