Informed Consent in Addiction Treatment: An Ethical Obligation

Informed Consent in Opioid Addiction Treatment: An Ethical Obligation

This article was originally published in The Carlat Addiction Treatment Report, Volume 2, #3, May 2014

Source: 

 CATR, May 2014, Vol 2, Issue 3, Opioid Addiction

Mark Willenbring, MD

Founder and CEO, Alltyr Clinic, St. Paul, MN, Former Director, Division of Treatment and Recovery Research, National Institute on Alcohol Abuse and Alcoholism, Bethesda, MD

Dr. Willenbring has disclosed that he has no relevant financial or other interests in any commercial companies pertaining to this educational activity.

Informed consent—whether it be for psychotherapy, prescribing a medication, or performing a surgical procedure—is an ethical principle firmly established in law and medicine.

While there has been no formal research on this subject, my experience suggests that many addiction treatment programs fail to obtain valid informed consent. The starkest example occurs in the treatment of opioid addiction, where the practices and beliefs of clinicians often differ markedly from the evidence regarding effective treatments.

What is Informed Consent?

Informed consent refers to the collaborative process that a provider and patient go through to develop a treatment plan for the patient’s problems. This moral requirement is based on the principle of respecting a person’s autonomy, that is, their right “to hold views, to make choices, and to take actions based on their values and beliefs” (Beauchamp TL & Childress JF.Principles of Bio-medical Ethics, 7th ed. New York: Oxford University Press, 2013:122–123).

Valid consent fulfills three criteria (Grimm DA, N M Law Rev 2007;37(1):39–83). First, the patient needs to have decision-making capacity. Capacity, in a medical context, refers to patients’ ability to understand information, appreciate their situation, use reason to make a decision, and communicate their choices (Applebaum PS, N Engl J Med 2007;357(18):1834–1840). This is referred to as the “capacity” criterion.

Second, the provider needs to present the full range of available treatment options based on current scientific knowledge. During this discussion, he or she needs to outline the risks and benefits of these various options and what could be reasonably expected if the patient declines treatment altogether. This is called the “disclosure” criterion.

Finally, valid consent requires that patients are free from coercion—that is, they are in a position to voluntarily choose any treatment option that they feel is best for them. This is described as the “voluntariness” criterion.

A provider has failed to obtain valid informed consent if any of these elements are missing.

Legal Standards

Legal requirements for consent have evolved over centuries. Until relatively recently, courts used a physician-oriented point of view: the physician was required to provide information he or she felt was in the patient’s best interests. This resulted in practices such as informing a spouse, but not the patient, of a terminal disease. In other cases, providers deliberately omitted certain treatment options from their discussions with patients because of their personal beliefs or biases against them.

Through a series of court decisions, a new standard, the “reasonable person” or “prudent person” standard, emerged. Providers are now expected to present patients with information that a reasonable or prudent person would want to know in order to make healthcare decisions (Berg JW et al.Informed Consent: Legal Theory and Clinical Practice, 2d ed. New York: Oxford University Press, 2001:48).

In clinical practice, a provider is not allowed to withhold information from a patient based on his or her judgment that one treatment is better than another. The provider is thus required to present the scientific evidence supporting available treatment options, the expected outcomes of these various treatments, and the clinician’s recommendation for the patient and the rationale for it. This recommendation also needs to take into account any patient-specific features that factored into the provider’s decision-making.

This means that clinicians are legally obligated to provide information that they may prefer to withhold. The purpose of informed consent, however, is not to “conveniently promote a treatment plan; it requires informing patients with the recognition that they may disagree with a recommended treatment plan and retain the authority to do so” (Berg et al, op.cit).

There is also an important distinction between the actual process of obtaining autonomous authorization for a treatment or procedure and institutional requirements that patients sign informed consent documents. Patients frequently sign such documents in the absence of true informed consent (Beauchamp & Childress, op.cit).

Evidence-Based Treatment

Providers are obligated to summarize the scientific data concerning the effectiveness of various treatment options. The only treatment with consistent, strong evidence of effectiveness for opioid addiction is indefinite opioid maintenance therapy with either buprenorphine or methadone (Mattick RP et al, Cochrane Database Syst Rev 2014;2:CD002207).

Currently, the World Health Organization, US Centers for Disease Control and Prevention, US Department of Health and Human Services, and many other agencies and organizations recommend methadone and buprenorphine maintenance as first-line treatments.

