Wednesday, December 26, 2012

Can Suboxone Induction Be Done at Home?

This recent article investigated whether heroin addicts could make the transition from heroin to buprenorphine at home, rather than in the office. Office-based inductions have been preached as the standard of care. But in this study, most addicts did fine. I've been doing this way for some time now, without a problem. 

MW


 Home- versus office-based buprenorphine inductions for opioid-dependent patients.

Sohler N.L., Li X., Kunins H.V. et al.
Journal of Substance Abuse Treatment: 2010, 38, p. 153–159.
Unable to obtain a copy by clicking title above? Try asking the author for a reprint (normally free of charge) by adapting this prepared e-mail or by writing to Dr Sohler at nsohler@sci.ccny.cuny.edu. You could also try this alternative source.
Is is safe and will heroin-dependent patients complete the process and stay in treatment if they start buprenorphine maintenance at home rather than being observed and doses adjusted at the clinic? This US study suggests this is feasible, saving time for all concerned, but also hints at possible (in this case, rare) complications.
Summary This US study from the Bronx district of New York documents the induction safety and retention record of a primary care health centre providing buprenorphine/naloxone maintenance treatment for addiction to heroin or other opioids. After two years of offering this treatment, the clinic switched from requiring all patients to start treatment under supervision at the clinic (entailing two to four hours during which the dose was adjusted), to allowing the doctor and patient between them to agree instead that the patient would be given a 'take-home' induction kit to enable them to start their treatment at home. The kit contained enough buprenorphine/naloxone pills for patients to themselves build up their doses over three days so they no longer felt withdrawal symptoms, other medicines to help control withdrawal symptoms, plus instructions. They were scheduled to return to the clinic within the week to discuss longer term treatment.
In the first two years 28 patients were inducted on to buprenorphine/naloxone at the clinic. In the next two, 51 patients opted with their doctors for home-based inductions and 36 were inducted as before at the clinic. The study compares initial experiences of all those inducted at the clinic with those inducted at home, 115 patients in all. About 70% had been using heroin, nearly all were Hispanic or black, and over two thirds were unemployed.

Main findings

In the second two years when home inductions were available, patients who with their doctors opted for these were more likely to have had previous experience of buprenorphine treatment. Those who opted to be inducted at the clinic were more often of Hispanic descent, unemployed, had only state-provided health insurance, and had recently used cocaine or sedatives or benzodiazepines.
Across all the patients, about 17% experienced difficult inductions regardless of whether inducted at home or at the clinic. Only one patient (in the home-based induction group) was hospitalised immediately following induction. This was due to complications secondary to benzodiazepine abuse which the patient had not fully disclosed. Tests did not reveal any clinically significant disturbance of liver function following inductions. A month later virtually the same proportions of patients (78%) remained in treatment regardless of the induction site. This result was essentially unaltered when differences between patients who opted for induction at home versus at the clinic were taken in to account.

The authors' conclusions

In a health centre that serves an economically disadvantaged community, people treated for opioid dependence with home-based buprenorphine inductions were as likely to be retained in treatment for 30 days as those with traditional clinic-based inductions. There was also no indication that either induction type was associated with greater difficulties with the induction process. The implication is that both office- and home-based buprenorphine inductions are feasible in the primary care setting.
The findings reflect the ability of patients and providers to select the induction type best suited to the patient's needs, abilities, and beliefs about health care. Given the importance of the induction process for longer term opioid addiction management, these data should be encouraging providers to consider treating opioid-dependent patients in primary care.

Monday, December 24, 2012

Do relapse rates rise around the holidays?

Many people assume that the time between Thansksgiving and the winter solstice holidays are the most difficult time of the year for people in  recovery. Temptations are harder to avoid, what with office and holiday parties, family gatherings, and so forth. Many people with alcohol dependence come from families with many heavy drinkers, so alcohol may be flowing freely, and there may be others who are intoxicated. (Ever notice how boring and obnoxious intoxicated people can be if you're not intoxicated yourself?) So cue-induced craving is certainly an issue, whether your cues are visual, smells, other being surrounded by others who are drinking. How can someone protect themselves, what are the best strategies?

