ARCA in the News

Alternative to alcoholism: A little known drug, naltrexone, is hailed for its success

By Thomas Ropp
The Arizona Republic

 

Linda was homeless and wanted to die. Phil, a carver, holds up hands mutilated by his own tools.

They are alcoholics. A few months ago they had hit bottom. Lost everything. Now they say they have focus. Alcohol has lost its buzz. Its taste is often repugnant.

The difference they say is a little known drug called naltrexone. It blocks the pleasurable “high” that alcoholics crave. Some claim results within hours of taking it.

“Sometimes I feel like a midwife because I’ve witnessed the rebirth of so many people in this program,” Lloyd Vacovsky said. Vacovsky runs a pioneer recovery program for alcoholics as a case manager at Central Arizona Social Services. He turned to naltrexone 2 1/2 years ago after he heard about its startling results.

“For 10 years I had referred thousands of people to various programs and I couldn’t document one successful recovery from alcoholism. So when I heard about naltrexone I figured, ‘What do we have to lose?’”

Judge Darell W. Stevens of Chico, Calif., discovered naltrexone when he was surfing the Internet, searching for alternative treatments for alcoholism in the wake of increasing repeat drunk driving convictions in his jurisdiction. Since 1995, Stevens has mandated in the sentences of more than 100 DWI offenders that they enter naltrexone programs. As with Vacovsky, he reports significant success.

People like Linda and Phil claim remarkable results from taking the $5 tablet once a day for 90 days. But, naltrexone is prescribed by only a few physicians nationwide and few, if any, residential treatment centers use it despite its minor side effects and testimonials from longtime alcohol abusers.

Well-tolerated drug

Chandler physician Dr. Alan Kazan is one doctor who prescribes naltrexone. A specialist in addiction medicine and a member of the Arizona Medical Association, Kazan has ordered naltrexone for about 150 patients over the past three years. He says naltrexone is not a cure-all, but he would prescribe it to anyone who wanted it because “it’s a well-tolerated drug.”

In addition, Kazan uses Antabuse, another drug used in the treatment of alcoholism. However, unlike naltrexone, Antabuse does not break the cycle of craving. It causes alcoholics to become violently ill when they drink while taking it.

“I probably have used more naltrexone than any other doctor at the beginning,” Kazan said. “I think it’s a very good medication as an adjunct for other treatment modalities (counseling, support groups), but it’s not a magical pill.”

Naltrexone, manufactured by DuPont Merck Pharmaceutical Co. in Delaware under the brand name REVIA, is a relative newcomer when it comes to treating alcoholics. The U.S. Food and Drug Administration approved the drug for this use in late 1994.

Naltrexone had been around since the ’80s to treat heroin addiction. However, it wasn’t considered a treatment for alcoholism until researchers accidentally discovered that alcoholic test rats became teetotalers after they were fed naltrexone.

No one knows

So why is naltrexone such a secret? Especially in light of statistics from the Institute of Medicine that estimate substance abuse costs $3 billion a year in direct medical expenses, crime and lost productivity. And approximately 38 percent of adult Americans have alcoholism or alcohol abuse in their families.

“That’s the most frustrating part,” Vacovsky said. “We have this incredible medicine to help people with alcoholism and no one knows about it. Many of the people in my program first heard about naltrexone not from a doctor but from a local radio talk show.”

Dr. Joseph Volpicelli said that part of the problem is naltrexone represents a new way of thinking about the addiction.

“Alcoholism is not a spiritual disease, it’s a medical one,” he said.

Volpicelli is credited for recognizing naltrexone’s potential to treat alcoholism. He is a psychiatrist and psychologist at the University of Pennsylvania Medical Center in Philadelphia.

He said naltrexone stops the cycle of craving by blocking what are called opioid receptors. Here’s how Volpicelli describes it: “Endorphins are released when an individual experiences pain or consumes alcohol. These endorphins bind to opioid receptors. This is what kills pain and produces euphoria.

“Naltrexone simply blocks the opioid receptors so the endorphins can’t get there. This can in turn stop the vicious cycle of alcohol addiction in which one drink nearly always leads to a full blown relapse.”

Limited exposure

He estimates that of the 20 million alcoholics in America, only 15,000 have received naltrexone.

