Archive for the ‘Buprenorphine’ Category

Expanding Access to Buprenorphine

aaaabalance

My last blog post stimulated some lively debate, and I thought this topic deserved further discussion. However, I would like to ask commenters to talk about the issue and please refrain from mentioning specific names of previous commenters. Please and make your points in a thoughtful and respectful manner. Thanks for your cooperation.

Given our present epidemic of opioid addiction and opioid overdose deaths, authorities are considering lifting the 100-patient limit for physicians who prescribe buprenorphine from office-based settings. Some people in the addiction treatment field oppose expanding access to buprenorphine in the office setting, saying some of these patients don’t get the counseling that they need, but only medication. They say there aren’t enough regulations to prevent shady physicians from opening buprenorphine mills.

Experts on both sides of the debate make good points. It’s a tough topic, but let’s explore the issues further.

1. “You don’t provide enough counseling.”

Weirdly, this used to be a main complaint against OTPs, but now OTP personnel are directing the same complaint toward office-based buprenorphine physicians.

Is there any data to help us decide how much counseling is enough for opioid-addicted patients who are started on medication, either buprenorphine or methadone?

The POATS trial gives some information on this topic. (Weiss et al, 2010, http://ctndisseminationlibrary.org/protocols/ctn0030.htm )

POATS showed that opioid-addicted patients maintained on buprenorphine/naloxone were likely to reduce illicit opioid use during treatment with the medication, but most relapsed after being tapered off the medication at twelve weeks. So this part of the study supported keeping patients on medication longer, just like the older data with methadone for heroin users. No surprises so far.

Now comes the interesting part: POATS showed similar outcomes for patients getting standard medical management versus standard medical management plus fairly intense counseling. The group with added counseling didn’t do any better than the standard medical management group.

However, the standard medical management consisted of an hour-long first visit with the doctor, and a fifteen- to twenty- minute visit per week for the first four weeks, then every two weeks.
This may be more than an average buprenorphine doctor provides in real life. It’s a little more than I do for my office-based patients. My first visit with new patients is one hour, and usually I see them back in one week for a twenty-minute visit. But then, if they are doing well, I see them every two weeks, until the patient is established in counseling. After that, if all is going well, I cut down to monthly visits. I conclude that the average buprenorphine doctor may have to increase visit frequency to get the results seen in the POAT study.

The group with enhanced counseling treatment got 45 minutes with a counselor twice per week for the first four weeks, then twice per month. At present, patients of OTPs must have two counseling sessions per month, even at the beginning of treatment. Opioid clinic opponents say twice per month isn’t even close to enough counselling, and use this point as a reason to say opioid treatment programs deliver bad care.

The POAT study was relatively short. Twelve weeks may not be long enough to detect an improvement in patients getting enhanced counseling. We know life changes usually don’t happen quickly. Maybe it is unfair to say the counseling didn’t help, because the patients weren’t followed long enough.

Now let’s look at interim methadone. Interim methadone was proposed as an alternative to long waiting lists for patients to enter an opioid treatment program. People were concerned about the welfare of opioid addicts who wanted help, but had to wait for a treatment slot to open. Interim methadone is a short-term, simplified treatment where methadone medication is started for the opioid addict, until the patient can be admitted to an OTP. With interim methadone, some counseling given, but only for emergency situations. Drug screening is still done, but is more limited than for OTP patients. These interim patients can transition to a traditional opioid treatment program when a slot opens for them.

It appears that starting just methadone, with limited other services, still helps the patients. Studies show these patients are less likely to continue to use heroin, are less likely to commit crimes, and more likely to enter a full-service OTP when admission is offered. [1]

Would “interim buprenorphine” work as well? I don’t think there are any studies to give us data, but it seems logical that it would.

2. “Just apply to be an OTP”

Government officials have said that if office-based physicians wish to see more than one hundred buprenorphine patients, the physician should apply to become an opioid treatment center.

