Archive for the ‘Evidence-based Treatments’ Category

Qualities of Good Opioid Treatment Programs

Not all opioid treatment programs are created equal, meaning some are better than others. Over the years, studies have shown which clinic factors are associated with better patient outcomes. Over the next week or so, my blog postings will elaborate on each of the following factors:

  • Good communication between medical, counseling, and administration portions of the clinic
  • Experienced staff with adequate training and low turn-over
  • Low patient to counselor ratios
  • Program follows evidence-based guidelines for dosing
  • Opioid treatment program provide more care than just methadone treatment (also provide primary care, vocational rehabilitation, etc)

Today I’ll blog about communication between staff members. Communication is a good quality in any business, allowing it to run more smoothly. But it’s even more important in healthcare, where patients’ lives and well-being are affected.

In opioid treatment programs, communication happens in many ways, but case staffing is the most formal and efficient. Case staffing is when multiple members of the treatment team gather in one place, usually at a set time, to discuss what’s going on with patients. The treatment team usually includes all of the counselors, the nurses, the doctor, and the program manager. Besides communicating information about patients, case staffing also helps generate creative solutions to problems, and checks for negative emotions among staff. This can also be a forum where concerns about clinic protocols can be raised by staff.

At the program where I work, once or twice per week, after we finish seeing the day’s patients, the nurses, the counselors, nurses, program director and program manager sit in our lobby and discuss patients. First we talk about the new admissions. I tell the staff of any medical concerns I found on my intake assessment. For example, if a patient was found to have an enlarged liver on my exam, I ask the counselor to follow up with the patient later in the week to make sure the patient makes an appointment with his primary care doctor. The counselors raise concerns about new patients. Perhaps one of the counselors noticed symptoms of depression and we decide I should check that patient again the next week, when opioid withdrawal isn’t as severe.

Then we discuss established patients, and try to problem-solve. For example, maybe a patient needs to travel out of town for work, and there’s no opioid treatment program nearby where he can guest dose. We talk about the patient’s progress and whether it’s appropriate to ask the state methadone authority for extra take-home doses. We have some leeway to decide about Sunday and holiday take home doses, and discuss who is ready for these take homes.

Counselors may ask about how to approach ongoing drug use. The approach is different for different types of drugs. If a patient has had repeated relapses to opioids, maybe the methadone dose needs to be increased. If benzos are a problem, we must discuss if it’s safe to continue to dose that patient with methadone. For marijuana and cocaine, more intense counseling is indicated, and we discuss the best approaches.

Case staffing also helps us watch each other for negative attitudes. Patients with addiction sometimes behave badly. In active addiction, some addicts have had to lie and deceive to survive, and these tendencies don’t disappear overnight. The whole staff of an opioid treatment program needs to watch each other for negative or pessimistic attitudes developing toward patients.

For example, recently I was in a case staffing where we were talking about the repeated relapses of a patient. I made a comment which was more negative than the situation warranted, and this patient’s counselor appropriately challenged my comment. I’m no different than any other human and can take a skeptical view of a patient when it’s not reasonable. This counselor made me re-consider my opinion, and she was right to do so.

We talk about clinic policies that may need to be changed. For example, when patients can’t pay for treatment, how long do I have to taper their methadone dose? I’ve worked in clinics where if you didn’t have money for that day’s dose, you didn’t get a dose. They had no policy in place to allow a taper. I’ve worked in clinics where the dose was tapered over 4 days. At my present clinic, the dose is tapered over ten days. That’s still too short, and I’d prefer to keep everybody in treatment for free, but that’s not possible. The program would fold. I’ve had the unpleasant experience of working for a methadone program that closed because it ran out of money to operate. So it’s important to include the clinic administrators in some aspects of case staffing.

The best part of case staffing is talking about patient successes. Counselors talk about patients who are participating in counseling, who’ve had negative drug screens, and qualify for take home levels. Unless any staff member has concerns, I sign a form to make it official. We talk about patients who have recently gone through difficult situations without using drugs. We even have an unofficial “patient of the week,” a term for the patient who has worked hard on recovery and had a recent success. Sometimes it’s a patient who got a job promotion. Sometimes it’s a patient who has started going to 12-step meetings. Sometimes it’s a patient who has a negative drug screen for marijuana because he’s stopped smoking pot for the first time in his entire adult life.

