Three noteworthy medication assisted treatment (MAT) studies

There have been a few noteworthy medication assisted treatment (MAT) studies published recently.

Two studies evaluated the comparative effectiveness of extended-release naltrexone (Vivitrol) versus buprenorphine-naloxone (Suboxone).

Anticipation of these studies has been heightened by questions about Vivitrol’s effectiveness and marketing.

Study 1

The first of these was published in JAMA in October and summarized their conclusions as follows:

Extended-release naltrexone was as effective as buprenorphine-naloxone in maintaining short-term abstinence from heroin and other illicit substances and should be considered as a treatment option for opioid-dependent individuals.

This study was done in Norway and the only information about other treatments received was this:

Following induction into either medication regimen, participants were asked to attend standard drug counseling, but no behavioral interventions could be initiated.

What that means, I don’t know.

They initiated medication in 143 subjects and had only 1 overdose, which was in the buprenorphine group.

Here is some discussion about this, some subject characteristics, and other findings:

Satisfaction with treatment and willingness to recommend their treatment to others were significantly higher among extended-release naltrexone participants. This finding may be due to the perception of being protected against relapse of opioid use and possible overdose and better opportunities to return to work or educational activities when not having to meet daily or every second day for supervised intake of an opioid agonist. However, the high availability of OMT in Norway34 makes it likely that the majority of participants were mainly motivated to receive the novel extended-release naltrexone treatment and not buprenorphine-naloxone. As treatment preference has been shown to be important for treatment satisfaction and adherence in other settings,35,36 it is difficult to know whether extended-release naltrexone would be equally effective in individuals with lower motivation for opioid abstinence.

There was only 1 reported overdose in the study, which is much lower than most reports on the first 12 weeks after discharge from treatment or prison.9,37,38 This low rate may reflect the high motivation for treatment and good response to regular follow-up by the same study worker in this group of participants.

The rather low reported mean use of opioids the last 30 days before inclusion is probably due to the fact that a number of participants included in the study had already completed detoxification or had sustained abstinence for varying periods of time (prison or inpatient treatment), while others were still actively using opioids at study enrollment.

They report that the medications were equally effective, but I’m not clear exactly what the relapse rates were throughout the study. (I’m not sure I’m reading it right, but did days of heroin and opioid use actually increase in both groups?)

Study 2

The second study comparing the effectiveness of extended-release naltrexone (XR-NTX) versus buprenorphine-naloxone (BUP-NX) was just published by the Lancet and I have been unable to get a full copy.

They summarized their conclusions as follows:

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.

What did they mean by more difficult to initiated?

As expected, XR-NTX had a substantial induction hurdle: fewer participants successfully initiated XR-NTX (204 [72%] of 283) than BUP-NX (270 [94%] of 287; p<0·0001). Among all participants who were randomly assigned (intention-to-treat population, n=570) 24 week relapse events were greater for XR-NTX (185 [65%] of 283) than for BUP-NX (163 [57%] of 287; hazard ratio [HR] 1·36, 95% CI 1·10–1·68), most or all of this difference accounted for by early relapse in nearly all (70 [89%] of 79) XR-NTX induction failures. Among participants successfully inducted (per-protocol population, n=474), 24 week relapse events were similar across study groups (p=0·44).

This is not surprising, give subjects must be abstinent for 7 to 14 days before beginning extended-release naltrexone. Successful initiation of it is probably going to require a lot of support.

What about overdoses?

Five fatal overdoses occurred (two in the XR-NTX group and three in the BUP-NX group).

I’ve been unable to find much about other treatments involved. The clinicaltrials.gov registration reports the following.

The study is conducted in 8 CTN-affiliated CTPs that provide or partner with detoxification services (inpatient/residential) which have the capacity to maintain participants opioid-free for approximately 3-7 days, have the capacity to provide medication-assisted therapy, and can provide a minimum of one group or individual counseling session per week during the 24-week treatment period.

Again, they report that the medications were equally effective, but I’m not clear exactly what the relapse rates were throughout the study.

Study 3

The third study is on neuropsychological function in subjects on buprenorphine-naloxone.

This is important because of questions about cognitive impairment due to maintenance medications.

Their conclusions are as follows:

Among OUD patients, greater adherence to buprenorphine/naloxone is associated with improved neuropsychological functioning over time. In contrast, depressive symptomatology is not associated with neuropsychological functioning over time. Supporting adherence to buprenorphine/naloxone may improve and/or preserve learning and memory functioning in individuals treated for OUD.

