Something Great Happened Today

 

 

 

 

Today we admitted a young man to our opioid treatment program who was referred from a Big City Hospital, where he was started on buprenorphine/naloxone. Everything happened exactly like it should, and the patient got excellent care. This should happen everywhere.

This patient went to the emergency department at Big City Hospital at the urging of his family, who recently discovered he had opioid use disorder. They were worried about him and convinced him to seek help at the hospital close to them, BCH.

Big City Hospital admitted him for detoxification and started him on a low dose of a buprenorphine product. Over the four days that they kept him, they slowly increased his dosage to a total of 8mg per day. At that dose, his withdrawal symptoms resolved, and he had no cravings to use illicit opioids. BCH also drew blood from him, and he tested negative for infectious diseases and other medical problems.

Once he was stable, the social worker at Big City Hospital needed to find a program or provider  his community that could take over his care. As it happened, he wanted to move away from where he’d been living. He feared his friends, with whom he’d using drugs, could lead him to relapse back to drug use. He decided to move in with some supportive relatives, who happen to live near our opioid treatment program. The social worker called our program and arranged an appointment for admission for the day after he was to leave BCH.

BCH gave him a dose the afternoon he was discharged from their hospital, and he kept his appointment with our program early the next morning. He was just starting to feel a little withdrawal from his last dose of buprenorphine. Big City Hospital had already faxed his records to us, so those were available for me to review.

He was a nice young man from a good family who had fallen, as so many have, into opioid use disorder before he knew what was happening. He had a strong desire to change his life and leave his addiction behind. We continued his dose of buprenorphine products, and started intensive counseling right away.

I’m so happy that appropriate treatment was offered to this young man at the time he reached out for help. He was admitted, started on treatment and then transferred to us without any gap in treatment. A successful inpatient treatment episode flowed seamlessly into our outpatient program, without relapse and without the patient being forced back into withdrawal.

All worked as it should. It’s not that hard.

So how can a large hospital nearly a hundred miles away refer a patient to us but we don’t get referrals from our local hospital a few miles away?

My answer is that though our local hospital is close in miles, it’s far away in its ideology about the role of buprenorphine and methadone in the treatment of patients with opioid use disorder.

However, there’s reason to hope that this is changing.

A few weeks ago, I was asked to come to the hospital to give a presentation of opioid use disorder and its treatment with medication for nursing personnel. I was thrilled. Our program director and clinical director were thrilled. We scheduled a “Lunch ‘N Learn” for noon, with the hospital graciously furnishing the food.

I was surprised and pleased when a room full of people showed up for my talk. The head of pharmacy was there, who has always supported MAT, with a few pharmacy students. None of the staff nurses were there, but nursing supervisors were, and some people from our local mental health agency, who just got a grant to care for pregnant ladies on MAT. We had the director of the local health department, who has always been supportive, and many other people. Two doctors and at least two physician assistants were there too.

I gave my usual 50-minute presentation, and the audience asked great questions when I was done. Then, to drive the message home, we had a former patient tell her story of life on methadone, off methadone, and now back on methadone. She has that gift of speaking from the heart, and I think she helped inform audience members more than anything I could have said.

I wanted to get copies of TIP 63 to pass out to all people in the audience, but it was bad timing – TIP 63 wasn’t available because it’s being re-done. I like to give people TIP 63 because when they challenge me on this point or that, it contains all the pertinent studies supporting what I say about MAT.

One audience member appeared to disapprove of starting pregnant patients with opioid use disorder on methadone or buprenorphine. She claimed that all babies born to moms taking these medications had withdrawal when born, and that the withdrawal lasts for many months. I tried to describe the results of the MOTHER trial, done right here in North Carolina, since it was one of the most recent landmark studies.  It showed that around 50% of babies born to moms on buprenorphine or methadone have withdrawal bad enough to need medication, and that babies born to moms on buprenorphine had much less severe withdrawal and stayed in the hospital about half as long as babies born to moms on methadone.

I did not get through to her. I sensed she relied much more on her own perceptions and experiences than on data from research studies done on hundreds of patients.

Despite that disagreement, I thought the event was a great success.

Now we are asking to come back and do another presentation for the staff nurses.

We’ll keep trying. Someday I hope to see a local patient who arrives in our local hospital’s emergency department, gets diagnosed with opioid use disorder, is treated in a respectful and compassionate way, gets started on buprenorphine and then gets referred to our opioid treatment program (or other MAT program) right away.

I’d like to see a Big City response to our rural crisis.

Continuum of Care for Opioid Use Disorder

 

 

 

 

 

 

“Continuum of care is a concept involving an integrated system of care that guides and tracks patient over time through a comprehensive array of health services spanning all levels of intensity of care.” (Evashwick, 1989)

Continuum of care isn’t a new concept. It’s a pattern of care that we use to treat patients with all sorts of chronic medical illnesses. For mild forms of a chronic illness, primary care providers manage patients’ illnesses. For more severe forms of the same illness, patients are referred to specialists, with more experience and training in that area of medicine. Ideally these shared patients flow back and forth between specialists and primary care providers as needed based on the severity of illness as it may fluctuate over time.

We ought to apply this same concept for the management of opioid use disorder. It’s a chronic illness which can have exacerbations and remissions over time, just like diabetes and asthma.

I try to follow this concept at the opioid treatment program where I work. Patients new to treatment often are ill, not only from the drug use, but also from neglected physical and mental health issues. They need more intense care. An opioid treatment program offers more structure and supervision than an office-based practice, so it’s a level of care that’s appropriate for such patients.

At the opioid treatment program, we can do daily observed dosing, to make sure patients take the dose I prescribe. We assess the adequacy of the dose by asking about withdrawal symptoms and observing withdrawal physical signs. We can monitor for side effects. We can do frequent drug screens, to provide information about the proper level of counseling needed. Counseling, both group and individual, are built into the system at opioid treatment programs.

At the other end of the spectrum, stable patients with years of recovery in medication-assisted treatment need less care. We still need to monitor for relapses, but they usually don’t need as much counseling, and no longer require observed dosing. They need the freedom that office-based practices provide.

Stable patients on methadone get more take home doses, but opioid treatment programs are their only option for treatment setting. Stable patients on methadone can’t get their treatment in primary care settings. It’s illegal for office-based physicians to prescribe methadone for the purpose of treating opioid use disorder. Primary care doctors can prescribe methadone to treat pain, but not if the patient also has opioid use disorder.

It’s different for patients on buprenorphine (Suboxone, Subutex, Zubsolv, Bunavail). Since 2000, it’s been legal to prescribe this medication from office-based settings for patients with opioid use disorder.

But that doesn’t mean this is the right setting for all patients with opioid use disorder.

I have an advantage, since I see patients in both settings, both opioid treatment program and an office-based practice. I have the luxury of being able to treat new patients in the opioid treatment program, and after they stabilize, talk to them about transitioning to the office-based practice. If a patient encounters a rough patch, I can ask them to return to the opioid treatment program for more intense treatment until they again stabilize.

I can use the same concept as used with other chronic medical illnesses.

Sometimes a new patient can safely be treated in an office-based program. This all depends on individual patient circumstances. One patient may have a fantastic support system at home, while another may have to put up with active drug use in his home. Obviously, the latter patient needs more support from treatment staff.

Sometimes patients on buprenorphine aren’t appropriate for office-based treatment, even after months of treatment.

Unfortunately, most patients with opioid use disorder aren’t placed in a treatment setting based on their needs. Most patients end up in whatever facility they enter for the duration of their treatment, which may not be the best thing for the patients.

It’s rare for an office-based practice to refer their patients who are struggling to opioid treatment programs. Many office-based providers, enthusiastic about treating patients with opioid use disorder, still regard opioid treatment programs with great suspicion. It’s partly due to lack of knowledge about OTPs. It’s also partly due to that old bugaboo that blocks so much of appropriate treatment for people with substance abuse disorders: stigma. Some providers believe all sorts of outlandish things about what takes place at opioid treatment programs.

It’s painful to admit, but some providers’ opinions are formed based on the actions of poorly run opioid treatment programs. Some opioid treatment programs provide little more than daily dosing of medication. In our business, those programs are referred to derisively as “juice bars,” meaning patients get a daily dose of methadone, which looks like red juice, and little more.

