Law Enforcement Behaving Badly

Many law enforcement personnel and members of the legal community resist medication-assisted treatments. They seem to have difficulty letting go of their idea that addiction is a choice that deserves blame, and have a punitive stance towards addicts. I find it difficult to work with these professionals. They have low opinions of addicts who are using drugs, but often have no better opinion of a recovering addict who has sought treatment and is doing well on replacement medications, like methadone or buprenorphine. Law enforcement personnel have ways of letting methadone patients know they are regarded as if they’re still using drugs.

            When I worked at a methadone clinic in the mountains of North Carolina, we had a Tennessee resident, a pregnant woman, who committed a crime before she sought treatment at our methadone clinic. By the time she was sentenced to three months of incarceration, she was seven months pregnant. She asked to begin her sentence after delivering her child and her request was denied by the judge. He said he would cure her addiction by placing her in jail and then, at least, the baby wouldn’t be born addicted to methadone. He had been informed she was in treatment at a methadone clinic in North Carolina.

The patient contacted her counselor at the methadone clinic, in a panic, because she knew she could miscarry if denied methadone.  Opioid withdrawal could even kill her fetus. Her counselor called me and related all of the details.

I was surprised that a judge would make a medical decision like that, and if he did, it was only because he didn’t have information about methadone. I called the judge’s office, but couldn’t get through to him. I explained everything to his clerk, and believed the patient would either be given methadone in jail or have her sentence postponed.

The next day the patient called, and said she was still going to start her sentence in two days, and that the judge hadn’t changed his mind. I called the judge again, and was told the judge wasn’t going to come to the phone to speak with me, the clerk had relayed the message, the mother was going to jail and no, she would not be given methadone.

Now irritated and worried, I composed a letter, detailing the possible medical complications that could occur, as a result of the judge’s uninformed and ill-advised decision, and told him this was a medical decision that should be made by doctors. I described the preterm labor that could occur, if the mother was allowed to go into withdrawal. The fetus may not be able to survive if born at seven months’ gestation. I ended with a plea that no matter what he thought of the mother, the baby at least should be given the best chance for survival. I faxed a copy to the judge and a copy to the patient’s lawyer. Later, I heard she was allowed to deliver a healthy baby boy, prior to beginning her three month sentence.

Recently, I was asked to speak at an addictions conference, in the heart of the Blue Ridge Mountains, about methadone and its use in the treatment of opioid addiction. The speaker who gave a presentation after me was a lawyer with the local drug court. He explained how drug court got addicts, who committed crimes related to drug use, to participate in treatment, rather than just sending them to jail.

During the question and answer session, he was asked if patients on methadone could participate in the drug court program. He said no. When asked why this was, he said that to participate, the addicts must be completely drug free. Another member of the audience asked why this was the case, if methadone was a legitimate treatment and it had been started by a physician.

            The lawyer did not give a clear answer, but turned to the program director of a local outpatient treatment center, sitting in the audience.  The drug court contracts with this outpatient treatment center, to provide the counseling needed for the addicts participating in drug court. This program director said that addicts on methadone couldn’t come to the counseling his center provided because they “would give their methadone to other patients and nod off in treatment sessions.”      

            This was a clear example of the biases methadone patients face. I had just completed a lecture about methadone and had explained how opioid treatment center patients don’t receive take home doses for at least the first three months, and how patients on the right dose are not sedated, unless they use nerve pills or other sedatives. In the above case, both the court and the treatment program were opposed to methadone, and they didn’t have a clear policy on buprenorphine.

            That said, at present, the majority of drug courts don’t allow participants to be on methadone, though methadone has been shown to be very cost effective as well as beneficial to opioid addicts.

            At Rikers Island, in New York City, opioid-addicted prisoners charged with misdemeanors or low grade felonies can be enrolled in a program known as KEEP (Key Extended Entry Program). This program treats opioid addicts with methadone and counseling. Upon release from Rikers Island, these patients are referred to methadone treatment centers in the community. Seventy-six percent have followed through with their treatment, post-release. The results of this program show significant reduction in reincarceration and significant reduction in criminal activity.

            Drug courts would be well-advised to look at the Rikers Island program, for an example of the effectiveness of methadone maintenance. They should also consider the amount of money it can save the community. Studies have shown a cost savings of at least four dollars for every one dollar spent on methadone treatment. This money is saved because methadone patients require fewer days of hospitalization and other healthcare costs, and also because of reduction in criminal activity and incarceration costs. (1)

            Many jails will not dispense methadone to prisoners who are patients in at a methadone clinic, even if they are doing well and on a stable dose. Many times, these patients are allowed to go through a terrible withdrawal. Patients tell me they have been taunted for being ill from withdrawal from methadone, and refused access to medical care. This refusal to treat an illness with an accepted and effective medication has been costly to at least one county in Florida.