Another major trigger for many are negative or painful feelings. The constant drumbeat and ceaseless streaming of happy families enjoying their time together is very different from what most of us experience. Especially in early recovery, loneliness is common, and made so much more painful as we imagine all the other people surrounded by relatives and friends, all enjoying themselves and each, celebrating their good fortune. And that's how families usually are right? (Wrong!) Interactions with family members are often their most difficult and painful during the holidays. Young adults home for the holidays fall into acting like 15 year-olds, and parents play along. Having to endure another holiday with your obnoxious brother in law from the other political party or religious group seems like it will make you explode.

Finally, we all get knocked out of our normal rhythms of self-care and self-regulation during the holidays. We get swept off our feet, we lose our ground. Our work-out routine gets disrupted. If we travel our time clock gets out of whack. If we're working a 12-Step program, our home group and sponsor may be back home while we're visiting relatives in Seattle. If we're in therapy or seeing a psychiatrist, those appointments are harder to find. And then there's Seasonal Affective Disorder (SAD,) so in temperate climes, we may become more depressed. Most people with Major Depression or Dysthymic disorder have seasonal sensitivity, making depression worse in the winter. We eat too much, sleep too much (or too little), get lazy. It's a wonder any of us make it through sometimes.


One basic strategy for managing the holiday season comes from cognitive behavior therapy (CBT.) The principles are: Recognize, Avoid and Cope. Recognize a high risk situation before you're in it. Anticipate it. Ruminate about it. How might you be affected? What are your triggers? How solid are you feeling in your recovery right now? Main principle: don't test yourself. If you're feeling shaky, pay attention. Second principle: take care of yourself. No one else will. Then, if you can, Avoid the high-risk situation completely. Don't let guilt or a sense of obligation push you into a high risk situation. Your recovery is more important than anything or anyone else. Finally, if you cannot avoid the situation, Cope with it. Devise strategies for managing it. Talk to your therapist, support friends and family members, psychiatrist, or sponsor. Consider using an anti-relapse medication over the holidays, even if you usually don't. Antabuse, which makes you ill if you drink, is a particularly useful one, but naltrexone is also good. Topiramate is less so because it takes a long time to ramp up on the dose. If you are in a 12-Step program, schedule your meetings, being specific about when and where. Decide what your emergency strategy is is you are in a situation and don't trust yourself to drink. For example, get out of there, go for a walk, excuse yourself and go to a meeting or meet up with a friend, or call a supporter. Can you identify supportive people at the gathering? Or, better yet, bring your own! Make sure you pay attention to sleep and exercise and alone time. Meditate or have a relaxation training session. Get a massage. Well, you get the idea.

So, do relapse rates go up during the holiday season? Here's a graph from a fascinating study by Mark Goldman and colleagues, who tracked drinking for 365 days in young adults. (Goldman M, et al., Psychol Addict Behav. 2011 March; 25(1): 16–27.)


As you can see, the major peaks for young adults are Spring Break, New Years, Halloween and July 4th. Thanksgiving ranks about the same as the Super Bowl. Christmas is, like, nada. On the other hand, a study in Finland found that alcohol poisoning fatalities were greatest there during Mayday, Midsummer and Christmas celebrations. A 1989 study by the CDC found increased rates of alcohol-related traffic crashes and fatalities during the holiday season, but with the changes in DUI laws, it is hard to extrapolate. But I couldn't find one study in PubMed examining relapse rates among recovering alcohol dependent persons over the holidays.

So what's the answer? Well, we don't have good scientific evidence one way or another. In my clinical experience, alcohol dependence, like other serious chronic illnesses, often have a pattern of their own. Serious depression and suicide don't go up over the holidays. (Suicides peak in the spring.) My own impression is that there is no big jump in relapses in general, although specific people may struggle more during this time. But it always helps to be prepared. Recognize, Avoid, Cope, and have a great solstice celebration!

MW

Friday, December 21, 2012

Gender Specific Treatment Reduces Recidivism by 67%

Here's the abstract from a new study that used random assignment in prison (a nearly impossible task in itself) and found that trauma-informed, gender-specific care served female inmates better. Not very surprising but the authors are to be commended for their methodological rigor. Even more impressive, though was a whopping 67% reduction in reincarceration within 12 months after parole. Wow!