Susan Pritchard, a spokesperson for the drug’s manufacturer, said only about 2,000 physicians are currently prescribing naltrexone for their patients. Of those, 60 percent are psychologists who specialize in addictions.

Pritchard agrees with Volpicelli. “I think the reason naltrexone has not been embraced is due to a reluctance by the medical community to treat alcoholism as a disease.” She also noted that few family physicians treat alcoholism.

In addition to its relative obscurity, another roadblock to naltrexone’s more widespread use is insurance companies.

“Insurance companies often don’t allow naltrexone to be prescribed by a primary care physician,” Tania Graves, spokeswoman for the Arizona Medical Association, said. “Their point of view is that drug or addiction problems should be sent to a specialist.”

These obstacles frustrate Vacovsky, who said he’s had 250 people go through his recovery program. They have come to him either referred by adult probation or the Department of Corrections, or they have walked in themselves, willing to pay $1,000 for the 12-month program.

He claims 80 to 90 percent of his clients are no longer alcohol-dependent after completing the program, which includes weekly group therapy.

Patients praise effectiveness

Of the three dozen people attending a recent Tuesday night therapy session, each one praised the drug’s effectiveness.

Brian, 43, is nearing the end of the program. He had been a firefighter and then a swimming pool contractor until he lost his contractor’s license. He ended up in prison after a DWI conviction.

“After prison I really went on a binge,” he said. “There’s no way I should be alive. But believe it or not, one hour after my first pill I no longer had the craving to drink.”

His sobriety was such a shock to his wife that she couldn’t handle his new personality and left, he said.

Volpicelli’s most recent research indicates naltrexone can be effective doled out in much the same way as prescription allergy medicine for “people whose alcohol drinking has not irrevocably impaired their social relationships or occupational functioning and who are not profoundly depressed.”

“With just the support from a nurse we’re finding as good, if not better, outcomes using that approach.”

Mac, an alcoholic from Vacovsky’s recovery group, is simply grateful the demons from his own world have disappeared. In his words:

“It’s like someone reaches into your brain and pushes a reset button. I had nothing before naltrexone, and I have nothing after naltrexone.” He grins. “But at least now I know it.

New Drugs for Old: Pharmaceutical Treatments for Addiction

by David Maher

The idea doesn’t rest easy with some. Treating addiction with pharmaceuticals raises too many ethical dilemmas. Won’t it undermine the seriousness of substance abuse, or just replace one drug with another? Isn’t psychological treatment what’s really needed? David Maher examines how changing attitudes are driving the development of addiction pharmacotherapies.

Sam has been drinking for over 10 years. Once a best friend, alcohol has become an enemy, taking over his life and leaving it in ruins. Sam is not alone – 20 million people in the US and Europe are estimated to be dependent on alcohol – yet acknowledging the problem and seeking help pose a daunting challenge.

Nevertheless, with the new developments in treating alcoholism and other substance abuse, including the incorporation of pharmacotherapy into rehabilitation programs, it would seem like a good time to try and overcome this desperate condition.

The story of naltrexone

The development of naltrexone, an opiate receptor antagonist, is a curious story. First approved by the FDA in 1984 for the treatment of opiate addiction, naltrexone then showed its effectiveness in alcoholics. Researchers found that an hour or two after administration the drug suppressed the effects of alcohol and also reduced the cravings that addicts experience so desperately. The FDA approved naltrexone for use in the treatment of alcohol dependence on December 30, 1994.

Yet naltrexone is still infrequently prescribed. “People don’t understand how naltrexone works,” says Joseph Volpicelli of the University of Pennsylvania’s Treatment Research Center, and one of the foremost researchers into naltrexone. “Most people are unaware the drug exists. Patients and their families often ask me ‘Why hasn’t this ever been mentioned to me before?’ They have experienced how effective the drug can be and fail to understand why they haven’t been told about the treatment. Naltrexone is safe and effective yet is horribly underutilized.”

It is important not to be over simplistic. “Naltrexone is not a magic drug nor a silver bullet that will in itself destroy alcoholism,” says Lloyd Vacovsky, director of the Assisted Recovery Centers of America. A patient’s motivation is vital to ensure success and the drug is more effective with certain types of alcoholics. Patients from better off socioeconomic backgrounds usually benefit the most.