            In 1997, an Orange county jail inmate died after being denied her usual dose of methadone. She spent twelve days in withdrawal, before she was found dead in her cell. The family sued the county and won a three million dollar settlement. (2) Then in 2000, a second person died in the very same Orange county jail, under nearly identical circumstances. (3) She had been a patient at a methadone clinic for about five months, before entering the jail. She was denied her medication, and was found unconscious three days later, from an apparent seizure. She was then taken to a hospital, and her family removed her from life support five days later.

            In 2001, Orange County decided to offer methadone to patients who were already established at a methadone clinic, and continue their dosing. They’ve worked out arrangements with a local methadone clinic to provide the necessary methadone. Opioid addicts who are not established in any kind of treatment are treated with a standard opioid withdrawal protocol. Soon, Orange County may begin to use buprenorphine in this jail setting.                                                                                                                                                              More jail facilities would be wise to heed the experience of Orange County.

            In Cook County, Illinois, a man serving a ten day sentence for a traffic violation died of methadone withdrawal on his sixth day of imprisonment. He was an established patient of a methadone clinic, but the jail refused to provide his methadone medication. He made repeated requests for medical attention, but was denied care, despite his obvious physical suffering, witnessed by at least three jail employees. (4) He died of a cerebral aneurysm, as a result of opioid withdrawal. His wife and estate sued the county, for failing to provide timely medical treatment, charging them with deliberate indifference to the suffering of the prisoner. 

I’m glad to see these lawsuits. I’ve heard appalling stories from many methadone patients, who were denied their medication while incarcerated. I’ve heard tales of jailers taunting these prisoners, when they became sick. There is no defense for such cruelty.

            On a positive note, more jails and prisons across the U.S. are beginning to offer access to medication assisted therapies, with both methadone and buprenorphine. Colorado has several counties that coordinate care with local treatment centers. A clinic within Albuquerque’s city detention center offers treatment with methadone. Rhode Island’s department of corrections contracts with a local treatment center, to treat opioid addiction. The jail in Seattle-King County, Washington, plans to offer both methadone and buprenorphine soon.

            Will this country ever become civilized enough to provide appropriate medical care to patients on replacement medications while they are in jail? I hope so. Sadly, it appears that litigation is the only way to get the attention of some jail facilities.

1. California Department of Drug and Alcohol Programs, 2004, California drug and alcohol treatment assessment (CALDATA) California Department of Alcohol and Drug Programs. California Drug and Alcohol Treatment Assessment (CALDATA), 1991-1993 [Computer File]. ICPSR02295-v2. Ann Arbor, MI: Inter-university Consortium for Political and Social Research [distributor], 2008-10-07. doi:10.3886/ICPSR02295
2. “Outrageous: the death of Susan Bennett raises serious questions about the competence and quality of the jail’s nursing staff” Orlando Sentinel, editorial, March 27, 1998.
3. Doris Bloodsworth, “Inmate begged for methadone” Orlando Sentinel July 12, 2001.
4. Davis vs Carter, #05-1695 US Court of Appeals, Seventh Circuit http://openjurist.org/452/f3d/686/davis-v-carter

New Form of Suboxone: Dissolving Film

Yesterday the FDA approved a new delivery system for the medication buprenorphine. Reckitt Benckiser, the drug company that makes the brands Suboxone (a combination pill of buprenorphine and naloxone) and Subutex (containing only buprenorphine), is now approved to manufacture and sell Suboxone in the form of a thin film that is placed under the tongue to be absorbed. According to early studies, patients think the film tastes better, dissolves more quickly, and is easier to use. I don’t yet have any information on the relative cost of this new film.

Since it was just approved, it’s not likely that a generic form of the film will be available for many years.

 This film of buprenorphine, the active ingredient, can’t be obtained as a generic, and it may be a few weeks before it appears in retail pharmacies.

 I’m hoping the sublingual (under the tongue) film will be harder to snort or inject, because there are reports of addicts misusing the Suboxone and Subutex tablets. And every addict misusing the name brands or the generic of buprenorphine who comes to the attention of law enforcement endangers the existence of the buprenorphine program.

 In the past I worried about prescribing Subutex, the form of the drug that doesn’t contain naloxone, or the newer generic buprenorphine, which also doesn’t contain naloxone. But apparently, some addicts are able to inject Suboxone, and the naloxone in it doesn’t put them into withdrawal. At least, they don’t go into intolerable withdrawal.

 It just shows me again that people are so different in the way they react to medications.

Which is better, Suboxone or methadone?

 

Patients often ask which medication is better to treat opioid addiction: methadone or Suboxone? My answer is…it depends.

 First of all, the active drug in Suboxone is buprenorphine, and I’ll refer to the drug by its generic name, since a generic has entered the market. We’re no longer just talking about one name brand.