In contrast, there is no evidence commending drug-free (or so-called abstinence-based) treatments (Mayet S et al, Cochrane Database Syst Rev2005;1:CD004330). Moreover, there is good evidence that psychosocial or intensive behavioral approaches fail to improve outcomes compared to minimal drug counseling in patients receiving opioid maintenance therapy (Amato L et al, Cochrane Database Syst Rev 2011;10:CD004147; Fiellin DA et al, Am J Med 2013;126(1):74.e11–17).

Naltrexone is the only other medication that has been approved by the FDA for opioid addiction. Oral naltrexone (ReVia) is ineffective (Minozzi S et al,Cochrane Database Syst Rev 2011;4: CD001333) and the efficacy of extended-release, injectable naltrexone (Vivitrol) was established in just a single, industry-sponsored study conducted in Russia, where buprenorphine and methadone are not legally available (Krupitsky E et al, Lancet2011;377(9776):1506–1513).

Presently, evidence for Vivitrol’s effectiveness is limited and generalization of clinical trial data to other countries is questionable. (For more, see“Vivitrol: Another Option for Opioid Addiction?”)

Meeting the Capacity Criterion

In addiction treatment, patients who are experiencing severe withdrawal symptoms may not have capacity due to pain and emotional distress. Other confounders include co-occurring mental disorders and cognitive impairment associated with prescribed medications and substances of abuse. Although beyond the scope of this article, simple bedside instruments allow providers to evaluate and easily document a patient’s decision-making capacity (Tunzi M, Am Fam Physician 2001;64(2):299–306).

Meeting the Disclosure Criterion

Providers need to have a clear understanding of available treatment options and the scientific evidence supporting each one, so they can meet their obligation concerning disclosure.

This article’s brief summary may serve as a starting point. Standard textbooks are also a ready source of such information (eg, Strain EC & Stitzer ML eds. The Treatment of Opioid Dependence. Baltimore, MD: Johns Hopkins University Press, 2006). In addition, a number of plain language resources geared toward patients are available (eg,http://1.usa.gov/1ibCKou).

Providers need to present patients with more than their program’s philosophy or even the community standard of care. Remember, the standard for disclosure is what a reasonable or prudent patient would want to know, not a narrow presentation concerning usual care or the provider’s personal preferences. In the case of opioid addiction, this means summarizing the scientific data on the effectiveness of treatment options. This is a fiduciary duty that trumps the clinician’s personal preferences and their program’s philosophy of care.

Meeting the Voluntariness Criterion

Providers need to be very sensitive to overt, and more subtle covert, coercion when discussing treatment options with patients. Many people presenting for substance use treatment are subject to significant coercion from the legal system, employers, and families. Thus, we need to ensure that consent is truly voluntary and that we are not using coercion to impose our own views concerning treatment upon patients.

This ethical obligation may require advocating for a treatment option different than what a judge, probation officer, employer, or family prefers or recommends.

CATR’s Take: Addiction treatment has historically been very prescriptive and patients often had little choice about the care that they received. This article is a good reminder that providers have an affirmative duty to obtain informed consent and engage patients in shared decision-making.

Who Benefits from Additional Drug Counseling among Prescription Opioid Dependent Patients on Suboxone?

In a secondary analysis of the Prescription Opioid Addiction Treatment Study (POATS), the original study's author, Roger Weiss, and colleagues parse the data to determine if there are common characteristics among those who benefited from additional opioid dependence counseling (ODC) - above and beyond the standard medical management (SMM) and buprenorphine-naloxone medication. It is a very good question, considering the host of recent studies which found no additional benefit to counseling in terms of measured outcomes, including the large and highly-regarded POATS.

In searching for an answer, the authors looked at two sources of variability - patient characteristics, and adherence to treatment. Specifically, the authors sought to answer three questions: 1) Did participants with more severe problems have better outcomes with SMM + ODC than with SMM alone (N=360)? 2) Among participants with adequate adherence to treatment, were those assigned to SMM + ODC more likely to have successful outcomes than those receiving SMM alone, regardless of severity (n = 266)? And 3), among participants with adequate adherence to treatment, were those with more severe problems more likely to succeed with additional counseling than with standard medical management only (n = 266)?

