Vivitrol: A Shot in the Dark - Page 2

By Walter Armstrong 05/05/13

The Fix evaluates Vivitrol, the newest anti-addiction drug—actually an injectable form of the oral medication, naltrexone. It's definitely better than nothing. But is it $1,100 a month better?

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Vivitrol: An Injectable Formulation of Naltrexone, opiate addiction, withdrawal,
The compliance solution? Photo via

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Naltrexone’s effectiveness against opiates is another matter. In Cochrane’s 2011 review of all 13 available studies, naltrexone was no better than placebo. It did not help more patients stop or reduce their drug use; it did not keep more people in the trial and taking the pill. Nor was it superior to either Suboxone or the benzodiazepines (like Klonopin). The sole success naltrexone chalked up was in reducing by half the number of opiate users who got busted and locked up.

As for Vivitrol, Cochrane noted that there are not enough studies to do a fair review, but that “the available studies indicate [it] might have comparable effects…to those of oral naltrexone.”

Study results, whether positive or negative, strive for objectivity. But they cannot tell you how a drug works in the real world. The real world, however, tends to offer subjective anecdotes that often come down to “she said, he said.” Consider these: 

Wanda was addicted to pain pills, and in and out of rehabs, starting at age 12. Now in her 40s, she has been taking Vivitrol for two years and vouches for its dramatic effects. "This is the first time in my life that I've been clean for this long," she says. "The Vivitrol shot is way better than naltrexone. I used to hide the pill in my gum, and then go use." She used to be on methadone, but kept using because the cravings remained. Vivitrol has cut the cravings. Wanda admits that the shot is pricey but considers it money well spent—an investment in her health.

The shot that is awesome for Wanda was merely "meh" for William, a former alcoholic in his 50s. “My problem was binge drinking on the weekends,” he says. “Naltrexone blunted the pleasure I got from booze, but I just kept downing one beer after another anyway.” He took naltrexone on and off for a number of years in his journey to sobriety. His drinking did not get worse on naltrexone, and he had no side effects, so he kept giving it another try. As for Vivitrol, it was unaffordable. “My doctor said there was no reason for anyone to jump to Vivitrol unless the problem was compliance,” he says. “They are the same drug. If naltrexone doesn’t work, why try Vivitrol?” 

Some addiction specialists are gung-ho about Vivitrol and see a higher success rate than one in nine. "Only about 40% of people respond to Vivitrol," says UCLA's Timothy Fong, "but rates can be as high as 80% and as low as 20%.” 

"There is a big difference between Vivitrol and naltrexone—people just don't take the pills every day. With the shot, it's a different game."

Robert Woolhandler, MD, an addiction physician in Pittsburgh, is fervent about Vivitrol’s compliance advantage. Over his career, he estimates that he has given some 3,000 Vivitrol shots. "There is a big difference between Vivitrol and naltrexone—people just don't take the pills every day," he says. "With the shot, it's a different game."

His one caveat is that the medication may work too well. Because Vivitrol eliminates cravings, patients can be lulled into the belief that their sobriety is more solid than it really is. They may not follow through with the rest of their recovery program, which should include psychosocial supports, such as the 12 Steps or counseling.

No drug works for everyone, and a 50% efficacy rate is about average for psychiatric medications. The trick is identifying who will benefit, and why.

"We've known for some time that naltrexone affects different people in different ways," says James Garbutt, MD, medical director of the Alcohol & Substance Abuse Program at UNC-Chapel Hill. "And we're still trying to figure that out."

Given the high cost of Vivitrol, a diagnostic test for sensitivity to, or likely success of, naltrexone would be immensely cost-effective. But given the immense complexity of addiction, such a test is only a remote possibility.

The limited research confirms what is already known about recovery odds. More severe forms of the disease, dual diagnoses with mental illness and other psychosocial or health problems all decrease recovery rates. Predictably, high motivation and effective adjunctive therapy boost your chances.

But in the 2006 COMBINE study, which looked at 1,383 abstinent people from 2001 to 2004, only those people who combine naltrexone with medical management (basic alcoholism education) did better than those on placebo; naltrexone-takers who were also in alcoholic counseling (12 Steps and/or cognitive-behavioral therapy) did worst of all. Go figure.

Other clues are suggestive but scattered.

For certain addicts, opiate receptor blockers like Vivitrol are a problem, not a solution, says NYU’s Erin Zerbo. These people have an "endogenous opioid deficiency”—their brains don't produce the normal supply of natural opiates. Only methadone or Suboxone may correct this chemical deficit by substituting a slow but steady opiate release.

Genetic testing of individuals in the COMBINE study showed that those who have a particular variant on the gene that regulates opiate receptors have a high success rate with naltrexone. But they are a minority of the population. Those who lack that variant did no better on naltrexone than on placebo. In any case, gene testing is too expensive to serve as a diagnostic tool.

So, to Vivitrol or not to Vivitrol? The best and maybe the only answer is a tautology: Take it if it will work for you.

The prevailing treatment philosophy is that no single approach is best for everyone. Tailoring the treatment to the individual is the standard of care, even if doing so can involve trial and error. "I like to have a lot of treatment options," says UCLA’s Timothy Fong. "I don't have just one philosophy."

That may also be the optimal approach for anyone who is serious about getting and staying sober. Under certain conditions, Vivitrol may well be worth a shot: If you can afford it (check your health insurance formulary); if you have severe cravings and frequent slips (check your track record); if you have problems with compliance (check out generic naltrexone otherwise); and if you can make it to monthly injection appointments (check your fear of needles).

Addiction treatment is a long way from a “functional cure” that would control the disease for the vast majority of people over a long period of time. A more realistic goal is for researchers to better identify the processes of addiction in the brain and, by using them as targets, develop more and better drugs.

“What we hope to do is to actually have a menu of treatments that clinicians could choose from,” Raye Litten, associate director of the National Institute on Alcohol Abuse and Alcoholism, told The New York Times last year. “If one drug doesn’t work, patients try another one and so forth, and hopefully they’ll find one that is effective.”

Vivitrol and naltrexone are two of the the best choices on that very short list right now. But it pays to be mindful that no drug will work unless you also work, every day, at your recovery.

EDITOR'S UPDATE: Vivitrol was recently approved for court-ordered use by a drug court in Oregon and another in Canada. 

Walter Armstrong is former Deputy Editor at The Fix.

Raphael Rosen did much of the research, reporting and fact checking for this investigation. Rosen is a Brooklyn-based science communications professional, social media strategist and independent museum consultant. He has written for the Wall Street Journal, The Fix, the World Science Festival, Discover magazine, Sky & Telescope and NASA.

Home page image via Shutterstock.

 

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Walter Armstrong is the Medical Editor at  Saatchi & Saatchi Wellness and the former deputy editor of The Fix. You can find him on Linkedin.