 The principle behind both methadone and buprenorphine is the same: both are long-acting opioids, meaning they can be dosed once per day. At the proper dose, both medications will keep an opioid addict out of withdrawal for 24 hours or more. This means instead of having to find pain pills or heroin to swallow, snort, or shoot three or four times per day, the addict only has to take one dose of medication. Addicts can get back to a normal lifestyle relatively quickly on either of these medications. Both methadone and buprenorphine are approved by the FDA for the treatment of opioid addiction, and are the only opioids approved for this purpose.

Buprenorphine is safer then methadone, since it’s only a partial opioid. A partial opioid attaches to the opioid receptors in the brain, but only partially activates them. In contrast, methadone attaches to opioid receptors and fully stimulates them, making it a stronger opioid. Because buprenorphine is a partial opioid, it has a ceiling on its opioid effects. Once the dose is raised to around 24mg, more of the medication won’t have any additional effect, due to this ceiling. But with methadone, the full opioid, the higher the dose, the more opioid effect.

 Because buprenorphine is a safer medication, the government allows it to be prescribed in doctors’ offices, but only if the doctor has taken a special training course in opioid addiction and how to prescribe buprenorphine, or can demonstrate experience with the drug. This office-based treatment of addiction has a huge advantage over treatment at a traditional methadone clinic. Treatment in a doctor’s office doesn’t have to follow the strict governmental regulations that a methadone clinic must follow. Methadone clinics have federal, state, and even local regulations they must follow, and patients have to come to the clinic every day for dosing, until a period of months, when take home doses can be started for weekends.

 The law allowing buprenorphine to be prescribed for opioid addicts from offices instead of clinics was passed in 2000. It was hoped that relatively stable opioid addicts would get treatment at doctors’ offices, and addicts with higher severity of addiction would still be treated at methadone clinics.

 But it hasn’t worked out quite like that. Because buprenorphine is relatively much more expensive than methadone, addicts with insurance or money go to buprenorphine doctors’ offices, and poor addicts without insurance go to methadone clinics. Rather than form of treatment being decided by severity of disease, it’s decided by economic circumstance. This means that some of the opioid addicts being treated through doctors’ offices really aren’t that stable, and have been selling their medication, making it a desirable black market drug. Most of the addicts buying illicit buprenorphine have been trying to avoid withdrawal or trying the drug before paying the expense of starting it.

 Treating opioid addicts for the last nine years, I’m continually surprised at how people’s physical reactions to replacement medications are dissimilar. Some patients don’t feel well on buprenorphine, but feel normal on methadone. For other patients, it’s just the opposite. For many, either medication works well.

 Addicts (and their doctors) tend to assume that all opioid addicts will be the same in their physical reactions to these replacement medications, but they aren’t. For example, last week I saw a lady who insisted she’s never had physical withdrawal symptoms from methadone. But most patients find methadone withdrawal to be the worst of all opioids.

 And sometimes I have a patient I expect will do very well on buprenorphine, but they don’t. they feel lousy.

 So the answer to question of which medication is best – buprenorphine is safer, and not as strong an opioid, so it’s the preferred medication. It’s also more convenient, but much more expensive at present. But a great deal depends on the patient, and how she reacts to medications.

 Neither medication is meant to be the only treatment for opioid addiction. Best results are seen when these medications are used along with counseling, to help the addict make necessary life changes.

Interview with a Suboxone Doctor

The following is an interview with one of the first prescribers of Suboxone in Charlotte, North Carolina. Dr. George Hall is an experienced physician, board certified in both Family Practice and Addiction Medicine, who has worked in both fields for many years and helped countless addicts and their families:

JB: What have your experiences been, treating opioid addiction with buprenorphine, or Suboxone?

GH:   It’s been pretty incredible from day one…….watching people, and the difference it’s made in their lives, when they come on buprenorphine.

JB: Of the patients you’ve started on buprenorphine, what percentage would you say improved on it?

GH: Ninety-plus percent, I would think. You’ll have the occasional patient who doesn’t come back, and an occasional patient who can’t afford it, but there’s not many that stand out in my mind through the years [who have done poorly with buprenorphine].

JB: Can you describe how you decide to do a detoxification with a patient on buprenorphine, versus keeping the patients on it for longer, and what your experiences have been?

GH: The people I detox on buprenorphine are the ones who have to come off of it in a short period of time. They say, “I want off by one month or two months or three,” and generally those people actually change their mind over a period of time, as they see their life getting better.

So, most of the time, it’s patient-driven. As you know, the data for opiate dependency shows that this population just doesn’t seem to do very well. Perhaps that’s the reason I have such a positive feeling about buprenorphine. We’ve used it for maintenance, since day one, in a lot of patients, and those are the people whose lives you see continue to change over a long period of time.

JB: Are there any problems that you’ve seen with buprenorphine?

GH: I think the problem with buprenorphine is similar to the problem with methadone …we see these people getting extremely well. They don’t get euphoric, but they’re not ill any longer. They’re able to function, they’re able to sleep. It’s a long-acting medication that allows them to have a normal day. When they’re out on the street or they’re buying from the internet or they’re going to multiple doctors, they just don’t have normal days.