In response to question 1, the analysis found that "the association between severity and outcome did not vary by treatment condition for any of the three severity measures." Those without past use of heroin had more favorable outcomes across the entire study. Regarding question 2, "adequate adherence" was defined as attending at least 60% of scheduled scheduled sessions in both treatment conditions, and most participants (73.9%) attended at least 60% of sessions. Subjects in the SMM-only condition were more likely meet this criterion but, once again, outcomes did not differ by treatment condition. Finally, in answering question 3, the authors found that, "Among participants who had ever used heroin, those assigned to SMM + ODC were more likely to succeed than those in SMM only (66.7% vs. 35.0%, n = 70, χ2(1) = 6.88, p=.016)."

 Table 1

Likelihood of successful opioid use outcomes at Phase 2, weeks 9–12. ^a

	OR	95% CI      p Value
(a) All participants ( n= 360)
Main effects
Heroin	2.0	1.3–3.3      .004
Chronic pain	1.3	0.8–2.0      .240
Drug severity	2.9	0.2–58.2    .484
Interaction with Phase 2 treatment
Heroin	1.6	0.6–4.2      .342
Chronic pain	0.6	0.2–1.4      .218
Drug severity	0.2	0.0–76.8    .585	.
(b) Participants with adequate adherence to treatment ( n= 266)
Main effect of Phase 2 treatment	0.7	0.4–1.1     .107
Interaction with Phase 2 treatment
Heroin	3.7	1.1–11.8     .03
Chronic pain	0.5	0.2–1.5      .213
Drug severity	1.5	0.001–4023.5   .915

^a All models were adjusted for Phase 1 treatment condition.

Treatment outcomes did not appear to differ among those who had never used heroin, suggesting that prescription opioid-addicted patients with a history of heroin use may be the participants who are most likely to benefit from additional counseling in suboxone treatment. Importantly, those patients had to also attend enough sessions (and receive an adequate "dose" of counseling) in order to see their outcomes improve to rates similar to those without a history of heroin use.

So, do these results line up with the experience of the readers of this blog? Are there populations with whom you believe counseling is especially important? Or, do the results simply reinforce the lessons of past studies? Let us know

What Aren't More Docs Prescribing Buprenorphine?

On the heels of recent coverage over the "dangers" of the medication buprenorphine, researchers are seeking to better understand what keeps doctors from using one of the two the most effective tools for opioid use disorders at their disposal. The most recent study, "Barriers to Primary Care Physicians Prescribing Buprenorphine", was published in the Annals of Family Medicine and is available in-full online - for free. The study came out of the Rural Opioid Addiction Management in Washington state, during which 120 physicians were trained in opioid addiction and buprenorphine prescribing. Disappointingly, of the 78 respondents who were analyzed for the study, 50 went on to obtain a DATA waiver, yet a mere 22 doctors ever went on to prescribe the medication to anyone. It begs the question: why aren't more docs prescribing buprenorphine?

Here's the breakdown from the piece of perceived barriers to prescribing:

Among the barriers cited by the doctors in the study, "Lack of psychosocial support" was cited as the number one barrier by both prescribers and non-prescribers, despite the lack of evidence that behavioral adjuncts or additional counseling improve outcomes. (Granted, the authors point out that in order to get reimbursed by a number of payers, additional counseling must be offered to patients.)

A quick scan across the literature leads us to another important and common driver of physician attitudes toward this medication: institutional support. It appears that study after study cite the impact of the hospital/clinic/practice culture on the subsequent interest. training and prescription of buprenorphine by its docs. In the present study, "resistance from practice partners" and "lack of institutional support" were commonly cited as barriers. A recent article from the March issue of the Journal of Substance Abuse Treatment described how important "A strong leader championing the new treatment" was to the implementation of buprenorphine prescribing across a large system. 

What do you think? How can we be more effective at impacting change at the prescriber level? If culture plays an important role, how do we improve the culture around this proven tool?

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

Researchers Take a Novel Approach to Vivitrol Induction

Researchers and clinicians at Duke University performed a small, open label study to test a new induction protocol for opioid detoxification in an outpatient setting. Much has been written about the pros and cons of antagonist medication for opioid dependence, with most evidence supporting agonist medications like buprenorphine or methadone. One of the most difficult aspects of maintenance antagonist treatment is the detoxification and induction phases of treatment, considering the intolerability of the experience to most patients - especially those in outpatient settings. So, the authors of a new study, published recently in Drug and Alcohol Dependence, sought to make this experience a little more tolerable. The administered increasing doses of naltrexone and decreasing doses of buprenorphine to treatment-seeking opioid addicts until their first dose of extended-release injectable naltrexone (Vivitrol). The results were encouraging:

Abstract

BACKGROUND

The approval of extended release injectable naltrexone (XR-NTX; Vivitrol®) has introduced a new option for treating opioid addiction, but studies are needed to identify its place within the spectrum of available therapies. The absence of physiological opioid dependence is a necessary and challenging first step for starting XR-NTX. Outpatient detoxification gives poor results and inpatient detoxification is either unavailable or too brief for the physiological effects of opioids to resolve. Here we present findings from an open label study that tested whether the transition from opioid addiction to XR-NTX can be safely and effectively performed in an outpatient setting using very low dose naltrexone and buprenorphine.

