Archive for the ‘Suboxone’ Category

The MOTHER trial – New Information about Buprenorphine and Methadone in Pregnancy

 The long-awaited MOTHER trial is done, and the data just published. (1) MOTHER (Maternal Opioid Treatment: Human Experimental Research) was one of the first studies to follow pregnant opioid-addicts during pregnancy and up to 28 days after they delivered their babies.

 The purpose of the study was to compare the use of buprenorphine during pregnancy with the use of methadone. For the past forty years, methadone has been the treatment of choice for opioid-addicted pregnant women. This is because it prevents withdrawal in the mother and fetus. With short-acting, illicit opioids like heroin or OxyContin without the time release coating, the mother and baby get high peaks of opioid followed by periods of withdrawal.

 Healthy adults get very sick while in withdrawal, but they usually don’t die. However, the developing fetus can die during opioid withdrawal, and miscarriage or preterm labor are more likely to occur. Methadone, since it’s a long-acting opioid, can keep both mother and baby out of withdrawal for twenty-four hours, when properly dosed. Compared with opioid-addicted mothers left untreated, or treated with non-opioid means, methadone-maintained mothers have fewer complications, better prenatal care, and higher birth weight babies.

 Now for the bad part: about half of the infants born to moms maintained on methadone have opioid withdrawal symptoms. No one wants to see a newborn having symptoms of opioid withdrawal. And yet, it’s still better than the alternatives.

 But now, it appears that the use of buprenorphine during pregnancy gives as much benefit as methadone, but less severe withdrawal in the newborns. The percentage of babies with opioid withdrawal was similar in the methadone and buprenorphine groups, but the severity and duration of the babies’ withdrawal were markedly less.

 If a woman addicted to heroin or pain medications discovers she’s pregnant, her best choice is to get into treatment with buprenorphine. But if that’s not available, methadone is still better than other alternatives.

 1. “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.

Tennessee, the State of Malignant Denial

 

For the last ten years, local officials in the small towns of Eastern Tennessee have been denying the presence of opioid addiction in their midst. Ironically, as the map shows, Eastern Tennessee has one of the very highest rates of opioid addiction in all of the U.S.

National Survey of Drug Use and Health

   

Over the last ten years, various treatment centers, wanting to treat these addicts with methadone and/or buprenorphine programs, have tried to open in this area. In a show of NIMBY (Not in My Back Yard), town officials vote for zoning changes meant to make it essentially impossible to get approval to open such clinics. Tennessee officials say it will bring drug addicts to the area.

From the Kingsport, Tennessee Times-News, 3/18/09,

“The Church Hill Board of Mayor and Aldermen unanimously approved the first reading Tuesday of an ordinance which, in essence, makes it almost impossible for a methadone clinic to locate within the city limits.

Earlier this month, the Planning Commission recommended the ordinance, which restricts methadone clinics and drug treatment facilities to areas of the city that are zoned M-1 (manufacturing). Without the ordinance, methadone clinics and drug treatment facilities would be permitted in any area of the city zoned to allow medical uses.”

“I think we’re all in the consensus that we don’t want it anywhere,” the alderman said (name deleted).

Similar laws have been passed in Johnson City, Tennessee.

So what happens to untreated pain pill addicts?

There aren’t any studies following pain pill addicts long-term, but we do have studies of heroin addicts.

They die.

Methadone maintenance has been shown to reduce death rates by factors ranging from three fold to sixty-three fold. (1, 2, 3, 4, 5, 6)

In one study, heroin addicts enrolled in methadone treatment were one-quarter as likely to die by heroin overdose or suicide as were heroin addicts not in methadone treatment. This study followed 296 heroin addicts for more than 15 years. In another study, a group of heroin addicts were followed over twenty years. One-third died within that time. Of the survivors, 48% were enrolled in a methadone program for treatment. The authors of the study concluded that heroin addiction is a chronic disease with a high fatality rate, and that methadone maintenance offered a significant benefit.