So is that a problem? Only if you define any sort of recovery as abstinence-based. But, if you’re defining recovery as improvement in quality of life, not using other substances, able to hold jobs, able to have families and interact with families, treat their depression, then these people do extremely well.

But…I think the problem for me is…..once they begin to do so well, it’s just like with anything else, whether it’s an alcoholic or a cocaine addict or a marijuana addict that’s been in recovery for a period of time. The acuity of the disease drops in the patient’s mind, and it seems like they think, “I’m cured,” and “I’m just normal now so I don’t need to do other things. I don’t need to go to NA meetings. I don’t need counseling. Why do you keep pushing me to do this, because I haven’t used in two years? I’m doing great.”  Whether this is the disease talking to them or it’s just part of life…

And that’s what I see with any addiction…the disease itself says you don’t have a disease, whether it’s alcohol dependency or opiate dependency, and perhaps we see that even more with opiate dependency. We see that on maintenance therapy.

JB: If you had an opiate addicted patient who had unlimited money, time, willingness, and resources, what treatment would you recommend first? If they were addicted only to opiates?

GH: When I think about that question, I think about gold standards of treatment. The people who have the highest recovery rates are professionals. Physicians in North Carolina have over a ninety percent recovery rate at five years. It’s not because they’re physicians, it’s not because they’re brilliant, it’s because they’re made to do a lot of stuff to help convince them they have an illness, and to treat it as an illness on an ongoing basis. They are made to do at least twenty-eight days, to three months, to six months of inpatient treatment, most of them from the beginning. If we had an IV opiate-addicted anesthesiologist, [he would get] probably at least twelve weeks of inpatient treatment, monitoring, and perhaps even a job change. So [addicted doctors] do extremely well. Not that they have unlimited funds, but if they want to remain a physician, they have to do certain things.

So that kind of brings me around to what you’re asking. If money were no object, I would think fairly long term – two to four months of inpatient treatment, with a slow detox with something such as buprenorphine, which is a very soft detox compared to some of the ones we’ve used in the past – followed up by intensive group therapy,  and then getting them involved in 12-step recovery programs. And after we bring them out of inpatient treatment, [they would get] some sort of follow up over a period of one to two years if we are looking at unlimited funds, and the willingness to do that. Which isn’t practical in the general population.

JB: Because of the expense and time?

GH: Because of the expense and the time we have.

Methadone Clinics Behaving Badly

Not all methadone clinics are equal. We know what qualities are associated with the best outcomes, and hopefully every clinic is trying to improve.

First, many clinics should be called “opioid treatment centers,” because they offer more than methadone; they also prescribe and dispense buprenorphine. In the future, buprenorphine will likely be the first line treatment for opioid addiction replacement medication, with methadone saved for people who don’t do well on buprenorphine, usually because it’s not strong enough. In the very near future, buprenorphine may replace methadone as the treatment of choice for opioid-addicted pregnant patients.

Besides the ability to offer buprenorphine, the best clinics have well-trained staff with low turnover. This seems obvious. It’s difficult for a patient to participate in counseling with enthusiasm when they’ve had three different counselors within four months. Sadly, this is an area of counseling that has difficulty retaining counselors.

 And while we always need to be open to learn from our patients, a counselor should already know the basics about opioid addiction and its treatment with replacement medications before he sees the first patient. I’ve heard the occasional counselor voice doubts about the benefits of replacement medications. If the counselor can’t wholeheartedly support their patients, they need to go back and read the basic research, or move on to a different field. An ambivalent and uninformed counselor can taint the treatment milieu at an otherwise good clinic.

Doctors prescribing the methadone or buprenorphine should be willing to give adequate doses. Clinics who were stingy with dosing had worse patient outcomes in many studies. In the past, clinics were reluctant to dose above 60 or 70mg, but we know now that patients do better at adequate doses, and there’s a wide variation between patients as to what’s an adequate dose. Most patients stabilize on between 80 to 120mg, but some need much more and some need much less. Cookie cutter dosing isn’t best practice.

Counselors shouldn’t have overwhelming caseloads. The regulations say each counselor should have no more than 50 patients, but even that’s too many with the growing documentation requirements.

Clinics shouldn’t let a few patients, not doing well and causing chaos in the community, to remain in the clinic, dosing daily with methadone or buprenorphine. The reputation of opioid treatment centers is too important and too fragile. In many communities, laws have been passed to limit the number and type of drug addiction treatment centers, because of the community’s perception that the patients will create havoc locally. In reality, very few patients behave like this, but the ones that do create the illusion that all patients will drive while impaired, or shoplift at local stores. Some patients are too sick or too unwilling to do well at an opioid treatment center. These centers owe it to their other patients and their community to refer patients doing poorly to other options.

Now for the number one most important factor that determines how well a patient will do while in treatment at an opioid treatment center…a warm and empathetic relationship with treatment center staff. This means all staff, not just their counselor. It includes the nurses and doctors and clerical staff.

