Researchers: Supervised Methadone and Buprenorphine Dosing Adds Little Therapeutic Benefit

Methadone, the full agonist synthetic opioid, is one of the most tightly regulated medications on the planet - at least, that is, when it's being used to treat opioid addiction.  Here in Minnesota, no fewer than 5 regulatory bodies oversee the clinics that provide methadone maintenance treatment (MMT).  One of the core federal requirements of "opiate treatment programs" is daily supervised dosing, requiring patients to come daily to the clinic to receive their dose, observed by trained nursing staff for at least the first 3 months.  After that, patients earn one additional day of "take-home" doses at a time until they've earned 1 week (after the 8th month of treatment), then 2 weeks (after the first year in treatment), and finally 4 weeks of take-home doses (after 2 years of sustained participation in the program).  The rationale for these highly restrictive federal rules, ostensibly, has been that it will protect patient safety, decrease diversion, and will improve outcomes among MMT patients.

A recent review of the literature throws these assumptions into question.  The review, analyzed and shared by the folks at Drug and Alcohol Findings, found "no evidence that supervising consumption meant patients were better safeguarded or that the treatment more effectively reduced illegal drug use."  Instead, these policies tend to be quite costly to programs and burdensome to patients.  They reinforce negative stereotypes about MMT patients and have prevented people from seeking potentially lifesaving treatment. 

Here at Alltyr Clinic, we routinely hear from patients that the ability to receive a monthly prescription of Suboxone has meant they could keep their job or maintain their role within the family.  With all the national attention being given to the recent spike in overdose statistics, maybe it's time the feds re-visit these burdensome regulations and increase access to the highly effective treatments. 

From the Findings UK article:

Supervised dosing with a long-acting opioid medication in the management of opioid dependence
http://findings.org.uk/PHP/dl.php?file=Saulle_R_1.txt&s=eb&sf=sfnos

Key points
From summary and commentary

Guidelines recommend making opioid-dependent patients take their methadone or other opioid substitutes at the clinic or pharmacy to safeguard the patient and prevent medication being ‘diverted’ to other people.

Randomised trials and studies study which monitored patients in routine treatment afforded no evidence that supervising consumption meant patients were better safeguarded or that the treatment more effectively reduced illegal drug use.

However, introduction of supervision to UK treatment services was associated with fewer methadone-related overdose deaths.

Findings and expert opinion support initial supervised consumption and its relaxation on an individual basis, depending on assessment of the patient.

Study: Are Drug Screens Sufficient for Adolescent Treatment?

Could it be that we are missing something when it comes to treating adolescents with a substance use disorder? According to a study in the most recent edition of the Journal of Studies on Alcohol Drugs, if you aren't using drug screens when treating this population, the answer is likely "Yes".
In the article, Schuler, et al. looked at data from SAMHSA's CSAT 2007 adolescent treatment database, which tracks outcomes for CSAT-sponsored providers. The total sample consisted of 5,186 adolescents who received either Motivational Enhancement Therapy/Cognitive Behavioral Therapy5 (MET/CBT5) - with or without biological drug screen (BDS) - or were part of the BDS-only or No-Treatment groups within another study. Below is a breakdown of the subjects:

All participants responded to the GAIN structured clinical interview, so scores on the Substance Use Frequency Scale and Substance Problem Scale were the primary outcomes measured. Propensity score methods were used to adjust for baseline differences among youth in the four groups, given the non-randomized nature of the data. The results are striking:

The BDS-only condition seemed to outperform all groups at baseline, 3-, 6- and 12-months on Substance Problem Scale scores and at 6- and 12-months on Substance Frequency Scale scores.
What could account for the significant differences? The authors point out that many adolescents who are involved in treatment and/or the criminal justice system may earn rewards for negative drug screens - or face significant consequences for positive screens. Therefore, the self-report nature of the data could skew the results. That would not necessarily explain the consistent differences across groups, however.

What do you think about these results? If you work with adolescents, does this surprise you? Could evidence like this impact the interventions you use?

"First Controlled Study of LSD-Assisted Psychotherapy in More Than 40 Years"

Researchers from Switzerland and the Multidisciplinary Association for Psychedelic Studies have conducted what they are calling the first study of its kind in over 40 years: a randomized, double-blind, active placebo-controlled study of LSD-assisted psychotherapy. The participants, 12 patients with anxiety related to life-threatening illnesses like metastatic cancer, non-Hodgkin's lymphoma, Parkinson's disease, etc., participated in drug-free therapy sessions as well as 2 LSD-assisted psychotherapy sessions over the course of the study. Follow-up interviews were conducted at 2- and 12-months post-treatment and indicated lasting, statistically-significant improvements in anxiety. The study is posted in its entirety for free online via The Journal of Nervous and Mental Disease.

The main outcome measures were scores on the State-Trait Anxiety Inventory (STAI). Exclusion criteria included current drug or alcohol disorders, primary psychotic, dissociative or bipolar 1 disorders, neurocognitive impairment or pregnancy/nursing. Participants in the experimental arm participated in 2 full-day LSD-assisted psychotherapy sessions, 2 to 3 weeks apart, that were "embedded within an ongoing process of [six]drug-free psychotherapy sessions for preparatory and integrative purposes." Subjects received doses of 200 micrograms of pure LSD and the day-long sessions lasted 8 hours, or until the effects of the medication wore off. Participants in the active placebo group received the exact same set of psychotherapy sessions, but were given 20-microgram doses of LSD. After the 2-month follow-up interview, these participants were informed of their place in the control group and were offered the full, open-label intervention.