These programs taint the reputation of good opioid treatment programs which offer an array of services all meant to help the patient. This is a real shame.

So, what about me? Do I refer stable buprenorphine patients at our opioid treatment program to other office-based buprenorphine practices? Well…not so often.

I know plenty of excellent office-based buprenorphine providers across the state who are diligent and painstaking about the care they deliver. And I know some providers in my area who don’t meet that standard. I’m hesitant to refer to them.

For example, one nearby provider charts extensive patient visits. These notes include everything from history of present illness, complete review of systems, and complete physical exam for each visit. Yet I was troubled about how similar each visit was, and suspected there was a whole lot of “cut and paste” going on, and that the charted care wasn’t actually being delivered.

Recently a patient transferred from this practice back to me, at the opioid treatment program, for purely financial reasons. We requested a copy of her charts, as we do for all patients who have been seeing other practitioners. This is good medical practice, even if it hasn’t been all that helpful with this particular provider in the past.

I was reading the records, and was confused. I read in the exam section of her last visit, “Abdomen consistent with eight month pregnancy.”

How had I missed this, I thought. I’m no obstetrician, but even I should pick up an advanced pregnancy on exam.

I slid my eyes back to the patient, sitting on a chair near the corner of my desk. Her abdomen looked flat.

“Um, so…are you pregnant?”

“No! Why?”

“Well you don’t look pregnant,” I added, not wishing to offend her. “It’s just that this last note says you’re eight months pregnant.”

She sighed and rolled her eyes. “The baby is seventeen months old. I guess they just never changed it in my chart.”

I looked back at each note. Sure enough, the exams for each date all read, “Abdomen consistent with eight month pregnancy.” For many months. Clearly, this was cut and paste charting. It’s not quality care, and may be illegal if the provider charged for services not delivered.

This confirmed my worst suspicions about the level of care provided at that practice, so I don’t think I will be referring patients to them.

In this country, we do have obstacles to providing a continuum of care for patients with opioid use disorders. We have some office-based practices that aren’t well-run and have little oversight. We have substandard opioid treatment programs providing little more than medication dosing, and we have undeserved stigma against opioid treatment programs that have been providing quality care for many years.

In fact, opioid use disorder may have the least organized continuum of care of all chronic diseases.

What’s the answer? Better communication and better education among medical providers.

I’m doing my part.

I go to many conferences, to learn the latest data and standards in my field. I also meet other providers at these conferences, even though by nature I’m a bit of a recluse. I’ve given talks, both to community groups and at medical meetings, to do my part to pass on what I know. I don’t enjoy public speaking, but find that once I get involved in my topic, I lose my fears.

All providers of care for people with opioid use disorders need to do this – we must meet each other, talk to each other, and learn from each other.

Here are a few wonderful opportunities to interact and learn:

ASAM conferences: the American Society of Addiction Medicine holds several conferences per year at the national level, and these are excellent for learning and meeting the leaders in the field. You can read more at their web site: www.asam.org

 

In my state of North Carolina, you can get some valuable information from the Governor’s Institute, at https://governorsinstitute.org/ and also their blog: http://www.sa4docs.org/

You can attend webinars, get clinical tools, and obtain mentoring from the Providers’ Clinical Support System MAT, at https://pcssmat.org/

If you are a provider in North Carolina and want CME hours while you teleconference with peers and mentors, you can participate in the UNC ECHO project. You can read more about that here: https://uncnews.unc.edu/2017/02/15/unc-chapel-hill-initiative-will-combat-opioid-use-disorders-overdose-deaths/

Write to me if you want to participate and I can forward you to the people that can make that happen.

Media Maintains Methadone is Menacing Mountains

 

NEWS CAT

Last week, a colleague of mine directed my attention to local news coverage of the opioid use disorder epidemic. It’s a four-part series titled “Paths to Recovery.”

Anytime the press covers opioid use disorder and its treatments, I feel hope and dread. I hope the report will be fair and unbiased, and give the public much-needed information. And I dread the more likely stigmatization and perpetuation of tired stereotypes about methadone as a treatment for opioid use disorder.

Overall, the four segments of this news report had some good parts, and some biased parts. It was not a particularly well-done series, and could have benefitted from better editing. It was disjointed and contained non-sequiturs, which I suspect confused viewers.

In the introduction to the first segment, the report says their investigators have spent months digging into treatment options in the area. Their conclusion: there’s a variety of options and treatment is not one-size-fits-all. The report goes on to give statistics about how bad the opioid use disorder situation has become, and they interviewed a treatment worker who says we’re two years in to this, and the community doesn’t grasp the seriousness of the situation. They also interviewed some harm reduction workers, and discussed naloxone rescue for overdoses and needle exchange.

So far, so good, except that of course we are more like two decades into the opioid crisis, not two years.

Part two of this series was “Mountain methadone clinics.” As soon as I saw the dreadful alliteration, I cringed, fearing the content of the segment.

This report didn’t say good things about methadone. In fact, one physician, supposedly the medical director of a new opioid treatment program in the area, says on camera, “Methadone is very dangerous. It has some effects on the heart. The rhythm of the heart, it has some drug interactions.” He went on to say that at the right dose, people could feel normal, and that it replaced the endorphins that were lacking, but I worry people will remember only that a doctor said methadone was a very dangerous drug.

Methadone can be dangerous, if you don’t know how to prescribe it, or if you give a person with opioid use disorder unfettered access to methadone. But in the hands of a skilled and experienced physician, at an opioid treatment program with observed dosing, methadone can be life-saving.

The news report outlined the failings of existing methadone programs in the area, saying staff had inadequate training, and failed to provide enough counseling for patients. It said one program made a dosing error and killed a patient, while another program had excessive lab errors.

All of that sounds very bad.

No positive aspects were presented as a counterpoint to that bleak picture. I felt myself yearning for an interview with a patient on methadone who has gotten his family back, works every day, and is leading a happy and productive life. Of course, those people are hard to find, since they are at work and harder to find by the media, even reporters who have supposedly been “working for months” on this story.

And then…of course they interviewed patients who had misused methadone. One person criticized his opioid treatment program because they allowed him to increase his dose to 160mg per day, and he said “…that’s a lot. I didn’t need that much…” and goes on to admitting to selling his take home medication. Another patient said the methadone made him “sleep all the time.” Another patient said methadone made him “high all the time.”

There will always be such patients…ready to lie to treatment providers to get more medication than needed, break the law by selling that medication, and then blame it all on the people trying to help them. Unable to see their own errors, they blame it all on someone else, or on the evil drug methadone.

Every program has such patients. But these people can also be helped, if they can safely be retained in treatment long enough, and get enough counseling.

Even though these patients are few, they get far more media attention compared to the many patients who want help and are willing to abide by the multitude of rules and regulations laid on opioid treatment programs by state and federal authorities. These latter patients are why I love my job. I see them get their lives back while on methadone. They become the moms and dads that they want to be. They go back to school. They get good jobs and they live normal lives. They don’t “sleep all the time,” as the patients on this report said.

But not one such patient was interviewed for this report.

As I watched this segment, I thought back to an interview the A. T. Forum did with Dr. Vincent Dole, one of the original researchers to study methadone for the treatment of opioid use disorders. This was in 1996, before our present opioid crisis gained momentum.

A.T. FORUM: It seems that, over the years, methadone has been more thoroughly researched and written about than almost any other medication; yet, it’s still not completely accepted. How do you feel about that?

1. VINCENT DOLE:It’s an extraordinary phenomenon and it has come to me as a surprise. From the beginning of our research with methadone we were able to rehabilitate otherwise hopeless addicts that had been through all of the other treatments available. I expected methadone would be taken up very carefully by the addiction treatment community, but with some enthusiasm. Instead of that, we’ve had endless moral and other types of objections which are really irrelevant to the scientific data.

I was surprised, because my background in research had led me to expect that the medical community was a very critical but nonetheless objective group that would respond to solid, reproducible data. Instead I find that we still get the anti-methadone argument of substituting one addictive drug for another.

This is ignoring the scientific data showing that, as a result of methadone treatment, people who have been hopelessly addicted and anti-social and excluded from any normal life or family, are in a wonderful way becoming responsive to social rehabilitation and today constitute a very large number of people who are living normal lives. The fact that people, especially medical practitioners, would dismiss that as unimportant simply staggers me!

