Archive for the ‘Evidence-based Treatments’ 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

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

aaabenzos

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:

http://ireta.org/sites/ireta.org/files/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.

Inspired at AATOD

aaaaaaatod

I just got back from the AATOD (American Association for the Treatment of Opioid Dependence) conference, and I feel inspired, enthusiastic, and relaxed.

Several days before I left for the conference, I talked to a pregnant patient at one of the opioid treatment programs where I work. This patient, dosing on methadone, said her obstetrician insisted she taper down on her dose during pregnancy. When she told me that, my shoulders slumped with fatigue and disappointment. This was a doctor I’ve called on the phone a few times, and met in person once. We’ve talked collegially, and I physically, personally handed her a copy of ACOG/ASAM (American College of Obstetrics and Gynecology, American Society of Addiction Medicine) position paper on the treatment of opioid-addicted pregnant patients.

Needless to say, that document does NOT advise taper of methadone during pregnancy. When I talked to this obstetrician, I’d explained why we usually need to increase the dose during pregnancy. Yet now she’s telling a patient to lower her dose. This is not best practices.

I felt tired, and hopeless about improving physician education in my area. Do these doctors have Teflon brains, and all the information I’ve been trying to provide keeps sliding off their cortexes, into the ozone somewhere?

Yesterday at the AATOD conference, I heard a lecture by one of the main authors of the MOTHER (Maternal Opioid Treatment: Human Experimental Research) trial, Dr. Karol Kaltenbach. I’ve posted blogs about this trial (see Dec 16, 2010, March 23, 2013), which randomized opioid-addicted pregnant women to treatment with either methadone or buprenorphine. The goal was to compare outcomes of the babies born to moms maintained on methadone versus buprenorphine.

Dr. Kaltenbach opened her lecture by making an excellent point: use of legal drugs such as alcohol and tobacco during pregnancy are viewed as public health problems, even though they cause as much or more harm to the fetus as illicit drugs. Yet the general public demonizes moms who use illegal drugs. Pregnant women who use illegal drugs are faced with harsh moral judgments, and punitive responses.

Alcohol, a legal drug, causes harm to 40,000 kids per year, and is the leading preventable cause of developmental disabilities. Consistently, research shows physical and behavioral effects in the children born to moms who drink alcohol. Even though researchers have stated that there’s no safe amount of alcohol during pregnancy, according to the 2011 NSDUH (National Survey of Drug Use and Health), 9% of pregnant women said they were current drinkers, 2.6 said they were binge drinking, and .4% were heavy drinkers.

Pregnant smokers of tobacco are more likely than non-smokers to have a variety of complications, including spontaneous abortions, placenta previa and placental abruption, retardation of fetal growth, low birth weight babies, and preterm labor and birth. After delivery, the risk of SIDS (Sudden Infant Death Syndrome) is six times higher than for babies of non-smoking moms. Their babies are more likely to have ADHD, inattention disorders, ear and respiratory infections.

Yet newspapers now publish sensational articles about “addicted babies” born to mothers with opioid addiction, while ignoring the more common and more harmful effects of alcohol and tobacco. Remember the “crack baby” scare of the 1990’s, which was a media creation with no backing by science?

From the MOTHER study we learned that babies born to moms on buprenorphine have about the same risk of withdrawal, called neonatal abstinence syndrome (NAS), as babies born to moms on methadone. In both groups, fifty percent of the babies had NAS severe enough to need medication to treat opioid withdrawal. The babies were scored on the Finnegan scale, which grades the babies on many signs of withdrawal to indicate when treatment is needed. (By the way, at the AATOD conference I sat near Loretta Finnegan, creator of the Finnegan scale and internationally recognized for her many contributions to the field of alcohol and drug abuse!)

So in both groups, about half of the babies needed medication for withdrawal symptoms. However, the babies with NAS born to the moms on buprenorphine required 89% less medication (morphine solution) and spent 43% less time in the hospital as compared to the babies with NAS born to moms maintained on methadone. The babies born to moms on buprenorphine also spent 58% less time being medicated to treat their NAS.

That’s a significant benefit.

This study was very important for many reasons, but after these results, buprenorphine is slowly becoming the standard of care for pregnant opioid-addicted moms, if it’s available. True, there was a higher drop out of the moms on buprenorphine, but it was not statistically significant, and the moms didn’t leave treatment; they dropped out of the study for whatever reason.

Now for the exciting part: a supplemental study of these children is being completed. This data hasn’t yet been published, but Dr. Kaltenbach says it will show that kids of moms on methadone and buprenorphine were compared and assessed at three months, six months, twelve, twenty-four, and thirty-six months. A standardized scoring system for infant development called the Bayley Scale was used to study these children, and the groups were compared to scores for normal children.

Dr. Kaltenbach says there are no differences between the babies born to methadone versus buprenorphine, and better yet – both groups showed scores in the normal ranges on this scale. The scale measured things like language and motor skills, cognitive abilities, and conceptual and social skills.

The kids are alright!

This data is going to be a huge comfort to worried moms, dosing on methadone or buprenorphine.

And I got inspired at the AATOD conference. I heard one speaker tell the audience “you do it until they get it. You tell them over and over and over again. Whatever it takes.” And I thought to myself, this is correct. I can’t give up on the obstetricians in my area. Maybe they don’t agree with me, but I am not out on a limb with what I’m saying. It’s backed up with fifty years of studies and science. I am listening and reading information from the experts in the field. I need to be persistent, and keep repeating the data, mailing the data…skywriting the data…whatever.

It’s refreshing to be around people who understand opioid addiction and its treatment. It’s encouraging to hear how workers in the opioid addiction field are finding new ways to help our patients and advocate for them.