The results indicate statistically significant STAI scores for both state and trait anxiety at 2 and 12 months for the experimental groups. The active placebo did not produce statistically-significant improvements. The researchers calculate the effect size at 1.1 for trait anxiety, and 1.2 for state anxiety. They also, as you would imagine, call for more research with larger controlled studies. Importantly, neither the experimental drug nor the placebo produced any serious adverse effects, leading the authors to seem confident in the safety of this type of therapy.

Considering the research on LSD ground to a halt by the 1970s, do readers think it's time to revisit this(or other psychedelics, for that matter) as a therapeutic tool? If you have experience with this, it would be fascinating to hear your take, too.

Interested to hear readers opinions on the matter...

Source:
http://journals.lww.com/jonmd/Documents/90000000.0-00001.pdf

Maintenance, not abstinence, will save addicts' lives

Read Dr W's Op-Ed in this week's Star Tribune:

http://www.startribune.com/opinion/commentaries/246619891.html

Are Financial Incentives the Answer to SBIRT Implementation?

Researchers from Imperial College London may have found a way to increase alcohol screening and brief intervention in a primary care setting: financial incentives. The results, published online Dec. 26 in the Journal of Public Health, show that offering a points-based incentive for successful screening, brief intervention and referral to specialists significantly increased the number of patients who were screened. As a result, the authors say, more patients with risky alcohol intake were identified and offered care, reducing hazardous and harmful drinking in some.

While the evidence for SBIRT is abundant and well-known, there have been considerable problems in promoting widespread implementation - especially in primary care. Financial incentives could be one effective means of changing this. (Granted, a large-scale effort by the federal government or the insurance companies would likely be required to provide funding. In this study, data was collected from 2008-2011, until the UK's Quality and Outcomes Framework funding was withdrawn.)

Abstract

Introduction Alcohol screening and brief intervention (ASBI) is effective but underprovided in primary care. Financial incentives may help address this. This study assesses the impact of a local pay-for-performance programme on delivery of ASBI in UK primary care.

Methods Longitudinal study using data from 30 general practices in north-west London from 2008 to 2011 with logistic regression to examine disparities in ASBI delivery.

Results Of 211 834 registered patients, 45 040 were targeted by the incentive (cardiovascular conditions or high risk; mental health conditions), of whom 65.7% were screened (up from a baseline of 4.8%, P< 0.001), compared with 14.7% of non-targeted patients (P < 0.001). Screening rates were lower after adjustment in younger patients, White patients, less deprived areas and in patients with mental health conditions (P < 0.05). Of those screened, 11.5% were positive and 88.6% received BI. Men and White patients were significantly more likely to screen positive. Women and younger patients were less likely to receive BI. 30.1% of patients re-screened were now negative. However, patients with mental health conditions were less likely to re-screen negative than those with cardiovascular conditions.

Conclusion Financial incentives appear to be effective in increasing delivery of ASBI in primary care and may reduce hazardous and harmful drinking in some patients. The findings support universal rather than targeted screening.

Source: http://intljpubhealth.oxfordjournals.org/content/early/2013/12/26/pubmed.fdt121.abstract

12-Step Familiarity vs 12-Step Facilitation

A pair of studies were published last month to little fanfare and which seem to be contradictory in nature. Both papers involve 12-step programs and focus on the role of the counselor in delivering Twelve-Step Facilitation (TSF), a SAMHSA-recognized evidence-based practice. Published in the American Journal of Drug and Alcohol Abuse, the studies come to the following conclusions: Therapist familiarity and personal experience with twelve-step programs (TSPs) improves their credibility among clients and, in turn, therapeutic alliance; yet therapists who viewed TSPs favorably and who described themselves as being in recovery tended to do a poorer job at maintaining fidelity and adherence to TSF in a large, multi-site trial.

In the first paper, researchers at the State University of New York administered surveys to clients and counselors at a host of treatment programs in and around Albany. Clients (n=180) rated counselors on their perceived familiarity with  TSPs, the amount of time in-session devoted to discussion of TSPs, and the credibility of each counselor, as rated in a 12-point questionnaire. In addition, counselors (n=30) answered a demographic questionnaire, reporting such information as education level, recovery status, and months of experience in the field. As hypothesized, counselors who were perceived to be in recovery and more personally-familiar with TSPs received higher ratings of credibility from their clients, presumably resulting in better therapeutic alliances and, therefore, better outcomes.

In the second paper, researchers in Oregon and California sought to determine the characteristics associated with fidelity and TSF adherence among therapists participating in a large trial of the EBP. Notably, the authors found that 1) "Therapists reporting more positive attitudes toward 12-step groups had lower adherence ratings;" 2) "Being in recovery was associated with lower fidelity in univariate tests, but higher adherence in multivariate analysis;" and 3), "Fidelity was higher for therapists reporting self-efficacy in basic counseling skills" (as well as for therapists with a graduate degree) "and lower for self-efficacy in addiction-specific counseling skills." 

The "juxtaposition" of the two outcomes, as Yale's Steve Martino puts it, leads the reader to believe that the ideal therapist in this setting can't possibly exist, or ar the very least is exceedingly rare. Someone who is very familiar with 12-step principles is likely to report a positive attitude toward them, and counselors in recovery are likely to rate themselves as possessing strong addiction-specific counseling skills. So, what is the moral to the story, if one exists? Where do we focus workforce development energy with mixed messages like these? It would be interesting to hear from readers who fall on either side (or both sides) of this issue...