[http://atforum.com/interview-dr-vincent-dole-methadone-next-30-years ]

 

What would Dr. Dole think now, twenty more years later, during a terrible wave of death from opioid use disorders, about the continued stigmatization of methadone?

Then next segment was about buprenorphine, and how it can be prescribed in a doctor’s office, making it a better choice for patients. It wasn’t a bad segment, and contained some useful information. Physicians who were interviewed had nothing but good things to say about buprenorphine.

Or rather, they had good things to say about Suboxone.

The brand Suboxone was heavily promoted by this piece. Not once did the reporter use the drug’s generic name, buprenorphine. Every time, the medication was called by its brand name, Suboxone, and every picture of the medication was of Suboxone film. No mention was made of the other brands: Zubsolv, Bunavail, Probuphine, or even that there are generic combination buprenorphine/naloxone equivalents for Suboxone film, for less than half the price.

I know buprenorphine is kind of a mouthful for non-medical reporters, but still, I thought it was odd to use only the name of one brand: Suboxone. It’s as if this was a commercial for that drug company. Indivior, the manufacturer of Suboxone, must be delighted with this coverage. To me, it felt like an advertisement rather than journalism.

Another segment was about sober recovery homes. The investigative reporter talked to owners of sober recovery houses and the tenants at those homes. She said NC has no regulations or standards for recovery homes. She talked on screen to a patient advocate who says patient brokering is going on in Asheville, as well as lab scams at recovery homes where the patients’ best interests aren’t at the heart of the way these homes function.

She talked to Josh Stein, NC Attorney General, about passing laws to better regulate these sober homes, and he agreed that if these laws were needed, they should be passed.

No controversy with that one.

There was a segment about how there’s not enough beds in residential facilities for patients with opioid use disorder who want help. I agree, though I’m not sure this is breaking news for anyone. I don’t think there’s ever been enough beds to meet the treatment need.

Overall, I was left with a bitter taste after this reportage. The news program missed an opportunity to educate viewers about all evidence-based treatments for opioid use disorder, but ended up doing an advertisement for Suboxone and denigrating methadone.

Buprenorphine and methadone both work under the same principle: they are long-acting opioids which, when dosed properly, prevent withdrawal and craving while also blocking illicit opioids. While buprenorphine is a safer drug with fewer drug interactions, it isn’t strong enough for everyone. Methadone has countless studies to support its use to treat opioid use disorder, showing it reduces death, increases employment, decreases crime… but why go on, since facts don’t seem to matter as much as sound bites.

In my opinion, WLOS bungled an opportunity.

Bad Science: “Miracle” Cures for Addiction

 

 

Addiction is hard to treat. Like other chronic illnesses, relapses are common, and frustrating to both the patient and the family. Substance use disorders cause considerable disability and even death. Treatments do help many people, especially medication-assisted treatment for opioid use disorder, but still aren’t as successful as we’d like.

Scoundrels looking to make a quick buck often prey on patients with diseases that are difficult to treat, like cancer, multiple sclerosis, substance use disorders, and the like. Sometimes bogus treatments have no basis in science at all. Sometimes minimally helpful treatments are touted as being more successful than science shows that they are. In all these cases, bad science is used to cover questionable, usually financial, motives.

I hate bad science. For the purposes of this blog post, I’m defining bad science as when people attempt to give their treatment, or method, or viewpoint, a sheen of scientific validity by using or misusing data, or by having no relevant data at all.

Some examples are more outrageous than others, and bad science has been used for decades.

Charles B. Towns, together with Dr. Alexander Lambert, declared the Towns-Lambert cure for alcohol and drug addiction to be 90% effective. The Towns-Lambert cure was a mixture of belladonna, hyoscyamine, and herb called prickly ash, castor oil, and mercury. Patients were also given chloral hydrate, a sedative similar to a barbiturate, along with morphine and paraldehyde. It fact, it was while he was a patient in Towns’ New York hospital that Bill Wilson, co-founder of Alcoholics Anonymous, had his vision that lead to his spiritual awakening, which in turn lead to the formulation of the Twelve Step program of AA.

Eventually, the number of repeat patients undermined claims of the cure rates of the Towns-Lambert method. Despite his lack of evidence, Towns’ claims became ever more extravagant, leading Dr. Lambert eventually to disassociate himself from Townes. Eventually, the Towns cure was discredited and disappeared.

This wasn’t the first treatment with better marketing than science, and it certainly wasn’t the last.

I had the displeasure of seeing a product being promoted at a recent conference I attended. This device, and I’m not going to give the name since I don’t want to give the promoter any free publicity, generates electrical pulses to the head. Three electrodes are placed just under the skin, and the device is worn for five days while the patient receives intermittent electrical stimulation. This supposedly gets rid of opioid withdrawal symptoms.

The person peddling this new invention shot himself in the foot in my view as soon as he said this device worked 100% of the time. When I asked for studies which had been published in peer-reviewed journals, he said they had loads of studies. Sadly, none were yet published that had been done in humans. He did have human data, but it wasn’t published yet, since an IRB (internal review board) hadn’t approved the study design before they undertook the study, so they had to find someone to approve the study after it was done.

Huh? No, that’s not the way review boards work. Review boards review studies before they are done, to assure no patient will be put in danger needlessly. I’ve never heard of a post-study review board.

So anyway, their human data hadn’t yet been published.

I hinted (oh OK, I came right out and said it) that perhaps it was a bit unethical to promote and expensive treatment ($500, not covered by insurance) unless they had human data, approved and reviewed by the research community, showing efficacy. The promoter of the item countered by saying it was unethical NOT to provide this device, given the benefit it provides.

He didn’t understand that my objection was to the lack of scientific process that all new treatments should undergo, to show they are of at least some benefit prior to use in clinical practice. This should be done before the treatment is marketed. But he pointed to all the success stories on their website, testimonials by patients of how effective this treatment was at preventing opioid withdrawal.

These testimonials are called anecdotal data in the scientific community. Anecdotal data isn’t nothing. It is a type of information that can suggest a potential effective treatment. But anecdotal data alone isn’t sufficient to claim efficacy. It’s only a potential starting point.

People tend to give testimonial type of anecdotal information more credence than they deserve. Hearing a story of miraculous healing touches our hearts. If we are also desperate for a similar cure, we risk making emotional decisions rather than rational ones.

I wasn’t trying to tell this salesman his product didn’t work. For all I know it will be the greatest breakthrough in addiction medicine in the last one hundred years. What I’m saying is that we don’t yet know if it works, because it hasn’t yet been properly tested. And therefore, I thought it was unethical to sell it before testing it.

Does anyone remember Prometa? It was all the rage ten years ago. News articles asked if it was the big breakthrough in addiction treatment. Anecdotal stories from former methamphetamine addicts were heart-warming. The company that supplies Prometa, Hythiam, was created by a former junk bond salesman, which could have been a red flag. That salesman heavily promoted Prometa with the anecdotal stories from addicts who had lost everything but were now drug free and happy.

The medications that made up Prometa are hydroxyzine (an antihistamine with sedating properties), gabapentin (an anti-seizure medication also used for neuropathy) and flumazenil ( a benzodiazepine antagonist). All three are FDA approved for uses other than addiction, but the proprietary combination of these made up Prometa, and it was sold as an addiction treatment cure without FDA approval. This is perfectly legal, by the way.

One drug treatment court, in Tacoma, Washington, paid $400,000 to buy Prometa for its participants. When it was discovered that several of the people making decisions for the drug court also owned stock in Hythiam, it left some people believing there was a conflict of interest. And after results from that drug treatment court were available, Prometa performed no better than traditional (and much cheaper!) treatments. [1]

Ten years later, I rarely hear the word Prometa. Hythiam changed its name to Catasys. Dr. Walter Ling, a very respected scientist in the addiction treatment world, completed a double-blind placebo-controlled studies showed Prometa to be no more effective than placebo.

But all this happened after that former junk bond trader made up to $15,000 for every Prometa patient treated. All those patients and their families were disappointed by another treatment that promised much and delivered nothing better than placebo.