Talking about this good stuff is so important for staff. We get to feel like we are at least some small part of the positive changes happening in the lives of our patients. Fortunately, there’s much to celebrate at every case staffing. As I’ve said before, I never saw the kind of positive changes when I worked in primary care that I see working in addiction medicine.

 

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?

Ibogaine: Cure or Con?

So there I was, happily watching a “Law and Order” mini-marathon. In one episode, the psychiatrist who works with the SVU staff goes on a diatribe about how ibogaine, a hallucinogenic root, cures opioid addiction. He’s trying to help a heroin-addicted youth detoxify from opioids, to enable him to testify against a rapist. Dr. Huang, the TV doctor, says ibogaine works great, but the big nasty drug companies won’t market it because it won’t make money, and U.S. doctors are (paraphrasing) too cowardly to do what’s right, and use something that really works.

 Sadly, some addicts are more likely to believe the words of a fictional character on a fictional TV program than their doctor.

 The truth is that ibogaine hasn’t been proven a safe and effective treatment for any kind of addiction.

 On the other hand, we don’t know for sure that it doesn’t work, either. NIH, the National Institute of Health, did laboratory studies with ibogaine in the mid-1990’s, but stopped work on the drug due to concerns about potentially fatal heart arrhythmias and neurotoxicity.

 However, the NIH tends to be a rather conservative bunch, and other scientists have taken up further research on the drug. At least two reputable doctors have independent, ongoing research projects on the drug. (1)

 So what is ibogaine? It’s a naturally occurring root found in Africa, and used in religious ceremonies there. In these ceremonies, rootbark from the plant Tabernanthe iboga is chewed to give a mild stimulant effect. With increased doses, this bark has hallucinogenic effects. Ibogaine is a sloppy drug, affecting at least three types of brain receptors. Ibogaine’s metabolite, noribogaine, has serotonin reuptake inhibition properties, like found in many antidepressants. It also has a weak opioid effect on the mu opioid receptors, and a stronger effect at the kappa opioid receptors, causing less dopamine to be released. It also has effects on at least two other receptor types.

 Ibogaine’s supporters claim this drug can cure addiction to alcohol, cocaine, opioids, and nicotine. Limited studies show that since the drug does block the release of dopamine, it may have some benefit in the treatment of addiction to these drugs, but we just don’t have enough information now.

 The drug’s reputation as a favorite of the drug culture may contribute to our government’s hesitation to approve studies of ibogaine in this country, but other countries are more permissive (or careless, depending on how you look at things).

 It’s also been difficult to get pharmaceutical companies interested in ibogaine. That’s not just due to the drug’s reputation as a recreational drug. Pharmaceutical companies tend to view all anti-addiction drugs as having low profitability (addicts tend to lack both money and insurance) and of course there’s still – sadly – the stigma of addiction and its treatment. (OK, so maybe Dr. Huang was partially right!) 

The limited data available so far suggest that at best, ibogaine may eventually prove to be another useful tool to use against addiction, but it’s unlikely to be the cure-all magic bullet that the fictional Dr. Huang claims. 

I hope we can see some well-done clinical trials before we decide what, if any, benefit this potential medication may have in the treatment of addiction.

 1.  http://www.ibogaine-research.org/Ibogaine-Research-Project/Areas/Media/JAMA.htm

Opioid Blockers: Do They Take All the Fun Out of Life?

According to an interesting article in the most recent copy of the American Journal on Addictions, the answer appears to be, “No,” at least for some people. (1)

 This article described a study where researchers asked patients on the extended-release opioid blocker naltrexone to rate the amount of pleasure they obtained from things like eating good food, sex, and exercise. These patients were on naltrexone for the treatment of alcoholism, but of course, the information may be helpful for opioid addicts who are treated with opioid blockers to prevent relapse back to opioid use. The subjects were asked to rate, on a scale of 1 to 5, the amount of pleasure they obtained from activities such as sex, eating good food, exercise, talking with friends, and other usually enjoyable things in life. A score of 1 meant they felt no pleasure at all, and 5 meant they felt much pleasure.

 The good news is that pleasure scores for these patients were relatively high. For example, the average score for pleasure from eating good food was 4.14, out of a possible 5. For listening to music, it was 4.00 out of 5. For sex, it was 3.92. For drinking alcohol, it was only 2.57 out of 5, which supports the use of this medication for alcoholics.