Advice for Consumers of Addiction Services

In the November issue of the prestigious journal Health Affairs, Anne Fletcher's book Inside Rehab got a very favorable review. Yours truly was highlighted with this paragraph from the review:

"Certainly the most useful part of the book is the advice provided by Mark Willenbring, former director of the Division of Treatment and Recovery Research at the National Institute on Alcohol Abuse and Alcoholism. He recommends that those seeking treatment should see themselves as customers and seek the best treatment that will work for them. They should get a comprehensive evaluation from someone not financially invested in a specific treatment program, demand nothing less than master’s degree–prepared therapists, and make sure the program treats any co-occurring issues. They should also not go through the same treatment protocols over and over again when it is obvious that they aren't working."

Thanks to Anne of course, and also to the reviewer, Rick Mathis (Richard_Mathis@bcbst.com), a a health
researcher at the BlueCross BlueShield of Tennessee Health Institute.

MW

I Challenge You to Find a Better Deal in Integrated Addiction & Psychiatric Treatment

First, my apologies for the drought in blogs lately. The last few weeks have been among the busiest in my life. Feels like internship all over again! Ian McLoone has been helping me with blog writing, and I haven't even had time to quickly look them over before publishing.

Busy is good to an extent, of course. The good news is that Alltyr is catching on, with very little marketing. Granted, being mentioned (with a very appreciated link) in Jane Brody's column, and the publication of Inside Rehab have propelled things along rather quickly, and to some extent it caught us off guard. But the new office in the 1st National Bank Bldg in St. Paul, MN is great. I love the building! Built in 1931, with lots of wonderful marble, and marvelous metalwork around the elevators. And, get this, planters with orchids all over the main level. In St. Paul, "the main level" is confusing. If you drive through downtown St. Paul, it looks like a kind of abandoned city on the street level. There's not much there except bus stops and the new light rail stops. Thing is, all the action occurs one story up, on the Skyway Level. Most buildings in downtown St. Paul and Minneapolis are connected to skyways. Skyways are connections between buildings 1 floor up from the street. So when I go to work there, I park in the heated garage in the building, leave my coat in the car, take the elevator to the skyway level. Here is where there are restaurants and delis, dry cleaning places, hair stylists, food courts, etc.

In addition to the office space, there are great amenities, including conference and training facilities at no extra charge and a modern workout facility, all included in the rent. And, we are in front of one of the new light rail stops, so it will be very easy to get here.

There are several suites on our current floor, which we are looking at for clinic expansion. My goal is to open a full -service SUD clinic in the fall of 2013. We are also talking to providers of sober housing. The idea is to create a comprehensive, state-of-the-art system of care that is based on 21st Century science, compassion and common sense.

We are also in discussions with local health plans, who are very interested in what we are doing. Remember, they are paying a lot for repeated useless residential and IOP rehabs. For example, a local nationally known provider charges about $30,000 for a 28-day residential rehab. I don't know what kind of discount the health plans get, but let's say they are paying $20,000 for it. Another prominent provider in the area charges $10,000 cash up front for a very pedestrian IOP with no housing. Alltyr's intensive services package, which includes a comprehensive evaluation by a physician (not a counselor), 10 1-hour psychotherapy and medication management visits, plus 25 30-minute therapy and medication visits over the course of a year, is only $4800, discounted from $5400 if purchased separately. Sober housing I'm going to estimate high at $1200 per month. So, for under $7,000, Alltyr Clinic will provide treatment services for a year plus 1 month supervised sober housing.  And with results that are guaranteed to be superior, because Alltyr's program includes completely integrated psychiatric treatment and uses all available treatment modalities.

I challenge you to find a better deal anywhere.

The Need for Something New in Addiction Treatment

It will come as no surprise to regular readers of this blog that there is a need for new approaches to treating addictions. In particular, people with substance use disorders (SUDs) and their families need access to current, scientifically based practice and greater consumer choice of treatment modalities. Today, I've been receiving a resounding validation of this fact from the response to Jane Brody's column for the New York Times three days ago. In the last two days, I've received almost 30 calls from all parts of the US from people who are interested, if not desperate, for something new, either for themselves or for a relative who is suffering from this disease. One person called me from China!

The main focus of Jane's column was a terrific new book by Anne Fletcher titled Inside Rehab. It's already #1 on the Amazon best-seller list for alcoholism recovery books, and it's been receiving widespread coverage that is overwhelmingly positive. And this is before it's actually available to the public! (Full disclosure: I was one of many experts in the field whom Anne used as resources for her book, and since she also lives in MN, we have become friends.) Jane, with whom I had previously talked with when I was at NIH, called to talk about the book and the state of the treatment field today, and this conversation figured fairly prominently in the column.

Of course, I'm grateful for the coverage of my efforts to change the treatment system and of Alltyr, but I'm saddened by the similarity of the stories I hear time and again. Mostly, it's about going through rehab over and over, almost all of them 12-step oriented, cookie-cutter programs that show films, give lectures, send clients to 12-step groups and use low-quality group  counseling. Clients of these programs are told that the program always works if they accept it, that they must not be motivated or willing, or that they are in denial, and so forth. Families often report nearly bankrupting themselves paying for expensive residential rehab programs that don't work. In too many cases, 12-step abstinence based treatment is used for opioid addiction even though all the evidence shows it doesn't work. Almost always, these are stories about repeated episodes of time-limited low quality treatment without continuity over time, attention to co-existing psychiatric and medical disorders, or meaningful family involvement. There is very little consumer choice or even information about the various options that have been shown to work. Little has changed from when I was at NIH, and frequently gave talks and interviews that were covered in the media. I would always receive calls and emails there asking how to find evidence-based treatment.

At the same time, I am heartened by this latest demonstration of how pressing the need is, how many people are desperately wanting something new. And it inspires me anew to keep pressing forward on a mission that at times feels overwhelming, where there are so many barriers and where progress is often difficult to see. The palpable pain and suffering I hear remind me why I'm doing this. And I know I am not alone, and as more people join the effort the momentum will continue to build.

