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Study of Long-acting buprenorphine published–17% respond

A new JAMA study

concludes, “Long-acting buprenorphine depot formulations appear to be efficacious for treatment of opioid use disorder.”

Keep reading.

They compared the effectiveness of sublingual (oral) and long-acting injections of buprenorphine to see if the long-acting injections are as effective as the sublingual version.

The study was 24 weeks. That’s better than we usually see.

They used two measures to compare them:

  1. Average percent of opioid-negative urine samples for 24 weeks.
  2. Percent of subjects with negative urine screens for illicit opioid use for at least 8 of 10 drug screens at prespecified points during weeks 9 to 24. (This was the criteria for being classified as responding to the treatment.)

Measure 1

  • Sublingual buprenorphine – 28.4% (1099 of 3870) of urine screens were negative for opioids.
  • Long-acting injectable buprenorphine – 35.1% (1347 of 3834) of urine screens were negative for opioids.

This means that 71.6% and 64.9% of the drug screens were positive for opioids. It’s also worth noting that they do not report whether they also screened for any other drugs.

Measure 2

  • Sublingual buprenorphine – 14.4% (31 of 215) of these subjects were negative for opioids in 8 out of 10 urine screens at prespecified points during weeks 9 to 24.
  • Long-acting injectable buprenorphine – 17.4% (37 of 213) of these subjects were negative for opioids in 8 out of 10 urine screens at prespecified points during weeks 9 to 24.

So, this measure doesn’t tell us much about what happened during weeks 1 to 8, but we know that 85.6% and 82.6% of subjects screened positive for opioids at least 3 times during the 10 testing points over weeks 9 to 24.

Recovery?

Do we know anything about the number of subject who achieved recovery during this 6 month study?

Not really.

What we know

  • There was a lot of opioid use by subjects.
  • 15.8% of all subjects screened negative for opioids >80% of the time at those 10 testing points.

What we don’t know

  • Did any subjects successfully abstained from opioids?
  • Despite the high rates of opioid use, did some subjects migrate toward something resembling stable recovery?
  • What were the rates of alcohol and other drug use?
  • What kind of quality of life improvements were made over the course of the 6 months?
  • What was the retention rate? (There’s no mention of dropout. If dropout was not an issue, how did they achieve that?)
  • How would these subjects have done if they were offered the gold standard treatment?
  • What other services/supports subjects received.*

Press releases about this study refer to it as effective, positive and promising. Keep in mind, when people say maintenance medications are the most effective treatments, this is what they are talking about.

It’s not that these medications can’t be or shouldn’t be part of the treatment system. In fact, I believe that they ought to be available to every single person who wants them. At the same time, when some patients, families, providers, and other systems are reluctant to embrace these outcomes, there may be reasons other than stigma or ignorance.*

I’ve only seen the abstract and I’m waiting for a copy of the full text. If there’s anything noteworthy, I’ll add an update to this post.

(* denotes an update to the original post)

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What would things look like if we believed they could recover?

Over the last week, there have been two noteworthy stories on supervised injection sites.

NYC planning supervised injection sites

The first story was in the New York Times and reported on NYC considering supervised injection sites and looking to Toronto for their experience.

The scouts from NYC are seeking to learn what they can to avoid quality of life problems:

The Toronto police are currently studying crime trends to figure out whether the quality-of-life issues have worsened because of the new facilities or from other factors like the general rise in drug overdoses in the city over the same period.

In Toronto, calls to 911 have risen near the biggest sites. “Public urination, public defecation, prostitution, sexual assault, robberies, noise, you name it, we’re hearing about it,” said Staff Superintendent Mario Di Tommaso of the Toronto Police Service. “And that’s all coming from the public.”

The Works, Toronto’s largest supervised injection site, sits just off the corner of Yonge-Dundas Square, the equivalent of Times Square in New York.
Indeed, groups of users, drugs in hand, are a common sight outside the biggest of these centers; many arrive before the doors open, some unable to wait to use inside.

For health officials, users and advocates, that underscores the need to have a place safe from overdose, or from worries about robbery while the drugs are taking effect. Several times in recent weeks, staff members had to revive people overdosing outside a center.

