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In 2006, the United States Food and Drug Administration (FDA) approved a drug called Vivitrol for the treatment of alcohol dependence. The drug, an extended-release form of the opioid receptor antagonist naltrexone, was considered an exciting step forward for those suffering from addiction. Four years later, the FDA approved Vivitrol for use once again, but this time to treat opioid addiction. Medical professionals everywhere praised the decision, including the director of the National Institute on Drug Abuse who called Vivitrol “the first non-narcotic, non-addictive, extended-release medication approved for the treatment of opioid dependence.” The FDA approval, she said, marked “an important turning point in our approach to treatment.”
Whenever a drug is added to the addiction treatment arsenal, it is important to analyze the positive and negative effects the drug may have on a person in recovery. How effective is it? Is the drug a necessity to maintain recovery? Is there potential for abuse? Here, we look at Vivitrol – as well as its advocates and critics – to determine this drug’s value for individuals struggling with addiction to alcohol or opioids.
When someone uses drugs (in this case, an opioid), receptors in the brain attach to the active chemicals in the drug. This creates the high feeling associated with the substance. When someone uses an opioid receptor antagonist like naltrexone, the drug attaches to those same receptors. Unlike opioids, this drug fails to bring on any feeling of euphoria.
Instead, it blocks the receptor from attaching to any opioid molecules, diminishing or even eliminating a person’s ability to get high. Vivitrol is a slow-release form of naltrexone, which means that its effects last much longer. In fact, according to pharmaceutical manufacturer Alkermes, Inc., one Vivitrol injection can effectively block opioid receptors for a full month.
Nearly every drug holds the potential for a few negative side effects, and Vivitrol is no exception. Some physical side effects include:
Individuals taking Vivitrol can also run the risk of more serious health problems. Naltrexone, the drug’s active ingredient, has been associated with liver damage and hepatitis in individuals using the drug before. Other people using Vivitrol have experienced severe infections at the injection site, some of which have even lead to tissue death.
Some Vivitrol users have also reported negative mental side effects. Psychological side effects of Vivitrol include:
Some doctors theorize that these side effects are a result of a non-functioning opioid system. When Vivitrol blocks the opioid receptors in the brain, it also blocks some stimulation to the brain’s reward center. Critics of Vivitrol say that this blockage can lead to depression and other distressing mental states. Dr. Sam Snodgrass expressed this point plainly in a 2016 issue of Alcoholism and Drug Abuse Weekly by saying, “If we do not have a functioning opioid system, we are not normal.”
It is important to remember that no drug can actually cure an addiction. According to the American Association for the Treatment of Opioid Dependence, “[Vivitrol] should never be regarded as any type of ‘cure’. It is simply a tool which, when used in combination with inpatient and outpatient drug rehabilitation, counseling, and NA/AA meetings could improve the patients’ chances for a successful recovery.” The reasons why someone develops an addiction are both physical and mental, and this means individuals need both medical and psychological treatment.
In the near decade since the FDA gave its approval, Vivitrol has been hotly contested throughout the medical world. Some say that the drug curbs cravings for alcohol or opioids, effectively curing addiction on the cognitive level. Others say that Vivitrol merely blocks the brain’s receptors, acting as a band-aid rather than a comprehensive treatment. Some even see Vivitrol as a harmful substance, like Mary Jeanne Kreek, MD, who argued in an article for Frontline that “To block [a person’s] opiate receptors with [naltrexone or Vivitrol] makes them feel rotten 24 hours a day.”But despite Dr. Kreek’s objections, studies have shown that Vivitrol is effective for some individuals. A 2016 study in the New England Journal of Medicine examined the efficacy of Vivitrol among criminal justice offenders, and their findings suggested that slow-release naltrexone managed to keep test subjects from relapsing during their first 24 weeks of treatment. During this treatment period, individuals taking Vivitrol relapsed at a rate of 43 percent, compared with 64 percent of individuals using standard treatment methods. These numbers add to a growing body of evidence that points to Vivitrol’s value as a treatment option.However, it is important to note that this same study also found a limit to Vivitrol’s efficacy. As the study authors stated, “The prevention of opioid use by extended-release naltrexone did not persist through follow-up … approximately 6 months and 12 months … after the treatment phase had ended.” This evidence suggests that Vivitrol may not benefit people as a long-term treatment option. For this reason, individuals taking Vivitrol are encouraged to find a support group, therapist, or 12-Step program during those initial weeks of treatment. While Vivitrol keeps cravings at bay, the person can develop a foundational support network – the kind of network that could be save their life a short six months later.
Because Vivitrol is an opioid receptor antagonist, there isn’t much potential for addiction. The drug does not yield any kind of high, nor would it if a person mixed it with other drugs, which makes it relatively safe in terms of creating dependency. However, it is still possible for an individual to abuse Vivitrol. One of the most common ways a person can abuse the drug is by continuing their opioid use after they have started treatment. Even though Vivitrol impairs the brain’s response to opioids, there have been reports of individuals taking high opioid dosages while also taking Vivitrol (presumably to override the antagonist effects). This behavior is very dangerous, and it can often lead to an opioid overdose.
Additionally, some people find that Vivitrol makes them more sensitive to opioids after they have completed treatment. Of course, the goal of Vivitrol is to start individuals on the path of recovery, and that means that they will not be using opioids in the future anyway. But in the event of a relapse, using a high dosage (or even what someone once considered an “average dosage”) can result in a dangerous overdose.
Finally, another way that people can abuse Vivitrol is simply by ignoring the prescribing doctor’s advice. Before someone begins Vivitrol treatment, they must be completely clean of all opioids for 7-14 days. Not every patient follows this rule successfully, but the risks of ignoring it can lead to sudden opioid withdrawal – a severe condition that can land an individual in the hospital.
When Vivitrol is used properly – under a doctor’s supervision and in addition to comprehensive addiction therapy – the drug can be a very effective way to prevent relapse in people suffering from opioid addiction. Ultimately, Vivitrol can help an individual avoid the cravings and urges that are so common with addiction, giving them the clarity of mind to get the help they need. While Vivitrol (or more specifically its active ingredient, naltrexone) still has its detractors in the world of medicine, the drug remains a benefit to people seeking recovery.