MW

Counseling Adds Nothing to Buprenorphine Alone for Opioid Addiction

In a surprising new study, David Fiellin and his colleagues at Yale found that adding cognitive behavior therapy (CBT) to buprenorphine plus medical management along did not change outcomes. That's right, folks, nothing. This adds to the growing evidence that the primary reason people get better with Suboxone (buprenorphine is the primary ingredient) is the drug not the counseling. In another recent study, Roger Weiss and colleagues with the NIDA Clinical Trials Network found that the intensity of counseling made no difference in outcomes. Of course, they also found that after 11 weeks of Suboxone maintenance, when subjects were tapered off, the relapse rate within 8 weeks was more than 90%.

Here's a graph showing the final comparative outcomes. Note that in the first 12 week, pharmacotherapy management along (PM) actually had better outcomes, although not significantly so.

This will be hard to hear for many who are deeply committed to and believe passionately that it's the other way around, that counseling is the primary ingredient of treatment. That's why SAMHSA and others have tip-toed around this issue, calling treatment with Suboxone or methadone (another drug used to treat opioid addiction) Medication Assisted Treatment. Well, guess what? With opioid addiction it's the other way around: Counseling Assisted Medication. Or maybe: medical treatment with counseling as needed for problems other than opioid addiction. Hhhhmmmm. Sound familier? Let's see now, isn't that how we treat diabetes, hypertension, heart disease, stroke, allergies, whatever?

So for all you flat-earthers out there who cling to 12-Step or other counseling as the Holy Grail, I suggest you consult The Farmers Almanac, your horoscope, the I Ching, tea leaves, Tarot cards and the Mayan Calendar for guidance. Because you certainly don't seek any from science.

MW

References:

David A. Fiellin, MD, Declan T. Barry,  et al., A Randomized Trial of Cognitive Behavioral Therapy in Primary Care-based Buprenorphine. The American Journal of Medicine, Volume 126, Issue 1, January 2013, Pages 74.e11–74.e17

Weiss, R. D., J. S. Potter, et al. (2011). "Adjunctive Counseling During Brief and Extended Buprenorphine-Naloxone Treatment for Prescription Opioid Dependence: A 2-Phase Randomized Controlled Trial." Arch Gen Psychiatry: 68: 2011-2121.

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

Hazelden Starts Suboxone Maintenance!

Many of you may already have heard that Hazelden is starting a pilot project involving Suboxone maintenance treatment. This landmark shift is primarily due to the skill and persistent effort of Marv Seppala, MD, Hazelden's Chief Medical Officer. Marv and I go way back. I was on the faculty in the Department of Psychiatry at the University of Minnesota when Marv was a resident and then, subsequently, an addiction psychiatry fellow. He and I have stayed in touch ever since, and he and I and Carol Falkowski, another member of the old guard in Minnesota get together for lunch every few months. Marv is a great guy in addition to being a top-notch physician and psychiatrist. He is one of the few people who could make something like this happen. He is widely respected in the 12-Step and addiction treatment worlds, yet he is also a true professional who reads the research and believes in science. When he returned here to Minnesota from Oregon (where his true home still is) to work at Hazelden the second time (he was Chief Medical Officer for a period of time, then left due to disagreements with the then-CEO of Hazelden, then came back to work under a new CEO) we had dinner one night. I argued that not providing Suboxone and/or methadone maintenance treatment to opioid addicts was negligent given how strong the support was in the literature, and at that time, he said that their outcomes for opioid addicts was similar to those of other patients. More recently, as we discussed this new initiative, he told me that one of the primary forces driving the Board to adopt this shift was the number of poor outcomes from strictly abstinence-based 12-Step treatment. (No news to me, some of my Suboxone patients have completed multiple 12-step treatments including at Hazelden.)

Hazelden's new approach is a seismic shift that is likely to move the entire industry in this direction. I told Marv that it was like the Vatican opening a family planning clinic! However, although this is a major positive step, they continue to be wedded to a strictly 12-Step approach along with the medication. I don't see this ever changing. Hazelden has always seemed to operate like a Catholic hospital: science was ok as long as it didn't conflict with ideology, and when it did, ideology won out. It is still pretty much like that I think, but to their credit they have been prescribing anti-relapse medications for alcohol dependence for some time. To those rabid, fundamentalist 12-Steppers who consider anti-relapse medications a "crutch" (in a negative way), my reply is that when you break your ankle, a crutch facilitates healing, and anti-relapse medications do so as well. Rather than "weaken" recovery, they can help some people achieve long-term recovery who would otherwise fall by the wayside. It will be interesting to see how this all plays out in the 12-Step community. My patients tell me that in Narcotics Anonymous there has been increasing acceptance of Suboxone in particular, in contrast to methadone maintenance, which is still regarded as "using" by many because you can still get high while taking it.

MW

Don't Believe Me, Believe Those Affected!

It's interesting that in response to my talking or writing about research on addiction treatment, I'll get anecdotes in return: "I don't care what the studies show, I got sober without medication!" So we've got to get the stories of people who have benefited from modern treatment methods out there too. I reader wrote an email to me recently, and gave me permission to publish it with identifying info deleted. If you don't believe in research, or believe me, perhaps you'll believe what the people directly affected have to say. Here's the email, and thanks again to the reader who allowed me to publish it. .

Hi Dr:

I have been reading some articles on you as my interest in Suboxone has come about because my 31 year old heroin addict son is trying it.  He has been in detox 4 times, holdings 3 times, 8 months of sobriety in the last year and currently got kicked out of a holding after waiting two months for a halfway house (for smoking).