METHODS

Twenty treatment seeking opioid addicted individuals were given increasing doses of naltrexone starting at 0.25 mg with decreasing doses of buprenorphine starting at 4 mg during a 7-day outpatient XR-NTX induction procedure. Withdrawal discomfort, craving, drug use, and adverse events were assessed daily until the XR-NTX injection, then weekly over the next month.

RESULTS

Fourteen of the 20 participants received XR-NTX and 13 completed weekly assessments. Withdrawal, craving, and opioid or other drug use were significantly lower during induction and after XR-NTX administration compared with baseline, and no serious adverse events were recorded.

CONCLUSIONS

Outpatient transition to XR-NTX combining upward titration of very low dose naltrexone with downward titration of low dose buprenorphine was safe, well tolerated, and completed by most participants. Further studies with larger numbers of subjects are needed to see if this approach is useful for naltrexone induction.

Mean opioid withdrawal and craving scores during induction and after naltrexone extended release administration (Days 1-9), using SOWS (Subjective Opioid Withdrawal Scale), COWS (Clinical Opioid Withdrawal Scale) and VAS (Visual Analog Scale) for craving. Time point scores are the results of the mean score of each day of treatment, error bars represent + -1 SEM. Number of participants is reported on the X-axis.

In-treatment proportion of opioid positive urine samples (Day1-9, N = 20).

Source:

http://www.sciencedirect.com/science/article/pii/S0376871614000568

SAMHSA Releases State and National Behavioral Health Barometer

The federal Substance Abuse and Mental Health Services Administration recently released its yearly report on the general state of behavioral health needs and services in the US. Based on population and treatment-facility data sets from state to state, the Behavioral Health Barometer is a sweeping, in-depth look into adolescent and adult drug use, treatment and mental health service utilization.

Among the highlights:
- Nationally, youth and young adult use of nonmedical pain relievers is declining in general.
- Past-month cigarette use among teens nationally and locally is declining, although Minnesota saw a small increase in 2011-2012
-Over 50% of Minnesota adolescents, and over 60% of adolescents nationally, did not receive treatment for their past-year depressive episode.
-In Minnesota, only 6.6% of people with past-year alcohol dependence received treatment. For illicit drugs, the number is 14.6%
-In Minnesota, while the number of people receiving methadone treatment has increased by nearly 1000 people since 2008, the number of people receiving buprenorphine has actually decreased in that time (owing to a sharp drop from 2008-2009.

The national report is here:
http://www.samhsa.gov/data/StatesInBrief/2K14/National_BHBarometer.pdf

Read the MN report here:
http://store.samhsa.gov/shin/content/SMA13-4796/SMA13-4796MN.pdf

And find your state here:
http://store.samhsa.gov/product/Behavioral-Health-Barometer-2013/SMA13-4796

Cochrane Releases New Reviews on MAT

The highly-respected Cochrane Library, known for its meticulous reviews of the current state of medical knowledge, has updated and released two reviews on medication-assisted treatment recently. The first, "Maintenance agonist treatments for opiate-dependent women", aims to " assess the effectiveness of any maintenance treatment alone or in combination with psychosocial intervention compared to no intervention, other pharmacological intervention or psychosocial interventions for child health status, neonatal mortality, retaining pregnant women in treatment and reducing the use of substances." The second, "Pharmacological interventions for drug-using offenders" aims to " assess the effectiveness of pharmacological interventions for drug-using offenders in reducing criminal activity and/or drug use." In both cases, the authors note the effectiveness of opioid medications in assisting patients to achieve desired outcomes (although the effect on criminal activity in the second study was significant, but less pronounced). However, they cautioned against generalizing the findings as the body of evidence of both topics is still too small.

