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Study Comparing naltrexone (Vivitrol) and buprenophrine + naloxone (Suboxone)

cduggles

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By Max Blau
November 14, 2017


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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.”

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.

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 investigativereports 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.”

Source Article

Study Summary

Interpretation

In this population it is more difficult to initiate patients to XR-NTX than BUP-NX, and this negatively affected overall relapse. However, once initiated, both medications were equally safe and effective. Future work should focus on facilitating induction to XR-NTX and on improving treatment retention for both medications.
 
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This is basically an add for Vivitrol, painting it like something comparable to Suboxone. The two meds have next to nothing (outside of maybe the blockage effect) in common.

The article also reinforces common (inaccurate) myths surrounding buprenorphine - such as the mistaken belief it's "just substituting" one drug for another, which entirely misses the point (my response to that statement is generally, "so what? how is naltrexone not doing exactly the same thing?").

The funny thing is how lightly the article glances over the finding suggesting that buprenorphine is actually more effective than naltrexone. It would have also been more interesting to see how folks in the study did at the 2yr point, as that tends to be more indicative of long term recovery than a mere 6 months.

Also funny how methadone isn't even mentioned here, despite treatment being more effective for that population than Suboxone or Vivitrol... But like I said, it's basically a fluff piece geared to support Vivitrol...

And as usual, Volkow is still (mostly) full of shit...

I also like how "both medications are safe and effective" yet 50% or more people using them have relapsed around 6 months. I mean, to some degree something used to treat something with a relapse rate of opioid use disorder could be seen as safe and effective even though 50% of people using it relapsed by the six month point (that would still be better than inpatient rehab that only used "traditional" techniques), but still...
 
The fact that 28 percent of vivitrol assignmend group couldn't get the treatment because it requires a longer period of abstinence to get is a major point the article glanced over.i think vivitrol has its place but comparing it to Suboxone is disingenuous. It seems to me that there is a war on maintenance medications in general right now which is sad because so many people are dying
 
The article by Blau is disingenuously worded. The study does not claim that naltrexone is "roughly equivalent" to or "as effective" as buprenorphine/naloxone. For the specific indicator that the source article studies, naltrexone is clearly shown to be inferior. You can't just put the induction failures aside as a "caveat" and declare the two treatments to be equal. The fact that Dr. Volkow is doing this shows how biased she is.
 
^^I agree with wholeheartedly with all these posts.

I posted because 1) large n in hard to follow population, 2) data on drug efficacy (although it was presented in a biased manner and didn't include methadone), and 3) doctors read the Lancet.

I'm discouraged (but not surprised) that the pharmaceutical industry and some physicians seem to despise drug addicts. They are viewed as a source of $$$ rather than people who need help.
 
Has anyone here ever used Naltrexone for alcohol dependency?

I have a script but its about $150 for a months subscription and when you are living in Australia it seems to be just cheaper to keep on drinking as drink prices here are dearer.
 
The article by Blau is disingenuously worded. The study does not claim that naltrexone is "roughly equivalent" to or "as effective" as buprenorphine/naloxone. For the specific indicator that the source article studies, naltrexone is clearly shown to be inferior. You can't just put the induction failures aside as a "caveat" and declare the two treatments to be equal. The fact that Dr. Volkow is doing this shows how biased she is.

How Dr volkow keeps her job is beyond me. Her leadership has been a total failure. Especially the response to the opiate crisis.

I would like to see a study comparing the naltrexone shot to the buprenorphine shot. That would be interesting especially if it took quality of life into account for both treatments
 
The article by Blau is disingenuously worded. The study does not claim that naltrexone is "roughly equivalent" to or "as effective" as buprenorphine/naloxone. For the specific indicator that the source article studies, naltrexone is clearly shown to be inferior. You can't just put the induction failures aside as a "caveat" and declare the two treatments to be equal. The fact that Dr. Volkow is doing this shows how biased she is.

Yup, Volkow is notorious for this kind of thing.