 In summary, the study found that subjects on extended-release naltrexone still experienced a good amount of pleasure from life.

 There were limitations to this study, however. We don’t have a pre-naltrexone baseline for these patients. In other words, we know pleasure ratings were fairly high while on naltrexone, but it’s possible these subjects had even higher pleasure scores before naltrexone. Also, there was no placebo control in the study. Maybe people getting pretend, or sham, treatments would have had higher pleasure scores, but we don’t know. 

In my mind, the biggest weakness was that the study enrolled 187 patients, but only 74 completed the intended survey. That means about 60% of the subjects dropped out of treatment, and the article doesn’t say why they dropped out. Maybe the drop-outs were the ones to feel a lack of pleasure in their lives from being on naltrexone, and the ones who stayed on it didn’t have this same side effect. If so, this would obviously skew the results.

 But even with these admitted weaknesses, and even though the study was paid for by the company that manufactures the sustained-release naltrexone (Vivitrol), this article gives hope that Vivitrol may work for opioid addiction. It may help prevent relapses, without interfering with life’s pleasures. And we need every tool we can get to fight addiction.

  1. 1.      O’Brien, Charles; Gastfriend, David; Forman, Robert; Schweizer, Edward; Pettinati, Helen, Long-Term Opioid Blockade and Hedonic Response: Preliminary Data from Two Open-Label Extension Studies with Extended-Release Naltrexone, American Journal on Addictions, Vol. 20 (2), March/April 2011, pp106-112.

Doctors Are Poorly Trained About Addiction and Recovery

Addiction? What addiction?

Most medical schools and residency programs place little emphasis on educating future physicians about addiction. A survey conducted by the Center on Addiction and Substance Abuse at Columbia University (CASA) revealed that physicians are poorly trained to recognize and treat addictive disorders. (1)

CASA surveyed nine-hundred and seventy-nine U.S. physicians, from all age groups, practice settings, and specialties. Only nineteen percent of these physicians said they had been trained in medical school to identify diversion of prescribed drugs. Diversion means that the drug was not taken by the patient for whom it was prescribed. Almost forty percent had been trained to identify prescription drug abuse or addiction, but of those, most received only a few hours of training during four years of medical school. More shocking, only fifty-five percent of the surveyed doctors said they were taught how to prescribe controlled drugs. Of those, most had less than a few hours of training. This survey indicates that medical schools need to critically evaluate their teaching priorities.  

Distressingly, my own experience mirrors this study’s findings. My medical school, Ohio State University, did a better job than most. We had a classroom section about alcoholism, and were asked to go to an Alcoholics Anonymous meeting, to become familiar with how meetings work. But I don’t remember any instruction about how to prescribe controlled substances or how to identify drug diversion.

Is it possible that I’ve forgotten I had such a course? Well, yes. But if I can still remember the tediously boring Krebs cycle, then surely I would have remembered something juicier and more practical, like how to prescribe potentially addicting drugs. Similarly, less than half of the surveyed doctors recalled any training in medical school in the management of pain, and of those that did, most had less than a few hours of training.

Residency training programs did a little better. Of the surveyed doctors, thirty-nine percent received training on how to identify drug diversion, and sixty-one percent received training on identifying prescription drug addiction. Seventy percent of the doctors surveyed said they received instruction on how to prescribe controlled substances. (1)

This last finding is appalling, because it means that thirty percent of doctors received no training on how to prescribe controlled substances in their residency programs.  Could it be true that nearly a third of the doctors leaving residency – last stop for most doctors before being loosed upon the populace to practice medicine with little to no oversight – had no training on how to prescribe these potentially dangerous drugs? Sixty-two percent leaving residency had training on pain management. This means the remaining thirty-eight percent had no training on the treatment of pain.