When I first read this suggestion, I laughed, because it sounded so silly to me. Well-intentioned though this statement might be, it starkly exposed a lack of knowledge of the average physician’s economic circumstances.

I don’t know many doctors like me who have the necessary capital to do this. Some professionals in the field estimate it takes starting capital of around a quarter of a million dollars. I’ve seen one OTP fold due to inadequate financial support and management, and another escape closure by a narrow margin. These days, it takes deep pockets to afford the eighteen to twenty-four month process to establish an OTP. Getting the certificate of need alone can take years. (Just look at Crossroad’s struggles to get a CON in Eastern Tennessee, an area with arguably more opioid addiction per capita than most other states!)

OTP sites must be approved by multiple agencies: the DEA, CSAT, SOTA, and local authorities to name a few. The pharmacy has to meet strict regulations, as do personnel. If you want to accept Medicaid, that’s another avalanche of regulation and paperwork.

I’m not saying it’s impossible for a physician to open an OTP, but I am saying that it would cost so much that most doctors who treat opioid addiction wouldn’t consider it. I could be wrong – maybe my colleagues are making a whole lot more than me…

3. “In it for the money.”

Experts in the field who work for opioid treatment programs oppose expansion of office-based treatment, saying doctors charge exorbitant fees for their patients. Sadly, in some cases, they are right. But many office-based doctors charge reasonable fees. If we allowed doctor to treat more than one hundred opioid-addicted patients at one time with buprenorphine, wouldn’t that reduce demand for services? And when demand decreases, shouldn’t cost of treatment drop too?

For example, let’s take a community where one buprenorphine doctor is price gouging, and charging $500 per month for only one doctor’s visit. The second buprenorphine doctor charges $250 per month for the same service plus addiction counseling. Both are at their one- hundred patient limit. If both were allowed to increase the number of their patients, wouldn’t the second, more reasonably-priced doctor get some of the more expensive doctor’s business?

Conversely, some advocates for office-based treatment say that opioid treatment programs are upset because they have lost money in recent years. They accuse organizations like AATOD of wanting to limit further expansion of office-based programs because it cuts into their business. With more access, more patients would abandon OTPs for these less restrictive programs

DATA 2000 changed the landscape of opioid addiction treatment. OTPs aren’t the only option for patients seeking treatment for their opioid addiction.

My point is, both OTPs and buprenorphine doctors can accuse the other group of being in it for the money. But as I pointed out in my last blog…no medical treatment in this country is free.

4. “My medication is better than your medication.”

Patients entering opioid addiction treatment often ask me, “Which is better, buprenorphine or methadone?” I say, “Both.” Each has its advantages, and I’ve discussed this in previous blog entries. Briefly, buprenorphine is safer, since there is a ceiling on its opioid effects, but it’s more expensive. Patients on buprenorphine also seem to leave treatment prematurely more often than methadone patients. This isn’t a good thing, since the majority of these patients relapse back to illicit opioid use.

Methadone, as a full opioid agonist, may be more difficult to taper off of, and maybe fewer patients leave treatment prematurely because of that feature. Methadone has been around for fifty years now, with a proven track record. It works, and it’s dirt cheap. Methadone does have more medication interactions, but those can usually be managed if all the patient’s doctors communicate with each other.

Buprenorphine isn’t strong enough for all opioid addicts. Because it’s a partial agonist, there’s a ceiling on its opioid effect. This property means it’s much safer than methadone, but it doesn’t work for everyone.

Buprenorphine is safer than methadone, which to me is its best quality. I’ve started hundreds of patients on buprenorphine and never had an induction death. Sadly, I cannot say the same of methadone. I am not saying overdose death is impossible with buprenorphine…I’m saying it’s much less likely, and that’s worth a lot to me.

Buprenorphine’s superior safety profile is one reason it was approved for use in an office setting. Methadone is riskier to prescribe from an office, because misuse and diversion is more likely to be fatal with this drug. That’s why buprenorphine has fewer restrictions on it. Neither medication is good or bad; the difference between the medications is pharmacologic, not moral.