Here are the abstracts, via Wiley:

Maintenance agonist treatments for opiate-dependent pregnant women

Abstract

Background

The prevalence of opiate use among pregnant women can range from 1% to 2% to as high as 21%. Heroin crosses the placenta and pregnant, opiate-dependent women experience a six-fold increase in maternal obstetric complications such as low birth weight, toxaemia, third trimester bleeding, malpresentation, puerperal morbidity, fetal distress and meconium aspiration. Neonatal complications include narcotic withdrawal, postnatal growth deficiency, microcephaly, neuro-behavioural problems, increased neonatal mortality and a 74-fold increase in sudden infant death syndrome.

Objectives

To assess the effectiveness of any maintenance treatment alone or in combination with psychosocial intervention compared to no intervention, other pharmacological intervention or psychosocial interventions for child health status, neonatal mortality, retaining pregnant women in treatment and reducing the use of substances.

Search methods

We searched the Cochrane Drugs and Alcohol Group Trials Register (September 2013), PubMed (1966 to September 2013), CINAHL (1982 to September 2013), reference lists of relevant papers, sources of ongoing trials, conference proceedings and national focal points for drug research. We contacted authors of included studies and experts in the field.

Selection criteria

Randomised controlled trials assessing the efficacy of any maintenance pharmacological treatment for opiate-dependent pregnant women.

Data collection and analysis

We used the standard methodological procedures expected by The Cochrane Collaboration.

Main results

We found four trials with 271 pregnant women. Three compared methadone with buprenorphine and one methadone with oral slow-release morphine. Three out of four studies had adequate allocation concealment and were double-blind. The major flaw in the included studies was attrition bias: three out of four had a high drop-out rate (30% to 40%) and this was unbalanced between groups.

Methadone versus buprenorphine: the drop-out rate from treatment was lower in the methadone group (risk ratio (RR) 0.64, 95% confidence interval (CI) 0.41 to 1.01, three studies, 223 participants). There was no statistically significant difference in the use of primary substance between methadone and buprenorphine (RR 1.81, 95% CI 0.70 to 4.69, two studies, 151 participants). For both, we judged the quality of evidence as low. Birth weight was higher in the buprenorphine group in the two trials that could be pooled (mean difference (MD) -365.45 g (95% CI -673.84 to -57.07), two studies, 150 participants). The third study reported that there was no statistically significant difference. For APGAR score neither of the studies which compared methadone with buprenorphine found a significant difference. For both, we judged the quality of evidence as low. Many measures were used in the studies to assess neonatal abstinence syndrome. The number of newborns treated for neonatal abstinence syndrome, which is the most critical outcome, did not differ significantly between groups. We judged the quality of evidence as very low.

Methadone versus slow-release morphine: there was no drop-out in either treatment group. Oral slow-release morphine seemed superior to methadone for abstinence from heroin use during pregnancy (RR 2.40, 95% CI 1.00 to 5.77, one study, 48 participants). We judged the quality of evidence as moderate.

Only one study which compared methadone with buprenorphine reported side effects. For the mother there was no statistically significant difference; for the newborns in the buprenorphine group there were significantly fewer serious side effects.

In the comparison between methadone and slow-release morphine no side effects were reported for the mother, whereas one child in the methadone group had central apnoea and one child in the morphine group had obstructive apnoea.

Authors' conclusions

We did not find sufficient significant differences between methadone and buprenorphine or slow-release morphine to allow us to conclude that one treatment is superior to another for all relevant outcomes. While methadone seems superior in terms of retaining patients in treatment, buprenorphine seems to lead to less severe neonatal abstinence syndrome. Additionally, even though a multi-centre, international trial with 175 pregnant women has recently been completed and its results published and included in this review, the body of evidence is still too small to draw firm conclusions about the equivalence of the treatments compared. There is still a need for randomised controlled trials of adequate sample size comparing different maintenance treatments.

http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD006318.pub3/abstract

 

Pharmacological interventions for drug-using offenders

Abstract

Background

The review represents one in a family of four reviews focusing on a range of different interventions for drug-using offenders. This specific review considers pharmacological interventions aimed at reducing drug use and/or criminal activity for illicit drug-using offenders.

Objectives

To assess the effectiveness of pharmacological interventions for drug-using offenders in reducing criminal activity and/or drug use.

Search methods

Fourteen electronic bibliographic databases (searched between 2004 and 21 March 2013) and five additional Web resources (searched between 2004 and 11 November 2011) were searched. Experts in the field were contacted for further information.