We suspect, but don’t know for sure, that pain pill addicts will have similar rates of death, since both groups are addicted to opioids. Studies are being done now, following pain pill addicts to see if their outcome will be similar to heroin addicts.

The young addicts of Eastern Tennessee are paying a heavy price for the denial of local officials.

  1. Caplehorn JR, Dalton MS, et. al., Methadone maintenance and addicts’ risk of fatal heroin overdose. Substance Use and Misuse, 1996 Jan, 31(2):177-196. In this study of heroin addicts, the addicts in methadone treatment were one-quarter as likely to die by heroin overdose or suicide. This study followed two hundred and ninety-six methadone heroin addicts for more than fifteen years.
  2. Clausen T, Waal H, Thoresen M, Gossop M; Mortality among opiate users: opioid maintenance therapy, age and causes of death. Addiction 2009; 104(8) 1356-62. This study looked at the causes of death for opioid addicts admitted to opioid maintenance therapy in Norway from 1997-2003. The authors found high rates of overdose deaths both prior to admission and after leaving treatment. Older patients retained in treatment died from medical reasons, other than overdose.
  3.  Goldstein A, Herrera J, Heroin addicts and methadone treatment in Albuquerque: a year follow-up. Drug and Alcohol Dependence 1995 Dec; 40 (2): p. 139-150. A group of heroin addicts were followed over twenty years. One-third died within that time, and of the survivors, 48% were on a methadone maintenance program. The author concluded that heroin addiction is a chronic disease with a high fatality rate, and methadone maintenance offered a significant benefit.
  4. Gronbladh L, Ohlund LS, Gunne LM, Mortality in heroin addiction: Impact of methadone treatment, Acta Psychiatrica Scandinavica Volume 82 (3) p. 223-227. Treatment of heroin addicts with methadone maintenance resulted in a significant drop in mortality, compared to untreated heroin addicts. Untreated addicts had a death rate 63 times expected for their age and gender; heroin addicts maintained on methadone had a death rate of 8 times expected, and most of that mortality was from diseases acquired prior to treatment with methadone.
  5. Scherbaum N, Specka M, et.al., Does maintenance treatment reduce the mortality rate of opioid addicts? Fortschr Neurol Psychiatr, 2002, 70(9):455-461. Opioid addicts in continuous treatment with methadone had a much lower mortality rate (1.6% per year) than opioid addicts who left treatment (8.1% per year).
  6. Zanis D, Woody G; One-year mortality rates following methadone treatment discharge. Drug and Alcohol Dependence, 1998: vol.52 (3) 257-260. Five hundred and seven patients in a methadone maintenance program were followed for one year. In that time, 110 patients were discharged and were not in treatment anywhere. Of these patients, 8.2% were dead, mostly from heroin overdose. Of the patients retained in treatment, only 1% died. The authors conclude that even if patients enrolled in methadone maintenance treatment have a less-than-desired response to treatment, given the high death rate for heroin addicts not in treatment, these addicts should not be kicked out of the methadone clinic.

Buprenorphine implants – study results

This week I read an article in the latest issue of the Journal of the American Medical Association describing the results of a randomized controlled trial comparing implantable buprenorphine compared to placebo. Buprenorphine implants are four (five for some patients) small cylinders, inserted just under the skin of the upper inner arm. They are each about an inch long, and release medication up to about six months.

Buprenorphine (brand names Suboxone or Subutex) works well for the treatment of opioid addiction, but only if the patient takes it every day. Like other doctors, I have some patients who occasionally stop taking buprenorphine, so they can use illicit opioids to get high. This problem is eliminated with buprenorphine implants, because the patient receives a steady level of buprenorphine for as long as the implants are in place.

The other problem with Suboxone tablets has been its diversion from patients to the black market. Granted, it’s the safest opioid on the streets, given the ceiling on its opioid effect, but diversion to the black market isn’t desirable to doctors or law enforcement. But the implants, for obvious reasons, can’t be diverted, or at least would be extremely difficult to divert.

In this trial of the buprenorphine implants, patients were randomized to receive either placebo implants or buprenorphine implants. The patients and study evaluators didn’t know who had placebo implants and who had the real thing.

