Update on Suboxone Films

In the past, I’ve blogged about how some of my patients were having problems with their Suboxone films. When they opened the foil packets, the films were broken into pieces or so fragile they broke when handled. But now over the last two or three months, my patients tell me the films are no longer breaking or fragile, making them easier to use.

I’m glad. The Reckitt Benckiser drug company, manufacturer of Suboxone, wants doctors to switch patients to film because it dissolves faster, is easier to use, is less dangerous to children because the package is so hard to open, and it’s less likely to be snorted. They also say it’s harder to divert and has less value on the black market. And they say tablets are more likely to trigger patients who were addicted to tablets.

There’s validity to much of that, but I believe the biggest reason they want patients to switch is because their patent on the film runs for at least seven more years. Call me cynical.

About half of my patients who tried the film didn’t like it. Nearly all were patients in good recovery, stable for months to years, and if they wanted to tablets rather than the film, I was OK with that. When the film became crumbly, a few more patients wanted to switch back to the tablets.

Now, I’m more enthusiastic about the films. I can prescribe the film with more confidence since they no longer crumble. I prefer to use the films for patients tapering off Suboxone. I know the drug company says the films (and tablets) shouldn’t be cut, but of course everyone has been cutting both. With sharp scissors, the films can be cut into equal and small portions, ideal for a gradual taper of the dose.

I have more success with tapers in patients taking the film. In my next blog, I’ll talk about some of the “recipes” for taper my patients and I have used.

New Health Care Laws: How Will They Affect Office-based Treatment with Suboxone?

Last week, one of my office-based buprenorphine patients asked me how I thought the new healthcare laws would affect my business. I’ve considered this question with a mix of anxiety and hope. Until we have more details, I’m not certain I’ll like the new changes. And of course since I’m a healthcare provider, I’ll look at changes differently than if I were an insurance executive.

I told my patient that it will be excellent for my patients in buprenorphine (Suboxone, Subutex) treatment who don’t have insurance now, and are paying out of pocket. My patient then remarked that I’ll be much busier, because more pain pill addicts will be able to afford treatment.

“No,” I said, “I can still only have one hundred Suboxone patients at any one time, so I can’t add any new patients.”

My patient was quiet for a moment and said, “So if an addict calls you because he just got insurance to pay for his treatment, you couldn’t see him anyway?”

“That’s right, unless I lost a patient for some reason, and had an open spot for him.”

“So even if addicts get insurance, they can’t use it? That’s crazy. Why does the government have that law?”

I explained to him about the newness of the DATA 2000 Act, and that some lawmakers were skittish about this program from the beginning. They were worried Suboxone “mills” would open, where hundreds of addicts were treated with little physician oversight or precautions.

Lifting that limit would be the easiest way to get more opioid addicts into treatment.

My private practice, where I treat opioid addicts with buprenorphine (Suboxone, Subutex), is a bare bones operation. Because of the one hundred patient limit, I have enough patients to keep me busy for one day per week. On the other days, I work at opioid treatment programs. I enjoy my own office practice because of the autonomy, and because I have some great patients that I’ve known for years. But at my own office, I make far less than half what I make at the opioid treatment programs.

I have the usual fixed overhead of rent, utilities, answering service, internet, etc., and most of the money I take in goes towards that. I have a part-time health care coordinator, who makes appointments for patients, calls them to remind them of appointments, does most of my office drug screens, screens my after-hours calls, handles the filing, copying and other record-keeping tasks, and deals with those pesky pre-authorization requests that insurance companies make. (She and the counselor have decided I ought not to be allowed to talk with the insurance companies, since I often erupt into profanity).Then I have the best LCAS (Licensed Clinical Addiction Specialist) counselor in the world who works with me on Fridays, doing individual counseling (he’s my fiancé). Since I don’t file insurance, but rather give the patient a receipt so they can file it themselves, I avoid that personnel expense.

And I don’t accept Medicaid or Medicare as payment for treatment. I feel guilty for admitting that, but I don’t think I could stay in practice if I accepted what these government programs pay for treatment. When I first opened my own office in 2010, I saw a handful of these patients for free, since trying to file and going through the necessary red tape isn’t worth the pittance these programs pay for an office visit.

So if my uninsured patients get Medicaid, I’ll have to decide how to deal with that problem.