Could it be that many of these physicians were in residencies or specialties that had no need to prescribe such drugs? No. The participating doctors were in family practice, internal medicine, OB/GYN, psychiatry, and orthopedic surgery. The study included physicians of all ages (fifty-three percent were under age fifty), all races (though a majority at seventy-five percent were white, three other races were represented), and all types of locations (thirty-seven percent urban, thirty percent suburban, with the remainder small towns or rural areas). This study reveals a hard truth: medical training programs in the U.S. are doing a poor job of teaching future doctors about two diseases that causes much disability and suffering: pain and addiction. (1)

 I remember how poorly we treated patients addicted to prescription medications when I was in my Internal Medicine residency program. By the time we identified a person as addicted to opioids or benzodiazepines, their disease was fairly well established. It didn’t take a genius to detect addiction. They were the patients with thick charts, in the emergency room frequently, loudly proclaiming their pain and demanding to be medicated. Overall, the residents were angry and disgusted with such people, and treated them with thinly veiled contempt. We regarded them more as criminals than patients. We mimicked the attitudes of our attending physicians. Sadly, I did no better than the rest of my group, and often made jokes at the expense of patients who were suffering in a way and to a degree I was unable to perceive. I had a tightly closed mind and made assumptions that these were bad people, wasting my time.

Heroin addicts were not well treated. I recall a discussion with our attending physician concerning an intravenous heroin user, re-admitted to the hospital. Six months earlier, he was hospitalized for treatment of endocarditis (infected heart valve). Ultimately his aortic heart valve was removed and replaced with a mechanical valve. He recovered and left the hospital, but returned several months later, with an infected mechanical valve, because he had continued to inject heroin. We discussed the ethics of refusing to replace the valve a second time, because we felt it was futile.

I didn’t know any better at the time. We could have started him on methadone in the hospital, stabilized his cravings, and then referred him to the methadone clinic when he left the hospital. Instead, I think we had a social worker ask him if he wanted to go away somewhere for treatment, he said no, and that was the end of that. Small wonder he continued to use heroin.

At a minimum, the attending physician should have known that addiction is a disease, not a moral failing, and that it is treatable. The attending physician should have known how to treat heroin addiction, and how to convey this information to the residents he taught. Instead, we were debating whether to treat a man whose care we had mismanaged. Fortunately, he did get a second heart valve and was able to leave the hospital. I have no further knowledge of his outcome.

 Despite having relatively little training in indentifying and treating prescription pill addiction, physicians tend to be overly confident in their abilities to detect such addictions. CASA found that eighty percent of the surveyed physicians felt they were qualified to identify both drug abuse and addiction. However, in a 1998 CASA study, Under the Rug: Substance Abuse and the Mature Woman, physicians were given a case history of a 68 year old woman, with symptoms of prescription drug addiction. Only one percent of the surveyed physicians presented substance abuse as a possible diagnosis.  In a similar study, when presented with a case history suggestive of an addictive disorder, only six percent of primary care physicians listed substance abuse as a possible diagnosis. (2)

Besides being poorly educated about treatments for patients with addiction, most doctors aren’t comfortable having frank discussions about a patient’s drug misuse or addiction. Most physicians fear they will provoke anger or shame in their patients. Physicians may feel disgust with addicted patients and find them unpleasant, demanding, or even frightening. Conversely, doctors can feel too embarrassed to ask seemingly “nice” people about addiction. In a CASA study titled, Missed Opportunity, forty-seven percent of physicians in primary care said it was difficult to discuss prescription drug addiction and abuse with their patients, for whom they had prescribed such drugs. (2).

From this data, it’s clear physicians are poorly educated about the disease of addiction at the level of medical school and residency. Even when they do diagnose addiction, are they aware of the treatment facilities in their area? Patients should be referred to treatment centers who can manage their addictions. If patients are addicted to opioids, medications like methadone and buprenorphine can be a tremendous help.

  1. Missed Opportunity: A National Survey of Primary Care Physicians and Patients on Substance Abuse, Center on Addiction and Substance Abuse at Columbia University, April 2000. Also available online at http://www.casacolumbia.org

2. Under the Rug: Substance Abuse and the Mature Woman, Center on Addiction and

Substance Abuse at Columbia University, 1998. Available online at http://www.casacolumbia.org

The Facts About Methadone

methadone

The treatment of opioid addiction (heroin or prescription pain pills) with methadone still has an unwarranted stigma attached to it.  I wanted to devote at least one blog entry to a summary of the most well-known studies that support this evidence-based treatment. When people speak against methadone, they usually say they don’t “believe” in it, without being able to give any scientific basis for their stance. 

Well, this is why I do “believe” in it. It’s not opinion. It’s science.

