In the United States, it’s estimated that 20.5 million people have a substance use disorder. Of those with a substance use disorder, 2 million are struggling with an opioid use disorder. The current Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5) separates the severity of an individual’s opioid use disorder into three distinctive categories (mild, moderate, severe) that can help guide a provider toward an appropriate modality of treatment. The diagnostic criterion in the DSM-5 is listed below:

  1. Taking the opioid in larger amounts and for longer than intended
  2. Wanting to cut down or quit but not being able to do it
  3. Spending a lot of time obtaining the opioid
  4. Craving or a strong desire to use opioids
  5. Repeatedly unable to carry out major obligations at work, school, or home due to opioid use
  6. Continued use despite persistent or recurring social or interpersonal problems caused or made worse by opioid use
  7. Stopping or reducing important social, occupational, or recreational activities due to opioid use
  8. Recurrent use of opioids in physically hazardous situations
  9. Consistent use of opioids despite acknowledgment of persistent or recurrent physical or psychological difficulties from using opioids
  10. Tolerance as defined by either a need for markedly increased amounts to achieve intoxication or desired effect or markedly diminished effect with continued use of the same amount. (Does not apply for diminished effect when used appropriately under medical supervision) *
  11. Withdrawal manifesting as either characteristic syndrome or the substance is used to avoid withdrawal (Does not apply when used appropriately under medical supervision) *

*This standard is not considered to be met for those individuals taking opioids solely under appropriate medical supervision.

Of the above noted characteristics, 2-3 would need to be present for mild, 4-5 for moderate and 6-7 for severe.

The New Treatment

The new treatment being prescribed by doctors is called Vivitrol. Vivitrol is an opioid agonist, meaning it attaches to the opioid receptors in the brain and will block and subsequently, in theory, control opioid cravings. What separates Vivitrol from its predecessors is that it’s an injectable medication with a longer release time as compared to the popular medical treatments for opioid addiction, suboxone and Methadone. Vivitrol is also not a lighter form of an opioid like suboxone and methadone.

If we want to try to cast some shade on treating substance use disorders with more drugs, methadone has become one of the leading causes of prescription opioid overdoses in the United States. Methadone has become known to lead a patient back to heroin or toward other opioids in search of that feeling of euphoria and relaxation. Similarly, suboxone has become an addictive substance that was originally meant to serve as an opioid agonist to stop addiction. Suboxone can be abused by crushing up the pill and snorting it or it can be abused orally but the former approach has a stronger and faster reaction. We can’t really blame people for trying to find a new drug treatment considering the addictive nature of methadone and suboxone. We must tread carefully when subscribing to a new treatment.

Vivitrol is currently controlled by one company, Alkermes. Alkermes has been using Vivitrol to treat opioid abusers since 2010 and their popularity has boomed more recently. While the control remains under one roof, like all drug patents, enough time will pass for the patent to lapse and more companies will have access to the formula and begin distributing a generic alternative to providers. The spread of Vivitrol and its eventual generic siblings can increase the risk of the drug finding its way to the street or being overprescribed when legislation can’t keep up with treatment provider regulations.

Remember His Name

Steve McCaffrey. Why is he important to Vivitrol? Steve McCaffrey is the President and CEO of Mental Health America of Indiana. The organization is an affiliate of Mental Health America, which is known for promoting mental health wellness using a variety of approaches including but not limited to conferences, campaigns, mental health awareness days and months, social media and other on and off-line content. The mission statement of McCaffrey’s sector in Indiana is, “Our mission is to work for America’s mental health and victory over mental illness”. Sounds great, doesn’t it? What mission statement doesn’t sound optimistic and exciting though?

What McCaffrey failed to add to his mission statement was a disclaimer that sounds something like, ‘I will promote mental health wellness drugs…as long they are within my lobbying efforts for a large pharmaceutical company, Alkermes’. In 2010, Alkermes spent less than $200,000 on lobbying efforts to spread the use of their drug to new treatment settings. In 2016, they spent $4.4 million. What’s more concerning is that McCaffrey assisted Indiana Rep. Steve Davisson with writing an addiction treatment bill. The bill limits treatment options for people with opioid use disorders and is creating a situation where some treatment facilities for opioid addiction can only administer Vivitrol as a pharmacological treatment. The bill also increases access to Vivitrol.

While McCaffrey has a responsibility as a role model to his organization and followers, he’s not bound by law and is welcome to accept money for lobbying. Alkermes has been open about their attempts to influence lawmakers as evidenced by their lobbying efforts and their government affairs director, Jeff Harris, stating “We have an entire team of people fanned out across the country working from coast to coast with state and local government officials,”.

If we want to preserve faith in the President of a large mental health organization, we can hope that McCaffrey means what he says when he wants to move toward more “evidenced based treatments”, which he was quoted as saying during a testimony at the Indiana Statehouse. What’s still and will remain baffling is Alkermes’ approach as they are not necessarily tasking doctors, scientists, psychiatrists and others of similar disciplines to review the drug in multiple controlled experiments. They are asking them to accept money to promote the drug. We all presumably know the answer. Money and politics mix together like, well, money and politics.

While McCaffrey is one example, there could be more to come based on Alkermes approach to marketing.

Clinical Trials

As it is with many chronic diseases, when treatment stops the symptoms will most likely return. Keep in mind, a substance use disorder is a disease, meaning individuals have a genetic predisposition to addiction just like someone may for heart disease.

