The largest head-to-head study to date between two leading drugs to treat opioid addiction has found them roughly equivalent — an outcome that could dramatically change prescribing habits and boost the fortunes of the newer drug, Vivitrol.

The study, sponsored by the National Institute on Drug Abuse, found that a monthly shot of naltrexone (sold as Vivitrol) is as effective as its main competitor, the daily pill of buprenorphine and naloxone (sold as Suboxone). Researchers found that about half of people with opioid addiction who took either drug remained free from relapse six months later.

Previously, there’s been a “widespread belief” that patients “don’t do as well on naltrexone as they do on buprenorphine,” said Dr. Nora Volkow, director of NIDA. “We’re hopeful this changes the prejudice.”

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The finding, however, comes with a major caveat. A large number of people were unable to even start treatment with Vivitrol. That’s because participants had to thoroughly wean themselves off opioids for a period of three days before they could start taking Vivitrol, to avoid sudden symptoms of opioid withdrawal. Because of that hurdle, patients failed to start on Vivitrol at four times the rate that they did Suboxone.

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Vivitrol, which received Food and Drug Administration approval in 2010 for opioid treatment, is seen as attractive option because patients only have to take it once a month, and it doesn’t contain opioids. Suboxone, by contrast, has been treated with skepticism by some physicians and officials — including former Health and Human Services Secretary Tom Price — because it’s “substituting” one opioid for another. But Vivitrol, which costs about $1,000 a shot, is also much more expensive than Suboxone, and up until now has had limited evidence showing how well it works.

Addiction experts say this study, which confirms the results of a smaller head-to-head trial recently published, offer more clarity at a time where misconceptions have clouded the public’s judgment about treatments for opioid addiction.

Costs and benefits

The research was conducted between 2014 and 2017 at eight community-based inpatient treatment facilities across the U.S. A group of 570 opioid-dependent adults — the majority of whom were white men between the ages of 25 and 45 — received one of the two medication-assisted treatments.

Over the subsequent six months, researchers both solicited self-reports of opioid use as well as weekly urine samples. Participants also reported side effects and their level of opioid craving. At the end of six months, 52 percent of those who had received Vivitrol had relapsed, compared with 56 percent of those receiving Suboxone. However, 28 percent of participants assigned to Vivitrol couldn’t make it through the detox period, as compared to 6 percent of people who quit the study before initiating Suboxone dosage. Taking into account all the participants, Suboxone had a lower rate of relapse than Vivitrol.

Dr. Joshua Lee, an associate professor with New York University’s School of Medicine and a leading author of the study, which published in the Lancet on Tuesday, said the findings indicate that each drug can help certain patients, rather than one simply being better than the other.

“Both medications worked quite similarly and, therefore, both should be discussed as treatment options,” Lee told STAT. “The problem is not enough people are getting into treatment anyway, and when they do go into treatment, they don’t get any of these treatment options. Enough of the circular firing squad among the addiction treatment providers, and the war amongst all these different medications.”

But other addiction doctors said that the gap in rates of people who successfully started each treatment was an alarming sign.

“The take-home from this study is that buprenorphine [Suboxone] is more effective” than Vivitrol, said Dr. Sarah Wakeman, the medical director of the Substance Use Disorders Initiative at Massachusetts General Hospital. She said the study confirmed what she sees at her clinical practice — that it is easier to initiate Suboxone treatment with patients, and patients stay with the treatment longer.

She also pointed out that many of the overdoses in the study occurred after detox — a phase that isn’t required if patients are given Suboxone.

Dr. Andrew Kolodny, co-director of the Opioid Policy Research Collaborative at Brandeis University, agreed. “Buprenorphine outperformed naltrexone, period,” he said.

The need for evidence

One charge the study does settle is that there is a lack of evidence supporting Vivitrol’s touted effects. Alkermes, which manufactures the drug, was dinged by a number of investigative reports earlier this year highlighting the company’s expansive claims about the drug’s potential to investors and its aggressive lobbying of federal lawmakers.

Alkermes did not donate drugs to this trial. But two of study’s senior authors — Lee and Dr. John Rotrosen, a psychiatry professor at NYU’s School of Medicine — had received free drugs from Alkermes for an unrelated trial. Two other researchers involved in the study disclosed receiving either research support or consulting fees from Alkermes in the past. In a statement, Alkermes CEO Richard Pops said the “data from the study reinforce the value of [medication-assisted treatment] and the distinct differences between two important options” for opioid-use disorder.

Indivior, the company that makes Suboxone, donated drugs to this trial and “had access to periodic safety data only, with no input or review of this manuscript,” according to the study.

Volkow, for her part, believes physicians should be prescribing medication out of a series of choices. For instance, Vivitrol might be a better treatment for someone in a rural area because he or she wouldn’t have to drive as frequently to a faraway clinic; chronic pain patients might respond better to Suboxone, as it blocks pain receptors.

Ultimately, Volkow feels more long-term research and development of opioid addiction treatments — including extended-release buprenorphine — is needed now to truly know what works best for patients.

“They’re not perfect — in this trial 50 percent of the patients relapsed after six months,” Volkow said. “So it behooves us to research more and develop more medications.”

David Armstrong contributed reporting.

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  • Thank God for some of the doctors who are actually thinking based on evidence rather than being pushed or steam rolled by uninformed hysterics. This highlights the value of input by ‘patients’ who are most affected and by good doctors who care about patients’ experiences.