Next week, I’ll describe my OTP, where we provide methadone, buprenorphine under the OTP license, and buprenorphine under my office-based license, all on the same premises. I think we’ve created a continuum of care that’s able to meet the needs of patients as their recovery evolves.

At our program, it’s not one program versus another. Difference patients need different things, and the same patient may need different things at different points in recovery.

1. Schwartz et al, “A Randomized Control Trial of Interim Methadone,” Archives of General Psychiatry, 2006

New Buprenorphine Product: Bunavail

Manufacturer's ad

Manufacturer’s ad

Until this month, only buprenorphine in the sublingual form was FDA approved for the treatment of opioid addiction. This includes commonly known brands like Suboxone and Zubsolv, and generic buprenorphine both with and without naloxone added.

But earlier this month, the FDA approved Bunavail (B-YOU-na- vail), a buprenorphine product that is absorbed through the mucosa of the cheek. This method of delivery is termed “buccal.” The company making Bunavail says the product has an adhesive, which they call “BioErodible MucoAdhesive,” that improves absorption through the cheek mucosa. This product has twice the bioavailability of Suboxone film, and that’s the selling point for this new product.

Bioavailability is the percent of the drug that is absorbed into the bloodstream out of the total amount of the drug that is administered. If a drug is injected, by definition it has 100% bioavailability. Other routes of administration have less than 100% bioavailability because not all of the drug is absorbed orally, or due to the first-pass metabolism seen with some drugs like buprenorphine. When using a route of administration with lower bioavailability, more of the drug must be given to achieve the same blood level as when the drug is injected.

Buprenorphine has poor gastrointestinal availability. If a drug company made an oral tablet to be swallowed, less than 10% of the drug would be absorbed into the bloodstream. Sublingually (under the tongue), bioavailability of buprenorphine is said to be anywhere from 30 to 50%, and can be influenced by things like the pH of oral secretions (an acid environment interferes with absorption, which is why we tell patients not to drink any soft drinks, coffee, or tea for fifteen minutes prior to dosing).

So what does Bunavail’s higher bioavailability mean on a practical level? Bunavail’s films contain less buprenorphine than Suboxone, but deliver the same blood level. And if the blood level’s the same, the effect of the drug is the same. In other words, individual patients should feel the same.

Other than that, I can think of a few potential advantages. With higher bioavailability, fewer grams of buprenorphine would be prescribed, and fewer grams of buprenorphine that could make it to the black market.

Since less of the drug is needed per unit dose, perhaps the price will be lower. I have no information about the costs of this new product…but I’m going to make a wild prediction that Bunavail won’t be significantly cheaper than Suboxone. Zubsolv has higher bioavailability but I don’t think it’s significantly cheaper than its competitors.

The makers of Bunavail are making a big deal about the inconvenience of sublingual forms of buprenorphine compared to their new product, which sticks to the side of the cheek. In an interview on Bloomberg News, one of their scientists said patients taking Bunavail can talk and swallow while their medication is dissolving, something that can’t be done with their sublingual competitors.

OK, maybe that’s an advantage…but what are we talking about, five or ten minutes at most? I don’t know if patients will think that’s a big selling point, but time will tell.

On their website, the manufacturers caution, “Do not switch from BUNAVAIL to other medicines that contain buprenorphine without talking with your doctor. The amount of buprenorphine in a dose of BUNAVAIL is not the same as the amount of buprenorphine in other medicines. Your doctor will prescribe a dose of BUNAVAIL that may be different than other buprenorphine-containing medicines you may have been taking.”