Selection criteria

Randomised controlled trials assessing the efficacy of any pharmacological interventions for reducing, eliminating or preventing relapse in drug-using offenders were included. Data on the cost and cost-effectiveness of interventions were reported.

Data collection and analysis

We used standard methodological procedures as expected by The Cochrane Collaboration.

Main results

A total of 76 trials across the four reviews were identified. After a process of prescreening had been completed, 17 trials were judged to meet the inclusion criteria for this specific review (six of the 17 trials are awaiting classification for the review). The remaining 11 trials contained a total of 2,678 participants. Nine of the eleven studies used samples with a majority of men. The interventions (buprenorphine, methadone and naltrexone) were compared to non pharmacological treatments (e.g., counselling) and other pharmacological drugs. The methodological trial quality was poorly described, and most studies were rated as 'unclear' by the reviewers. The biggest threats to risk of bias were generated through blinding (performance and detection bias) and incomplete outcome data (attrition bias). When combined, the results suggest that pharmacological interventions do significantly reduce subsequent drug use using biological measures, (three studies, 300 participants, RR 0.71 (95% CI 0.52 to 0.97)), self report dichotomous data (three studies, 317 participants, RR 0.42, (95% CI 0.22 to 0.81)) and continuous measures (one study, MD -59.66 (95% CI -120.60 to 1.28)) . In the subgroups analysis for community setting, (two studies, 99 participants: RR 0.62 (95% CI 0.35 to 1.09)) and for secure establishment setting, (one study, 201 participants: RR 0.76 (95% CI 0.52 to 1.10)), the results are no longer statistically significant. Criminal activity was significantly reduced favouring the dichotomous measures of re arrest, (one study, 62 participants, RR 0.60 (95% CI 0.32 to 1.14)), re-incarceration, (three studies, 142 participants, RR 0.33 (95% CI 0.19 to 0.56)) and continuous measures (one study, 51 participants, MD -74.21 (95% CI -133.53 to -14.89)). Findings on the effects of individual pharmacological interventions on drug use and criminal activity show mixed results. Buprenorphine in comparison to a non pharmacological treatment seemed to favour buprenorphine but not significantly with self report drug use, (one study, 36 participants, RR 0.58 (95% CI 0.25 to 1.35)). Methadone and cognitive behavioural skills in comparison to standard psychiatric services, did show a significant reduction for self report dichotomous drug use (one study, 253 participants, RR 0.43 (95% CI 0.33 to 0.56)) but not for self report continuous data (one study 51 participants) MD -0.52 (95% CI -1.09 to 0.05)), or re incarceration RR 1.23 (95% CI 0.53 to 2.87)). Naltrexone was favoured significantly over routine parole and probation for re incarceration (two studies 114 participants, RR 0.36 (95% CI 0.19 to 0.69)) but no data was available on drug use. Finally, we compared each pharmacological treatment to another. In each case we compared methadone to: buprenorphine, diamorphine and naltrexone. No significant differences were displayed for either treatment for self report dichotomous drug use (one study, 193 participants RR 1.23 (95% CI 0.86 to 1.76)), continuous measures of drug use MD 0.70 (95% CI -5.33 to 6.73) or criminal activity RR 1.25 (95% CI 0.83 to 1.88)) between methadone and buprenorphine. Similiar results were found for comparisons with Diamorphine with no significant differences between the drugs for self report dichotomous drug use for arrest (one study, 825 participants RR 1.25 (95% CI 1.03-1.51)) or Naltrexone for dichotomous measures of re incarceration (one study, 44 participants, RR 1.10 (95% CI 0.37 to 3.26)), and continuous outcome measure of crime MD -0.50 (95% CI -8.04 to 7.04)) or self report drug use MD 4.60 (95% CI -3.54 to 12.74)).

Authors' conclusions

Pharmacological interventions for drug-using offenders do appear to reduce overall subsequent drug use and criminal activity (but to a lesser extent). No statistically significant differences were displayed by treatment setting. Individual differences are displayed between the three pharmacological interventions (buprenorphine, methadone and naltrexone) when compared to a non pharmacological intervention, but not when compared to each other. Caution should be taken when interpreting these findings, as the conclusions are based on a small number of trials, and generalisation of these study findings should be limited mainly to male adult offenders. Additionally, many studies were rated at high risk of bias because trial information was inadequately described.

http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD010862/abstract

Is Florida Turning a Corner?