 Amato L, Davoli, et. al., An overview of systematic reviews of the effectiveness of opiate maintenance therapies: available evidence to inform clinical practice and research. Journal of Substance Abuse Treatment 2005; 28 (4):321-329. In this overview of meta-analyses and other reviews, they conclude that methadone maintenance is more effective in the treatment of opioid addiction than methadone detoxification, buprenorphine, or no treatment. Higher doses of methadone are more effective than low or medium doses. 

Bale et. al., 1980; 37(2):179-193. “Therapeutic Communities vs Methadone Maintenance” Archives of General Psychiatry Opioid-addicted veterans who presented to the hospital for treatment were assigned to either inpatient detoxification alone, admission to a therapeutic community, or to methadone maintenance. One year later, patients assigned to therapeutic communities or methadone maintenance did significantly better than patients whose only treatment was detoxification. Patients in these two groups were significantly more likely to be employed, less likely to be in jail, and less likely to be using heroin, than the patients who got only detox admission. Patients in the therapeutic communities needed to stay at least seven weeks to obtain benefit equal to patients assigned to methadone maintenance. 

Ball JC, Ross A., The Effectiveness of Methadone Maintenance Treatment. New York, NY: Springer-Verlag Inc., 1991. This landmark study observed six hundred and thirty-three male patients enrolled in six methadone maintenance programs. Patients reduced their use of illicit opioids 71% from pre-admission levels, with the best results (no heroin use) seen in patients on doses higher than 70 milligrams. Longer duration of treatment with methadone showed the greatest reductions in heroin use. Of patients who left methadone maintenance treatment, 82% relapsed back to intravenous heroin use within one year. This study also found a dramatic drop in criminal activity for addicts in methadone treatment. Within one year, the number of days involved in criminal activity dropped an average of 91% for addicts maintained on methadone. This study showed that methadone clinics vary a great deal in their effectiveness. The most effective clinics had adequate dosing, well-trained and experienced staff with little turnover, combined medical, counseling and administrative services, and a close and consistent relationship between patients and staff.

 Caplehorn JRM, Bell J. Methadone dosage and retention of patients in maintenance treatment. The Medical Journal of Australia 1991;154:195-199. Authors of this study concluded that higher doses of methadone (80 milligrams per day and above) were significantly more likely to retain patients in treatment.

 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. 

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.

 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.

 Condelli, Dunteman, 1993: examined data from TOPS, the Treatment Outcome Prospective Study, assessed patients entering treatment programs from 1979 – 1981 and found data on improvement similar to DARP; longer duration of treatment in methadone maintenance shows lower use of illicit opioids. 

Dole VP, Nyswander ME, Kreek, MJ, Narcotic Blockade. Archives of Internal Medicine, 1966; 118:304-309. Consisted of thirty-two patients, with half randomized to methadone and the other half to a no-treatment waiting list. The methadone group had much higher rates of abstention from heroin, much lower rates of incarceration, and higher rates of employment.

 Faggiano F, Vigna-Taglianti F, Versino E, Lemma P, Cochrane Database Review, 2003 (3) Art. No. 002208. This review article was based on a literature review of randomized controlled trials and controlled prospective studies that evaluated the efficacy of methadone at different doses. The authors concluded that methadone doses of 60 – 100mg per day were more effective than lower doses at prevention of illicit heroin and cocaine use during treatment.

 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.

 Gordon NB, Appel PW., Functional potential of the methadone-maintained person. Alcohol, Drugs and Driving 1995; 11:1: p. 31-37. This is a literature review of studies examining performance and reaction time of patients maintained on methadone, and confirms that these patients don’t differ from age-matched controls in driving ability and functional capacity.

 Gowing L, Farrell M, Bornemann R, Sullivan LE, Ali R., Substitution treatment of injecting opioid users for prevention of HIV infection. The Cochrane Database of Systematic Reviews, 2008, Issue 2, Ar. No. CD004145. Authors reviewed twenty eight studies, concluded that they show patients on methadone maintenance have significant reductions in behaviors that place them at risk for HIV infection.

 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. 

Gunne and Gronbladh, 1981: The Swedish Methadone Maintenance Program: A Controlled Study, Drug and Alcohol Dependence, 1981; 7: p. 249 – 256. This study conducted a randomized controlled trial on inpatient opioid addicts to methadone maintenance with intensive vocational rehabilitation counseling, or a control group that were referred to drug-free treatment.  Over 20 years, this study consistently showed significantly higher rates of subjects free from illicit opioids, higher rates of employment, and lower mortality in the group maintained on methadone than the control group.

