No one argues that the opioid epidemic is real and growing. Similarly, no one believes alcoholism will go away any time soon. How we combat these diseases is a pressing question that has finally come to the forefront of cultural and political commentary in our society. When this happens, it seems people double their efforts to create new and inventive means of combatting disease whether that’s a new medical treatment or a new therapeutic method. Our concern, in this article, is to weigh in on the Naltrexone implant. What is it? Does it work, what problems are associated with it and is it dangerous?
History of Naltrexone
Naltrexone was created in 1963 to help combat opioid addiction. Animal studies performed during the 1980s showed that naltrexone affected opiate receptors in the brain, leading to decreased opioid and alcohol consumption. Human trials that followed established that naltrexone reduced cravings for alcohol and opioids, as well as reduced relapse rates. The FDA approved it for use to treat addiction to opioids in 1984, with approval to use it to treat alcohol use disorder following in 1994. Naltrexone brand names include Vivitrol, Depade, and ReVia; the former is an injectable form of the drug, while the latter two are taken orally. Naltrexone is also available as a long-lasting surgical implant, although only one manufacturer has gained FDA approval to date, limiting availability.
Each administration method for naltrexone has its benefits and drawbacks. Primary concerns when choosing an administration method should include both the safety and sterility of the drug itself, as well as the reliability of the administration method itself. While all three can be effective, there is a clear favorite that maximizes safety, efficacy and reliability.
Naltrexone in pill form has been available through various manufacturers since its original FDA approval in 1984. The drug is taken on a daily basis, and therein lies the biggest issue with this particular format: it relies on the person in recovery to be completely medication compliant to maintain the efficacy of the treatment. While the drug mitigates cravings and pleasurable effects of opiates and alcohol, it is not psychoactive – that is, it does not affect brain function or behavior. What this means in practice is that a change in one’s willpower – for example, something as simple as stress – can affect the administration of the drug, and thus its efficacy, allowing the person to relapse and experience the drug as they typically would. Given the multitude of stressors in early recovery, it is extremely difficult for these individuals to be 100% medication compliant. To expect a person in early recovery to chemically manage their addiction and maintain the medical tools that help them maintain sobriety is, in most cases, overly optimistic. This application is only practical for those who have strong support systems and very stable home lives outside of addiction, which describes only a small subset of those in early recovery.
Vivitrol is the brand-name for injectable naltrexone, which has been in use now since FDA approval in 2006. The injectable version of the drug is an extended-release formulation delivered intramuscularly, commonly known as a depot injection. Generally, intramuscular naltrexone is effective for up to 30 days from the date of administration, as the medication releases over time and builds up a residual presence in the bloodstream. The biggest benefit of the injection is that no effort is required by the recipient to maintain the drug in their system – it’s just there and continues to work over the period it is released into the bloodstream. One doctor visit a month allows the individual to maintain the benefits of the drug without administering a daily medication regimen. This has been shown by studies to increase the efficacy of the drug and the likelihood of long-term sobriety.
The latest innovation with this drug is commonly referred to as “the pellet.” The pellet is an implantable, extended-release form of naltrexone that can be effective for anywhere from two to six months. The implant itself is about the size of a fingernail and is inserted under the belly button. While this treatment method shows promise and carries many of the benefits of the injection, there are many safety concerns surrounding this new format at this time. As with any surgery, there is a risk of complications and infection. More importantly, though, is the source of the implant itself: only one compounder is FDA-approved to make the drug at present, and some practitioners have taken to sourcing the implant from outside of the U.S. These sources are not FDA-approved and are often of dubious quality; unless the doctor is forthright, there is no way to know whether the implant one receives is FDA compliant or safely compounded. While this method carries the added benefit of a longer period of efficacy, the risks simply outweigh the benefits at this point in time.
According to WebMD, side effects can include nausea, headache, dizziness, anxiety, tiredness, and insomnia. Mild withdrawal symptoms may still be experienced while using naltrexone, which include cramps, muscle aches, joint pain and nasal discharge. However, these symptoms are felt to a much lesser degree than during a full-fledged opiate withdrawal. Naltrexone does interact directly with opioid-class drugs, so those who have not completed a medically-supervised detox program should not take naltrexone until they have completely detoxed. This restriction includes opioid agonists like suboxone and methadone, so those on a long-term maintenance program should detox before using naltrexone.
What Do Insurers Think?
Aetna’s policy on naltrexone states that they consider the implant application of the drug experimental at this time, excluding it from coverage. While they recognize the efficacy of the drug itself, they are dubious about this particular route of administration due to the lack of published clinical data supporting its efficacy in the long-term. Until such time that sufficient research exists to prove the effectiveness of this modality, one should expect insurers to be dubious about it and exclude it from coverage, even with FDA approval.
In Conclusion: The Best Use for Naltrexone
While the efficacy of naltrexone has been vetted by the FDA, additional data should still be collected to evaluate and determine the most effective delivery method for the drug to ensure optimal long-term results. Until the FDA more fully investigates and approves the naltrexone implant, safety concerns should preclude it from regular use – there is just too much risk for the average person to handle, especially in early recovery. At present, injectable naltrexone is the most appropriate choice for most individuals who need help maintaining sobriety – it alleviates concerns about medication compliance while avoiding the risks that come with a surgical implant. The oral application can be appropriate for those with very stable support or extreme cost concerns, but for the vast majority of those for whom naltrexone is appropriate, the injection grants the best shot at long-term sobriety.
However, the medication alone cannot cause a person to get and stay sober, especially in an era where addiction is often complicated with issues like trauma and mental illness. Long-term therapy and a formal support network are needed in addition to medication to encourage maintained sobriety and success. Often, this can be coordinated in concert with medication administration, allowing the individual to focus on recovery and not the coordination of continued support services.
So, all things considered; Is Naltrexone good? Yes, in concert with long-term clinical therapy and support. Can it be bad? Yes, if compounded in a pharmacy that is unsanitary or left to an individual in early recovery to maintain. Is Naltrexone ugly? It sure can be, especially if the implant is not sterile.
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