Number of references to recovery = zero.

Number of references to treatment = two (both weak references). One quote from a client saying treatment didn’t stick and describing opioids as the devil. The second just mentions that one of the injection sites also provides methadone.

The lack of attention to treatment and recovery leaves readers wondering whose quality of life they have in mind.

There are references to fatal overdose rates but it’s hard to know what to make of them:

In Toronto, the largest city in Canada, opening sites became a recent imperative: In 2013, there were 104 fatal opioid overdoses; in the first 10 months of 2017, there were 263, according to the latest data available from the city’s health department.

That’s an alarming increase, but fatal overdoses are increasing at alarming rates everywhere. The article does not provide context to evaluate the injection sites’ impact on overdose rates.

The sites are doing a lot of OD rescues and are using an approach that’s new to me.

There have been 123 overdoses through April, and most are brought back with oxygen. The goal is to treat the overdose without reversing the high — a result when naloxone is used — so that the user is not thrust into immediate withdrawal and a new search for drugs. Staff administered naloxone in fewer than a third of overdoses.

At Moss Park [another site], volunteers have reversed roughly 215 overdoses since August, usually with oxygen rather than naloxone, an overdose reversal medication; last week, a 36-year-old woman was brought back after overdosing on fentanyl.

Take the time to read the entire article.

Overdose-prevention sites set to grow in Vanvouver

The second article is in The Globe and Mail and describes the growth supervised injection sites in Vancouver, long identified as a model for the implementation of harm reduction services.

The article describes a grassroots program started in a tent.

In December, 2016 – the worst month on record for overdoses to date, with 162 dead – B.C.’s Ministry of Health not only gave Ms. Blyth’s overdose-prevention site a government stamp of approval, but ordered health authorities to open nearly 20 more across the province.

Ms. Blyth’s tent was replaced by a trailer the same month and began receiving funding from Vancouver Coastal Health. This past December, it moved indoors, into a storefront owned by BC Housing next door. The site maintains an outdoor tent for those who smoke their substances.

The overdose-prevention site has logged 180,437 visits since receiving government approval in December, 2016. During that period, there were 431 overdoses, 403 naloxone administrations and zero deaths. There have been an additional 60,000 visits by smokers since April, 2017.

In comparison, Insite, the first supervised-injection site set up in Vancouver, logged 175,464 visits in the 2017 calendar year. There was an average of 415 injection room visits a day, 2,151 overdose interventions and 3,708 clinical treatment interventions such as wound care.

I did notice that some sites were referred to as “overdose-prevention sites”, while others were referred to as “supervised-injection sites.” The article explains the distinction.

Overdose-prevention sites differ from supervised drug-use sites in that they are traditionally set up by volunteers through a quicker process as an emergency measure. Supervised drug-use sites tend to offer more robust services such as clinical care and counselling.

Number of references to treatment = zero.

Number of references to recovery = zero.

Low expectations?

These stories seemingly celebrate the expansion of these services.

When one considers the absence of any meaningful discussion of treatment, it’s hard for me to see these as as anything other than the “soft bigotry of low expectations.”

Of course, dead people don’t recover. That’s indisputably true. AND, severely ill people are very unlikely to recover without comprehensive treatment of adequate quality, intensity and duration.

What happens when we respond with compassion but without hope? What does that response do to the people suffering? What does it do to their loved ones? What effect does it have on the community?

We need to look beyond preventing death and look toward facilitating recovery by flooding these people with care of adequate quality, intensity and duration. In the context of this crisis, we need both/and approaches. As Scott Kellogg says, ” at some point you need to help build a life after you’ve saved one.”

About 10 years back, I proposed some organizing ideas for recovery oriented harm reduction.