Read more about it here.

MW


 A randomized experimental study of gender-responsive substance abuse treatment for women in prison

UCLA Integrated Substance Abuse Programs, 1640 S. Sepulveda Blvd., Suite 200, Los Angeles, CA 90025, USA
Received 1 July 2009; received in revised form 26 August 2009; accepted 20 September 2009. published online 16 December 2009.

Abstract 

This experimental pilot study compared postrelease outcomes for 115 women who participated in prison-based substance abuse treatment. Women were randomized to a gender-responsive treatment (GRT) program using manualized curricula (Helping Women Recover and Beyond Trauma) or a standard prison-based therapeutic community. Data were collected from the participants at prison program entry and 6 and 12 months after release. Bivariate and multivariate analyses were conducted. Results indicate that both groups improved in psychological well-being; however, GRT participants had greater reductions in drug use, were more likely to remain in residential aftercare longer (2.6 vs. 1.8 months, p < .05), and were less likely to have been reincarcerated within 12 months after parole (31% vs. 45%, respectively; a 67% reduction in odds for the experimental group, p < .05). Findings show the beneficial effects of treatment components oriented toward women's needs and support the integration of GRT in prison programs for women.

Tuesday, December 18, 2012

Why Don't We Have New Treatments for Addiction?

I just got back from a meeting of the American Academy of Addiction Psychiatry, and one of the most striking things was the lack of anything new in the treatment of addiction. There was a lot of tweaks of existing modalities, both behavioral and pharmaceutical, but nothing groundbreaking. As a clinician, I encounter this every day. We have a handfull of psychotherapeutic and pharmaceutical treatments available, but it is no where near enough.

Far too many patients respond modestly or not at all to available treatments of all kinds. Don't drink the Kool-Aid of 12-Step programs that tell you that their approach is 100% effective among those who truly want sobriety and work the program. It's simply not true, and most older AA'ers will admit that. There are very few treatments that even approach that level of efficacy. In most of medicine, we are simply slowing the rate of deterioration, if that.

I believe that talking therapy approaches have reached the point where further refinement of them will not improve outcomes, or at least not much. There are two areas of research that may eventually transform care: more direct approaches to reprogram the preconscious or unconscious mind, and pharmacotherapy. I'll leave the former for a later blog, but today I'd like to address concerns about the lack of medications in the medication development pipeline.

This is not a problem that only afflicts addiction treatment. It's true throughout health care. With a few notable exceptions, very little progress has been made in the past 10 years on developing new medications for our most vexing and common disorders: heart disease, depression, addiction, high blood pressure, cancer, arthritis, pain. And the pipeline looks so dry it's almost scary.

It's not because Big Pharma isn't investing in R&D either. According to Phrma.org, the industry website, industry investment in R&D has not dropped, either as real dollars or as percentage of revenue.  For example, in 1990, Pharma spent $8.4 billion on R&D, but in the past few years, it's been hovering around $50 billion. And yet, as this chart in an article by Scannell et al. (Nature Reviews Drug Discovery 11, 191-200) shows, the number of new drug approvals as a function of R&D investment has been dropping for 60 years. Why? Tune in tomorrow for the next blog!





Monday, December 3, 2012

Potential New Treatment for Cocaine Addiction?

In a recent article, Mariani and colleagues reported on a pilot study of a combination of mixed amphetamine salts (MAS; most commonly known as Adderall) and topiramate (Topamax) in the treatment of cocaine addiction. Their study appeared in the journal Biological Psychiatry (the reference is Mariani et al., Volume 72, Issue 11, 1 December 2012, Pages 950–956.) In the study, subjects were randomized to receive either a combination of MAS and topiramate, an anticonvulsant used for epilepsy and migraine prophylaxis and which is also effective for treating alcohol dependence, or placebo. They found that the proportion of subjects able to achieve 3 consecutive weeks of abstinence from cocaine was significantly better over a 4-week period. The figure below, from the article, shows the difference between the two groups over the course of the study. By study end, 4/13 of subjects receiving the medication combination had complete 3 weeks of abstinence, compared to 0/11 of the control group receiving placebo. No conclusions can be drawn from such a small study, but the results are intriguing. They point to the potential importance of therapies that provide some low potency, long-term stimulation of the receptors involved in a specific addiction. These agonist therapies include current medications such as methadone and buprenorphine (Suboxone) for opioid addiction and varenicline (Chantix) for smoking cessation. Agonist therapies are likely to provide the most effective treatments in the future, as opposed to antagonist therapies that block the receptors and thus the effects of the drug. A current example is naltrexone (Vivitrol) for opioid addiction. Some effectiveness if external coercion is used, but much less or no effectiveness in other circumstances.