I think it’s unethical for a company to bring a product to market before there’s adequate science to prove that it works. This rather rigorous process is what makes a product or procedure or methadone evidence-based.

Until you’ve got something that’s evidence-based, please don’t waste my time by trying to sell it to me.

When the marketing of a medication outpaces the research supporting it, watch out. We are in snake oil territory.

If a salesman blathers about how good his product is, but can’t hand you a good study published in a peer-reviewed journal, beware. With science, you’re supposed to do the studies first, then present at a conference of your peers, or in a peer-reviewed journal. The data should be able to be replicated by other facilities before we can see it is an evidence-based treatment. Barring that, it’s only a possible treatment among many possible treatments.

1. “Prescription for Addiction,” 60 Minutes, CBS News, December 9, 2007 http://www.cbsnews.com/news/prescription-for-addiction/3/
2. Ling et. al., “Double-blind placebo-controlled evaluation of the PROMETA program,” Addiction, 2012 Feb;107(2):361-9

Opioid Addiction in Pregnancy: More Information about the Use of Methadone Versus Buprenorphine

The MOTHER (Maternal Opioid Treatment: Human Experimental Research) trial of 2012 (Jones et al) gave us much-needed information about how buprenorphine compares to methadone when used to treat opioid-addicted pregnant women. This landmark study showed us buprenorphine can be just as effective as methadone. Babies born to moms on buprenorphine had the same incidence of opioid withdrawal (called neonatal abstinence syndrome, or NAS) at 50%, but the withdrawal was significantly less severe, the babies required about half the medication as the babies born to moms on methadone. Also, buprenorphine-exposed babies spent significantly less time in the hospital – about half as long as methadone-exposed infants.

Some doctors point out that more women on buprenorphine dropped out of that study than women on methadone, and say that proves buprenorphine is less effective. However, the majority of those women didn’t leave treatment; they just left the buprenorphine arm of the study.

This week I read another study, by Meyer et al, soon to be published in the Journal of Addiction Medicine. This study also looked at pregnant patients being treated for opioid addiction.

The authors of this new study pointed out that the MOTHER trial was a placebo- controlled, double- blind study comparing buprenorphine with methadone, but in real life, the decision to start an opioid-addicted pregnant woman on buprenorphine versus methadone is more complex, and determined by other factors. So the study by Meyer et al did a retrospective analysis. They looked at cases where the choice of buprenorphine versus methadone was made by the patient and physician, as happens in real life, then studied the outcomes. The authors of the new study believed findings will be more pertinent to what happens in everyday clinical practice.

In this retrospective cohort study, 609 pregnant patients were started on either buprenorphine (361) or methadone (248). This study took place over the years from 2000 to 2012 at a single site, University of Vermont.

The study collected various data about the newborns: their sex, estimate gestational age at delivery, birth weight, head circumference, length of stay in the hospital, whether the baby received breast milk, and if the child was sent home with the mother. The study also looked at if the newborn has NAS and if the baby needed medication, and length NAS treatment.

In the results, first-time mothers were significantly more likely to start buprenorphine than methadone. Mothers positive for Hepatitis C were more likely to be started on methadone. In both groups, more than 80% of the moms were smokers. About 30% of both groups had to have a C-section at delivery.

Both groups had similar prenatal care; more than 65% of the mother in both groups initiated care within the first trimester. However, women in the buprenorphine group were significantly more likely to get what the authors defined as “adequate” prenatal care. Women on buprenorphine were also more likely to already be in treatment when they became pregnant, compared to the women in the methadone group.

Nineteen women switched from buprenorphine to methadone, out of the three-hundred and sixty-one women who started on buprenorphine. Only five of those patients switched because buprenorphine was not strong enough for them, or other medication side effects. Most were switched to methadone because they needed more intensive monitoring at an opioid treatment program due to continued positive urine drug screens. Only three women out of the three-hundred and sixty-one started on buprenorphine dropped out and were lost from treatment.

No women were switched from methadone to buprenorphine, as one would expect. That’s because in order to switch from a full opioid, methadone, to a partial opioid, buprenorphine, the pregnant opioid addict would have to go into at least mild withdrawal, thus putting her at risk for adverse events. That’s not a risk most doctors are willing to consider.

Babies born to moms on buprenorphine, as compared to methadone, were significantly more likely to have longer gestational age. This is a good thing, because it means there were significantly fewer preterm deliveries on buprenorphine compared to methadone. The babies born to moms on buprenorphine were significantly more likely to have higher birth weights and bigger head circumference.

Just like what we saw in the MOTHER trial, this study also showed that the infants born to moms on buprenorphine required significantly less medication to treat neonatal abstinence syndrome. The buprenorphine-exposed babies required medication for a significantly shorter time than methadone-exposed newborns.

More than 95% of the infants were sent home in the care of the mother or family, which makes me think this study was done on women with fairly good stability at the time of delivery.

The authors of the study concluded that this evidence suggests that buprenorphine gives outcomes that are at least as good as with methadone.

I’d take that conclusion one step farther and say we now have several studies that show less neonatal withdrawal in babies exposed prenatally to buprenorphine compared to methadone. I have to ask myself: knowing what I do from these studies, which medication would I want to take during pregnancy? I’d prefer buprenorphine, and if it didn’t work for any reason, I’d switch to methadone.

I explain all of this to pregnant patients with opioid addiction upon admission, though I’m careful to also point out that methadone is still officially the gold standard in many places.

I think that will change soon. We are getting more information that shows outcomes equal to methadone with less severe neonatal withdrawal.

The Benzodiazepine Dilemma: New Guidelines for Opioid Treatment Programs from IRETA

I’ve written about benzodiazepines before in this blog (See my post of November 3, 2012). I worry about overdose deaths and other complications in patients for whom I prescribe methadone who are also taking benzodiazepines, prescribed or illicit.

Now doctors at OTPs have help from the Institute for Research, Education and Training in Addiction (IRETA). This well-respected organization located in Pittsburgh, Pennsylvania just issued an evidence-based document titled, “Management of Benzodiazepines in Medication-Assisted Treatment.” You can access this document at IRETA’s website: http://ireta.org/

I love IRETA for tackling this subject. There’s much misinformation about the use of benzodiazepines, even for patients without addiction. But for patients with addiction, benzodiazepines can be deadly when combined with opioids including methadone and buprenorphine.

IRETA’s document first describes how and why these guidelines were created. Opioid treatment programs often have patients who also use benzodiazepines, both by prescription and illicitly. Physicians at OTPs have widely varying responses to these patients. Some programs have zero tolerance, meaning they won’t allow anyone on benzodiazepines to be in their opioid treatment program. Other physicians at OTPs actually prescribe benzodiazepines for their patients when they feel it’s clinically indicated. IRETA wanted to delve into actual scientific literature and consult a panel of experts for interpretation of that data. This IRETA document describes in detail how the literature search was done. It also goes into exhaustive detail about how each statement in the set of guidelines was vetted by experts.

This paper’s guidelines fall into seven categories:

General guidelines
Assessment for MAT
Addressing benzodiazepine use
MAT for patients with concurrent benzodiazepine use
Noncompliance with treatment agreement
Risk management/Impairment assessment
Special circumstances

Here are the general guidelines, taken directly from the document:

CNS depressant use is not an absolute contraindication for either methadone or buprenorphine, but is a reason for caution because of potential respiratory depression. Serious overdose and death may occur if MAT is administered in conjunction with benzodiazepines, sedatives, tranquilizers, anti-depressants, or alcohol.
People who use benzodiazepines, even if used as a part of long-term therapy, should be considered at risk for adverse drug reactions including overdose and death.
Many people presenting to services have an extensive history of multiple substance dependence and all substance abuse, including benzodiazepines, should be actively addressed in treatment. MAT should not generally be discontinued for persistent benzodiazepine abuse, but requires the implementation of risk management strategies.
Clinicians should ensure that every step of decision-making is clearly documented.
Clinicians would benefit from the development of a toolkit about the management of benzodiazepines in methadone treatment that includes videos and written materials for individuals in MAT.
Please note that under the third point of the general guidelines, it says patients shouldn’t be taken off MAT because of repeated benzo use, but need “risk management strategies.” That’s a little vague, but IRETA guidelines go into more detail later in the document.