It appears that behavioral change with addiction is more likely to occur when the people trying to help are caring and compassionate.

What an epiphany of the obvious.

Buprenorphine, Part 2

Changing a patient’s medication from methadone to buprenorphine is trickier than from other opioids, because of methadone’s long duration of action. Patients need to stop the methadone at least seventy-two hours before starting buprenorphine. Since methadone is also a much stronger opioid, the patient should be stable on methadone forty milligrams per day or less. Otherwise, dropping from a higher dose of methadone to buprenorhpine often leaves the patient with feelings of low-grade withdrawal for the first few weeks of buprenorphine.

I’ve had a few strongly motivated patients make the switch from higher doses of methadone than I would recommend, to buprenorphine. One patient was dosing at 70mg of methadone, stopped it for about five days, and then started buprenorphine. He didn’t have a very pleasant first week. I worried it would be too difficult, but he did it. By two weeks he felt pretty good, and he’s done great for the last three years, on a relatively low dose of buprenorphine. Because he also has chronic back pain, he’s decided to stay on buprenorphine as the best solution to both his chronic pain and opioid addiction.

Because buprenorphine is a partial opioid agonist, there’s a ceiling on its effects. This is why it’s now permitted to be prescribed through a doctor’s office, without all the regulations that methadone clinics have. After the buprenorphine dose reaches twenty-four (some say thirty-two) milligrams per day, further increases in the dose have no additional effects. This makes the drug much more resistant to overdoses. However, if mixed with sedatives like benzodiazepines (Xanax, Valium) or alcohol, it can still be fatal.

 Most patients say they “just feel normal,” after taking buprenorphine. When the drug works, many patients have returned to my office on the second visit saying, “It’s a miracle!” They say they feel just like they did before they got addicted. They don’t think about pain pills, don’t feel withdrawal, and don’t feel like they’re medicated. Patients who have been on both methadone and buprenorphine say the methadone is heavier, and they feel medicated, but on buprenorphine they feel lighter.

A dose of buprenorphine can stimulate opioid receptors anywhere from twenty-four to sixty hours, so some patients feel stable when they dose only every other day, though I think overall best results are seen with stable daily dosing. There is no impairment of thought processes or motor function in patients on a stable dose of buprenorphine. These patients can drive, work, and play with no limitations.

I try to temper patients from being overly enthusiastic about buprenorphine. Sometimes patients feel so good on this medication, they don’t realize how much psychological work needs to be done before they can taper and stay off of buprenorphine. Patients feel so good, they minimize their addiction, and are reluctant to get the counseling they need. One of my doctor friends says that the drug’s main problem is that it works so well.

Buprenorphine is ideal for patients with opioid addiction who have lower tolerances, who have relatively stable lives, or who have been using for shorter lengths of time. Buprenorphine is a better drug than methadone for patients who have been addicted less than one year, because methadone is more difficult to stop, once it’s started, for most patients.

 Buprenorphine has the same side effects as other opioids: constipation, sweating, decreased libido (sex drive), and possible weight gain. Usually, these side effects are much less pronounced in patients taking buprenorphine than in patients taking methadone. Unlike methadone, there is no increased risk for fatal heart rhythms, because it doesn’t affect the QT interval. Most patients do complain about the bad taste of the sublingual tablets.

 Buprenorphine doesn’t seem to cause lasting damage to the body, even if it’s continued indefinitely, though elevated liver function tests can be seen in some patients. Liver function blood tests should be checked periodically in patients who are infected with hepatitis C or B.

Buprenorphine can be fatal if taken by children. It can also be fatal in adolescents or adults not accustomed to opioids. Patients should always store their medication safely out of reach, and with a child proof cap. Since buprenorphine is absorbed through the oral mucosa, if a child puts a tablet in his mouth, some can be absorbed, even if the pill is retrieved fairly quickly. Any handling of a Suboxone pill by a child should be viewed as a possible overdose, and the child must be taken to the hospital emergency room immediately.

Why do people snort buprenorphine? I don’t know. I don’t think there’s any difference in the rate of absorption. If anything, buprenorphine probably crosses the thin mucus membranes of the mouth much more quickly than the thicker skin of the nasal mucosa. I suspect people who snort Suboxone and generic buprenorphine are actually more addicted to the act of snorting, rather than getting any true pharmacologic benefit (“high”) from snorting. That’s on my list of things to ask the Suboxone rep to find out for me. Anyone reading this have ideas about why people snort Suboxone?

More Information about Buprenorphine

Buprenorphine, commonly known by the brand name Suboxone, is an exciting new option for opioid addicts seeking help, and for the doctors who treat them. For the first time in nearly one hundred years, people with the disease of opioid addiction can be treated in the privacy of a doctor’s office. Addicts no longer have to go to special clinics to get medication for their disease. Since many opioid addicts don’t live near a methadone clinic, or live near a methadone clinic that has a six month wait for admission, or wouldn’t be caught dead in a methadone clinic due to the stigma, buprenorphine is a fresh option.