To me this means I will have to be careful if I have a patient who wishes to switch buprenorphine products. However, the package insert says that 4.2/.7 mg of Bunavail is equal to Suboxone 8mg/2mg. The package insert goes on to say that patients should be started at 2.1mg and increased in increments of 2.1mg until a maintenance dose of 8.4mg is reached, though patients may go as high as 12.6mg

The insert also says not to tear or cut the film. Manufacturers of Suboxone say the same thing about their film, though cutting those films is fairly standard practice. I think that since the drug company hasn’t done any testing of their products when cut or torn, they can’t say for sure that it’s OK.

The company behind Bunavail, BioDelivery Sciences International Inc. (BDSI) has several other unique products. For example, they already market Onsolis, which is fentanyl also in a buccal (absorbed through the cheek) film. They’re also in phase 3 trials now with another buprenorphine product that uses the special mucoadhesive they developed, but it will be marketed for moderate to severe chronic pain. No information is available yet regarding the doses contained in this product.

Bunavail is expected to be marketed to doctors the last quarter of this year.

Choices

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Today’s blog is more a ramble of my recent musings than a march toward a specific point.

Over the last few weeks I’ve been working out of town, covering an opioid treatment program for a doctor who is out on sick leave. At my usual work sites, about half of the patients who come for admission at these OTPs specifically request to be started on buprenorphine (better known as Suboxone, Subutex). At these new sites, many patients are opposed to buprenorphine, and want to start on methadone.

That’s fine with me. Methadone has been around for fifty years now, and we have reams of data to show it works. I have no problems starting these patients on methadone, but I’m curious about the resistance opioid addicts have towards buprenorphine in this area of the state, as opposed to my “home” opioid treatment program.

Some addicts bought Suboxone or Subutex illicitly, and when they took it, they got sick. Because of their bad experiences, they are much opposed to trying buprenorphine again. I try to explain that because buprenorphine is a partial opioid with a higher affinity for opioid receptors than their usual opioids of abuse, their prior experience probably occurred because they took the buprenorphine too soon. If they took it before they were in withdrawal, it caused precipitated withdrawal. I try to explain that I can help them start buprenorphine at the right time, to avoid precipitated withdrawal.

Other patients entering opioid treatment programs say they want methadone because they also suffer from chronic pain. I used to go along with that, and agree with them, because I believed methadone would also treat their pain in addition to their addiction, and do it more effectively than buprenorphine. But recent studies call that into question, and show that patients with both addition and chronic pain got as much pain relief with buprenorphine as with methadone. Also, there’s some evidence that full opioids like methadone actually increase chronic pain in some patients, due to hyperalgesia.

A few patients said they still felt a little bit of euphoria from methadone, and preferred it over buprenorphine for that reason. I appreciate the honesty of those patients, and I think that is true to some extent, but in most cases, the euphoria subsides as tolerance for methadone increases. It is rare for patients on methadone to continue to feel euphoria from it if they are on maintenance for more than a few months.

I’m proud to work for a company that has pushed for its opioid treatment programs nationwide to incorporate treatment options other than methadone, even though there’s less of a profit margin for OTPs who prescribe buprenorphine. That’s because methadone, which has been around for years, costs pennies to dose, but buprenorphine costs much more.

Also, as a regional manager for this company pointed out to me, buprenorphine patients spend less time in treatment and come in & out of treatment more than methadone patients. Treatment retention isn’t as good for buprenorphine patients.

Is that a bad thing? Probably, yes. Studies show better outcomes with better treatment retention. It’s certainly worse for the bottom line of the opioid treatment program, which makes it even more admirable for OTPs to offer buprenorphine.

In my usual neck of the woods, I see patients come into treatment for buprenorphine who say they would never consider methadone, due to the stigma. Those are patients who would not enter treatment if we didn’t offer buprenorphine, and I’m happy we can reach them.

Buprenorphine is much safer than methadone, and has fewer side effects with other medications. And if patients do well in treatment, they can get take home doses much more quickly than with methadone, because of the increased safety.

Most patients on buprenorphine don’t feel the intense withdrawal that patients on methadone feel, if they miss days of treatment. This quality of buprenorphine is probably why patients on buprenorphine leave treatment more frequently than patients on methadone. They don’t feel as bad if they miss treatment for days at a time.