IRETA’s second section of guidelines is about assessment for MAT. The guidelines say all of the usual things; for example, they say a doctor should do a complete evaluation of a patient presenting for treatment, as described in SAMHSA’s TIP (Treatment Improvement Protocol) 40 and 43. The evaluation should include the patient’s history of medical problems and history of all drug use, even over the counter medication. A mental status assessment and a drug screen should also be included.

Also under the assessment section, IRETA suggests adding patient education about the dangers of mixing benzos with methadone or buprenorphine. I like this idea, and I do something similar. When I ask about past drug use, I always warn patients about the potential bad outcome of mixing benzos and alcohol with the medication I’m going to prescribe, and I repeat the warning at the end of our interaction.

IRETA suggest doctors go farther, and give patients information not only about overdose risk, but also about the other problems benzodiazepines can cause. Benzodiazepines are associated with a greater risk of depression and suicide. Having a prescription for benzodiazepines doubles a patient’s risk for an auto accident, and increases the risk for other accidents, like falls. Taking a benzodiazepine prescription is associated with an increased risk for hip fracture.

The IRETA guidelines remind us that there is “Substantial and growing literature that suggests long term use of benzodiazepines (especially in large doses) leads to cognitive decline.” (page 16 of the report) the guidelines also say that benzodiazepines are associated with emotional blunting, and long-term sleep and mood disturbances. Even more relevant, studies show that patients on benzodiazepines have worse outcomes in medication-assisted treatment.

The third section of IRETA’s guidelines is about addressing benzodiazepine use. They say that a patient should be willing to address their benzo addiction. IRETA says that uncontrolled use of benzodiazepines is a contraindication to treatment with methadone or buprenorphine because of the “extremely high risk for adverse drug reaction involving overdose and/or death during the induction process.”

I’m in the “amen” corner for that one! But it’s hard for me to know which patients use benzos occasionally to help opioid withdrawal, and which patients use benzos heavily in an uncontrolled manner. Most patients, seeing me for admission to MAT, minimize their use of benzodiazepines, knowing it’s a big issue. If they’re getting benzodiazepine prescriptions in large amount from multiple doctors, I can see that on our state’s prescription monitoring program. If the patient is taking benzos illicitly, I may not have a way to know this. Information from family members and friends can sometimes help, if the patient will allow. Or family members and friends may be as heavily involved in addiction as the patient presenting for treatment.

The IRETA guidelines remind us that patients on long-term benzodiazepine therapy are at risk for adverse drug reactions which can include overdose and death. The guidelines say that central nervous system depressants are not absolutely contraindicated with methadone, but also put patients at risk for overdose and death. I assume at this point in the document, its authors are referring to other non-benzo central nervous system depressants like carisopradol (Soma), zolpidem (Ambien), and the other “z” sleep medications, and perhaps pregabalin (Lyrica).

IRETA’s benzodiazepine guidelines for OTPs are extensive, so I’m going to split my review of the contents over two blog entries. Stay tuned…or even better, go read them for yourself:

Click to access Best%20Practice%20Guidelines%20for%20BZDs%20in%20MAT%202013_0.pdf

1. Thomas et al, “Benzodiazepine use and motor vehicle accidents. Systematic review of reported association.” Canadian Family Physician, 1998 April;44:799-808.
2. Smink et al, “The relationship between benzodiazepine use and traffic accidents: A systematic literature review.” CNS Drugs, 2010 Aug.24(8)6390653.

Methadone Dosing: Use the Evidence

methadone

The most successful opioid treatment programs and the most successful patients in those programs use evidence-based dosing of methadone. Many studies over the last 40 years show patients do better on adequate doses of methadone. They have better outcomes when they’re on enough methadone to block physical withdrawal signs and symptoms than when they’re on insufficient doses.

In the past, methadone clinics often had dose caps. Some clinics told their patients they didn’t need any more than 60 or 70mg of methadone per day. But over the last 40 years, we have multiple studies showing poorer outcomes at clinics with these low dose caps, as opposed to individualized dose determination. Numerous studies show higher drop-out rates in patients on doses less than 60mg, as well as more illicit opioid use and higher rates of HIV infection, as compared to patients on 100mg or more. For most patients, the blocking effect is seen in the neighborhood of 80 to 120mg of methadone per day. (In Tennessee, there are still dose caps. In that state, doctors have to get approval from a non-physician at the state’s Department of Mental Health to take a patient’s dose above 120mg.)

Patients vary widely the way they metabolize methadone. A patient with slow methadone metabolism may do best on 30mg of methadone per day, and a fast metabolizer may need much more than 120mg per day. This rate of methadone metabolism is probably determined by our genetics. When patients ask me how much methadone they should be taking, my answer is, “Enough.” I’m not advocating taking doses higher than they need to be, but if the patient looks like they’re in withdrawal, and they feel like they’re in withdrawal, it’s best to take the dose up. We want to use the lowest effective dose.
There are still misguided opioid treatment programs that try to keep methadone doses low. Sometimes clinic staff can send shaming verbal or nonverbal messages, and imply patients who ask for an increase in their dose are somehow trying to get one over on the clinic. Staff shouldn’t shame patients who ask for a dose increase; staff should defer decisions about methadone dosing to their medical personnel.

Sometimes patients don’t want to increase their dose of methadone because they have mixed feelings about their treatment. If they feel guilty about being in a methadone program, they may want to keep their dose low. Sometimes family members, with the best of intentions, will demand the patient stay on a low dose, not understanding that their loved one is less likely to do well on an inadequate dose.

Frequently I see patients who are feeling bad, not sleeping, and achy all over in the mornings, and dosing at 40mg. I ask them if we can increase their dose, and they say something like, “No, I promised myself I wouldn’t go higher than 40mg.” Too often, patients don’t increase their dose for fear that coming off methadone will be harder to do at higher doses. This may be partly true. It may not be harder to come off of, but it take longer to taper off a higher dose. But the patient won’t do as well while they’re in treatment, so what’s the point?

Some patients prefer low doses because they want to have just enough methadone per day to keep them out of terrible opioid withdrawal, but not so much to block the euphoria they get from using an illicit opioid later in the day.
I tell patients that methadone is a little like chemotherapy. For chemo to work, you have to take a big enough dose to do the job. It’s the same way with methadone. It’s not a perfect analogy but patients get what I’m saying.

Let’s turn to the other side of dosing. I’ve seen some clinics with many patients on what I would consider very high methadone dosing. It’s hard to criticize, because I do think there are some patients who need doses higher than 250mg, particularly if they’re on certain medications, or are pregnant. But that’s rare, and at some clinics, many patients seem to be on these big doses. Since these patients have their dose increased slowly, they build a tolerance to the methadone, so such patients aren’t sedated. There’s no long-term damage to the body with very high dose methadone, but higher doses can cause some problems.

It may be hard for a patient on a very high dose to transfer to another clinic. Some methadone clinic medical directors are hesitant to accept a patient in transfer if they’re on 200-plus milligrams of methadone, unless there’s evidence that this dose is required. For example, I was looking over the records of a patient on 290mg, in preparation for transfer. This man was on no other medications and otherwise healthy. When I saw the peak and trough data, I was puzzled, because they were both high, and this was done at 200mg of methadone. So why was the patient taken to 290 milligrams? I know peak and trough levels aren’t the only factor to be considered when determining the right methadone dose, but there was scant information about why the doctor decided to raise the dose, or even if the patient had even seen the doctor recently. I wasn’t particularly concerned the patient would be sedated, because the dose had been raised slowly, over months. But I was concerned that the patient was on more methadone than he needed, especially since many of the patients at this clinic were on doses of more than 200mg per day.

Some studies have shown higher doses of methadone affect the way electrical impulses are transmitted through the heart. In some studies, higher methadone doses are more likely to produce prolongation of the QT interval than lower doses. (2) This QT prolongation does put patients at risk for a potentially fatal heart rhythm problem. The medical literature at present suggests that periodic EKG screening of patients on doses above 100mg is probably a good idea, but there’s still disagreement on this issue.