Congress passed the Drug Addiction Treatment Act of 2000 in order to allow the treatment of opioid addiction in office-based practices, instead of the more cumbersome methadone clinics. In 2002, the FDA approved buprenorphine as the first schedule III controlled drug that could be used under the DATA 2000 Act. The drug became available in pharmacies in 2003. Thus far, buprenorphine is the only medication that’s approved by the FDA to treat opioid addiction in a doctor’s private office.

 The Supreme Court’s interpretation of the Harrison Drug Act of 1914 made it illegal for physicians to prescribe opioids from an office setting for the treatment of opioid addiction, and it remained illegal until DATA 2000 was passed. DATA 2000 was therefore quite remarkable for the change of attitude it showed on the part of government policy makers. It showed an open mindedness rare in the history of addiction treatment in the U. S.  For the first time in more than eighty years, the government was not only granting permission for appropriately trained and licensed office-based doctors to prescribe controlled substances to treat opioid addiction, but they were actually encouraging it. However, buprenorphine still has special restrictions on its use.     

  In order to prescribe buprenorphine to treat addiction, a physician must have a special DEA number, called an “X” number. To get that number, the physician must attend an eight hour training course to learn about opioid addiction and its treatment with buprenorphine. After a doctor is qualified by training, she can then apply to the Substance Abuse and Mental Health Services Administration (SAMHSA) for a waiver from the regulations of the Controlled Substances Act. If granted, this means the physician doesn’t have to meet all of the conditions and regulations of traditional opioid addiction treatment centers (methadone clinics).

 The doctor must certify she has the capacity to refer patients for counseling in addition to prescribing buprenorphine, and cannot treat any more than thirty patients at any one time. After SAMHSA grants the waiver, the DEA gives the doctor a special DEA number, to be used only for patients who are being treated for addiction. After one year, the doctor may apply for permission to treat up to one hundred patients at any given time.

 By September of 2009, nearly 24,000 physicians were trained to prescribe buprenorphine, but only around 19,000 of these doctors applied and received their DEA number to prescribe buprenorphine. Only 3,685 doctors applied for permission to treat up to one hundred patients. By 2009, around 500,000 patients were receiving buprenorphine prescriptions. (1) About twenty-seven percent have been on tapering detoxification schedules and the rest, seventy-three percent, have been on a maintenance schedule. (2)

Recently, there has been a trend toward using buprenorphine as a maintenance medication, rather than for a relatively quick detoxification, as studies are showing greater benefit with longer use. One large study being performed specifically on prescription opioid addicts showed very high relapse rates (96%) if buprenoephine is tapered after only four months of fairly intense counseling. (3) As this study procedes, we’ll get more information about what duration of treatment is ideal with buprenorphine.

  Just as with methadone, the medication alone rarely is enough to get the patient into successful long term recovery. Buprenorphine is not meant to be a stand-alone treatment, but must be combined with some sort of counseling. According to the government regulations, the prescribing physician must have the capability to refer the patient for counseling, though it doesn’t specify the type or intensity of the counseling.

 Buprenorphine is an opioid. If it’s stopped suddenly, a typical opioid withdrawal will begin within several days. Addicts (and their doctors and families) want a pill that cures opioid addiction, but has no withdrawal symptoms if stopped, but that’s not how this medication works.

 Buprenorphine treats the physical symptoms for as long as the drug is taken, and reduces mental obsession for opioids. Most patients say buprenorphine withdrawal is somewhat milder than withdrawal from other opioids, but a small number say it’s worse. A few patients have said they felt no withdrawal after stopping it. If a patient wishes to be taken off buprenorphine, the dose should be reduced gradually, as some patients tolerate a faster taper than others. Patients appear to vary widely in their ability to tolerate buprenorphine taper.

 Buprenorphine works because of its unique pharmacology. Buprenorphine, like methadone, is a long-acting opioid. This means both drugs prevent withdrawal for at least twenty-four hours, which makes them ideal to use as opioid replacement medications.

 Buprenorphine is a partial opioid agonist. This means that while it activates the opioid receptors in the body, it does so less vigorously than full agonists like morphine, methadone, or oxycodone. People usually experience it as an opioid, but in those already addicted to opioids, it doesn’t cause a high or euphoria. If someone has never taken opioids, buprenorphine will cause a high, but tolerance develops quickly to that effect.

 Buprenorphine has great affinity for the opioid receptors, which means it sticks to them like glue. If any other opioids are in the body, buprenorphine will kick them off the opioid receptors. Because it’s a weaker opioid, this can put the patient into relative withdrawal. Therefore, to start buprenorphine successfully, it’s important for the patient to be in at least moderate opioid withdrawal. This is very important, for if an opioid addict takes buprenorphine while he is taking another opioid, he will suddenly feel terrible, and have what is called precipitated withdrawal, the sudden onset of opioid withdrawal symptoms. Most addicts want to avoid that awful feeling at all costs. Some physicians, not knowing about the need to be in withdrawal before starting this medication, have put their patients into precipitated withdrawal by starting Suboxone too early.