MW



Wednesday, November 28, 2012

Health Care Changes Important to Addiction Treatment

Among the various things I do, I work about half time for a large health care organization (HCO) in Minnesota called Allina Health. Currently Allina is the largest HCO in Minnesota, but it is likely to become the second largest due to continuing consolidation in HCOs. HealthPartners and Park Nicollet, two other HCOs in Minnesota desire to merge, and it does not appear that there will be any barriers from either the MN Attorney General or federal agencies. So it is likely to proceed, which would produce a larger HCO than Allina. Consolidation in health care is almost a torrent right now. It's happening very rapidly. In the Twin Cities area in Minnesota, there are almost no independent primary care practices; they've all been purchased by large HCOs. The health plans like Blue Cross/Blue Shield and HealthPartners are working very closely with the large HCOs to create products that maximize value to the consumer. So the future of health care is one dominated by a few large HCOs that dominate a market. Unfortunately, this is all to familier. Witness the consolidation in airlines and in cable television, internet and wireless services.

But there are important changes in perspective that will drive a much more pronounced and determined effort to deal with behavioral health issues, including both mental health and addiction. The most important of these is the movement from fee for service to capitated approaches. In fee for service, a clinician is paid a specific amount for providing a service, such as a primary care visit or an addiction counseling session. This rewards providing more services for fewer people, and it drives up costs without regard to quality or outcomes. Increasingly, health plans are moving towards a different model where the HCO is accountable for outcomes, not just whether the service was delivered. In a capitation model, a HCO is given a single fee for treating someone with a given diagnosis. It is up to the HCO to figure out how to do this efficiently and effectively.

This is a good thing. Here's an example. Someone with an addiction goes to a time-limited, intensive rehab program, which is the current standard of care. Let's say that this intensive outpatient program costs $2400. Someone else who was able to produce equivalent outcomes for $1800 would be attractive to a health plan, not to mention someone paying out of pocket. Similarly, a $15,000 or $20,000 residential treatment program would go out of business if it could not produce substantially better outcomes than someone providing office-based treatment for a third of that amount. I think this is quite possible to do, since there is no demonstrated benefit to residential treatment. There is room here for innovation, for modernizing our approach to addiction treatment. It's time for addiction treatment providers to take responsibility for the outcomes of their treatment. It's time to end the idea that treatment failures are the patient's fault. In the future, this isn't going to fly. One of my goals is to make sure this happens. We can generate better outcomes at much less cost.

What if, instead of being paid $30,000 for a residential treatment lasting 28 days regardless of whether that actually produced a good outcome, HCOs were only paid for treatment that worked? What if payment was based on outcomes rather than the treatment provided? I can tell you, that would change the addiction treatment world in a heartbeat. Give patients that same treatment over and over even though it's already proved ineffective? No way! Give everybody the same treatment whether they need it or whether it's been shown to improve outcomes? Forget about it? Changes in how payment is made for services will force change in the treatment delivered. And it's about time.

What's the silver lining? We can lead the way. Many of the very high utilizers of health care have addiction and mental health problems. We have to figure out ways to improve their care and outcomes. That's our challenge and our opportunity.

MW

Tuesday, November 27, 2012

Change: Continuous and Discontinuous

Recently I have several patients who have made remarkable progress in a short time. I would call this discontinuous change. That is, there is a prevalent notion that change occurs gradually, step by step. And sometimes that's how it happens. But then there are times when people change in multiple ways, on multiple dimensions, all at once. Change can be continuous or discontinuous. Now, in some ways this distinction requires some kind of arbitrary decision about what those terms mean. Ultimately, it's an issue of measurement. So, "continuous change" occurs at a smaller scale than the current measurement can detect, while "discontinuous change" occurs in a way that is distinct, a detectable change. Or, one could define it quantitatively or qualitatively. For example, "discontinuous change" could be defined as a change of a certain magnitude, or changes of a certain magnitude on multiple levels or in multiple scales.