I find it hard to know what to make of this study. The following confused me:

  • It had only 20 subjects and put all of the subjects on buprenorphine-naloxone, yet they report “sixteen participants had a current substance use disorder (SUD)”. Why put people without a current SUD on buprenorphine-naloxone.
  • While self-reported substance use declined, positive opioid screens increased from baseline to study completion.

There’s also no mention of other services, like counseling.

Thoughts

Dawn Farm takes informed consent seriously with clients with opioid use disorders. (We do with all clients, but this post is about OUDs and the opioid crisis has made it a very salient issue.) We have developed services to facilitate, support and monitor initiation and ongoing use of extended-release naltrexone. (We also provide screening and referral to other MAT treatment options and provide ongoing outpatient care and recovery support services.) Given our use of extended-release naltrexone and the controversy around the treatment, we’re happy to see evidence to support it.

A lot of attention is given to these studies and others. These studies will be used to write policy and will be referenced by journalists, treatment providers, policy makers, advocates, etc. These studies will determine what all of these people declare the “standard of care”.

Again, the first two studies provide support for a tool we use. (Who doesn’t like validation?)

The questions on my mind have been these: Would I want to be a subject in any of these studies? No. Would I want a loved one to be a subject in any of these studies? No.

These studies looked at the effects of the medications, but they don’t look at the kinds of real world treatments most people get or want. There was little or no counseling. I saw nothing about recovery in any of the studies. I saw nothing about community or family support.

For understandable reasons, they look at easy to measure outcomes like positive drug screens and # of days using. Most people are looking to use fewer days—they are looking for abstinence (from heroin and opioid misuse), recovery,  and a restoration of their quality of life.

So . . . these studies may tell us something. They may tell us some important things. However, what they can tell us is very limited.

It seems hard to draw strong opinions about proper care when I would not want the care provided in the study. (And, when the researchers would never receive similar care.)

These studies provide some data, but they say little about what can be accomplished with treatment of appropriate quality, duration, and intensity, or what it looks like.

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Google update – How much $$$ are we talking about?

Bloomberg follows up on the recent stories about Google shutting  down addiction treatment related AdWords ads (emphasis mine):

Google has been actively pursuing profits from the business, despite complaints that it’s a magnet for criminals. There’s an entire sales division in Cambridge, Mass., Google Health Systems, that focuses on medical markets, including addiction treatment. It’s sent account executives to peddle AdWords and other services at addiction treatment conferences and webinars. Google may be raking in $1 billion or more a year from addiction treatment advertisers, according to Williams, who based the estimate on average marketing spending. (Google declined to comment on anything related to its revenue sources.) “I thought it just happened organically, that because it’s Google, it would naturally get a lot of companies that would pay to market,” says Aronberg. “I did not realize Google is actively courting the industry, suggesting the right keywords and going to conferences. That’s crazy.”

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Hazelden shares rationale for Suboxone over methadone

Hazelden just sent a newsletter that included a teaser about the rationale for their adoption of Suboxone over methadone.

It links to this article that describes their reasoning this way:

We found that buprenorphine was a better medication for our patient population and our goals of transitional use of MAT versus long-term medication maintenance. While methadone is very effective and useful for certain populations, most people in methadone maintenance programs commonly don’t have an abstinence orientation, which can result in continued use of benzodiazepines, cocaine, alcohol, marijuana, and other drugs.

Some context makes this interesting.

The federal government, the media, treatment providers, and medication manufacturers have put tremendous energy into promoting maintenance treatments. Most of these efforts do not differentiate between treatments.

Hazelden’s embrace of maintenance medication was seen as a sort of breakthrough for MAT.

The fact that they would characterize methadone programs in this way (and use the word “most”) is noteworthy.

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Overdose – How protective are knowledge and medication?

10120260443_560161d92b_bJana Burson provides a synopsis of a recent study on the role of the user’s knowledge in OD. (Her blog provides her perspective as a doctor who prescribes buprenorphine. It is worth your time.)

The findings will not be a surprise to anyone who talks with injection users about their knowledge and experience.

The authors of the study concluded that these experienced drug users were aware of common risks for overdose, yet drug intoxication from sedatives such as alcohol or benzodiazepines may have clouded the user’s thinking when injecting opioids. They also found that unexpected availability of drugs contributed to overdoses.