Nevertheless, Mr Vacovsky argues that the drug is an important tool in the battle against addiction, “a modern medical response to what is essentially a medical problem.” He has seen it work with many of the Assisted Recovery patients. It makes sense: reducing cravings for alcohol will lower the risk of relapse and consequently boost the patient’s chances of completing a full treatment program.

Pharmacotherapy in the wilderness

So why is the pharmacotherapy of substance abuse and addiction so little employed? Firstly, while there may be 20 million people dependent on alcohol, few are willing to search for help. It is estimated that less than 10 percent of alcohol-dependent people are in specialized treatment. “Alcoholics don’t drink to feel good,” says Mr Vackovsky, “they drink so they don’t feel bad. The need to feel ‘normal’, which they attain through alcohol, surpasses any other need, including those of health, no matter how serious the consequences can be.” Undertaking a lengthy course of treatment to cure their disease, especially if they do not consider themselves to be ill, is unrealistic.

The road to recovery is long and arduous as patients learn to live life all over again without alcohol as their ‘best friend’. Most sufferers cannot advance past the initial cravings, however the use of naltrexone essentially addresses this first hurdle. Another drug, Acamprosate, reduces alcohol consumption and helps to prevent relapse. It is approved in Europe and is in development in the US.

Of course, encouragement, support and counseling are also important. The Assisted Recovery Centers of America advocate the Pennsylvania Model Recovery, an approach that combines drugs such as naltrexone with individual and group psychosocial support. This is in contrast to the Minnesota Model or 12 Step Format that is the cornerstone of programs offered by Alcoholics Anonymous, among others. This format concentrates on behavioral therapy and self-help groups but does not, and seemingly will not, use pharmacotherapy.

A concentration on the psychological aspects of addiction is not the only factor behind the slow uptake of naltrexone. Views that those who are alcohol-dependent are themselves to blame – and therefore treatment should represent some form of ‘punishment’ – have not helped the progress of pharmacotherapy in rehabilitation programs.

Furthermore, the use of one drug to treat the abuse of another can create a sea of new problems for the patient. However, evidence suggests that naltrexone is not addictive. “There is the danger of simply replacing one drug for another in an attempt to tackle the problem. Naltrexone is different in that it doesn’t create dependence,” says Ray Litten of the US National Institute on Alcohol Abuse and Alcoholism (NIAAA). Like Mr Vacovsky, he advocates a broad approach. “It is not a case of replacing one therapy for another but rather incorporating different therapies to maximize the outcome.”

The general feeling of those who are involved in the pharmacotherapy of substance abuse is that, with well-trained healthcare professionals using effective treatment protocols and medications, an uptake of pharmaceutical treatments will inevitably occur. “Once there are more medications on the market to treat alcohol, the credibility of pharmacotherapy and substance abuse will increase. This should mark the beginning of growth in this market,” argues Dr Litten.

Pharmacotherapy and the opiate

Alcoholism is by no means the only market for pharmacotherapies. There are an estimated one million heroin addicts and 3.6 million cocaine addicts in the US; Jim Elder of DrugAbuse Sciences believes that the Pennsylvania Model is a viable way to fight opiate addiction. “The drugs that we have in development are designed to address specific issues in treatment so as to improve treatment compliance in some cases, block the euphoric effect of the substance in other cases, or reverse toxic effects with other medications,” he says.

DrugAbuse Sciences is the first company to focus solely on therapies for the treatment of substance abuse and has a variety of drugs in development for opiate, cocaine and alcohol treatment. Naltrel, for example, is a sustained-release formulation of naltrexone designed to be administered by intramuscular injection on a monthly basis. It releases naltrexone continuously over 30 days from one administration, in an effort to enhance patient compliance. Patients addicted to heroin who are prescribed daily naltrexone tablets often stop taking their medication and relapse.

“As with treating any disease, treatment is most successful when a patient is involved in and committed to their treatment,” says Mr Elder. “[A persons will] is no more an obstacle to pharmacotherapy than for any other treatment of disease; the major problem with treatment for most disease states is generally patient noncompliance with their prescribed treatment protocol.”