He is now with his "clean" girlfriend and has gone on Suboxone.  He is going to NA meetings and the doctor is distributing the medication in small amounts, recommended my son see a therapist and of course, go to meetings.  I am hopeful but only "cautiously optimistic" but he feels good and looks good and has hope.

I don't understand all the negative publicity over addiction medications as if there is something out there that works, I don't care if he is on it the rest of his life.

I do believe in the 12 steps and the concept but I don't understand why addicts are punished for relapses and put back out on the street.  It is the worst thing for them.  I have gone the enabling route (didn't work) and now do not enable and have practiced tough love when needed.  I think it helps.  He no longer asks for anything and is truly hopeful.

I just wanted you to know that your information is good to read and necessary to educate all of us that there are alternatives out there.

Keep up the good work... You are saving lives.

Thank you for listening.

PS:  Have you ever heard of www.learn2cope.com?

It is a fabulous support group for family members of addicts.  it is a lifesaver for us parents and if you haven't heard of them, you might want to take a look. 

The Inadequacy of Mental Health Treatments

I've written about treating addiction in its chronic or recurrent form much like we treat other chronic illnesses. Arguably the most painful part of doing so is accepting the limitations of our current treatments. It does not diminish the progress we have made to acknowledge that our current treatments are far from ideal. They fail too many people. (Yes, fellow treatment providers, treatment does fail people, we can't keep blaming our patients for not responding.) Addiction has a significant mortality rate. Cigarette smoking alone kills close to half a million Americans a year, and hundreds of millions globally. Alcohol addiction kills 85,000, and other addictions perhaps another 10,000. It is hard to live with this, to work so hard with people only to see them struggle in spite of everyone's efforts.

But as time goes on, and as I've done more clinical work again, I'm finding that mental illness is at least as hard if not harder to treat. Depression and anxiety are the most common mental illnesses, and they frequently co-exist with addiction. One thing I've learned is that the more chronic illnesses you have, the harder it is to manage any of them well. And our treatments for depression and anxiety are far from adequate. Between the two, anxiety is the most difficult, because for most people none of the treatments are very effective. Psychotherapy done well is probably the most effective, but it is hard to access good therapy and many patients are ill suited for it. (On the other hand, lousy psychotherapy can be had on every street corner it seems.) Antidepressants are the primary medications used to treat anxiety, but although some people respond very well, most do not. Benzodiazepines such as alprazolam (Xanax), clonazepam (Klonapin), lorazepam (Ativan) and diazepam (Valium) are extremely effective in the short run, but often become ineffective over time, leading to ever escalating doses. Unfortunately, one of the more common alternatives to the "benzos" is a second-generation antipsychotic, such as quetiapine (Seroquel) or aripiprozole (Abilify.) Sec-gen antipsychotics are effective for treating schizophrenia and bipolar disorder, and may be useful as adjuncts to antidepressants for depression, but they come with a lot of baggage and risk. They are terribly expensive, and they frequently lead to substantial weight gain, diabetes and heart disease. And they don't even work very well. Antihistamines such as hydroxyzine (Vistaril, Atarax) and diphenhydramine (Benadryl) don't really work at all in my experience. Anticonvulsants such as gabapentin (Neurontin) are usually not helpful. Most of the time, we struggle to find anything that works. And an uncontrolled panic or generalized anxiety disorder in an individual with an addictive disorder is a prescription for chronicity of both.

Depression is a little, but only a little, better. In the STAR*D trial, going through multiple iterations of medications yielded a remission or recovery rate (not at all depressed, or normal mood) in about 50% of participants. This rate is as good as it gets, because participants were screened out if they had addictive disorders or serious medical problems, or were homeless or did not have transportation, and they had sterling follow up and pharmacotherapy focused on adherence. In real life the figure is likely to be substantially lower. A majority, even in real life, do eventually show a response although in most people there are residual symptoms such as low energy, pessimism or irritability. However, finding a medication that works is trial and error, because the science is not yet available for us to predict who will respond to which drug. Thus, it may take weeks or months, trying multiple medications for several weeks each before finding something that works. So, many patients are left struggling with a serious depression that is not responding well to treatment, even while they are trying to establish recovery from a substance use disorder.

Bipolar disorder, schizophrenia and other psychotic disorders respond to acute treatment, but the long-term course does not appear to have changed significantly as a result of modern treatments. Compared to these diseases, addiction has a much higher rate of recovery. It is ironic indeed that the chemical dependency treatment industry has been highly successful in convincing people that treatment outcomes are poor because they defined success as complete and permanent recovery. Meanwhile, the pharmaceutical industry and, yes, psychiatrists, convinced the public that success rates for treating depression, anxiety, bipolar disorder and schizophrenia are much higher than they are in practice.

MW

Can We Trust Scientific Research?

A comment from a Twitter follower (@AddictionDrW) asserted that studies supporting the effectiveness of opioid maintenance therapy for opioid addiction must have been funded or supported in some way by "Big Pharma" and therefore cannot be trusted. He rejected all the research, saying that we should be listening to recovering addicts instead, or that "evidence is mixed." Is that true?

Methadone was invented in Germany as an analgesic during WWII. The first study of methadone maintenance, by Vincent Dole, Marie Nisswander and then-resident Mary Jeanne Kreek, was funded not by Big Pharma (who wanted nothing to do with "junkies"), but by the Health Research Council of New York City, due to the failure of abstinence-based approaches in the face of a growing heroin problem (Joseph et al., 2000). To my knowledge, it's never been a significant money maker for a large pharmaceutical company. Subsequent studies have for the most part been funded by government organizations such as the National Institutes on Health (NIH). The most recent large study of Suboxone maintenance for prescription opioid addicts, was funded by the NIH.