 Hartel D, Selwyn PA, Schoenbaum EE, Methadone maintenance treatment and reduced risk of AIDS and AIDS-specific mortality in intravenous drug users. Abstract number 8546, Fourth Annual Conference on AIDS, Stockholm, Sweden, June 1988. This was a study of 2400 opioid addicts followed over fifteen years. Opioid addicts maintained on methadone at a dose of greater than 60mg showed longer retention in treatment, less use of heroin and other drugs, and lower rates of HIV infection. 

Hubbard RL, Marsden ME, et.al., Drug Abuse Treatment: A National Study of Effectiveness. Chapel Hill: University of North Carolina Press, 1989. Shows decreased use of illicit drugs (other than opioids) while in methadone treatment, and increased again after discharge.

 Kosten TR, Rounsaville BJ, and Kleber HD. Multidimensionality and prediction of treatment outcome in opioid addicts: a 2.5-year follow-up. Comprehensive Psychiatry 1987;28:3-13. Addicts followed over two and a half years showed that methadone maintenance resulted in significant improvements in medical, legal, social, and employment problems.

 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.

 Marsch LA. The efficacy of methadone maintenance in reducing illicit opiate use, HIV risk behavior and criminality: a meta-analysis Addiction 1998; 93: pp. 515-532. This meta-analysis of studies of methadone concludes that methadone treatment reduces crime, reduces heroin use, and improves treatment retention.

 Mattick RP, Breen C, Kimber J, et. al.,Methadone maintenance therapy versus no opioid replacement therapy for opioid dependence. The Cochrane Database of Systematic Reviews,  2003; (2): CD002209. This is a meta-analysis of studies of methadone treatment. The authors concluded that treatment of opioid dependence with methadone maintenance is significantly more effective than non-pharmacologic therapies. Patients on methadone maintenance are more likely to be retained in treatment and less likely to be using heroin. This study did not find a reduction in crime between the two groups. 

Metzger DS, Woody GE, McLellan AT, et. al. Human immunodeficiency virus seroconversion amoung intravenous drug users in- and out- of- treatment: an 18-month prospective follow up. Journal of Acquired Immune Deficiency Syndrome 1993;6:1049-1056. Patients not enrolled in methadone maintenance treatment converted to HIV positivity at a rate of 22%, versus a rate of 3.5% of patients in methadone maintenance treatment.

 Powers KI, Anglin MD. Cumulative versus stabilizing effects of methadone maintenance. Evaluation Review 1993: Heroin addicts admitted to methadone maintenance programs showed a reduction in illicit drug use, arrests, and criminal behavior, including drug dealing. They showed increases in employment. Addicts who relapsed showed fewer improvements in these areas. 

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).

 Sees KL, Delucchi KL, et.al. “Methadone maintenance vs 180-day psychosocially enriched detoxification for treatment of opioid dependence” Journal of the American Medical Association, 2000, 283:1303-1310. Compared the outcomes of opioid addicted patients randomized to methadone maintenance or to180-day detoxification using methadone, with extra psychosocial counseling. Results showed better outcomes in patients on maintenance. Patients on methadone maintenance showed greater retention in treatment and less heroin use than the patients on the 180 day taper. There were no differences between the groups in family functioning or employment, but maintenance patients had lower severity legal problems than the patients on taper.

 Sells SB, Simpson DD (eds). The Effectiveness of Drug Abuse Treatment. Cambridge, MA: Ballinger, 1976: This was an analysis of information from DARP, the Drug Abuse Reporting Program, which followed patients entering three types of treatment from 1969 to 1972 and showed that methadone maintenance was effective at reducing illicit drug use and criminal activity. This study also demonstrated that addicts showed more improvement the longer they were in treatment. 

Strain EC, Bigelow GE, Liesbon IA, et. al. Moderate- vs high –dose methadone in the treatment of opioid dependence. A randomized trial. Journal of the American Medical Association 1999; 281: pp. 1000-1005. This study showed that methadone maintenance reduced illicit opioid use, and more of a reduction was seen with the addition of psychosocial counseling. Methadone doses of 80mg to 100mg were more effective than doses of 50mg at reducing illicit opioid use and improving treatment retention. 