Many addicts at my new OTP site ask for methadone because of recommendations from their friends. I don’t hear as much talk about buprenorphine at the new OTP, so maybe addicts haven’t heard of some of the specific benefits.

I’m just happy their friends recommend treatment in any form.

Readers, why do you think patients starting treatment on medication-assisted treatment prefer methadone to buprenorphine?

Celebrity Overdose Deaths

a informed

Recently, the overdose death of a beloved celebrity restarted discussion of addiction treatment in the mainstream media. I have mixed feelings about such discussions.

On the one hand, I don’t think it’s appropriate for outsiders to comment on whether the celebrity got the best available treatment. It feels reckless for someone to say he should have had this treatment or that, without being privy to the personal medical history of the celebrity. Those details can make a big difference in deciding the most appropriate treatment. Of course in hindsight we can say the treatment chosen didn’t work… but as I’m painfully aware, even the best evidence-based treatments can have disastrous outcomes in individual patients.

On the other hand, celebrity deaths can focus the public on pertinent addiction issues facing society. For example, the death of 1980’s basketball star Len Bias helped change public perception about the risks of cocaine use. Mr. Bias, the second overall draft pick of the NBA in 1986, was the picture of physical health. When this young man died of a cardiac arrhythmia from cocaine use, people stopped looking at cocaine as a harmless party drug. There was a shift to a more realistic view of cocaine as a potentially addictive drug that can cause serious medical problems, including death, even in young healthy people. It’s possible Len Bias’s death, untimely and tragic, saved some number of young people from experimenting and becoming addicted to cocaine.

I am thankful that some light is being shed on the treatment of opioid addiction, even though the cause of this examination is due to a celebrity death. Perhaps something good can come of tragedy.

Realistically, are opioid addicts, including celebrities, being told of all evidence-based treatments for the disease? I don’t have facts or figures, but I’m confident the answer is a resounding “No.”. Most Minnesota model, 12-step based inpatient drug rehabs still discourage patients with opioid addiction from considering methadone or buprenorphine, even though medical evidence proves such treatments to be the most successful. Is this ethical? I don’t think so.

In a recent article from Alcoholism & Drug Abuse Weekly (Feb 10, 2014) on this same topic, even the deputy director of the White House Office of National Drug Control Policy Michael Botticelli says, “For people with opioid dependence, MAT should be the standard of care.”

So how are Minnesota Model facilities, opposed to MAT, able to maintain accreditation if they don’t inform patients of all evidence-based treatments? It’s unethical. Our first obligation is to do the right thing by our patients, based on scientific data.

This wouldn’t be allowed in any other field of medicine.

FDA Approves Zubsolv, New Brand of Sublingual Buprenorphine

aaaaaazubsolv

Suboxone is getting competition from the generic preparations of buprenorphine/naloxone, and now another name-brand preparation has just been approved by the FDA.

It’s called Zubsolv, and the manufacturer, Orexo, says it takes less time to dissolve, is a smaller tablet, and tastes better. The company added a menthol taste. They also say their preparation has higher bioavailability, and the tablets come in two strengths: 5.7/1.4 buprenorphine to naloxone ratio, and 1.4/.36 ratio. The lower doses of buprenorphine per tablet are due to the higher bioavailability. Also, each tablet is contained in unit dose packaging, to reduce the risk of pediatric exposures.

Interestingly, the package insert says not to switch from one buprenorphine preparation to another, because other tablets have different amounts of buprenorphine than Zubsolv. That’s a problem for established patients. I’d like the manufacturer to give prescribers some information on how blood levels of their tablets compare to blood levels of other preparations of buprenorphine. I guess new patients could be started on Zubsolv.

On the company’s website, they claim that nine out of ten people prefer Zubsolv to Suboxone.

This medication should be available in pharmacies by September of this year.