I’m going to call this OB – again –and re-inform her – nicely – about what’s found in that position paper, co-authored by doctors from her own specialty. I’m also going to suggest she direct some of her concern towards her patients who use the legal drugs of alcohol and tobacco, since they cause significant harm to infants.

And yes, I know most of the patients enrolled in OTPs also smoke, and I am going to help them with that, too…if they want it.

1. http://www.asam.org/docs/publicy-policy-statements/1-opioids-in-pregnancy—joint-acog-4-12.pdf?sfvrsn=2

2. “Neonatal Abstinence Syndrome after Methadone or Buprenorphine Exposure,” by Hendree Jones, Karol Kaltenbach, et. al., New England Journal of Medicine, December 9, 2010, 363;24: pages 2320-2331.

Methadone Dosing: Use the Evidence

methadone

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.

Certificate of Need for Johnson City, Tennessee, Opioid Treatment Program Denied

aaaaaaaawhy

Warning: this blog contains questions only. No answers.

I was gobsmacked to hear Tennessee’s Department of Mental Health denied the Certificate of Need (CON )for the opioid treatment program proposed for Johnson City, Tennessee.

I just want to know why. Why why why why WHY????

Certificate of need implies that the certificate is granted on the basis of need, which surely cannot reasonably be debated at this point. Thousands of people in Tennessee are addicted to opioids and dying from opioid overdoses and the sequella of addiction to opioids. This we know.

This is from Tennessee’s web page regarding the purpose of the certificate of need: “The CON program serves as a growth management and cost savings tool since it requires certain health providers to establish the need for new services and facilities before the providers will be allowed to build facilities, becomes licensed, or conduct certain business.” (Emphasis added by me) http://tennessee.gov/hsda/cert_need_basics.html

Um…there are no other opioid treatment programs in that part of the state, so denial based on growth management makes no sense. Patients in opioid treatment programs pay their own way, and each dollar they spend in this form of treatment has been shown to save taxpayers an estimated four dollars, mostly in reduced incarceration costs and reduced healthcare costs. It would seem like a no-brainer.

So why did Tennessee’s Department of Mental Health deny this certificate of need? Do they really not see the need for an opioid treatment program?

Was the certificate of need denied due to fears that this particular clinic would not be well-run? If they have specific objections, can they be addressed?

Did they deny based on political pressure alone, but give some lame non-reason for denying the CON? Because a CON shouldn’t be an opinion poll. I think a CON should be based on data.

I get tired of repeating this, but the treatment of opioid addiction with medications, methadone and buprenorphine, is one of the most evidence-based treatments in all of medicine.

How ironic that the day I heard of the CON denial, I got my latest issue of the Journal of Addiction Medicine. (Vol.7 (3) May/June 2013). In it, I read an article by Peles et al, describing yet another study comparing the death rates of opioid addicts in treatment with methadone with opioid addicts on a waiting list to enter treatment with methadone. Their findings were remarkably similar to other studies looking at this same issue.

Those patients on the waiting list had a death rate of 5.0/100 person years, compared with a rate of .42/100 person years for those in treatment on methadone. The authors’ conclusions: “Opiate addicts are at high risk for mortality during prolonged waiting periods for admission to MMT (methadone maintenance therapy), indicating an urgent need for immediate expansion of MMT availability.” (p 177)

I just don’t understand.

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

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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.

Important Meeting In Tennessee!

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Educated and informed people have an opportunity to make an impact on the life expectancies of opioid addicts in Eastern Tennessee!

The Tennessee Health Services and Development Agency is holding a fact-finding public hearing, regarding the certificate of need application for a methadone treatment facility, proposed to be located in Johnson City, Tennessee.

This meeting will be held on May 28th, 5pm, in the Jones Meeting Center, Johnson City Public Library, on 100 West Millard Street in Johnson City, Tennessee.

There’s a desperate need for medication-assisted treatment of opioid addiction in that part of Tennessee. Opioid addicts can get treatment in office-based Suboxone practices now, but as discussed in previous entries on this blog, this can be an expensive treatment. Many addicts don’t have insurance to pay for this treatment, which is then out of financial reach. For other addicts, buprenorphine, being a partial opioid, isn’t strong enough. Methadone can work beautifully for patients who don’t do well on buprenorphine (known to most as Suboxone or Subutex). However, there are no methadone treatment programs in Eastern Tennessee, so a clinic in that area is desperately needed. The nearest in-state clinic is in Knoxville.

People who know methadone works and saves lives need to go to this meeting to be heard. I suspect there will be people there who know next to nothing about methadone who are nonetheless opposed to a clinic. We’ve all met them: people adamantly opposed to methadone even though their brains are uncomplicated with any actual knowledge of methadone. And there will the NIMBYs, the not-in-my-backyard people.

Citizens who know there are scientific studies showing that methadone is an evidence-based treatment shown to save lives need to go and be heard. Tell other people at the meeting about the forty years’ of studies consistently showing that methadone maintenance reduces overdose death rates, improves overall physical and mental health, increases rates of employment, reduces the risk of suicide, dramatically reduces criminal activities of opioid addicts (by a whopping 91%), and reduces the rates of new cases of HIV.

It’s hard to imagine the certificate of need could be denied, but remember attempts to locate a methadone treatment center in Eastern Tennessee have tried – and failed – ten times before. Let’s hope science and reason can win over ignorance and prejudice.

If, like me, you can’t make the meeting, please send a letter to:

Tennessee Health Services and Development Agency
Melanie M. Hill, Executive Director
Frost Building, 3rd floor
161 Rosa Parks Boulevard
Nashville, TN 37243

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