Drug Abuse Sciences is also developing DAS-431, a dopamine DI receptor agonist that acts to reduce cocaine craving. Cocaine dependence differs from other substance abuse disorders as it has only been researched for about 15 years, yet this does not discourage Mr Elder. “Any medication that is shown to be safe and effective at reducing relapse can be a commercially viable product in light of the large number of cocaine addicts in the US.”

Future trends

As for naltrexone, Mr Vacovsky believes that the drug’s sales will grow because essentially it works. “It is simply too effective for it not to grow. It is not a case of hype, the drug works and as word gets out the drug will grow.” Dr Volpicelli backs him up.” At the moment we are experiencing a shortage [of naltrexone in the US] because of increased international sales. Sales are increasing and more patients are asking me for naltrexone. Naltrexone will grow.”

It seems inevitable that treatment for alcoholism will lead the market, if only because of the larger numbers of alcoholics. This use of naltrexone will improve the credibility of pharmacotherapies for addiction generally, and companies like DrugAbuse Sciences have recognized the potential for this market. Incorporated into a wider program of treatment, importantly including individual and group support, pharmaceuticals offer a powerful weapon to overcome substance abuse.

Clinical Concepts – Naltrexone in Action Against Alcoholism

A brief newspaper article in January 1995 caught Lloyd Vacovsky’s eye. It briefly noted how naltrexone had recently been approved by the FDA for alcoholism, and that the drug appeared to be extremely effective.

“The article said naltrexone suppressed alcohol cravings, with only minor side effects, and curbed the effects of alcohol,” Vacovsky remembers. “I thought, if half of this is true, we should be putting the drug in our city’s drinking water!” Not long thereafter, he founded Assisted Recovery Centers of Arizona, a naltrexone-based alcoholism recovery program based in Phoenix.

‘Frequent Flyers’

At the time of the article, Vacovsky was a social worker at Central Arizona Shelter Services (CASS), the state’s largest non-profit facility for homeless persons. “I was frustrated by the recidivism rate of our clientele,” he says. “After getting them on their feet, many were back in just 3 months, following a cycle of drinking and drugging. Traditional programs, from AA to expensive residential treatment, just weren’t working for these ‘frequent flyers.’”

In February 1995, Vacovsky arranged a test of naltrexone in one alcoholic. “The night before, he was washing down whisky with malt liquor. It was his ‘going away blast.’ The next morning we started him on naltrexone and within an hour we could see a calmness wash over him as the compulsion to drink dissipated. With the craving suppressed, he was able to deal with other issues in his life.”

Based on this success, Vacovsky set about mustering support for naltrexone in the local medical community. “Their immediate response was ‘no way,’” he recalls. “They said we were pursuing ‘voodoo medicine’ and they wouldn’t consider a pharmacologic option for alcoholism treatment.”

Why weren’t they more receptive? Vacovsky explains, “There hadn’t been a new medication for treating alcoholism in nearly 47 years, since disulfiram [Antabuse®] in 1948. The mentality was that there wasn’t anything worthwhile available, plus an attitude that lasting sobriety was best achieved the old-fashioned way no pain, no gain.”

Recovery Expected

Eventually, the program director at CASS suggested that Vacovsky start a program on his own. So, in April 1996, he created Assisted Recovery to implement a naltrexone-based alcoholism treatment program at the CASS shelter, with the county providing medical services for patient examinations and prescriptions. By May 1998, Vacovsky left the program at the shelter to devote full time to Assisted Recovery.

Since then, Vacovsky’s organization has served more than 300 patients, plus another 200 at CASS. “The age range has been 18 to 82 years, with the majority in their 40s, and an equal mix of men and women,” he comments. “We serve the general public and the adult probation departments of three local counties.”

Among those persons compliant with the medication and actively participating in their recovery, Vacovsky claims up to 80% success that is, patients abstinent from alcohol at the end of 6 months.

Dose Matters

The usual starting dose of naltrexone is 50 mg/day, but some patients are started at 25 mg/d. Dosages may be increased up to 100-150 mg/d until cravings are eliminated. Vacovsky notes that, although initial studies of naltrexone for alcoholism used a 50 mg/d dose for only 12 weeks, experience has shown that the 100 mg/d dose for 6 months seems to be the most effective. Interestingly, he has found that women often need higher doses than men.

Timing of the dose can be important. “Patients should take the medication at the time of day when cravings usually begin to appear,” Vacovsky advises. “For some, it’s first thing in the morning, for others it may be when they leave work the ‘happy hour syndrome.’”