I’m glad for every new buprenorphine product that’s released to the market, because I hope it brings the price down. Lower cost of medication means more opioid addicts could afford treatment.

I’m curious to see how this new preparation will be greeted by patients on buprenorphine.

New Forms of Buprenorphine for Opioid Addiction Treatment

depot injection of buprenorphine

depot injection of buprenorphine

At this year’s American Society of Addiction Medicine conference, researchers talked about innovative ways to dose buprenorphine (formerly known as Suboxone) that may be available in the future.

One of the new products doesn’t yet have a trade name. Researchers call it “CAM 2038.” It’s made by Camurus Pharmaceuticals, a small Swedish company that invented a nanoscale drug delivery system, as they say on their website. This “Fluidcrystal” injection containing buprenorphine comes in preparations of varying doses, and can be dosed once per week or once per month, depending on the preparation.

The liquid substance containing buprenorphine is injected subcutaneously (under the skin), where it forms a gel. Then a capsule-type substance surrounds it, allowing buprenorphine to be into the body over time. The capsulized gel makes the medication time release. Started weekly, the dose can be adjusted to meet patient needs. Eventually, the patient can move to once-monthly injections. The matrix of material is biodegradable, and eventually completely absorbed by the body.

This subcutaneous injection of medication has a very low viscosity, meaning it can be given with small needles that cause less pain to the patient. The medication is already pre-mixed, making it convenient for medical providers, and it is stable at room temperature for up to three years.

This form of buprenorphine is in Phase II trials in Germany now, so it will be some time before it’s even considered in the U.S. for FDA approval. Per the Drug Addiction Treatment Act of 2000, without this FDA approval, it can’t be used to treat opioid addiction. As we know, the buprenorphine implant (Probuphine) was turned down for approval by the FDA earlier this year, likely because the implants didn’t deliver a high enough dose of buprenorphine to patients.

Initial trials with CAM 2038 don’t appear to have this problem. The company’s initial studies show a fast delivery of medication, giving rapid onset and a steady blood level over one week or one month, depending on the preparation given. Safety data was pretty good; other than some headache and a low rate of inflammation at the injection site, it was well-tolerated. Because of the Fluidcrystal technology, if an addict attempts to inject into the vein, it will form a deposit at the injection site, blocking the vein.

Reckitt-Benckiser, the company who makes sublingual brand name Suboxone and Subutex, is developing a medication using a depot technology called Atrigel. Buprenorphine is put into the Atrigel preparation, a precipitation polymer that must be mixed before being injected. This delivery form of buprenorphine is also in Phase II trials now. RB apparently bought exclusive rights to use the Atrigel technology about four years ago.

These injectable depot forms of buprenorphine may be superior to sublingual forms of buprenorphine in the treatment of opioid addiction for several reasons:

First, with daily buprenorphine dosed sublingually, some patients relapse. They may decide to stop taking the buprenorphine for a few days so that they can use their opioid of choice and get high again. True, they have to do a little more planning to relapse than if they were not on buprenorphine, but relapse rates are still too high. The depot forms make relapse less likely, I think, because compliance is assured once the medication is injected.

Second, with the depot forms of buprenorphine, the patients don’t have to think about taking something to treat their addiction. They don’t have to think about their medication at all, and their addiction doesn’t have the chance to urge them to take more of their medication than prescribed. Thankfully with buprenorphine there is a ceiling to its opioid effect, so that patients already on a blocking dose of sublingual buprenorphine won’t usually feel any intoxication from taking more of their medication. But the disease of addiction is always telling the addict, “More!” so injectable forms thwart that urge completely.

Third, we’ve seen recent increases in the numbers of emergency department visits due to buprenorphine. Pediatric exposure remains a huge concern. Unlike pills which must be swallowed to have an effect, children who put the sublingual forms in their mouths will absorb the medication. Any pediatric exposure to buprenorphine is too much; unfortunately there have been a few pediatric deaths as well. With depot forms of buprenorphine, I don’t see how pediatric exposure would be possible.

