Surprise! Vivitrol Might Just Not Work on Opioid Addiction

(Let me preface all of this by noting that I am not saying that Vivitrol has never worked or could not possibly work for anyone. If you’ve found relief from addiction by way of Vivitrol, more power to you; nothing here is intended to rain on your sober parade. These are simply some observations about how the efficacy of the medication on any wide scale has simply not been demonstrated, and how each new bit of information that comes out seems to indicate that it’s simply not a good treatment for opioid and/or heroin addiction. Let me also point out that I would prefer kratom to be available as a first-line treatment for opioid abuse and dependence, but that’s another article entirely.)

Vivitrol is a once-a-month, extended-release shot of naltrexone, an opioid receptor antagonist that has been approved by the FDA since 2006 to treat alcohol dependence. As you probably know, opioid receptor antagonists block activity, while agonists activate receptors (buprenorphine, for example — the active ingredient in suboxone — is a partial opioid receptor agonist). In the past several years, the makers of Vivitrol have conducted some very vigorous *ahem* “public outreach” (marketing campaigns and lobbying) to encourage legislators, county commissioners, sheriffs, and other public officials to consider trying Vivitrol to treat heroin and opioid addiction. Their efforts have been singularly aggressive, and in short order the nation has seen many jails and even some prisons sink quite a lot of money into Vivitrol as a first-line medication-assisted treatment (MAT) for opioid addiction, while state laws have been amended to encourage Vivitrol use and make buprenorphine less widely accessible.

The problem? There’s just no good evidence that Vivitrol works for anything other than alcohol dependence. And the more evidence that comes out, the more obvious it becomes that the Vivitrol train is coming off of its tracks (which were pretty crooked to begin with).

Take for example this article that was recently published on cleveland.com: Medication Assisted Treatment in Drug Courts Proves Minimally Effective:

“Since 2013, lawmakers have sunk more than $33 million into introducing MATs into drug courts, including $1 million it paid Treatment Research Institute, of Philadelphia, for the most recent evaluation that looked at about 600 drug court participants in 13 counties... the only apparent result of giving participants [Vivitrol] for addiction was that some stayed in the court programs longer.”

Initially, the study wanted to look at the relative efficacy of various types of MATs, and specifically the relative efficacy of Vivitrol as compared to Suboxone (active ingredient: buprenorphine). That wasn’t really possible, however, because they found that nearly all of the participating courts (89%) used only Vivitrol. And the reason? Because Vivitrol is an antagonist rather than an agonist like Suboxone, it doesn’t really have a street value or diversion potential, and it can’t be abused like Suboxone can. Thus the drug court coordinators found Vivitrol to be a safer bet. In fact, in many drug courts across the country you are not allowed to participate if you use Suboxone, because (as the coordinators claim), they can’t tell via testing whether a participant is using or abusing Suboxone. In other words, many people are forced to choose between effective opioid addiction treatment and harsher criminal justice sanctions.

But the problem with the drug court coordinators’ reliance on Vivitrol as opposed to Suboxone is twofold: first, despite issues relating to dependence and diversion, Suboxone has been proven effective. It works. It has its problems, there’s no doubt about that — including a very long withdrawal time (think over a year) for those who wish to taper off of it after long-term use — but it cuts opioid dependence and attendant risk of overdose death in half. Second, there is no good evidence that Vivitrol is effective whatsoever. So the drug courts have gone the “safer” route, but the result has been that they haven’t actually accomplished the ultimate goal of reducing recidivism and helping addicts get and stay clean.

So what, may I ask, is the damn point? Why have so many public officials fallen hook, line, and sinker for the Vivitrol manufacturer’s (Alkermes) pie-in-the-sky promises of an opioid treatment without any of the icky side effects and externalities, sinking ungodly amounts of money into a “treatment” with no proven effect? I suspect much of it has to do with these officials’ desires to at least look like they’re doing something about the problem. And I also think they’ve fallen for the slick marketing campaign pushed by Alkermes.