  • I forecast a lot of the Suboxone clinics closing in the foreseeable future. Medicaid funding from individual states is decreasing, many states have faced across the board budget cuts. The clients overwhelmingly use Medicaid benefits to pay both the clinic for the doctor and the pharmacy for the prescription. There are very few using non government insurance. I don’t believe clinics are going to stay open for those who have private insurance. The state I am in has twice lowered compensation to providers in the past few months.

  • Detoxification under conscious sedation followed by daily naltrexone ingestion can be very effective.If Naltrexone given under direct observed therapy by a reliable caregiver can eliminate compliance issues.

    • Where can I receive this kind of treatment. I live in Chatham County NC. I am in great need of some guidance. I am having Neropathy associated with my buprenorphine MAT plan. Any advice will be greatly appreciated.

  • Why does no one ever mention chronic pain sufferers who are not addicts that need their meds to even be able to function and live in constant fear of being cut off? All this hysteria is BS. Suicide rates soaring because people are in so much pain and turning to the street. Insane! Look at how well prohibition worked. Any parallels?

    • Danny, I so agree with you. And from another side of it, I want to be taken off all pain med so I can find a baseline for my pain. ATT, I take oxycodone at 0600 and noon and then Xtampa at 1800 for overnight (allows me to get 8+ hours of sleep without wearing off too soon like OxyCotin can). I am really afraid of weaning off the meds. Don’t know if I can take the jitters/anxiety/etc. I am not afraid of the pain and I am not afraid of reusing outside a dr’s care because I have never abused my meds; I have always opted to take a little less & deal with the pain. I also have an implanted spinal cord stimulator for my mid- and lower-back. The meds are for the rest. I also take Cymbalta for nerve pain.

  • The article and the headline are completely at odds.
    How can they’re equally “as effective” and then include this sentence in the article? “Taking into account all the participants, Suboxone had a lower rate of relapse than Vivitrol.”
    Bizarre.

    • The two medications are equally effective when patients are able to follow through and complete the entire course of treatment. In other words, taken as directed, they are equally effective. However, it is more difficult for patients to take Vivitrol as directed; therefore, counting all participants in the study (including those who did NOT complete the entire course of treatment), Suboxone did better.

    • Bizarre is correct. Sounds like nonsense to me. My son has to fight every month with The insurance company to pay for his naltrexone injection . But they would pay for Suboxone or methadone all day long Or $160,000 for 31 days of rehab no questions asked !
      But a non-addicting opioid free medicine that helps him maintain sobriety he has to fight for every single month!
      I just can’t wrap my brain around it and it’s very disheartening to me !
      And that cost $1400 per injection and I can’t wrap my brain around that either!!!

  • I’m a bit confused as to your information. Suboxone absolutely requires a detox period of the exact same 3 days that vivitrol does! I know since it has deterred me in initiating treatment in the past. Since most of the conclusions in this article are based on that false fact alone I’m going to have to assume all of this is false.

    • No, it doesn’t “absolutely” require a detox period of 3 days. It does require some detoxification time, the length of which depends on the specific opioid’s half-life (for heroin, the time is 12-24 hours). Technically, you only have to wait until you score at a 5-6 no the COWS (measurement of withdrawal severity). However, you would be much safer if you waited until 10+. Even transferring from methadone requires that one only wait 36 hours (after one has tapered down to 30mg). So 3 days is not required for ANY standard opioid.

      This is far shorter than the 3 days mentioned in the article, which is actually incorrect (you are right to not trust articles, but you could at least do some research yourself). The vivitrol website recommends 7-14 days of opioid abstinence. Also add in the fact that suboxone will immediately stop withdrawals if taken correctly, whereas naltrexone will do nothing to make one feel better.

      I don’t know what your drug of choice is, but if you wait around 24 hours, you will probably be fine. You can even start with taking very small doses of buprenorphine (0.5mg) and waiting about 1 hour. If you feel much worse, than you should wait longer. And a small dose of buprenorphine will not block all receptors. The blocking effect of buprenorphine only becomes noticeable at larger doses). This means that if you feel worse, you can always stop the induction and use a full agonist opioid if needed. On the other hand, if you feel fine after that hour, take 1mg and wait another hour. Then 2 mg. If you can take 2mg without feeling worse, then there is probably no chance of precipitated withdrawals.

    • subs takes 24 hours detox if you are using short term opiates , but if you have been using methadone it may take 3 days or longer, or you may get a case of the paws, the worst detox symptoms you can imagine

  • Inaccurate and dangerous information . I’ve taken both and they are completely different medications. SUBOXONE has Naltrexone in it to deter the future use.. an opiate will not bind to a receptor that is already occupied by Bupes. Naltrexone blocks receptors from the binding of an opiate. Even if that opiate has already been ingested. That’s why one can overdose twice on the same opiate when the Naltrexone wears off.. flawed study setting a dangerous precedent for individuals dependant on opiates.

    • Not to mention the fact that Suboxone has the exact same detox requirement of 3 days like it’s competitor vivitrol. Since most of the conclusions and opinions in this article are based on that false statement, I must assume this whole thing is bull!

    • Oh my, you both are very misinformed. Suboxone has naloxone and buprenorphine, not naltrexone. The reason for less of a detox requirement for suboxone is due to the buprenorphine. You should both check Wikipedia

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