I’ve been thinking about a model of recovery-oriented harm reduction that would address the historic failings of abstinence-oriented and harm reduction services. The idea is that it would provide recovery (for addicts only) as an organizing and unifying construct for treatment and harm reduction services. Admittedly, these judgments of the historic failings are my own and represent the perspective of a Midwestern U.S. recovery-oriented provider:

  • an emphasis on client choice–no coercion
  • all drug use is not addiction
  • addiction is an illness characterized by loss of control
  • for those with addiction, full recovery is the ideal outcome
  • the concept of recovery is inclusive — can include partial, serial, etc.
  • recovery is possible for any addict
  • all services should communicate hope for recovery–recognizing that hope-based interventions are essential for enhancing motivation to recover
  • incremental and radical change should be supported and affirmed
  • while incremental changes are validated and supported, they are not to be treated as an end-point
  • such a system would aggressively deal with countertransference–some people may impose their own recovery path on clients, others might enjoy vicarious nonconformity through clients

What would we do if patients were being revived by defibrillators and walking out of the emergency department a few hours later with a passive referral to treatment that has a long wait list?

This isn’t a matter of opposing life-saving measures, it’s a matter of expecting more. Just as we expect more than a defibrillator for people with cardiac disease. The defibrillator is life saving first aid, and we all expect that everyone whose life is saved by a defibrillator gets comprehensive cardiac care of adequate quality. intensity and duration.

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Why is fentanyl use becoming widespread now?

Mark Kleiman responds to the question, why is fentanyl use becoming widespread now?

He describes the increase in availability of prescription opioids and the role of price in leading users to transition to heroin. Then, he describes the expansion of fentanyl.

At the same time, people in the U.S. were learning how to buy chemicals unavailable here – banned drugs, cheap unbranded pharmaceuticals, Human Growth Hormone, you name it – by mail-order from illicit or quasi-licit outfits in China, ordering over the Internet (and, when law enforcement made that dangerous, over the “Dark Web”) often paying in cryptocurrencies. Instead of using complicated smuggling schemes, sellers simply put these products in the mail; for about $20, you can get a package of up to four pounds mailed from China to New York.

It didn’t take long for some of those Chinese outfits to start making fentanyl; unlike heroin dealers, they didn’t need a source of opium. The chemistry involved isn’t especially challenging (not, for example, like making LSD). Fifty grams of fentanyl – an ounce and a half – has the potency of a kilogram of heroin, and it’s way, way cheaper.

He also describes how technology has affected dealing illegal drugs, producing significant gains in efficiency and reductions in risk.

But with mobile phones, texting, and social media, transactions can now be arranged electronically and completed by home delivery, reducing the buyer’s risk and travel time to near zero and even his waiting time to minimal levels. In the recent Global Survey on Drugs, cocaine users around the world reported, that their most recent cocaine order was delivered in less time, on average, than their most recent pizza order.

These efficiency gains and risk reduction provide even more downward pressure on prices. They also create new difficulties for enforcement and supply reduction.

Unfortunately, Kleiman paints a very grim picture, suggesting that we’ll have to wait for the crisis to burn itself out.

It’s worth keeping in mind that Kleiman’s expertise is in criminal justice policy, not treatment and recovery.

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Recovery is good buiness

CNN Money has a pretty inspiring story:

This past winter, John Stroup had a problem.

Roughly one out of 10 applicants for jobs at his factory in Richmond, Indiana, had failed their drug tests, disqualifying them for employment at the safety-conscious company. A handful of the 450 people already working there had failed random drug tests as well.

. . .

After a few meetings with board members and addiction experts, he came up with a plan. If an applicant or a current employee failed a drug test, but they still wanted the job, Belden would pay for an evaluation at a local substance abuse treatment center.

People deemed to have a low risk of developing an addiction could spend two months in a non-dangerous job before they are allowed to operate heavy equipment again, as long as they passed periodic random drug tests for the rest of their time at the company.

People at high risk would spend two months in an intensive outpatient monitoring and treatment program, with the promise of a job at the end if they made sufficient progress. On average, Belden figured it would have to shell out about $5,000 for each person it gave a second chance to.

If these workers get good care and achieve stable recovery, how hard working and loyal do you think they’ll be?

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“Legalize Pot, But Don’t Normalize It”

A typically thought provoking take from Tyler Cowan:

I propose that cities and suburbs restrict the sale and usage of marijuana to the same areas we use for garbage disposal and other “zoned out of sight” enterprises. We needn’t throw anyone in jail: If people or businesses violate these strictures, keep hitting them with the equivalent of parking tickets or injunctions, much as you would for an out-of-place repair shop.