Two years ago, NPR released a piece about this specific, and often underhanded, campaign: A Drugmaker Tries To Cash In On The Opioid Epidemic, One State Law At A Time. The article details how Alkermes has deployed lobbyists and politicians across the states to try to tinker with laws and rules pertaining to MAT, making it more difficult to prescribe (and fund) effective agonists like buprenorphine (Suboxone) while tailoring the laws to encourage the use of Vivitrol. All for the almighty treatment dollar. If this doesn’t sicken you, I’m not sure this discussion is one in which you’re terribly invested or about which you’ve been sufficiently informed.

There are other major drawbacks to Vivitrol from a practical standpoint. The patient can’t start it until he or she has been completely detoxed — several days at minimum, although I’ve seen recommendations that the patient be clean for two or three weeks before getting the first injection. That’s because using Vivitrol before you’ve detoxed from opioids can send you spiraling into what’s called “precipitated withdrawal”: an immediate, miserable, and overwhelming withdrawal that is sparked by the drug’s solid “fit” into the relevant opioid receptors, preventing those receptors from being activated at all and resulting in physical and psychological withdrawal symptoms so agonizing that they might just prevent a person from ever wanting to try to quit again. It’s also quite dangerous for a person who’s acclimated to using opioids and heroin to go into precipitated withdrawal without medical care at hand. That detox period is critical, and one of the reasons buprenorphine works is because it alleviates withdrawal symptoms. Vivitrol basically tells the person, “Get back to us when the worst part’s over and we’ll see what we can do for you.” It’s highly impracticable.

Side note about precipitated withdrawal: the “inactive” ingredient in Suboxone is naltrexone, which is the active ingredient of Vivitrol. A small amount is added to buprenorphine to prevent abuse by making attempts to smoke or otherwise improperly ingest the drug cause precipitated withdrawal. (Of course, anyone who’s familiar with hard-core opioid abusers knows that this is little deterrent; the small amount of naltrexone in Suboxone isn’t likely to stop a determined user from getting high, as he or she will be willing to tolerate the immediate negative effects in order to achieve the pleasant feelings that will ensue.)

There is also an increased risk of overdose death if a person stops taking Vivitrol suddenly and goes chasing the dragon. As explained in the NPR article: “Some clinicians are also hesitant to prescribe Vivitrol to patients because of relapse risk. Using opioids again after an extended period of opioid abstinence can increase the risk of overdose and death.” And it can’t be used for people who have constant pain on top of their addiction (the Vivitrol prevents any pain medication from being effective) or on pregnant women.

And it’s not cheap. A monthly shot of Vivitrol without insurance will set you back around $1000. Suboxone costs about half that much out of pocket, if not a bit less.

So basically, lawmakers and officials have thrown a lot of money at Alkermes and its “blockbuster” Vivitrol, and they have virtually nothing to show for it. As an amusing side note, there was an “Opioid Workshop” a couple months back in Orlando — the one in which I laid into the Governor’s representative, causing him to declare a state of emergency the following day — in which the operator of our Orange County Jail spoke glowingly about her voluntary post-release Vivitrol program… until someone asked about the participation rate. After months of offering the program, the total number of releasees who had chosen to take advantage of the jail’s Vivitrol offer was… one. One person.

I will be the first to acknowledge that Suboxone has its drawbacks, and that diversion, particularly in jails and prisons (it’s easy to sneak the film strips onto admissible reading material), is a major issue. But at this point, we have to look at harm reduction and admit that the negatives associated with buprenorphine (Suboxone) do not outweigh the potential benefits it carries in alleviating the opioid epidemic and allowing addicts to get on with their lives. Until better alternatives (hint: kratom) are more widely known and used by treatment professionals, it’s the only medication-assisted treatment available on an outpatient basis that we know works.

Lawmakers want a way to address the epidemic while keeping their hands clean — a treatment that works on opioid addiction while sidestepping all negative effects and consequences of buprenorphine. There is no such treatment; by all measures so far, Vivitrol fails on the efficacy front. At this point, it seems we need an anti-lobby to convince our lawmakers to stop wasting money on the cynical, ineffective nonsense that is extended-release naltrexone.