Patients are not required to detox before entering the program, but Vacovsky prefers that they be sober for up to 5 days, which reduces the incidence of potential naltrexone side effects. The most noticeable side effect appears to be fatigue. Nausea, headaches, and tremors can also occur; however, Vacovsky believes such symptoms are more often due to prolonged alcohol withdrawal.

He stresses that it is important to start treatment immediately when the person is ready, rather than expecting prior abstinence. “Naltrexone actually has a positive effect on detoxification, making it more bearable and allowing patients to be more functional.”

Patients are instructed not to drink while on naltrexone. Although, Vacovsky concedes, nearly three quarters of them do drink to test the effectiveness of naltrexone. “They find that naltrexone indeed works to dull the effects of alcohol and rarely will they even finish the first drink.”

Compliance, Honesty Critical

Success in the program depends heavily on compliance in taking naltrexone daily. The court program is closely monitored; probationers must stay on the program a full year and take the naltrexone every day under observation by Vacovsky’s staff, a probation officer, or other responsible person who would not be intimidated.

“For everyone else, we get an interested third party to help monitor compliance,” he says. “We find that an immediate indicator of an alcoholic’s commitment to sobriety and probable success is their being amenable to compliance monitoring.”

Vacovsky continues, “Patients also need to be honest about how the medication is helping them overcome alcohol cravings. Sometimes, the dosage needs adjustment.”

Furthermore, patients need to be counseled and educated on what to expect from naltrexone. “Many people are expecting a Valium effect, a buzz, or some other distinct feelings,” he observes. “Naltrexone is more like taking a vitamin in the subtlety of its effect. Absence of craving is the main symptom, and the person sometimes isn’t fully aware of that.”

Part of a Program

“Naltrexone isn’t a magic bullet it’s very effective, but it needs to be used as part of a basic cognitive-behavioral therapy program,” Vacovsky insists. “Otherwise, there’s probably a 90% chance of failure.”

Assisted Recovery offers group sessions every day, at varying times, and patients are expected to attend at least two groups a week for a minimum of 6 months. They are permitted to attend sessions beyond the 6 months, and Vacovsky says, “many do return to visit and share their ongoing successes with the others.”

Naltrexone dramatically changes the rules in recovery, he believes. “When people aren’t craving alcohol on a daily basis, they are better able to listen to the group’s message. Our program focuses on today and tomorrow, and how to adjust to not having alcohol as a part of life.”

“Alcoholics very quickly learn that they’ve ‘lost their sandbox’ that is, they can no longer stick their heads in the sand to avoid the problems they were self-medicating with alcohol. Among some patients there is a desire to sabotage the program by not taking the medication or overriding it by drinking, which doesn’t work because naltrexone blocks the effects.”

Most Assisted Recovery patients also attend Alcoholics Anonymous at one time or another, although Vacovsky believes naltrexone is most effective in naltrexone-based therapy groups. “We counsel patients that, when they attend AA meetings, they should be discrete about mentioning they are taking naltrexone.” While many AA groups have become enlightened, some individual members still oppose any pharmacologic therapy in recovery.

A Tool; Not a Cure

Vacovsky believes patients must stay on the medication long enough so cravings do not return once it is discontinued. ARCA reccommends staying on naltrexone for up to a year. “At the end of 12 months they are weaned from naltrexone, reduced first to 50 mg/d, and then 50 mg every second or third day. Soon, patients realize they don’t need it anymore.” They are encouraged to keep a small supply of 50 mg tablets on hand to use in special circumstances when they feel they might be uncomfortable, such as attending an event where there will be drinking.

Assisted Recovery also uses naltrexone to treat persons formerly dependent on opioids, and they attend the same group therapy sessions as alcoholic patients. However, since naltrexone is an opioid antagonist it cannot be used by anyone actively taking opioids e.g., heroin, methadone, certain painkillers or it will precipitate sudden, severe withdrawal.

In parting, Vacovsky reiterates that naltrexone is a tool, not a cure. “It effectively suppresses alcohol (and opioid) cravings so other issues can be addressed. However, we need to keep in mind that the individual needs to find a better, happier life as a result of treatment or it won’t be worthwhile.”