The results surprised no one. The buprenorphine implants were much more effective than the placebo implants. Patients with buprenorphine implants were retained in treatment longer and used less illicit opioids, both at week 16 and week 24. After six months, the implants were removed. The implants were fairly safe, with main problems being related to pain, swelling, or infection at the implant site. In the buprenorphine group, most common side effects compared to placebo were headache and insomnia.

This study is hopeful, but of course the real question is how do buprenorphine implants compare to the sublingual (under the tongue) Suboxone tablets and film? More studies are on the way. But for patients I worry might stop their Suboxone to relapse now and again, and in patients I worry might sell their Suboxone, these implants will be a good option when they become available.

Film Review: Suboxone

I had a chance to get more information about the new Suboxone film. I’ve decided I like it. It looks like one of those Listerine breath strips, and dissolves like one, too. When placed under the tongue, it dissolves faster than the tablets, but the taste is apparently about the same. The drug company’s representative brought me an inert (no active drug) film that’s supposed to taste exactly like the real thing. It was orange-flavored and bitterly sweet. While not terrible, it wasn’t tasty. But it was bearable. It dissolved very quickly, an advantage over the tablets.

I was concerned that my patients on 4mg or 12mg couldn’t use these films, as I heard they couldn’t be cut. But the drug company rep said the drug was evenly distributed on the film. Though the company’s official position was the film shouldn’t be cut into halves or fourths, it would probably work.  But she also reminded me that the drug company also says that about the tablets, but my patients use half-tabs frequently with no ill effects.

I don’t see any way the film can be snorted, though some creative and intelligent addict will probably find a way.

The films are contained in individual sealed pouches. Each pouch from the same box has the same number on it, meaning it would be very difficult to “fake” a pill (film) count if the doctor asked a patient to return to the pharmacy to make sure the appropriate amount of medication remains. If films from another box are substituted to make the count right, they will have different numbers. Very clever of the drug company. Oh, and the rep said the film would cost the same as the Suboxone tablet.

The film is available in pharmacies willing to stock it. If you are on Suboxone and want to try the film, be sure to ask your pharmacy to order it a few days before you think you will want to fill a prescription, to make sure they’ll have it.

I hope this delivery form is easier for patients and harder to divert or snort.

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.

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

Prescription Monitoring Programs

Most states now have electronic databases containing patient information, available to physicians, of all prescribed controlled substances, the date they were picked up at the pharmacy, and the prescribing physicians. The federal government has strongly encouraged states to form these databases to prevent patients from “doctor shopping.” The idea is that every physician will check this database before writing prescriptions for pain pills or other controlled substances, to make sure the patient in question isn’t getting pain pills from another doctor.

These programs have been incredibly helpful to me, since I treat people with addiction. Many of the patients are addicted to prescription pain pills. If a patient gets prescription opioids while I am treating them with methadone or buprenorhpine, my first step is usually to talk with them about what’s happening. If the patient is willing to give me permission to talk with the other doctor, and stop getting other opioids, the patient can usually stay in treatment with me. But if this happens more than once, I may decide it’s no longer appropriate to prescribe methadone or buprenorphine.

I’ve had some patients say that they don’t think it’s any of my business what their other prescriptions are. But I tell them that it’s only my business because they have asked me to prescribe medication to treat their addiction.

Most patients don’t fill any prescriptions without letting me know what they’re getting, but there are always a few patients who have mixed feelings about stopping their prescription opioids. Some patients are concerned that if I talk with their other doctor, they won’t be able to get more opioids from that doctor. I tell them that’s actually what I’m hoping for. It’s important to burn the bridges back to active addiction.

For now, state databases don’t connect with each other. Soon, a national prescription monitoring database may be accessible to physicians so that only one sources needs to be consulted, rather than multiple databases, for doctors who live near state borders.

I know the North Carolina prescription monitoring database has saved lives. Many people worry about their privacy with such a system, and I agree it’s a real concern, but hopefully the databases have adequate security systems to minimize risk.