There is another factor to be considered. This may offend some readers, but we need to acknowledge the nature of addiction. It’s a disease who tells its sufferers, “More is better!” I think it’s important to acknowledge this point, and discuss it openly, but not in a shaming way. This psychological part of addiction doesn’t always go away within the first few weeks.
My approach to a patient on a relatively high dose, who desires an increase in methadone, is to meet with the patient, preferable prior to dosing. Sometimes I like to meet the patient two hours post-dose if I’m worried about sedation. I ask about withdrawal symptoms and check for pupil size and reaction, and other signs. I check the last drug screen. If the patient doesn’t describe withdrawal symptoms, and I don’t see objective signs of withdrawal, I’ll ask the patient how they expect to feel on an ideal dose of methadone, and if it’s possible their addiction is driving the desire to increase. I’m surprised that most patients aren’t offended, but welcome the opportunity to talk openly. Some patients say they honestly can’t tell if they are in withdrawal, or if their addiction tells them they are in withdrawal. My job is to help decide which it is.

Some patients feel “high” for the first few days after a dose increase, but tolerance builds quickly to this feeling. Some patients mistakenly believe they should always get that high after dosing. If the addiction is driving the patient’s way of thinking, the dose may never be “enough.” When I explain this to patients, most understand.

1. http://international.drugabuse.gov/sites/default/files/pdf/methadoneresearchwebguide.pdf
2. Krantz, Lewkowlez, Hays, et.al., “Torsade de Pointes Associated with Very-High Dose Methadone, Annals of Internal Medicine, Sept. 17, 2002, Vol 137(6) pp 501-505.

Combining Medication-Assisted Treatment and 12- Step recovery: One Patient’s Success Story

A few weeks ago, I posted a few articles about 12-step recovery. Several readers became very upset, even saying that if I was pro-12-step, I couldn’t really be an advocate for medicated-assisted treatment of opioid addiction. That’s their opinion, and I honor their views, though I heartily disagree with them.

Now I’d like to present an interview I did with a very successful Suboxone patient who did find help from 12-step meetings.

JB: Please tell me about your experience with pain pill addiction and your experiences with buprenorphine (Suboxone).

XYZ: For me, my opiate addiction got so bad, I was taking two hundred and forty to three hundred and twenty milligrams of OxyContin per day, just to stay normal. It had gotten really, really bad. And it started out with a reason. I had kidney stones, and I was in all this pain, but then it got to the point where it solved some other problems in my life and it got out of hand. I tried a lot of different things. I went to detox, and they helped me, but it was…it was almost like I never came out of withdrawal.

JB: How long were you off pain pills?

XYZ: Even after being clean for thirty or sixty days, I would still feel bad. Bowels, stomach…really all the time.

JB: Did it feel like acute withdrawal or just low grade withdrawal?

XYZ: No…I’d try to fix it myself, sometimes, and I would just put myself back where I was. It got to the point where I was making myself sicker and sicker and sicker. And then I got off of it, and stayed off of it for a hundred and twenty days, I guess…but still just sick. Just miserable, and not feeling right. I was miserable. I wouldn’t eat, I was losing weight…

It [buprenorphine] gave me something that replaced whatever was going on in my head physically, with the receptors. It took that [prolonged withdrawal] away, to the point that I felt well. All that energy I would spend getting pills…and I was going to the doctors almost daily. Because taking that much medicine, nobody would write me for that much, so I had to doctor shop.

My only life was going to the doctors, figuring out what pharmacy I could use. I had a whole system of how many days it could be between prescriptions, what pharmacy to go to. It was sick. I was just trying to not get sick.

JB: And you were working during that time?

XYZ: Yeah! I was working, if you want to call it that. I wasn’t a very good employee, but I held a job. I was a regional vice president for “X” company. I traveled a lot, so I had new states where I could see new doctors. That was bad. When I came off the road, I owed $50,000 in credit card bills.

JB: And your wife didn’t know about it?

XYZ: No. It all came tumbling down. And I had gotten into trouble, because they were company credit cards, and they wanted the money back! So, all of the sudden my wife found out that not only do I have a pain pill problem, but we’re $50,000 short, and I wasn’t very ethical in the way I got the money, because it really wasn’t my credit, it was my company’s credit card.

JB: So addiction made you do things you wouldn’t do otherwise?

XYZ: Absolutely. I lied to people, I took money from people, I ran up credit cards tens of thousands of dollars, and really put my family in serious jeopardy at that time. But buprenorphine took away that whole obsessive-compulsive need for pills, made me feel better, and took away all the withdrawal symptoms at the same time. I didn’t worry about it.
To be honest, I was such a hypochondriac before. I haven’t been sick in years now. I haven’t had a backache or headache that ibuprofen didn’t cure [since starting recovery]. I was fortunate it was all in my head. I would milk any little thing. I had two knee operations that probably could have been healed through physical therapy, but I was all for surgery, because I knew I’d get pain pills.

JB: That’s the power of addiction!

XYZ: Yes. Finally I did some research about buprenorphine, online. Actually, I had some good family members, who did some research and brought it to me, because they were concerned for me, and they brought it to me and said, “Hey, there’s a medicine that can help. Call this number,” and I found places out there that would do it [meaning Suboxone], but my concern was the speed that a lot of them were doing it. A lot of them said, OK come in, and we can evaluate you, and after a week you’ll be down to this, and after a month you’ll be down to this.

This was in 2005. And when I asked them what their success rate is, it wasn’t very high. It was something like twenty percent of the people who were doing it [succeeded]. So when I’d finally gotten a hold of “X,” [receptionist for Dr. H], she saved my life over the phone. Because she said, you can come tomorrow, and she said that whatever it takes, they’ll work with you. And I felt good about going to a place where it wasn’t already determined how long it would take. Because I already knew how I was feeling after I would come off of opiates. I didn’t want to do that again.

I saw Dr. H. and felt better within twenty-four hours, although it took a little while to get the dosage right. I think we started off at a lower dose, then we went up on the dose and it kept me so level. I had no symptoms. It cured my worst withdrawal symptoms, my stomach and my bowels.

There’s always a kind of stigma in the rooms [12-step recovery meetings] because I’d been in NA for a little bit of time then [he’s speaking of stigma against medication-assisted treatment]. You realize who [among addicts in NA] is die-hard, one way to do recovery, and who is willing to be educated about some things and understand that there’s more than one way to skin a cat.
And I was fortunate that I had a sponsor at that time, and still do, who was willing to learn about what exactly it was, and not make me feel guilty about it. It wasn’t necessarily the way he would do it, but he was a cocaine addict, so he didn’t understand that whole part of it.

He said, “Your family’s involved, you’ve got a doctor that’s involved, your doctor knows your history. If all these people, who are intelligent, think this is an OK thing, then who am I to say it’s not going to work?” He was open-minded. And there are not a lot of people I would trust right off the bat [in recovery], that I would tell them. [that he’s taking Suboxone]. I’ve shared it with some people who’ve had a similar problem, and told them, here’s something that might help you. I always preface it with, [don’t do] one thing or another, you’ve got to do them together. You have to have a recovery program and take this medicine, because together it will work. Look at me. I’m a pretty good success story.

One of my best friends in Florida called me, and I got him to go see a doctor down there, and he’s doing well now. He’s been on it almost eleven months now and no relapses.

To me, it takes away the whole mental part of it, because you don’t feel bad. For me, it was the feeling bad that drove me back to taking something [opioids] again. Obviously, when you’re physically feeling bad, you’re mentally feeling bad, too. It makes you depressed, and all of that, so you avoid doing fun things, because you don’t feel good.

Once I trained myself with NA, how to get that portion of my life together, to use those tools, not having any kind of physical problems made it that much easier to not obsess.

JB: So, how has your life improved, as a result of being on buprenorphine?

XYZ: Well, the most important thing for me is that I’ve regained the trust of my family. I was the best liar and manipulator there was. I’d like to think of myself as a pretty ethical and honest person, in every aspect of my life, other than when it came to taking pills.

JB: So, you regained the trust of your family, felt physically better…

XYZ: I gained my life back! Fortunately, I had enough of a brain left to know it had to stop. Once I started on buprenorphine, it gave me back sixteen hours a day that I was wasting. That’s when I decided I really don’t want to jeopardize my recovery, by going out and looking for a job again [he means a job in corporate America, like he had in the past], because I’ve got this thing, this stigma…they’re going to check a reference and I’m screwed. I’m not going to get a job doing what I was doing for the same amount of money.