Fourth, and probably politically most important, diversion of buprenorphine into the black market is getting much attention from press and law enforcement officials. More people are being arrested with illicit buprenorphine tablets and films, and law enforcement personnel believe buprenorphine is a desirable street drug. Of course, research shows most people using it illicitly are trying to prevent withdrawal and not trying to get high. The actual proportion of this medication getting into the black market hasn’t really risen; it’s being prescribed much more, so there’s more buprenorphine to be diverted. But diversion makes buprenorphine look like a desired street drug, and puts the DATA 2000 program at risk. I don’t see how a depot injection can be diverted, though I don’t doubt someone will try.

According to the Drug Addiction Treatment Act of 2000, the FDA must give approval to any form of buprenorphine that’s to be used to treat opioid addiction. At present, only the sublingual form of buprenorphine has that FDA approval. Other forms of buprenorphine in patch (Butrans) or injectable form are illegal for a doctor to prescribe to treat opioid addiction. If these new preparations of buprenorphine get approved, there will be a second delivery form that can be used in patients with addiction.

I like the idea of these depot injections. I’ve decided I don’t want to learn to do the minor surgery required to place Probuphine implants, but I can already do intramuscular and subcutaneous injections. Plus, I’d be seeing the patients once a week or once a month, rather than every six months with the implants. That’s more opportunity to keep track of what is happening with the patient’s addiction treatment counseling, a key component of recovery from addiction.

I’m looking forward to more research on these new forms of treatment.

How to Switch from Methadone to Buprenorphine (Suboxone)

Change Can Be Good

Change Can Be Good

I’ve helped about thirty or forty people switch from methadone to buprenorphine. Some were patients at my office, where I do office-based treatment with buprenorphine (formerly known as Suboxone or Subutex), and some have been patients at one of the two opioid treatment programs where I work.

Most of the time, the transition goes smoothly; however, around fifteen percent of the time, the patient doesn’t feel right on buprenorphine and goes back to methadone. I haven’t found a way to predict who will do poorly with buprenorphine.

Most of these patients had been in treatment for months or years, and were trying to taper their methadone dose. These patients heard that since buprenorphine is a partial opioid, it’s easier to taper off of than methadone. For the most part, that seems to be true, but everyone’s different.

Some patients switched because they wanted a medication that wasn’t as “heavy” as methadone. Most patients say they feel lighter, or less medicated, or more normal, on buprenorphine as compared to methadone.

Buprenorphine seems to have fewer medication interactions. For patients with complicated medical problems on many medications, it’s a better choice. It’s also a better choice for patients who have prolonged QT interval syndrome (condition of the heart) from methadone.

Also, restrictions on take home doses for buprenorphine when it is prescribed at opioid treatment programs aren’t as strict as rules for methadone, because buprenorphine is much safer than methadone. Patients switch to buprenorphine to get take homes more quickly, particularly helpful if they live a great distance from their treatment program.

In January of 2013, the federal government dropped the time in treatment requirement for take home doses for buprenorphine. With methadone, a patient has to be doing well with negative urine drug screens for a minimum of ninety days before getting extra take home doses. According to the new federal law, buprenorphine patients can get take homes regardless of time in treatment, so long as they meet all the other seven requirements for take homes. (These are: negative drug screen including alcohol, no ongoing criminal activity, regular clinic attendance, absence of serious behavioral problems at the clinic, stability of home environment, assurance that take-home doses can be stored safely, and rehabilitative benefits to the patient outweigh risk of diversion).

Some states have more restrictive regulations than federal law. In that case, the opioid treatment program has to follow the more restrictive of the two laws. In my state of North Carolina, time in treatment regulations still apply. However, I can petition the state opioid treatment authority for early and extra take home doses for patients who are doing well, and those requests are nearly always granted.