Stine, Kosten; Medscape Psychiatric and Mental Health eJournal: article reminds us that though it’s clear that better outcomes for methadone patients are seen with higher doses (more than 80mg), many opioid treatment programs still underdose their patients.

 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.

 Do these studies mean that methadone works for every opioid addict? I don’t think so. Every medication has side effects and dangers. Methadone is no different. For a variety of reasons, methadone may not work for some addicts.  But this treatment has helped many addicts. At the very least, it can keep them alive until a better treatment comes along.

Description of Methadone Patients

The following is an excerpt from Chapter 2 of my book, titled, “Pain Pill Addiction: Prescription for Hope.” In this chapter I’m describing the patients I saw at methadone clinics where I worked in the years 2001 through 2009.

 I was surprised how casually people shared controlled substances with one another. As a physician, it seems like a big deal to me if somebody takes a schedule II or schedule III controlled substance that wasn’t prescribed for them, but the addicts I interviewed swapped these pills with little apprehension or trepidation. Taking pain pills to get through the day’s work seemed to have become part of the culture in some areas. Sharing these pills with friends and family members who had pain was acceptable to people in these communities.

In the past, most of the public service announcements and other efforts to prevent and reduce drug use focused on street drugs. Many people seemed to think this meant marijuana, cocaine, methamphetamine, and heroin. The patients I saw didn’t consider prescription pills bought on the street as street drugs. They saw this as a completely different thing, and occasionally spoke derisively about addicts using “hard drugs.” Most addicts didn’t understand the power of the drugs they were taking.

 Some opioid addicts came for help as couples. One of them, through the closeness of romance, transmitted the addiction like an infectious disease to their partner. Most were boyfriend/girlfriend, but some were married. The non-addicted partner’s motives to begin using drugs seemed to be mixed. Some started using out of curiosity, but others started using drugs to please their partner. I was disturbed to see that some of the women accepted the inevitability of addiction for themselves as the cost of being in a relationship with an addicted boyfriend. Often, addicted couples socialized with other addicted couples, as if opioid addiction bound them like a common fondness for bowling or dancing. Addiction became a bizarre thread, woven through the fabric of social networks.

 We saw extended family networks in treatment for pain pill addiction at the methadone clinics. One addicted member of a family came for help, and after their life improved, the rest of the addicted family came for treatment too. It was common to have a husband and wife both in treatment, and perhaps two generations of family members, including aunts, uncles, and cousins. Many addicts who entered treatment saw people they knew from the addicted culture of their area, and sometimes old disputes would be reignite, requiring action from clinic staff. Sometimes ex-spouses and ex-lovers would have to be assigned different hours to dose at the clinic, to prevent conflict.

 When the non-profit methadone clinic where I worked began accepting Medicaid as payment for treatment, we immediately saw much sicker people. Over all, Medicaid patients have more mental and physical health issues. Co-existing mental health issues make addiction more difficult to treat, and these patients were at higher risk for adverse effects of methadone. However, data does show that these sicker patients can benefit the most from treatment.

 When I started to work for a for-profit clinic, I saw a slightly different patient population. I saw more middle class patients, with pink and white-collar jobs. Occasionally, we treated business professionals. The daily cost of methadone was actually a little cheaper at the for-profit clinic, at three hundred dollars per month, as compared to the non-profit clinic, at three hundred and thirty dollars per month. However, the for-profit clinic charged a seventy dollar one-time admission fee, to cover the costs of blood tests for hepatitis, liver and kidney function, blood electrolytes, and a screening test for syphilis. The non-profit clinic had no admission fee, but only did blood testing for syphilis. I believe the seventy dollars entry fee was enough to prevent admission of poorer patients, who had a difficult enough time paying eleven dollars for their first and all subsequent days.

The patients at the for-profit clinic seemed a little more stable. Maybe they hadn’t progressed as far into their disease of addiction, or maybe they had better social support for their recovery. This clinic didn’t accept Medicaid, which discouraged sicker patients with this type of health coverage. Both clinics were reaching opioid addicts; they just served slightly different populations of addicts. The non-profit clinic accepted sicker patients, which is noble, but it made for a more chaotic clinic setting. This was compounded by a management style that was, in a few of their eight clinics, more relaxed.