This presents some serious challenges for harm reduction efforts.

Another interesting finding is this:

. . . more than half of the study subjects were in some form of treatment for substance use disorder. This finding is contrary to other studies, which have found being in treatment lowered the risk for overdose. Around 46% were in medication-assisted treatment with either methadone or buprenorphine. However, some of the overdoses happened on days that the person missed dosing for some reason, and substituted another opioid such as heroin or fentanyl. Thirty-two percent of study subjects dosed with either methadone or buprenorphine in the twenty-four hours prior to experiencing their overdose.

This will be a big surprise to anyone who follows the opioid crisis in the news and/or advocacy from the feds, pharma, and others. (Not such a big surprise if you follow the research and this blog.)

There’s no doubt that maintenance medications provide some protection from OD. However, studies like this suggest that this benefit is often overstated, even when patients actually take their medication. (Of course, there’s also the issue that people discontinue their medication at high rates.)

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Recovery Rising by Bill White

I just learned that Bill White’s memoir Recovery Rising: A Retrospective of Addiction Treatment and Recovery Advocacy is available as an e-book on Amazon. The paper copy should be available soon.

Bill described it this way:

I have worked in the arenas of addiction treatment, recovery research, and recovery advocacy for nearly half a century and have been blessed with opportunities to work with some of the leading policymakers, research scientists, clinicians, and recovery advocates of my generation. At this late stage of my life, it seemed a worthy effort to try to pass on some of the hard-earned lessons I have drawn from this work. Such was the inspiration for turning decades of professional journaling into a book of stories that highlight, through my own experiences, some of the major milestones in the modern history of addiction treatment and recovery.

Recovery Rising contains more than 350 vignettes with accompanying reflective questions that allow readers to explore their own thoughts and experiences related to some of the most challenging issues on the frontlines of addiction treatment and recovery support.

I look forward to reading it and sharing more about it.

If you’re someone who’s a little intimidated by big books or has a pile of unread books on your nightstand, take note of the description mentioning “more than 350 vignettes.” I’m pretty sure that means there are a bunch of independent stories (organized around various themes) that are a page or two long. That means there no big commitment to read 700 pages from front to back, just a page or two whenever you choose.

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Another hustle. Google steps in. (Thank you, Google.)

It’s the kind of thing that 99.9% of people would never know, but addiction treatment related keywords have long been the most expensive keywords in Google AdWords. By far.

There are treatment programs with, say, 80 beds that have 100 websites. Some identify the provider, most do not.

A few years back I published a post about some of these practices. It’s so bad that it’s difficult to get your head around because there are so many hustles at so many levels.

At any rate, Google decided to do something about it. (Good for them, particularly since I imagine this was pretty lucrative for Google.)

Around the country today, marketers in the $35 billion addiction treatment industry woke up to an unpleasant surprise: Many of their Google search ads were gone. Overnight, the search giant has stopped selling ads against a huge number of rehab-related search terms, including “rehab near me,” “alcohol treatment,” and thousands of others. Search ads on some of those keywords would previously have netted Google hundreds of dollars per click.

“We found a number of misleading experiences among rehabilitation treatment centers that led to our decision, in consultation with experts, to restrict ads in this category,” Google told The Verge in a statement. “As always, we constantly review our policies to protect our users and provide good experiences for consumers.”

Google is the biggest source of patients for most treatment centers. Advertisers tell Google how much they want to spend on search ads per month, which keywords they’d like those ads to run against, and then pay Google every time someone clicks on their ad.

Thanks to Greg Williams for bringing it to their attention.

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“I’m afraid of never finding people that understand”

I recently listened to this episode from the podcast Rumble Strip. Erica Heilman interviews a high school senior whose mom and grandmother are addicted.

She’s a really impressive young woman. I hope she’s doing well in college. (This was recorded a year or two ago.)

This interview does a great job illuminating the effects of addiction on kids. Jesse seems very resilient and you get the sense she’s going to be ok. (Though it’s easy to imagine she pretty good at giving the impression everything is ok.) It’s harder to think about a kid who’s less resilient.

It’s a great illustration of what’s at stake when a parent is addicted.

We need a full array of treatment options of adequate quality, duration, and intensity accompanied by assertive outreach and good information that allows patients and families to make informed decisions in a marketplace that’s rife with hype and greed.

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