To Be Continued

1. Clark, H. Westley, M.D., J.D., MPH, CAS, FASAM, Director of Center for Substance Abuse Treatment and Mental Health Services Administration, Keynote address, component Session 6,  American Society of Addiction Medicine’s Course on the State of the Art in Addiction Medicine, Washington, D.C., October 24, 2009
2. John Renner, MD, “Educational Status Report” lecture at American Society of Addiction Medicine, component session IV 905, New Orleans, LA, May 1, 2009.
3. Weiss, R, information from National Drug Abuse Treatment Clinical Trials Network Prescription Opioid Addiction Treatment Study, presented at the American Paychiatric Association Annual Meeting,  May 2010 New Orleans, LA

Urine Drug Screens for methadone and Suboxone (buprenorphine)

Many patients who are prescribed methadone or buprenorphine (better known to some as Suboxone) are concerned about their employment drug screens. Because of the stigma attached to opioid addiction and its treatment with methadone or buprenorphine, patients don’t want their employers to know about these medications, and thus about their history of addiction.

Most companies who do urine drug screening hire a Medical Review Officer (MRO), who is a doctor specifically trained to interpret drug screen results. This doctor is a middle man between the employer and the employee, and though this doctor may ask for medical information, and information about valid prescriptions, this doctor usually can’t tell the employer this personal information. The MRO reports the screen as positive or negative, depending on information given to her.

Most employment urine drug screens check for opiates, meaning naturally-occurring substances from the opium poppy, like codeine and morphine. Man-made opioids like methadone, buprenorphine, and fentanyl, to name a few, won’t show as opiates on these drug screens.

A few employers do drug screening that specifically checks for hydrocodone or oxycodone. This is infrequent. It’s rare for employers to screen for methadone, and they almost never screen for buprenorphine, unless the patient is a healthcare professional being monitored by a licensing agency. The screen for buprenorphine is pricey, so the only doctors who tend to screen for it regularly are the ones prescribing buprenorphine. These doctors want to make sure their patients are taking, not selling, their medication.

Patients ask if they should tell their employer they are on methadone or buprenorphine. In general, that’s probably a bad idea, unless it’s a special situation. So long as you can do your job safely, your medical problems aren’t any of your boss’s business.

The only exceptions to this are if you work in a “safety sensitive” job. This includes medical professionals, transit workers, pilots, and the like. These jobs may require disclosure of medical issues to protect public safety. For example, to get a commercial driver’s license (CDL), you have to be free from illnesses which may cause a sudden loss of consciousness behind the wheel.

The Dept. of Transportation still says that if you are taking methadone for the treatment of addiction, you can’t be granted a CDL. However, most of the studies done on methadone-maintained patients shows their reflexes are the same as a person not on methadone, so there’s no real scientific reason for the DOT’s decision. (1, 3, 4) Besides, since the urine drug screen for a driver’s physical doesn’t include methadone, they won’t know unless you tell them.

Patients can be impaired, and unable to drive safely, if they have just started on methadone, haven’t become accustomed to it, or are on too high a dose. These patients shouldn’t be behind the wheel until they are stable, even in a car, let alone an 18-wheeler. Methadone patients are likely be impaired and unable to drive if they abuse benzodiazepines. They shouldn’t drive any kind of vehicle. Ditto for alcohol. (2, 5)

1. Baewert A, Gombas W, Schindler S, et.al., Influence of peak and trough levels of opioid maintenance therapy on driving aptitude, European Addiction Research 2007, 13(3),127-135. This study shows that methadone patients aren’t impaired at either peak or trough levels of methadone.

2. Bernard JP, Morland J et. al. Methadone and impairment in apprehended drivers. Addiction 2009; 104(3) 457-464. This is a study of 635 people who were apprehended for impaired driving who were found to have methadone in their system. Of the 635, only 10 had only methadone in their system. The degree of impairment didn’t correlate with methadone blood levels. Most people on methadone who had impaired driving were using more than just methadone.

3.Cheser G, Lemon J, Gomel M, Murphy G; Are the driving-related skills of clients in a methadone program affected by methadone? National Drug and Alcohol Research Centre, University of New South Wales, 30 Goodhope St., Paddington NSW 2010, Australia. This study compared results of skill performance tests and concluded that methadone clients aren’t impaired in their ability to perform complex tasks.

4.Dittert S, Naber D, Soyka M., Methadone substitution and ability to drive. Results of an experimental study. Nervenartz 1999; 70: 457-462. Patients on methadone substitution therapy did not show impaired driving ability.