If NIH funded research, conducting in a rigorous way, is not trustworthy information, then what is? In my mind this is a way of asserting, in essence, that whatever one wants to believe is true. There are no objective methods to determine whether one assertion is true and its opposite is false. Therefore, there can be no accumulated knowledge, and we are all on our own, depending on whatever we wish to believe, or have heard from others. We can simply reject information we don't like or agree with and accept evidence that supports what we believe.


I don't think that is a supportable position, because it leads to the radical conclusion that there is no objective truth, only subjective opinions. Please, folks, how besides through scientific research are we going to improve outcomes for addiction treatment? And if we choose only to believe results that support our pre-existing ideas, how can we progress?

I understand that we all operate that way to a significant degree, because these biases are built into our brain structure and function, and are almost completely unconscious  Why is not clear, but then traits that nature selects through evolution seldom have immediately clear rationales. As my colleague, Steve Gilbert, argued in a previous blog, we make decisions and then rationalize them after the fact. We weave a coherent narrative of our lives because we need to. We need reasons why things happen, we need to feel in control, and we need to feel like a specific person with a specific history and characteristics. We need be able to explain how we arrived at a decision, and to simply say, "My gut told me so," is seldom adequate. Imagine a presidential debate where that was the rationale for political positions: "It just feels right to me."

On the other hand, it is because of these biases that the scientific method was devised: to minimize bias, to constrain interpretation, and to reveal the precise basis for arriving at a specific conclusion, so that others could replicate the study. Although single large trials may be provide evidence so strong that it changes thinking and practice, more often it is an accumulation of evidence from many studies conducted by multiple independent scientists. Evidence from multiple studies is then collected into systematic reviews, and if there are enough high-quality studies, are then subjected to an obscure procedure called meta-analysis. Meta-analysis is a systematic statistical method for combining findings across studies in order to determine whether, overall, a particular treatment is more effective than its alternative. Two famous examples are aspirin and beta-blockers for prevention of heart attacks after a first heart attacks. It wasn't until the meta-analyses were done that it became clear that these are effective approaches. Sometimes, it takes multiple meta-analyses before a conclusion can really be drawn.

Recent history is littered with examples of approaches that were fervently held and promoted prematurely. How many thousands of women underwent a horrendous and often fatal procedure, bone-marrow transplant, to treat end-stage breast cancer, before it was shown to be ineffective? At the time, women were lobbying legislatures around the country to mandate insurance coverage for it. Those of us who said, "Wait for the research before moving ahead," were shouted down, with tragic consequences for the unfortunate women who received the procedure and their families. Hormone replacement after menopause is another example, being strongly recommended and widely prescribed in the past, to prevent osteoporosis and heart disease, only to learn through meta-analyses, as well as very large well-done trials, that the treatment is actually harmful.

Perhaps the best recent example is that of PSA testing for prostate cancer in men. It was never clear that PSA testing was a good idea, but it became extremely widespread, if not universal. Millions of men have had  prostate biopsies (a very unpleasant procedure,) radical prostatectomies, radiation that scarred their rectums, and other treatments that left them incontinent and impotent. However, two large randomized controlled trials, one in the US and one in Europe, determined that almost all the tumors being treated were slow-growing and probably would never require treatment if left alone. In one trial, there was no difference in mortality, while in the other, there was a slight advantage to PSA testing, but 50 men would have to be treated in order to save one life. I know I don't want to be one of the 49 treated who didn't need it.

However, PSA testing is still popular in the US. Why? Because we are terrified of cancer, and we have been told that "catching it early and getting it out" is the best way to avoid dying of it. Many urologists refuse to believe the studies, based I would guess on their experience treating men with advanced, fast-growing tumors. (It's not even clear that treating fast-growing tumors alters survival.) I don't believe this is because of their financial interests in performing procedures; I know physicians too well to believe they don't have their patients' best interests in their minds and hearts. But they suffer from biases as well. We whack out prostates not because it is beneficial to most men undergoing surgery, we do it because it "feels like the right thing to do."

One of the reasons our health care costs so much is because of our refusal to stop funding ineffective or harmful medical procedures and treatments because "people want them." Here's another example: people presenting to the doctor with back pain were randomly (like the toss of a coin) assigned to either 1) receive regular XRays of their spine, or 2) to get an MRI. After one year, what was the result? In terms of function and pain, there were no significant differences. But there was one significant difference: people getting an MRI had more surgery. The fact is, most people over the age of 35 have abnormal MRIs of their spines, but the correlation with clinical symptoms is very low. And yet, people traipse into the doctor's office demanding an MRI of their back "because I want to know what it is." And the US does more back surgery than any other country in the world, probably more than the rest of the world combined, with highly dubious results. We also consume more prescription opioid pain medication than the rest of the world combined. So biases of this type are not limited to the field of addiction treatment. However, there is one difference: urologists and other physicians are obligated to advise patients of all alternative treatments and to do so in an unbiased way. The patient needs this information to make an informed decision.

A footnote about the "the evidence is mixed" strategy. This approach is not new, having been used by tobacco company executives and climate change deniers for many years. It is always possible to find one of 6 scientists in the world who reject climate change, and then present their opinions as equivalent to the 95% of scientists who are convinced of the evidence. This is a problem with current media, an obsession with presenting two sides to the story without providing the context of the overwhelming majority opinion or of the research itself. In the case of opioid maintenance treatment, the evidence is simply overwhelming in showing that it reduces relapse to addictive use, improves health and function, and reduces crime, and that abstinent-based approaches do not. If you choose to believe something else, that's up to you, but a professional in my opinion has en ethical responsiblity to accept scientific findings and act accordingly. In similar vein, anti-relapse medications for smoking and for alcohol use disorder are not home runs, but they improve outcomes consistently. To say otherwise is to filter the evidence according to preference, to see only what one wants to see. Treatment programs and their professional staff members who deny people with a devastating and often fatal illness access to these treatments, or even to information about them, are imposing their own biases and beliefs on their clients, in violation of the basic tenets of informed consent.