But clinically, there are times when I'm simply blown away. A patient comes in who is hardly recognizable, and not simply because of cosmetic or clothing or grooming changes, although they may be a part of it. It's more that a different person walks through the door. Someone who thinks, speaks and otherwise behaves in multiple ways they have not previously. This happens with both substance use disorders and with psychiatric disorders. All of a sudden, everything is different. And no one, least of all the person who just transformed, has any idea why this happened now, at this moment in time. These events are not predictable with current knowledge and scientific methods. They may never be. (A part of me hopes and, of course, therefore predicts, that they never will be.) Anyway, in the past several weeks I have been completely blown away by progress in some of my patients.

What causes the change? There may be environmental events that have powerful effects, such as a DUI, hospitalization, serious medical illness, interpersonal experience, and so on. But these are not very reliable predictors and are not always present. I have patients who have had a DUI and then stopped drinking, and I have others where it doesn't seem to make a difference. Most often, my changed patients report to me that they have either "gotten sick and tired of being sick and tired," or "just decided," or "I just woke up and felt different." We don't have insight into how or why we make the most important decisions in our lives. Our reasons, by and large, are constructions designed to continue a cohesive narrative of our lives. We decide and then construct the reasons. Now sometimes it is the other way around. A slow, rational deliberation (System 2 in Daniel Kahneman's scheme) often plays an important role. But more often I think it's the other way around.

Here's my working hypothesis: complex dynamical systems (including us) tend to configure into a number of discrete, finite states, rather than an infinite number of slightly different ones. We tend to flip from one state to another, much like a tornado suddenly forms out of a certain set of optimal circumstances (but not always, and not easily specifically predicted.) And for us, these states include cognitive, affective (emotional), perceptive, behavioral, genomic, metabolomic, organ, organ system, organismal and social components that may all change at once on multiple levels.

And the thing is, there is only one thing happening even though it is happening at multiple levels. This is a hard one, an idea I finally developed when I was at NIH. In complex dynamical systems, an event occurs on many levels at once. Of course, there may be an instigating event, let's say an adverse social interaction that sets off a crusade of processes ending in severe depression and extremely heavy drinking. The response of a particular person (organism) involves all different levels of analysis essentially at once, because there are millions or billions or trillions of extremely rapidly interactive events that make up the whole. Everything happens on all levels at once: from particle physics up to global and beyond. However, we cannot examine the whole, we need to examine a part of it. We may talk to the involved person, ask them about their experience, perhaps ask them to fill out some scales. We may examine their social interactions and networks, or patterns of communication. We might put them in an fMRI or PET scanner to examine brain blood flow and metabolism, we might measure the output of a stress hormone such as cortisol in the blood, and so on. But we delude ourselves if we think that by looking at one level of analysis, we can say much about the system's behavior. It's not simply linear: A causes B which causes C. It requires a different type of mathematical modeling to help predict the behavior of the system as a whole. But this science is new and will take a long time to mature.

What about therapy or treatment? Sometimes, I think that by creating a safe, therapeutic environment and providing straight, often difficult, but always compassionate feedback, I may make a change like that possible. It often feels like a lifeline - I provide a secure support and anchor for taking chances and making changes. Some patients volunteer this information - that having me in their corner allowed them to make changes they were previously afraid to make, or that I provided a direction they had not seen before. Other times, I have no idea. A patient changed suddenly to the better, and I don't feel I had much if anything to do with it. This isn't false modesty; I'm talking about people I may see every 3 months for medication checks, but who suddenly undergo a big positive change. Most of the time, it's pretty hard to tell. Maybe I made a difference, maybe not. But it's enough to keep going, doing my best, trying to help people in any way I can. And I'm grateful for that opportunity. People let me into their lives in the most intimate ways imaginable, trusting me not to betray them, not to hurt them. I feel very privileged and humbled by that trust and I do my best to be deserving of it.

MW