5.Lenne MG, Dietze P, Rumbold GR, et.al. The effects of the opioid pharmacotherapies methadone, LAAM and buprenorphine, alone and in combination with alcohol on simulated driving. Drug Alcohol Dependence 2003; 72(3):271-278. This study found driving reaction times of patients on methadone and buprenorphine don’t differ significantly from non-medicated drivers; however, adding even a small amount of alcohol (.05%) did cause impairment.

Suboxone, the “Miracle” Drug

The patient quoted in the Suboxone success story, printed in this blog over the last few days, obviously has a healthy recovery on buprenorphine, and plans to continue his present recovery program. He goes regularly to Narcotics Anonymous meetings, has a sponsor, works the twelve steps of recovery, and contributes to NA by sponsoring people and doing other service work. He had such a good outcome, because he didn’t neglect the psychological aspect of his recovery, even after Suboxone took away the physical withdrawal symptoms.

For the patients I treat with buprenorphine, the most challenging part is coaxing, coercing, and cajoling patients to get some sort of counseling. Whether they go to an individual counselor, pastoral counselor, or to 12-step meetings doesn’t matter to me. I’d love to be able to send them to local intensive outpatient treatment centers, but as will be discussed later, most of these centers require the patient be off buprenorphine completely, before they can enter treatment, which can create a curious circle of relapse. Fortunately, I know good counselors, knowledgeable about addiction and its treatments, willing to see my buprenorphine patients. They markedly benefit from this individual counseling, though group settings can give patients insights they won’t get any other way.

When buprenorphine was first released, the addiction treatment community and opioid addicts had very high hopes for this medication. Many patients say, “It’s a miracle,” on their second visit, after they‘ve started the medication. Most patients are surprised they don’t feel high, and don’t have any withdrawal symptoms.

However, it’s really not a miracle drug. It’s still an opioid, and though it’s weaker than other opioids, some patients have extreme difficulty when they try to taper off of this medication. One can read postings on internet message boards that describe the difficulty some patients have.

In my own practice, I’ve had some patients who stopped buprenorphine suddenly, and claim they had no opioid withdrawal symptoms. At the other extreme, I’ve had patients who wean to Suboxone one milligram per day and say they get a terrible withdrawal, if they go a day without even this one milligram. I’ve had many patients who gradually cut their dose on their own, until they take the medication every other day, and gradually stop it.

Patients appear to differ widely in their abilities to taper off buprenorphine. Some patients are dismayed to discover it’s just as hard to taper off of Suboxone, and stay off opioids, as it is to taper off methadone and stay off opioids.

If it’s appropriate to consider tapering a patient off of buprenorphine, best results are seen if the taper is done slowly. In the past, I have informed patients who wished to taper completely off buprenorphine that addiction counseling improves outcomes, and reduces relapse rates, but this may not be true.

Information presented at the American Psychiatric Association’s 2010 conference calls that advice into question. In a study of over six hundred prescription opioid addicts, relapse rates were remarkably high when patients were tapered over the course of one month, after two months of stabilization. (2) The addition of fairly intensive addiction counseling didn’t improve relapse rates. In the treatment as usual group, prescription opioid addicts met weekly with their doctors, and after their taper, ninety-three percent had relapsed within four weeks. Even in the group getting doctor visits plus twice- weekly one hour counseling sessions, ninety-four percent relapsed within the first four weeks after buprenorphine was tapered. This was the largest study done so far, specifically on prescription opioid addicts, as opposed to heroin addicts. The overall message from initial results of this study seems to be that adding fairly intense drug counseling doesn’t improve patient outcomes, if the buprenorphine is tapered off within the first three to four months.

Once a patient is on buprenorphine and doing well, he or she often becomes very reluctant to participate in counseling, or even 12-step meetings. Once patients feel physically back to normal, they begin to minimize the severity of their addiction, and don’t think they need any counseling.

Some patients admit they need counseling, but say they can’t afford it. This is a valid excuse, because counseling sessions can cost around a hundred dollars each. Private counselors usually like to see their patients weekly, so that’s an additional four hundred dollars per month that patients need to pay. Even patients with insurance are allowed only a limited number of sessions. Those without insurance have great difficulty affording counselor fees on top of all the other expenses, like doctors’ visits, drug screens, and medication. Patients have fewer valid excuses for not participating in Narcotics Anonymous or Alcoholics Anonymous, since they’re free, and located in nearly every city or town. I have more patients who will go to these meetings.

1. Amass L, Bickel WK, “A preliminary investigation of outcome following gradual or rapid buprenorphine detoxification” Journal of Addictive Disease, 1994; 13:33-45.
2. Weiss RD, The American Psychiatric Association 2010 Annual Meeting: Symposium 36, presentation 4. Information from the National Drug Abuse Treatment Clinical Trials Network Prescription Opioid Addiction Treatment Study, May 23, 2010, New Orleans, LA.

Suboxone Patient’s Success Story, continued

XYZ:My brother had enough faith in me that it was worth the risk of starting this business [that he has now] together. I spent hours setting up a company in a ten foot by twenty foot room above my house. 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 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 a tee-shirt 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.