It’s not legal for me to ask patients with Medicaid and/or Medicare to pay for treatment out of their pocket unless I opt out of those programs completely for a period of years. I can’t do that because some of the other treatment facilities that I work for do bill Medicaid.

So do I start taking Medicaid, with all its headaches, red tape and low re-imbursement? I don’t know. I don’t like the thought of it, but it will perhaps become a necessity. It will depend on reimbursement rates. Plus, I’ll be paid even less since I don’t have electronic medical records. Government programs have decreed that doctors without meaningful use electronic medical records will receive less money for Medicaid/Medicare patients than doctors with these programs.

I’m not against electronic medical records. I use them effectively at both of the opioid treatment programs. One program is completely paperless, and I like that much more than I ever thought. But in my small, one hundred patient office, I can’t afford any software for medical records. It’s not practical or feasible

Since I was trained and still am board-certified as an Internal Medicine doctor, I could fill my other days with primary care patients. I was talking to another doctor who was starting her own Suboxone practice, and she was wondering how to get by financially, only practicing Addiction Medicine. She too is a former Internal Medicine doctor. I suggested she could always do some primary care.

“Just shoot me in the head,” she said, summarizing my feeling exactly. I’ve never liked primary care as much as addiction medicine, to put it mildly.

Addicts are easier to deal with, and are often nicer people than the average soccer mom, demanding an antibiotic to treat her viral upper respiratory infection. But my biggest reason for preferring addiction medicine is that addicts get better. I never saw the big changes in health when I worked in primary care, like I do in people treated for addiction. Primary care feels like a step backwards. I don’t want to go back to treating non-compliant diabetics, and overweight people who won’t exercise. I’d prefer to keep my present patients, in whom I see an intense desire to get well.

I’m addicted to seeing the big changes that I see when I work in addiction medicine. I hope the new changes in healthcare will allow me to stay in the business of helping people change. Like the rest of the U.S., I’ll have to wait and see.

Helpful Websites for Patients on Medication-Assisted Treatment of Opioid Addiction

I’ve compiled some of my favorite web sites which deal with the medication-assisted treatment of opioid addiction. There are so many pitiful, ignorant sites on the web, it’s great to go to one of these for some sanity. 

http://www.methadonesupport.org/

This is just what the address suggests: a support site for people being treated with methadone for either addiction or pain. This site has message boards and discussion forums as well as good information for patients and their families. There’s information on pregnancy and methadone, with links to recent studies. There are several advocacy links. One describes current legislative challenges to treatment with methadone.

The forums have some interesting topics. For example, there was a thread with methadone clinic patients writing in to say what they would do if they saw a drug deal at their clinic. Would they notify clinic administrators or ignore it? The answers were interesting.

You can get information about Methadone Anonymous, and locations of current meetings. You can also enter a methadone anonymous chat room each evening between 8 to 9 EST, but you do need to register on the site to participate in meetings and to post on other sections.

This site it a little busy and some of it hasn’t been updated recently, but overall it’s a great site for support and information.

http://buprenorphine.samhsa.gov/

This is the website I give people when they’re trying to find a doctor who prescribes Suboxone. This is the most up-to-date list of Suboxone doctors, but it’s not 100% correct. Sadly, there are some doctors who don’t update their information at this site when they are no longer able to take patients. But besides the names, addresses and phone numbers of Suboxone doctors,, there’s some reliable information on this site about buprenorphine. This may be a site you pull up for a friend or family member who has misgivings about medication-assisted treatments of opioid addiction.

 http://www.methadone.us/

This is the best all-purpose site for information about methadone, information about opioid treatment centers, locations of treatment centers, and answers to FAQs about methadone. It also provides a link to a great blog: mine. I’m proud they carry my blog entries on their site. OK so maybe I’m a little biased, but check it out. It’s an extremely well-maintained site, and kept up to date with interesting and new information.

http://suboxonetalkzone.com/

This is a blog written by Dr. Junig, a physician who is obviously well versed in opioid addiction and its treatment with Suboxone. And it’s much more. He gives a link to his Ebook “User’s Guide to Suboxone.” I haven’t read it, but he says it contains information about situations that commonly arise during treatment with Suboxone, like acute pain management, surgery while on Suboxone, pregnancy on buprenorphine, and other problems. His blog has been around for many years, and I believe Dr. Junig is one of the first doctors to publically advocate for medication-assisted treatment for opioid addiction, and I admire this.