It should be possible to visit Colorado without knowing that marijuana is legal there. If someone is determined to ingest it, they can either drive to an industrial zone or order it online, and smoke it at home or up away in the mountains.

You might wonder why we should be so worried about public marijuana use. To put it bluntly, I see intelligence as one of the ultimate scarcities when it comes to making the world a better place, and smoking marijuana does not make people smarter.

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The treatment hustle makes Last Week Tonight

This weekend, John Oliver spent nearly 2o minutes describing several of the treatment industry’s biggest hustles.

CaptureIs this a sign of the times?

Maybe, but it’s not new.

In Recovery Rising, Bill White describes the business landscape in the 1980s:

The trend of private insurance companies paying for the treatment of alcoholism and subsequently other addictions unleashed an unprecedented wave of institutional profiteering. In addition to the proliferation of addiction treatment units in hospitals, private, free-standing treatment programs grew at record pace in the 1980s. It was a predator’s ball. People with little knowledge of addiction recovery entered the business of addiction treatment as an investment to make money and sucked every dollar possible out of these new businesses. The operational assessment philosophy was, “If you have the insurance, you have the disease.” The admonition to staff was, “If you can’t find it (substance use disorder diagnosis), you haven’t looked hard enough.” Inappropriate admissions and re-admissions, inappropriate lengths of stay, inadequate treatment, and insufficient post-treatment monitoring and support (the latter not reimbursed by insurance companies) were pervasive. It was only a question of time before it would all collapse. And when it did, it was once again those suffering from alcohol and other drug problems, their families, and local communities who were most injured.

In another paper, he described the scene at the beginning of the 20th century:

The field’s public reputation had been wounded by highly publicized breaches of ethical conduct. Newspaper exposés charged incompetence and fraud
in the field’s clinical and business practices. Allegations abounded of inadequate care, patient abuses, sleazy marketing practices, and the financial exploitation of patients and families. Muckraking investigations of the bottled addiction “cures” exposed products secretly loaded with alcohol, opium, morphine, and cocaine.

Bill ended that paper with the following thoughts:

We must both aggressively monitor the ecosystem within which we operate and take a more activist role within that ecosystem. We must get ourselves clinically and ethically re-centered. We must take a highly splintered field and find a way to speak with one voice. And we must rebirth a new generation of leaders who can carry our mission of serving the still suffering addict into the 21st century. If we fail to meet these challenges, we may be doomed to repeat an episode in history little known to today’s providers of addiction treatment. And that lack of knowledge is perhaps itself a source of great vulnerability. As the great comedic scholar Lily Tomlin once suggested, “Maybe if we listened, history wouldn’t keep repeating itself.”

Those words were written in 1999, after the field had collapsed from the 1980s boom. They are probably more important today than they were then.

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Blue Care Network of Michigan tests new opioid treatment with 2 mental health facilities

Why is BCN launching these pilots?

“Cost is one factor. We also look at quality of life. Our goal is to help people stay well,” said Beecroft, a psychiatrist, geriatrician and substance abuse specialist. “We have looked at return on investment and if you just treat the individual, you get 2-1 investment return. You spend $10,000 on treatment, and the overall medical spend return is $20,000.”

“Quality of life”? That’s very encouraging, but I’m a naturally skeptical sort.

Let’s see what they are planning.

Beecroft said Blue Care came up with the CLIMB program. CLIMB stands for community-based, life-changing, individualize, medically assigned and evidenced-based treatment. It is intended to add several components to how Maplegrove and Pine Rest treat opioid abuse patients. He said there will be more attention to post-acute care treatment and follow-up.

“We will be looking at how best to use recovery coaches, case managers from the plan, visiting and social workers to the home,” he said.

Bulat said she and other addiction specialist experts help Blue Care refine its CLIMB program. “They have the pilot now to track and see what we are doing to encourage others (providers) to do the same,” she said.

That kind of long-term and person-in-environment approach sounds like it could be a very good thing.

Hats off to Dr. Bulat (a friend of the Farm), BCN and Maplegrove. I wish them success.

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