My brother had enough faith in me that it was worth the risk of starting this business [that he has now] together. My wife and I started on EBay, making and selling [his product], and slowly grew it to the point that, three years later, I’m going to do over two million dollars in sales this year, I’ve got [large company] as a client, I’ve got [large company] as a client, I’m doing stuff locally, in the community now, and can actually give things back to the community.

JB: And you employ people in recovery?

XYZ: Oh, yeah. I employ other recovering addicts I know I can trust. I’ve helped some people out who have been very, very successful and have stayed clean, and I’ve helped some people out who came and went, but at the same time, I gave them a chance. You can only do so much for somebody. They have to kind of want to do it themselves too, right?

JB: Have you ever had any bad experiences in the rooms of Narcotics Anonymous, as far as being on Suboxone, or do you just not talk to anybody about it?

XYZ: To be honest, I don’t broadcast it, obviously, and the only other people I would talk to about it would be somebody else who was an opioid addict, who was struggling, who was in utter misery. The whole withdrawal process…not only does it take a little while, but all that depression, the body [feels bad]. So I’ve shared with those I’ve known fairly well. I share my experience with them. I won’t necessarily tell people I don’t know well that I’m taking buprenorphine, but I will let them know about the medication. Even though the information is on the internet, a lot of it is contradictory.

It’s been great [speaking of Suboxone] for someone like me, who’s been able to put a life back together in recovery. I’d tell anybody, who’s even considering taking Suboxone, if they’re a true opioid pill addict, (I don’t know about heroin, I haven’t been there), once you get to the right level [meaning dose], it took away all of that withdrawal. And if you combine it with going to meetings, you’ll fix your head at the same time. Really. I didn’t have a job, unemployable, my family was…for a white collar guy, I was about as low as I could go, without being on the street.
Fortunately I came from a family that probably wouldn’t let that happen, at that point, but who knows, down the road… I had gotten to my low. And that’s about it, that’s about as much as I could have taken.

It [Suboxone] truly and honestly gave me my entire life back, because it took that away.

JB: What do you say to treatment centers that say, if you’re still taking methadone or Suboxone, you’re not in “real” recovery? What would you say to those people?

XYZ: To me, I look at taking Suboxone like I look at taking high blood pressure medicine, OK? It’s not mind altering, it’s not giving me a buzz, it’s not making…it’s simply fixing something I broke in my body, by abusing the hell out of it, by taking all those pain pills.

I know it’s hard for an average person, who thinks about addicts, “You did it to yourself, too bad, you shouldn’t have done that in the first place,” to be open minded. But you would think the treatment centers, by now, have seen enough damage that people have done to themselves to say, “Here’s something that we have proof that works…..”

I function normally. I get up early in the morning. I have a relationship with my wife now, after all of this, and she trusts me again. Financially, I’ve fixed all my problems, and have gotten better. I have a relationship with my kids. My wife and I were talking about it the other day. If I had to do it all over again, would I do it the way I did it? And the answer is, absolutely yes. As much as it sucked and as bad as it was, I would have still been a nine to five drone out there in corporate America, and never had the chance to do what I do. I go to work…this is dressy for me [indicating that he’s dressed in shorts and a tee shirt]

JB: So life is better now than it was before the addiction?

XYZ: It really is. Tenfold! I’m home for my kids. I wouldn’t have had the courage to have left a hundred thousand dollar a year job to start up my own business. I had to do something. Fortunately, I was feeling good enough because of it [Suboxone], to work really hard at it, like I would have if I started it as a kid. At forty years old, to go out and do something like that…

JB: Like a second career.

XYZ: It’s almost like two lives for me. And if you’re happy, nothing else matters. I would have been a miserable, full time manager, out there working for other people and reaping the benefits for them and getting my little paycheck every week and traveling, and not seeing my wife and kids, and not living as well as I do now.

I joke, and say that I work part time now, because when I don’t want to work, I don’t have to work. And when I want to work, I do work. And there are weeks that I do a lot. But then, on Saturday, we’re going to the beach. I rented a beach house Monday through Saturday, with just me and my wife and our two kids. I can spend all my time with them. I could never have taken a vacation with them like that before.

JB: Do you have anything you’d like to tell the people who make drug addiction treatment policy decisions in this nation? Anything you want them to know?

XYZ: I think it’s a really good thing they increased the amount of patients you [meaning doctors prescribing Suboxone] can take on. I’d tell the people who make the laws to find out from the doctors…how did you come up with the one hundred patient limit? What should that number be? And get it to that number, so it could help more people. And if there’s a way to get it cheaper, because the average person can’t afford it.

The main thing I’d tell them is I know it works. I’m pretty proud of what I’ve achieved. And I wouldn’t have been able to do that, had I not had the help of Suboxone. It took me a little while to get over thinking it was a crutch. But at this point, knowing that I’ve got everybody in my corner, they’re understanding what’s going on…it’s a non-issue. It’s like I said, it’s like getting up and taking a high blood pressure medicine.

I originally interviewed this patient in 2009, for a book that I wrote. Since that time, he and his family have moved to the west coast, but I’ve stayed in contact with him. He’s been in relapse-free recovery for over eight years, he’s still on Suboxone, and still happy. He has excellent relationships with his wife and children, and his business has thrived and continues to grow.

He’s an excellent example of how a recovering addict’s life can change with the right treatment. For this person, Suboxone plus 12-step recovery worked great.

Pregnant Women Using Drugs

Pregnant addicts are the most stigmatized group in U.S. society. Even other drug addicts regard pregnant addicts with scorn. But the nature of addiction is the loss of control – pregnant addicts usually do want to stop using drugs, but have lost the power to do so without help. And even if they do seek help, pregnant women face special barriers to proper care. The stigmatization alone is enough to keep many women from getting help. They face overwhelming shame and blame from society and from their own families. Pregnant women don’t tell their obstetricians about their addiction, for fear they will be treated harshly by the professionals on whom they must depend to deliver medical care. I’ve already blogged about the atrocious misinformation some obstetricians accept as true about opioids addiction and treatment during pregnancy.  Female addicts, scared and ashamed to ask for help, try to hide their addiction as well as they can, and hope for the best.

If a pregnant addict does seek help, many treatment programs won’t accept her into treatment, because she is too high risk. Addiction treatment programs sometimes don’t want the liability of a pregnant addict.

At one of the opioid treatment programs where I used to work, a woman came for admission in her fifth month of pregnancy. I tried to be gentle as I asked her why she’d waiting so long to get help. She laughed without humor and told me she’d been turned away from three other treatment facilities. The first was an inpatient residential treatment program that turned her away because she was addicted to opioids. They told her if they took her into their treatment program, she would have to undergo withdrawal, because they did not “believe” in methadone or buprenorphine (Subutex). And if she went into withdrawal, she could miscarry.

They directed her to an inpatient detoxification program that also declined to admit her because they didn’t want her to miscarry while in their facility. They (correctly) referred her to an opioid treatment program. The first opioid treatment program offered only methadone, and since she preferred buprenorphine, they referred her to the clinic where I worked. This patient had (correctly) heard new studies showed less severe withdrawal in babies born to moms on buprenorphine (Subutex) compared to moms on methadone.  That clinic then referred her to our clinic, since we do use buprenorphine. All of this took a few weeks, delaying her entry to treatment. The treatment programs made the right decisions, but addiction treatment is so patchwork that it took time for her to ping-pong from place to place until she found the treatment she needed.

Pregnant women fear they will lose custody of their children if they admit to being addicted and ask for help. Sadly, in some counties in my state, their fear is well-grounded. Some women are told they will lose their children because they have enrolled in medication-assisted treatment with methadone or buprenorphine, even though it’s the treatment of choice for opioid-addicted pregnant women. In most cases, treatment center staff can act as advocates, and talk to social service workers who may not be well-informed about addiction treatment. Punishing a mom for getting help doesn’t help anyone. Word spreads in addict social networks, making other women less likely to get help for addiction.

Often, the pregnant addict’s husband or partner is also addicted. He may try to keep her away from drug addiction treatment, fearing loss of control over her, or he may feel like he’ll be asked to stop using drugs too. Even if she’s able to go to treatment, having a drug-using partner makes it more difficult to stop using herself.