Some patients switch to buprenorphine at the opioid treatment program to prepare for transition to an office-based buprenorphine program. Office-based treatment is better for patients who have made progress on their recovery, and need less oversight with dosing of their medication. It’s an excellent step for stable patients.

Buprenorphine is a partial opioid and methadone is a full opioid. And buprenorphine has a higher affinity for opioid receptors. This means that it sticks like glue to the receptors, and if there’s methadone on the patient’s opioid receptors, buprenorphine will toss it off, throwing the patient into withdrawal. That’s a simplistic explanation, but you get my drift. This is why patients on methadone have to be in at least moderate withdrawal before taking the first dose of buprenorphine. Otherwise, the patient will be miserable, in withdrawal, with little to be done to ease the situation.

I ask patients to taper to about 30 or 40 milligrams of methadone per day prior to making the switch. I recommend tapering by about 5mg per week, or more slowly if needed. If I’m in the opioid treatment program on Mondays, I ask the patient to take her last dose of methadone on Friday, and then skip Saturday and Sunday. I see her first thing on Monday and evaluate the degree of withdrawal. By then, this patient has gone without methadone for seventy-two hours, and should be in at least moderate withdrawal. We check vitals signs (blood pressure, heart rate, etc.) and check a COWS (clinical opioid withdrawal scale) score. I talk with the patient and do a quick exam. If she’s in enough withdrawal, we start buprenorphine, usually at 4mg. If possible, we have the patient stay for an hour or return in an hour so we can see how she’s feeling. Sometimes we give a second dose on that first day.

Here are some issues I’ve seen in patients making the switch from methadone to buprenorphine:
-Coming down too fast on the methadone dose. Don’t zoom from 115mg to 40mg in a week or two and expect the transition to buprenorphine to go well. It probably won’t. I tell patients that if you’re going to expend time, money, and energy in making the switch, do it the right way, and optimize your chance for success.
-Not planning ahead for the increased cost of buprenorphine. In most clinics, buprenorphine costs more than methadone. If it’s not financially feasible over the long term, it’s best to stay on methadone.
-Expecting to take buprenorphine for a few weeks and then taper off with no withdrawal. Most people do not have this experience. Even the taper off buprenorphine can take months and be difficult. Besides, getting off opioids is one thing; staying off is another. I tell patients not to taper off buprenorphine unless they are ready. Have they spent the time getting counseling against relapse? Have they changed friends, and put distance between them and people still using drugs? Do they work around people using drugs? Do they have a chronic pain condition that will require opioids intermittently? If so, what’s the plan to avoid relapse?
– If buprenorphine lasts longer than methadone, don’t be tempted to miss days without telling your counselor what is going on. Some patients on buprenorphine are able to dose three times per week, so talk to your doctor about setting this up instead of missing days on your own.
-DO NOT attempt to divert medication. At one treatment center, we’ve detected many patients trying to “save” part of their dose for later use. I think most are telling the truth, but some are probably selling their medication. I can’t tell who is selling and who is saving doses for later. If we have a problem with patients selling their medication in the community, our treatment program can get a bad reputation in the community and even get closed down. So we have to act on any attempt to divert medication, and at times may even have to dismiss a patient from treatment, which I hate to do. So don’t divert medication.
-Don’t feel bad if buprenorphine doesn’t work for you. No medication works for everyone. If methadone did work, go back to it. Methadone has been around for forty years and has a proven track record.

I’m happy to work for two opioid treatment programs who offer both buprenorphine and methadone. It’s a little more difficult to offer buprenorphine, and the profit margin is likely much slimmer than treatment with methadone, but it’s the state of the art treatment. I fear some methadone clinics are going to get left behind with their “methadone only” mindset. Methadone will always be needed, but now we need to have other choices readily available for patients seeking treatment. Soon, I think we will see opioid treatment centers also offer naltrexone/ naloxone, medications that can prevent opioid relapse in patients who have completed withdrawal from opioids.

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