According to a brand new study, published online this week in the journal, Pharmacoepidemiology and Drug Safety, Florida's recent legislative actions to 1.) strengthen the state's prescription drug monitoring program, and 2.) toughen the regulation of the state's pain clinics, seem to be having the desired effect: drug diversion has been dropping steadily since 2011. In addition, according to the state's commission of medical examiners, prescription opioid overdose deaths are dropping too. Here's the abstract from the article and a figure of the models of longitudinal change, according to each drug: 

Reductions in prescription opioid diversion following recent legislative interventions in Florida

Surratt, et al., 2013

Purpose
Florida has been at the center of the nation's ongoing prescription opioid epidemic, with largely unregulated pain clinics and lax prescribing oversight cited as significant contributors to the opioid problem in the state.

Methods
In an effort to mitigate prescription opioid abuse and diversion in Florida, legislative interventions were implemented during 2010 and 2011, which included two primary elements: (i) comprehensive legislation to better regulate the operation of pain clinics; and (ii) a statewide prescription drug monitoring program to promote safer prescribing practices. Using systematic longitudinal data collected on a quarterly basis from law enforcement agencies across Florida, this report examined changes in prescription opioid diversion rates following implementation of these regulatory initiatives. Quarterly diversion rates for buprenorphine, fentanyl, hydrocodone, hydromorphone, methadone, morphine, oxycodone, and tramadol were calculated, and subsequently, hierarchical linear models were fit to test for differences in diversion rates over the 15 quarter period of interest.

Results
Significant declines in diversion rates were observed for oxycodone, methadone, and morphine; hydrocodone displayed a marginally significant decline.

Conclusions
This study documented reductions in statewide opioid diversion rates following implementation of Florida's pain clinic and prescription drug monitoring program legislative interventions. Although these initial findings appear promising, continued surveillance of diversion is clearly warranted. Copyright © 2013 John Wiley & Sons, Ltd.

MMT and 12-Step Groups: Stigma Persists

In his latest contribution to the academic literature, William L. White and colleagues turn their focus on 12-Step participation among patients in methadone maintenance treatment (MMT). Rates of self-reported Narcotics Anonymous (NA) and Alcoholics Anonymous (AA) attendance were very high; however, participants frequently reported that their MMT status prevented them from taking part in many of the "key ingredients" of the groups that most members take for granted. When asked about the experience, nearly half of all respondents who had attended NA or AA reported that they had "received negative comments about methadone use" and nearly "a quarter (24.4%) reported having had a serious problem within NA or AA related to their status as a methadone patient."

The following table from the report details the "frequency with which respondents faced particular challenges":

Table 4: NA and AA Responses to MMT Patient Status                                NA            AA

Response to MM Patient Status:                                                                         (n=228)     (n=142)

Received negative comments about methadone use                                                43.0%     45.1%

Were pressured to reduce the dose of methadone                                                  21.9%     23.2%

Were pressured to stop taking methadone                                                             32.9%     34.5%

Were denied the right to speak at a meeting because of being
in methadone treatment                                                                                         14.5%      14.1%

Were denied the right to become a sponsor because of being                                  8.8%        9.9%
in methadone treatment


White and colleagues implemented this small study at not-for-profit opioid treatment program (OTP) in the Northeastern US. A total of 322 respondents answered a 53-question survey about their participation in recovery support groups. Of the 322, 259 (80.4%) reported a primary affiliation with a recovery support group. Of these, 88.8% reported it to be in some way a 12-Step group. Importantly, 66% of respondents reported past-year NA/AA participation, with 88-89% reporting the group was "helpful".

Despite these figures, the authors found MMT patients had low rates of participation in the "key ingredients" that seem to be critical influencers of long-term recovery outcomes: having a home group (50%), having a sponsor (26%), sponsoring others (13%), attending 12-Step social events (23%), and active step work (21%).

Anecdotally, we see a lot of patients at Alltyr who have a hard time finding a place in the local 12-Step scene. We even began compiling a list of medication-friendly meetings in the Twin Cities as we learned about them, but the stigma associated with maintenance is still prevalent. Could it be that we are on the verge of another breakthrough in medication acceptance? After all, there was a time when you weren't considered "sober" if you were on antidepressant or antipsychotic medications (but now, as Dr W likes to say, you're more likely to be referred to the psychiatrist by your sponsor than by anyone else). We would be interested to hear reader stories about this experience - or opinions on the topic. Are things changing - or not?