References
Joseph H, Stancliff S, Langrod J. (2000) Mt Sinai J Med 67:347.

Transformation in Action

Most people realize that the current system of care, developed in 1950 and based on the Big Book of Alcoholics Anonymous (AA), is not meeting the needs of patients, families, employers, the criminal justice system, or society at large. There is tremendous waste in providing the same series of lectures, group sessions, films and AA to people over and over again, thinking that someday it will "take." As a physician, that seems similar to treating one of the new "superbugs" with penicillin over and over, thinking that perhaps "this time" it will work. Even worse, in addiction treatment we blame the patient for not responding. At least the poor patient with treatment-resistant infection doesn't have to endure that: being blamed for not responding to available treatments.

The good news is this: people who suffer from addictions, their families and friends, employers, payers, and health care systems are not only ready for change, they are desperate for a new approach. The bad new is this: in order to fully implement modern, scientifically based treatment for addiction, we have to confront a very difficult reality. With the exception of maintenance therapy for opioid (painkiller or heroin) addiction, most other treatments we currently have only have modest effectiveness. To state that is not to belittle it, or to imply that addiction treatment is less effective than treatment for other conditions. When was the last time you knew someone who was cured of their diabetes or high blood pressure? Most chronic ailments respond modestly to available treatments. That's not ideal of course, but it's OK. After all, chronic diseases in humans are extremely complicated and difficult to treat.

We have an easier time accepting that for diseases below the neck. That's my term for diseases we consider "physical" or "medical," as opposed to "psychological." But this is old-fashioned thinking. Consider "psychological" illnesses, such as depression, anorexia, addiction or schizophrenia. If these disorders aren't "physical" what are they? Do they occur without a body, a physical structure which in this case happens to be the brain? No, they don't. The brain is a flesh-and-blood organ that regulates things, just like other organs. And, just like other organs it can get "sick," dysregulated, where it cannot perform it's intended function as well as it should.

MW

Program Thinking: The Bane of Addiction Treatment

I appreciate the two comments on my last blog, and they prompt a couple of responses from me. (If you didn't read them, click on the "Comments" link at the bottom of the blog.)

First, I'd like to clarify something in response to Dr. Dawson's comments. I was not arguing that people who are living in a sober structured environment do not need programming, or do not benefit from it. What I am saying is that there is no such thing as "residential or inpatient treatment." That is, studies have shown that staying overnight in the same place while receiving treatment has no outcome advantages over going home or to some other place, like a sober residence. So, there is treatment, and there is housing structure. Just like addiction psychotherapy, addiction pharmacotherapy, vocational counseling, psychiatric treatment, treatment for conditions below the neck (CBTN) (often but erroneously called "physical or medical" as opposed to "psychiatric," as if psychiatric conditions were somehow not organ-based or medical), transportation, family or marital therapy, and so on, addiction psychotherapy and housing structure are two very important, but essentially independent components of an interdisciplinary approach to comprehensive modern addiction treatment.

Marrying addiction psychotherapy to a residential treatment bed leads to "program thinking." Program thinking promotes a number of undesirable behaviors or characteristics. First, there is constant pressure to "keep the beds full." Thus, inclusion/exclusion criteria become flexible depending on bed occupancy, and people who could be treated quite well as outpatients are instead admitted to a residential program. This constant push leads to excessive costs without adding to outcome. Second, program thinking leads to cookie-cutter programming, because it's like running a factory, churning out patients and it is too difficult to have completely individualized lengths of stay or treatment plans. For example, the old joke in rehab is that we conduct a comprehensive individualized assessment and then send the client to group. It works much better to have the same groups for everyone, the same treatment for everyone, every time. Third, it leads to inappropriate levels of housing and of treatment services. Some people who need longer-term housing are pushed out at the end of the "program," while others who don't need sober housing are forced into it (and to pay for it.) Some patients need more intensive and comprehensive treatment services for a long time, but their treatment is interrupted arbitrarily, often with devastating consequences such as recurrent addiction along the way to connecting with some (different) outpatient follow up (inappropriately called "aftercare" rather than "care"). When treatment services are provided independently, then there is no disruption of services when a patient moves from one level of housing structure to another. Lack of continuity is compounded when the residential facility is geographically distant from the patient's home, which is often the case. It is always tempting to "send the patient away" to a distant facility so we don't have to worry about whether they are safe, but if we did that with every condition, we'd be sending out of control diabetics, not to mention almost all adolescents, to residential treatment too. We used to hospital people for long periods for psychiatric disorders such as depression and anxiety too, but when it became clear that that was actually harmful and expensive, it was stopped. It is long past time to stop it for addiction treatment too.

I'll respond to the other comment later.

Keep the comments and dialogue coming!

MW

How to Save $30,000 and Get Better Results

I have had numerous patients who have been pressured by their families to "go away" to some residential treatment program, usually it seems in another state (than Minnesota). Florida, Arizona and California seem to have a concentration of these, especially "Executive Programs" with gourmet food, precious handling, "equine therapy," "golf therapy," yoga, life coaching, and of course first class accommodations. They run from $20,000 to $70,000 for a month. These are people who have severe, recurrent addictions, usually to alcohol but some are addicted to opioids like heroin. Almost all have been through some sort of rehab multiple times before. Many but not all have money. Often enough, it's a family member who is coughing up the big bucks.