http://store.samhsa.gov/home

If you’re interested in the disease of addiction and recovery from it, you’ve got to go to this website. It’s the government’s publication site, where many pamphlets, booklets, and bulletins are free. Even postage is paid, so go browse at the site. It’s arranged so you can search by topic, by audience (patient, family, health professional, etc.), or by drug. There are even DVDs which are available for a small charge.

http://www.casacolumbia.org

This is the website for the National Center on Addiction and Substance Abuse at Columbia University. There’s great information here, though it’s not specific to medication-assisted treatments with buprenorphine and methadone. This site is packed with information about drug addiction, its treatment, and its costs to society. You can download CASA’s famous white papers about the following topics: “Adolescent Substance Use: America’s #1 Public Health Problem” or “National Survey of American Attitudes on Substance Abuse XV” or “Behind Bars II: Substance Abuse and America’s Prison Population.” These are excellent sources of information, much of it downloadable for free. My personal favorite is “You’ve Got Drugs,” about the ease of obtaining controlled substances over the internet.

CASA funds research of treatments for addiction, and also makes recommendations to policymakers in the country. They also provide information and help exchange of ideas between the government agencies, criminal justice system, service providers and education systems.

http://international.drugabuse.gov

This invaluable website is National Institute on Drug Abuse (NIDA) summary of all the research studies about methadone, upon which our present treatment recommendations are based. If you need to know any facts about methadone treatment, you can probably get them here, along with references to support the information. If you are in medication-assisted treatment with methadone, you need to go to this site. You can download the whole of the Methadone Research Web Guide, and can take it to anyone who is pressuring you to “get off that stuff” to show them the science behind treatment with methadone.

http://www.indro-online.de/

If you travel out of the U.S., go to this website to see what other countries allow regarding buprenorphine or methadone. For example, the website tells travelers to Russia: “Methadone or buprenorphine must not be brought into Russia.” Using medication-assisted treatment with these two opioids isn’t legal in that country, and clearly it’s risky to travel with your prescription medication. The site does go on to say that if you must, travel with a letter from your doctor, translated into Russian.

I’ve referred to this site several times, looking to see what’s required for a patient who traveling out of the U.S. It’s an interesting site to peruse, to see how different countries are. There are tips about necessary phrasing for the doctor’s letter that’s usually required.

Readers, do you have suggestions for other great sites about medication-assisted treatment of opioid addiction?

Methadone and Suboxone Can Cause Sweating

All opioids can cause sweating and flushing. But methadone is perhaps worse than the other opioids, since we use doses high enough to block opioid receptors, to get the maximum benefit from methadone in the treatment of opioid addiction. Buprenorphine (active ingredient in the brand Suboxone and Subutex) can also cause sweating, but since it’s a weaker opioid, people don’t seem to be as badly affected by it.

 We don’t know exactly why opioids make people sweat, but it is related to opioids’ effects on the thermoregulatory centers of the brain.

 Excess sweating can also be caused by opioid withdrawal.  If other withdrawal symptoms are present, like runny nose, muscle aches, or nausea, an increase of the methadone dose may help reduce the sweating.

 At least half of all patients on methadone report unpleasant sweating, but some patients have sweats that are more than just inconvenient. These patients report dramatic, soaking sweats, bad enough to interfere with life.

 First, non-medication methods can be attempted. These methods include common sense things like wearing loose clothing, keeping the house cool, and losing weight. Regular exercise helps some people. Talcum powder, sprinkled on the areas that sweat, can help absorb some of the moisture. Antiperspirants can be used in the underarm area, but also in any area that routinely becomes sweaty. The antiperspirant can be applied at bedtime so sweating won’t interrupt sleep. There are prescription antiperspirants, like Drysol or Xerac, but these sometimes can be irritating to the skin. Avoid spicy foods, which can also cause sweating.

 Make sure the sweating isn’t coming from any other source, like an overactive thyroid, and check your body temperature a few times, to make sure you don’t have a fever, indicating the sweating could be from a smoldering infection. A trip to the primary care doctor should include some basic blood tests to rule out medical causes of sweating, other than the dose of methadone.