How Dr volkow keeps her job is beyond me. Her leadership has been a total failure. Especially the response to the opiate crisis.

I would like to see a study comparing the naltrexone shot to the buprenorphine shot. That would be interesting especially if it took quality of life into account for both treatments

She keeps her job because all her research support continuing engaging in the war on drugs! She gets so much funding whereas other don't because her research directly justifies our draconian drug policy, whereas truly scientific voices of reason like Carl Hart and Bruce Alexander get short shifted.

I'm amazed Hart has been able to do all the work he has actually (unlike what happened with Alexander), considering his research directly questions the legitimacy and usefulness of current drug policy. He probably gets a lot of support from the research community and Columbia though.

Has anyone here ever used Naltrexone for alcohol dependency?

I have a script but its about $150 for a months subscription and when you are living in Australia it seems to be just cheaper to keep on drinking as drink prices here are dearer.

I have heard good things, certainly better than people who use it for opioid use disorder. That said, I would think there are other (possibly cheaper) meds out there like baclofen that would work better for alcohol use disorder. But naltrexone probably has less long term side effects than baclofen, so it would be worth trying.

$150/month doesn't sound so bad in terms of cost. Can you try and get it from a low cost clinic or something to try and get more financial support?
 
Man, lost a bit of respect for Dr. Volkow. I actually really liked her Ted talk. She?s just another Dr. , and Phd or not, nobody ever really knows unless they?ve been there. I?ll give u an example;

Checkout of detox on DAY 4 and they wanna give me an oral form of naltrexone until I can make it to day 7 ( or 10 )
For the viv shot. Well, thankfully they forgot to write me a scrip, but, now my wife thinks I?m gonna need it as a safegaurd... so, I ask MY pcp, ( the one that will also ne addmin. My viv shot ) about that and he says
?Sure, I can call some in. Well, I still wait til day 6 of no opiates, just straight dt?s
( don?t ever go to Cascade Behavioral Health in Tukwila WA ) worst detox EVER! And my doc says, well, try a half and see how that feels, and if your doing okay go ahead and eat the other later tonight. Has anyone actually precip off of Naltrexone? Not NALOXONE? Naltrexone? HO-Lee-S#!T that was 20 times more intense that ANY sub initiated precip wd I?ve EVER COME CLOSE TO. And I only ate a -1/4 of the 50mgm pill... omg, I?m so glad I didn?t eat a whole 50mgm on day 4! Can you f?ing imagine?! I contemplated calling an ambalance! Several times! I didn?t know wtf I was gonna do, but there had to be SOMETHING I could do. And there was. And my ?Dr.? didn?t give this, what could and would have been a SAVIOR for the first 3 1/2 to 4 hours of my hell ( trust me, it?s NOT LIKE NALAXONE at all. This stuff?ll have you climbing up the f?ng walls BACKWARDS. ) and it was in my desk the whole time. I saw on a post about it from like 2010 here on bluelight from guy going thru the same hell I was and he was asking if Suboxone would help? Many peeps ( Dr.?s, CDP?s, people trying to ?save? others most likely ) told him it wouldn?t and that he needed to jus ?tuff it out? and he was ?almost there!? ( easier said than done pal ) anyways, he comes back a few later, and guess what?! The subs did help! OMG thank god words from someone who has actually experienced ?our? collective hell of addiction and all it?s lovely baggage! So I ate some as well ( and some xanax ) but, it was all the Sub?s. The benzo?s weren?t even KIND of knocking me out. Now, here I am, the same night maybe 5 hours later, and I?m doing LOADS better.
 
Wait.... that?s SHOCKING to you? ? ( mind being blown ) Big Pharm, Western Medicine, ?mrrrrca?s health care ?industry?... ( key word there being industry )
 
I would really like to talk to people who fall in love while using naltrexone, given the role opioids/endorphins play in that whole process. If musical anhedonia is associated with naltrexone use, I wonder what impact it can have on other experiences of joy.
 
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