What do they get? One patient relapsed on the plane on the way home. Not a single one had any lasting benefit. Almost all relapsed within weeks, often days after returning home. In other circumstances, patients and families, and in Minnesota, state government, will pay for lengthy stays, 90, 120, 180 days in some "recovery environment." Again, it's plenty costly. But do they get any benefit? The vast majority do not.

It's an uphill battle to try to convince family members that sending their loved one away for some period of time to some "special place" is very unlikely to change their long-term outcomes. People just do not want to believe it. And admittedly, it's a hard pill to swallow. After all, the chemical dependency treatment industry has done a commendable job of spreading the idea that anyone can recover "if they really want to." And of convincing people that they have some unique answer to an ancient problem that defies easy resolution. The really difficult fact is this: all of our treatments (yes, that includes 12 Step treatment programs and AA) have modest effects at best. (The exception to this generalization is for opioid maintenance therapy with Suboxone or methadone for addiction to opioids such as Oxycontin or heroin. Opioid maintenance therapy is extremely effective and more cost-effective than almost any medical intervention other than vaccination.) Too many people do not respond to any available treatment. And they die of their illness. They die of a hereditary, brain-based behavioral disorder that makes them vulnerable to compulsive use of alcohol, opioids, cocaine, meth or cigarettes. It's not that they aren't motivated to change. I have to say, this is one of the cruelest things that rehabs do: people are told they could stop the process if they wanted to. But guess what? Some people can't. No matter how hard they try to "work the program." No matter what they do. Even if they go 90x90, or attend 1000 12-step meetings a year. They are mystified. "Why do I keep doing this? I'm not stupid! I know what will happen, but I do it anyway." This is the mystery of addiction.

In other chronic severe diseases, health care providers constantly experience failure of available treatments, and are able to accept it. People die of heart disease, cancer, diabetes, stroke, multiple sclerosis, dementia. But in the rehab industry, staff members are protected from experiencing treatment failure. First, treatment is time limited. So, instead of having to live with patients who come back with recurrent illness when the treatment doesn't work, staff members don't have to live with (and struggle to help) people who don't respond to treatment. Second, the entire industry (and unfortunately, too many 12-step program members) believe without doubt that "treatment doesn't fail patients, patients fail treatment." Try telling that to someone with metastatic cancer, end-stage liver failure, Parkinson's disease or chronic obstructive liver disease. But because we continue to stigmatize people with addiction, we get by with it, we are told to reject them, to use "tough love," to let them "bottom out." In my experience, in too many people "bottom" is 6 feet under ground. We condemn family members who don't abandon their loved ones as "enablers." What could be more cruel than this?

As a healer, one of the hardest things I do is to stay engaged with someone who dies of addiction. To not reject them. To not condemn them. To understand they are in the grips of something neither they nor I nor anyone else can control or stop, short of imprisoning them (and even then, prisons and mental hospitals are usually full of drugs.) To accept the limitations of our available treatments. To be compassionate even as death approaches. In the last year alone, in my part-time clinical practice, I have lost 6 patients to addiction.

It's not actually different than dying of diabetic renal failure, or of multiple sclerosis, or cancer. We can accept those illnesses as "not the person's fault." But when it's a brain-based disease, we cannot fathom that a brain can become dysregulated to the degree that someone loses control of their behavior to such an extent that they die from it. It's too frightening. We can't stand the thought that we aren't in full control of our lives. That we can't control our own behavior completely.

And yet, we all know better. We all have areas of problem, non-optimal behavior. We smoke. We drink too much. We don't exercise enough. We can't get our behavior right with our spouse or partner or children. We lose it. We shop too much. We can't handle money. We eat too much. We don't take good care of ourselves when we have a chronic illness. We lose our tempers. We work too hard, or not hard enough. We ignore important things. We procrastinate.

Yet we cling to the illusion of control. Of self-determination. We control our fates. Why can't "they"?

Just to be clear, I am not advocating that people with brain-based behavioral disorders not be held responsible for their behavior. For example, I am not advocating that people who commit crimes while intoxicated should be found innocent because of their addiction. As we move further into understanding the brain mechanisms underlying destructive and/or illegal behavior, this question looms large. But I have concluded that even though brain dysregulation might underlie much of this type of behavior, society only works if we hold people responsible for their behavior in spite of that fact. Individual responsibility for behavior is a social and political necessity that cannot be sorted out by science. In this blog, I am addressing how to provide health care for people with addiction and nothing else.

It's terrifying to think of having a behavior so out of control that it kills us. Anorexia nervosa. Depression. Bipolar disorder. Schizophrenia. Addictions. Antisocial and borderline personality disorders. All have substantial mortality rates. People with serious mental illness die 25 years early on average! Is it because people don't care if they die? I know that's not true, I've worked with too many of them. No, it's because the brain is a flesh-and-blood organ that can get sick, dysregulated, in specific ways that the individual cannot have insight into and cannot control. And it kills them. We have to come to grips with this grim reality if we have any hope of overcoming these dread diseases.

One thing I do know is this: some short-term high-end expensive rehab program is not going to change anything. The best hope is long-term care management with an experienced and qualified clinician or team of clinicians. That's what we do for diabetes, heart disease, cancer, stroke, arthritis. That's the best we can do for people with severe addictions. And it is a heck of a lot cheaper besides. Give me $30,000; I'll see you daily for a year! Geez, with 8 patients, I could make $240,000 a year!

I can obtain better results at a fraction of the price than any high-end time-limited treatment program. I guarantee it! And yet, I have to accept that despite all of my best efforts, and theirs, and their families', some of my patients will not respond. And some will die as a result. And they deserve our compassion, not condemnation.

What do you think? Please spread this around, comment on it, argue, agree or do something else. These are incredibly important questions.

MW