 Some prescription medications can help, to varying degree, with sweating.

 Clonidine, a blood pressure medication that blocks activation of part of the central nervous system, blocks sweats in some patients.

 Anticholenergic medicines, drugs block the effect of the neurotransmitter acetylcholine in the involuntary nervous system, block sweating. Anticholinergics tend to dry all secretions, causing such common side effects as dry mouth and dry eyes. These medications can cause serious side effects, so they must be prescribed by a doctor familiar with the patient’s medical history.

 Some examples of anticholinergics include oxybutynin (also used for urinary leakage), bipereden (used in some Parkinson patients), scopolamine (also used for sea sickness), and dicyclomine (used for irritable bowel syndrome). All of these have been used for excessive sweating with various degrees of success, in some patients.

 For unusually bad situations, Botox can be injected under the skin of the most affected areas, like armpits, palms and soles. Obviously, this is somewhat of a last-resort measure.

Patients affected with severe sweats, unresponsive to any of the above measures, need to decide if the benefit they get from methadone outweighs the annoyance of the side effects. In other words, if being on methadone has kept them from active drug addiction, which is a potentially fatal illness, it would probably be worth putting up with sweating, even if it’s severe.

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.

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.

Information about buprenorphine: pill, liquid, patch, implant

Many people get confused about the difference between Suboxone and Subutex. They are both used sublingually (under the tongue), and are two brand names of the drug buprenorphine are approved to treat addiction. Suboxone, besides containing the active drug buprenorphine, also contains a small dose of naloxone, which is an opioid antagonist, or blocker. Subutex contains only buprenorphine.

When Suboxone is taken in the proper way, dissolved under the tongue, the naloxone is not absorbed and is inactive. But if the Suboxone pill is inappropriately crushed and injected, the naloxone will be active and will put the addict into immediate withdrawal. If the naloxone weren’t in the drug, the buprenorphine alone could still be abused, to produce a high, or euphoria. In other words, naloxone is a safety feature, to discourage injection of the medication. The naloxone will not affect patients, if Suboxone is used correctly.

I’ve heard of addicts crushing Suboxone to snort, but since it gets absorbed as quickly through the membranes of the mouth as through the nose, it seems unlikely snorting would cause a high. There are some addicts who actually get a sort of a high from the act of snorting a pill, if that’s what they’re accustomed to.

 In the U.S, doctors are encouraged to prescribe Suboxone, rather than Subutex, because it’s safer. In some European countries where buprenorphine was used to treat opioid addiction, it was commonly misused by injection, and turned into a major drug of abuse. In Europe, a Suboxone-type medication with both buprenorphine and naloxone wasn’t available.

Buprenorphine is also marketed under one other brand name in the U.S., Buprenex. This liquid brand contains only buprenorphine (no naloxone) and is intended solely for intravenous or intramuscular injection. This form of the drug is not approved for the treatment of opioid addiction, but only for treatment of acute pain. Buprenex has been used in the U.S. for relief of acute pain since the 1980s. Relative to morphine, it is a fairly good analgesic. There hasn’t been much diversion of this drug to the black market in the U.S., though other countries, such as Scotland, have had large numbers of intravenous buprenorhpine addicts in the past.

To further confuse things, generic buprenorphine has recently come onto the market, though it’s still not much cheaper than the brand name Suboxone. One patient complained the generic was too hard to dissolve, and tasted so bad, that she was willing to pay the extra for the name brand.

Doctors are now conducting studies on other delivery forms of buprenorphine. Probuphine is a brand name of buprenorphine, which is contained in small cylindrical pellets, a little less than an inch long. These pellets can be implanted just under the skin, to release buprenorphine over time, in a similar way Norplant delivers its medication for birth control. Around four pellets are implanted, and the medication is delivered in continuous low levels for up to six months.

Studies have shown that Probuphine is more effective than placebo, but the real question is how it compares to standard therapy with sublingual buprenorphine tablets. The big advantage of implantable pellets is compliance, since the patient is obviously getting the medication if the pellets are in place. In this form, it’s highly unlikely to be diverted.

Buprenorphine is also marketed overseas in a patch form, for pain, but at present it isn’t marketed or approved in the U.S.

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.