Women, pregnant or not, tend to have childcare issues. If they want to get help, who will watch the children while they attend treatment?

Despite the difficulties faced by pregnant addicts, most want desperately to deliver a healthy baby. We know from several studies that harsh confrontation predicts addiction treatment failure in pregnant women. That is, if treatment facility personnel, obstetricians, nurses or any other member of the treatment team tries to blame and scare a pregnant addict into stopping drug use, it backfires. Pregnant women tend leave treatment when they are treated harshly, and have worse outcomes than women who stay in treatment.

I’ve written blogs about the negative attitudes some medical professionals have toward pregnant opioid addicts who come for treatment with buprenorphine (Subutex) or methadone. Thankfully, that’s not a universal attitude. Recently an obstetrician referred her patient to us, calling ahead to speed things along. I called her back after I saw the patient, and we had a cordial conversation which I appreciate all the more in view of negativity I’ve experienced in the past.

I thought again about the topic of opioid-addicted pregnant addicts because of an article in my most recent issue of Journal of Addiction Medicine. This article described the outcome of a study of opioid-addicted pregnant patients in rural Vermont. Since methadone and buprenorphine (Subutex) are the treatments of choice for these patients, the study looked to see if better access to these treatments improved outcomes. The results showed, not surprisingly, improved access to medication-assisted treatment for opioid addiction in pregnant addicts improved the health outcomes for both mothers and babies. Earlier research showed the same result, but this was a rural group, underrepresented in past studies.

Meyer, M, et. al, “Development of a Substance Abuse Program for Opioid-Dependent Nonurban Pregnant Women Improves Outcome,” Journal of Addiction Medicine, Vol. 6 (2) pp.124-130.

Methadone Dosing in Opioid Treatment Programs: Use the Evidence

The most successful opioid treatment programs and the most successful patients in those programs use evidence-based dosing of methadone. Many studies over the last 40 years show patients do better on adequate doses of methadone. They have better outcomes when they’re on enough methadone to block physical withdrawal signs and symptoms than when they’re on insufficient doses.

In the past, methadone clinics often had dose caps. Some clinics told their patients they didn’t need any more than 60 or 70mg of methadone per day.  But over the last 40 years, we have multiple studies showing poorer outcomes at clinics with these low dose caps, as opposed to individualized dose determination. Numerous studies show higher drop-out rates in patients on doses less than 60mg, as well as more illicit opioid use and higher rates of HIV infection, as compared to patients on 100mg or more. For most patients, the blocking effect is seen in the neighborhood of 80 to 120mg of methadone per day.

However, there’s a great deal of difference between how patients metabolize methadone. A patient with slow methadone metabolism may do best on 30mg of methadone per day, and a fast metabolizer may need much more than 120mg per day. This rate of methadone metabolism is probably determined by our genetics. When patients ask me how much methadone they should be taking, my answer is, “Enough.” I’m not advocating taking doses higher than they need to be, but if the patient looks like they’re in withdrawal, and they feel like they’re in withdrawal, it’s best to take the dose up. We want to use the lowest effective dose.                                                                                                                                 

There are still misguided opioid treatment programs that try to keep methadone doses low. Sometimes clinic staff can send shaming verbal or nonverbal messages, and imply patients who ask for an increase in their dose are somehow trying to get one over on the clinic. Staff shouldn’t shame patients who ask for a dose increase; staff should defer decisions about methadone dosing to their medical personnel.

Sometimes patients don’t want to increase their dose of methadone because they have mixed feelings about their treatment. If they feel guilty about being in a methadone program, they may want to keep their dose low. Sometimes family members, with the best of intentions, will demand the patient stay on a low dose, not understanding that their loved one is less likely to do well on an inadequate dose.

Frequently I see patients who are feeling bad, not sleeping, and achy all over in the mornings, and dosing at 40mg. I ask them if we can increase their dose, and they say something like, “No, I promised myself I wouldn’t go higher than 40mg.” Too often, patients don’t increase their dose for fear that coming off methadone will be harder to do at higher doses. This is partly true. It may not be harder to come off of, but it does take longer to taper off a higher dose. But the patient won’t do as well while they’re in treatment, so what’s the point?

Some patients prefer low doses because they want to have just enough methadone per day to keep them out of terrible opioid withdrawal, but not so much to block the euphoria they get from using an illicit opioid later in the day.

I tell patients that methadone is a little like chemotherapy. For chemo to work, you have to take a big enough dose to do the job. It’s the same way with methadone. It’s not a perfect analogy but patients get what I’m saying.

Let’s turn to the other side of dosing. I’ve seen some clinics with many patients on what I would consider very high methadone dosing. It’s hard to criticize, because I do think there are some patients who need doses higher than 250mg, particularly if they’re on certain medications, or are pregnant. But that’s rare, and at some clinics, many patients seem to be on these big doses. Since these patients have their dose increased slowly, they build a tolerance to the methadone, so such patients aren’t sedated. There’s no long-term damage to the body with very high dose methadone, but higher doses can cause some problems.

It may be hard for a patient on a very high dose to transfer to another clinic. Some methadone clinic medical directors are hesitant to accept a patient in transfer if they’re on 200-plus milligrams of methadone, unless there’s evidence that this dose is required. For example, I was looking over the records of a patient on 290mg, in preparation for transfer. This man was on no other medications and otherwise healthy. When I saw the peak and trough data, I was puzzled, because they were both high, and this was done at 200mg of methadone. So why was the patient taken to 290 milligrams? I know peak and trough levels aren’t the only factor to be considered when determining the right methadone dose, but there was scant information about why the doctor decided to raise the dose, or even if the patient had even seen the doctor recently. I wasn’t particularly concerned the patient would be sedated, because the dose had been raised slowly, over months. But I was concerned that the patient was on more methadone than he needed, especially since many of the patients at this clinic were on doses of more than 200mg per day.

Some studies have shown higher doses of methadone affect the way electrical impulses are transmitted through the heart. In some studies, higher methadone doses are more likely to produce prolongation of the QT interval than lower doses. (2) This QT prolongation does put patients at risk for a potentially fatal heart rhythm problem. The medical literature at present suggests that periodic EKG screening of patients on doses above 100mg is probably a good idea, but there’s still disagreement on this issue.

There is another factor to be considered. This may offend some readers, but we need to acknowledge the nature of addiction. It’s a disease who tells its sufferers, “More is better!”  I think it’s important to acknowledge this point, and discuss it openly, but not in a shaming way. This psychological part of addiction doesn’t always go away within the first few weeks.

My approach to a patient on a relatively high dose, who desires an increase in methadone, is to meet with the patient, preferable prior to dosing. Sometimes I like to meet the patient two hours post-dose if I’m worried about sedation. I ask about withdrawal symptoms and check for pupil size and reaction, and other signs. I check the last drug screen. If the patient doesn’t describe withdrawal symptoms, and I don’t see objective signs of withdrawal, I’ll ask the patient how they expect to feel on an ideal dose of methadone, and if it’s possible their addiction is driving the desire to increase. I’m surprised that most patients aren’t offended, but welcome the opportunity to talk openly. Some patients say they honestly can’t tell if they are in withdrawal, or if their addiction tells them they are in withdrawal. My job is to help decide which it is.

Some patients feel “high” for the first few days after a dose increase, but tolerance builds quickly to this feeling. Some patients mistakenly believe they should always get that high after dosing. If the addiction is driving the patient’s way of thinking, the dose may never be “enough.” When I explain this to patients, most understand.

I could be wrong, but I have an impression that very high doses are seen more frequently in patients enrolled in large, for-profit methadone clinic chains, with numerous facilities scattered across the country. I wonder if the doctors working there talk often with their patients, examine them, and talk about their symptoms and expectations.

I’d like to hear feedback from patients at opioid treatment centers. What do you think? Are clinic doctors too reluctant to order dose increases? Or too quick to increase doses, without talking to the patient?

 

1. http://international.drugabuse.gov/sites/default/files/pdf/methadoneresearchwebguide.pdf

      2. Krantz, Lewkowlez, Hays, et.al., “Torsade de Pointes Associated with Very-High Dose Methadone, Annals of Internal Medicine, Sept. 17, 2002, Vol 137(6) pp 501-505.