 For the seven years I worked for a non-profit opioid treatment center, I watched it expand from one main city clinic, and one satellite in a nearby small town, to eight separate clinic sites. The treatment center did this because they began to have large numbers of patients who drove long distances for treatment. This indicated a need for a clinic to be located in the areas where these patients lived. Most of this expansion occurred over the years 2002 through 2006.

 Three of these clinics were located in somewhat suburban areas, within a forty-five minute drive from the main clinic, located in a large Southern city. The other four clinics were in small towns drawing patients from mostly rural areas. One clinic was located in a small mountain town that was home to a modest-sized college. Nearly all of the heroin addicts I saw in the rural clinics were students at that college. But by 2008, we began to see more rural heroin addicts, who had switched from prescription pain pills to heroin, due to the rising costs of pills.

Within a few years, clinics near the foothills of the Blue Ridge Mountains of Western North Carolina were swamped with opioid addicts requesting admission to the methadone clinics. These clinics soon had many more patients than the urban clinic.

I saw racial dissimilarities at the clinic sites. In the city, we admitted a fair number of African Americans and other minorities to our program. Most of them weren’t using pain pills, but heroin. I don’t know why this was the case. Perhaps minorities didn’t have doctors as eager to prescribe opioids for their chronic pain conditions, or perhaps they didn’t go to doctors for their pain as frequently as whites. If they were addicted to pain pills, maybe distrust kept them from entering the methadone clinic. In the rural clinics, I could count the number of African-American patients on one hand. They were definitely underrepresented. The minorities we did treat responded to treatment just as well.

A recent study of physicians’ prescribing habits suggested a disturbing possibility for the racial differences I saw in opioid addiction. (1) This article showed statistically significant differences in the rate of opioid prescriptions for whites, compared to non-whites, in the emergency department setting. Despite an overall rise in rates of the prescription of opioid pain medication in the emergency department setting between 1993 and 2005, whites still received opioid prescriptions more frequently than did Black, Asian, or Hispanic races, for pain from the same medical conditions. In thirty-one percent of emergency room visits for painful conditions, whites received opioids, compared to only twenty-three percent of visits by Blacks, twenty-eight percent for Asians, and twenty-four percent for Hispanic patients. These patients were seen for the same painful medical condition. The prescribing differences were even more pronounced as the intensity of the pain increased, and were most pronounced for the conditions of back pain, headache, and abdominal pain. Blacks had the lowest rates of receiving opioid prescriptions of all races.

This study could have been influenced by other factors. For example, perhaps non-whites request opioid medications at a lower rate than whites. Even so, given the known disparities in health care for whites, versus non-whites in other areas of medicine, it would appear patient ethnicity influences physicians’ prescribing habits for opioids. The disparities and relative physician reluctance to prescribe opioids for minorities may reduce their risk of developing opioid addiction, though at the unacceptably high cost of under treatment of pain.

Interestingly, we had pockets of Asian patients in several clinics. We admitted one member of the Asian community into treatment, and after they improved, began to see other addicted members of their extended family arrive at the clinic for treatment. Usually the Asian patients either smoked opium or dissolved it in hot water to make a tea and drank it. When I tried to inquire how much they were using each day, in order to try to quantify their tolerance, the patient would put his or her thumb about a centimeter from the end of the little finger and essentially say, “this much.” Having no idea of the purity of their opium, this gave me no meaningful idea of their tolerance, so we started with cautiously low doses.

One middle aged patient from the Hmong tribe presented to the clinic and when I asked when and why he started opioid use, in broken English and with difficulty, he told me he had lost eight children during the Vietnam War, and was injured himself. After the pain from his injury had resolved, he still felt pain from the loss of his family and he decided to continue the use of opium to treat the pain of his heart, as he worded it. I thought about how similar his history was to the patients of the U.S. and how they often started using opioids and other drugs to dull the pain of significant loss and sorrow. I thought about how people of differing ethnicities are similar, when dealing with addiction, pain, and grief.

1. Pletcher M MD, MPH, Kertesz, MD, MS, et. al., “Trends in Opioid Prescribing by Race/Ethnicity for Patients Seeking Care in US Emergency Departments,” Journal of the American Medical Association, 2008 vol. 299 (1) pp 70-78.

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.