See the full paper by White, et al., here: http://www.williamwhitepapers.com/pr/2013%20Co-participation%20in%2012-Step%20Groups%20and%20Methadone%20Maintenance.pdf

New Findings in Medication-Assisted Treatment

Some interesting new studies are showing promising results for patients all over the world:

Turns out, Quality of Life improvements aren't just for the wealthy:
Quality of Life (QoL) scores significantly improved in ALL four domains (psychological, physical, social and environmental) of the WHO QoL scale in patients in low and middle income countries, according to the authors of a systematic review of 13 studies involving over 1800 participants. The findings, published online last week in the Journal of Drug and Alcohol Dependence, show that despite the apparent lack of resources in these countries, opiate replacement therapy with methadone or buprenorphine can be an effective treatment tool - with scores increasing along with the length of time at followup - and offering outcomes comparable to those seen in high income countries.
You can read the abstract of the study by Feelemeyer, et al., here: http://www.sciencedirect.com/science/article/pii/S0376871613004225

The methadone of methamphetamine?:
In encouraging news for stimulant users, a small study has shown methylphenidate (Ritalin) to both improve symptoms and reduce use episodes, in a cohort of criminal justice-involved stimulant users with co-occurring ADHD. Similar findings have been published supporting mixed-amphetamine salts (Adderall) plus topiramate (Topamax) for the treatment of cocaine dependence, and more recently topiramate by itself. The authors of the small study note the high prevalence of ADHD among stimulant users in the criminal justice population and in their research used dosages that were high enough to be therapeutically effective for patients with a history of substance use disorders (a flaw, they argue, in previous studies of this kind). Could it be that we are getting closer to an accepted agonist maintenance treatment for stimulant use disorders? Read the results of the Swedish study by Konstenius, et al., published online this month in the journal Addiction:
http://onlinelibrary.wiley.com/doi/10.1111/add.12369/abstract

Groups could improve access to AUD medications:
And finally, in a new study in the Journal of Substance Abuse Treatment, researchers have shown that group pharmacotherapy is an effective intervention for patients on medication-assisted treatment of alcohol use disorders. The authors provide a brief description of this novel approach and their experiences implementing the program. They note that, for many clinicians, providing ongoing monitoring of these effective medications can create a barrier to implementation. What the team found however, was that a "medication group" was not only feasible, but it actually increased their patients' access to meds like disulfiram (Antabuse), naltrexone and acamprosate (Campral). Read the abstract from the report by Dr Shannon Robinson and a team at San Diego's VA Health Care System here: http://www.sciencedirect.com/science/article/pii/S0740547213001347

Buprenorphine: 4 Counseling: 0

It hasn’t been a good couple years for counseling in the buprenorphine treatment literature. Yet another study, authored by a team led by the venerable Walter Ling, and currently available in Addiction Journal’s “early view” section online, has shown that counseling adds nothing to buprenorphine maintenance, in terms of measured outcomes. By our count, this makes four consecutive studies to show basically the same thing: counseling, while by no means harmful, has not been shown to add anything to buprenorphine maintenance in opioid-dependent patients without significant co-occurring psychiatric disorders.

Ling, et al.’s study is arguably the most convincing study yet. The team performed a randomized control trial in which patients were randomized to one of four behavioral treatment conditions, as adjuncts to buprenorphine maintenance: cognitive behavioral therapy (CBT), contingency management (CM), both CBT and CM, and no behavioral treatment. Counselors were master’s-level trained counselors who met with patients weekly for the initial phase of the study.

The results showed no differences in opioid use after the behavioral treatment phase, during the second (medication-only) phase, or at follow-ups at weeks 40 or 52. In addition, there were no statistically-significant differences in any of the secondary measures (retention, other drug use, withdrawal and craving, addiction severity index ratings, and adverse events).

Interestingly, there were differences in reported treatment satisfaction ratings. While the majority of participants reported being “very satisfied” with treatment, and 85% reported Suboxone was “very effective”, just 60% reported that their behavioral treatment was “very effective”. On the other hand, 21% of the no-treatment group reported that their behavioral treatment was “not effective”, compared to 3% of the CBT group and 0% of the CBT + CM group.

As a student of behavioral health counseling, this science is particularly hard to swallow. However, it does seem to affirm the fact that, for patients with opioid-use disorders, ensuring easy and affordable access to maintenance medications is currently our best and most important tool for their treatment.

What do you think?

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.

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.