There was a study conducted in the United States over a 24 week treatment phase with a several follow-ups, capping at 78 weeks, the chronic disease philosophy held true as many returned to their opioid addiction. The study compared traditional opioid agonist treatment (i.e. suboxone) versus Vivitrol. The lead author in the study, Dr. Joshua Lee, found that during the 24 week treatment phase, 43% of those on Vivitrol had a relapse event while 63% of those on the usual treatment had a relapse event.

It’s promising to hear that the rates of opioid relapse were lower during the treatment phase, however the relapse rates leveled out at the 52 and 78 week follow-ups, demonstrating the common attrition if treatment is not continued and supported by other modes of intervention such as behavior therapy. The study essentially ignored the chronic nature of drug addiction and the need for monitored treatment to extend beyond 24 weeks.

An important note to take into account about Vivitrol is that it cannot be administered to a patient until he or she undergoes a complete detoxification of opioid addiction, which may serve as a deterrent for an opioid user when deciding to pursue treatment. Suboxone can be administered to a user before detoxification occurs, which may be more attractive to a treatment provider and an opioid user with a history of relapse.

To be clear, Vivitrol is not an opioid like its predecessors, which is surely a selling point for Alkermes. The point of this of review treatment approaches is not to advocate for one drug treatment over another, it’s more so to provide education on the available treatments and their clinical history. Suboxone and methadone have not been the most successful so there should always be concern and several effective studies when a new drug is introduced.

A clinical trial was conducted in Russia, which demonstrated similar rates of success with Vivitrol. We could start and end the review of the study with the fact that suboxone and methadone are outlawed but we’ll trudge on anyway. Further demonstrating the limitations of the study, it only had 52 patients with 27 being in the group that received Vivitrol and 25 being in a placebo group. At the end of 6 months, 12 of 27 (44%) remained in the study and had not relapsed while 4 of 25 (16%) in the placebo group remained. This seemed to be enough for Alkermes to declare the treatment approach a ‘success’. Additionally, the small size of the study hasn’t stopped paid lobbyists and lawmakers from trudging on as well.

Vivitrol’s Perceived Success

The sales of Vivitrol have surged in the last 5 years with $209 million dollars in sales as compared to $30 million in 2011. The lobbying efforts aimed at lawmakers seem to be doing the trick despite the absence of published studies comparing Vivitrol and buprenorphine or methadone. It’s peculiar that a company with such an increase in sales and stock price hasn’t jumped on the opportunity to pay grants to doctors to conduct more studies, especially to prove their worth over the dominant drug treatment in the world of opioid addiction.

Alkermes has seemingly found the trump card (no pun intended) and is targeting politicians, much like McCaffrey did with Steve Davisson, which is most likely a symptom of a larger problem. This could be a model that may become a widespread approach used by drug companies. It’s concerning when we’re getting our medical advice from politicians with no history of providing substance abuse or medical treatment as opposed to doctors with extensive experience with people with substance use disorders.

To Drug or Not to Drug

The increase in pharmaceutical sales and the opioid epidemic is no secret as it’s made its way into several news reports and into peoples’ homes over the last 15 years. Speaking of, the rate of opioid overdose deaths has quadrupled over the last 15 years. The Substance Abuse and Mental Health Services Administration (SAMHSA) maintains that behavioral treatment should be coupled with medication. Some interventions recommended by are listed below:

  • Individual and group counseling
  • Inpatient and residential treatment
  • Intensive outpatient treatment
  • Partial hospital programs
  • Case or care management
  • Medication
  • Recovery support services
  • 12-Step fellowship
  • Peer supports

As you can see, it’s a one-way street in that SAMHSA acknowledges medication as an essential part of the treatment process as long as it’s in conjunction with a behavioral approach. McCaffrey did not discuss coupling Vivitrol with behavioral treatments in his testimony. When Peyton Manning won the Superbowl a few years ago, do you really think he was declaring his love for Papa John’s Pizza because he loves it that much?

We’re not expecting lawmakers to know as much as SAMHSA, which may leave us wondering why lawmakers without any behavioral treatment history have such a large hand in what’s administered to patients. To break it down further and close this review on a positive note, A few descriptions of behavioral treatment are listed at the end of this article. Try them on, even as a hypothetical and think about if it would help supplement a pharmacological intervention especially when it comes to abstaining from opioid use well beyond a 24 week treatment phase. You might be putting in more effort than our lawmakers.

Behavioral Treatments for Opioid Use Disorder

While we are all tirelessly searching for the “cure” to addiction, there is no one option that will work across the board. We are all different individuals with varying needs. However, we are all trying to achieve the same result. Find what works for you and commit to it – change your life. Below are alternative behavioral treatments that may just work for you.

  • Cognitive behavior therapy teaches individuals in treatment to recognize and stop negative patterns of thinking and behavior. For instance, cognitive behavior therapy might help a person be aware of the stressors, situations, and feelings that lead to substance use so that the person can avoid them or act differently when they occur.
  • Dialectical behavior therapy is designed to provide incentives to reinforce positive behaviors, such as remaining abstinent from substance use.
  • Motivational interviewing helps people with substance use disorders to build motivation and commit to specific plans to engage in treatment and seek recovery. It is often used early in the process to engage people in treatment.
  • 12-step approach seeks to guide and support engagement in 12-step programs such as Alcoholics Anonymous or Narcotics Anonymous.