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.

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.

Alltyr Clinic Featured on NPR's Weekend Edition!

Alltyr Clinic is featured on NPR's Weekend Edition Sunday today, June 8, 2014. We are positioned as an alternative to traditional rehab, in this case Hazelden. One of our patients, Shane Linehan, was brave enough to share his experience with both Hazelden (where he went first) and Alltyr Clinic (where he is being treated now.) I want to thank him and applaud his courage for speaking out. (For the record, Alltyr Clinic gave him no incentive; we simply offered the opportunity to many of our patients.) We are honored to be compared to arguably the best known traditional rehab in the country (if not the world.)

Unfortunately, in the summary on the program's landing page, our approach is described as being almost totally oriented around prescribing anti-relapse medications. Although we use every proven anti-relapse medication, we also use every evidence-based behavioral/psychosocial approach. This includes individual and group therapy using motivational, cognitive-behavioral, coping skills, 12-Step Facilitation, EMDR, CRAFT, DBT, psychodynamic, community reinforcement, couples and family approaches. Which we use depends on the needs of the patient. Our team includes addiction psychiatrists, addiction medicine specialists, psychologists, social workers, counselors and recovery coaches.

Furthermore, we fully integrate treatment for any co-existing mental health disorder, such as anxiety, depression, PTSD, personality disorders, bipolar disorder, cognitive disorders, as well as medical problems such as insomnia and chronic pain. We really aim to be a "one-stop shop." If sober housing is needed we work with community partners to help our patients secure it. 

The bottom line is this: coming to Alltyr Clinic is like coming to a mental health clinic or any other health care service using a multi-disciplinary approach. Each patient receives a comprehensive individual evaluation upon which the treatment recommendations are based. Selecting from a large menu of services, a truly individualized treatment plan is arrived at by the patient, the treatment team, and if appropriate, the family. After treatment is started, the plan is modified as needed. The length and intensity of treatment is also completely individual and flexible. We do whatever we can and we stay with you as long as it takes. We aren't a program, we're a clinic.

At Alltyr Clinic, "We Don't Just Call Addiction a Disease, We Treat It Like One."TM

Baclofen Shows Promise for Treating Relapse in Cocaine Use Disorders

Via ScienceDaily:

Relapse is the most painful and expensive feature of drug addiction -- even after addicted individuals have been drug-free for months or years, the likelihood of sliding back into the habit remains high. The National Institute on Drug Abuse estimates that 40 to 60 percent of addicted individuals will relapse, and in some studies the rates are as high as 80 percent at six months after treatment. Though some relapse triggers can be consciously avoided, such as people, places and things related to drug use, other subconscious triggers related to the brain's reward system may be impossible to avoid -- they can gain entry to the unconscious brain, setting the stage for relapse.

Researchers at Penn Medicine's Center for Studies of Addiction have now found that the drug baclofen, commonly used to prevent spasms in patients with spinal cord injuries and neurological disorders, can help block the impact of the brain's response to "unconscious" drug triggers well before conscious craving occurs. They suggest that this mechanism has the potential to prevent cocaine relapse. The new findings are reported in the Journal of Neuroscience.

"The study was inspired by patients who had experienced moments of 'volcanic craving', being suddenly overcome by the extreme desire for cocaine, but without a trigger that they could put their finger on," says senior author Anna Rose Childress, PhD,research professor of Psychiatry, director of the Brain-Behavioral Vulnerabilities Division in the Perelman School of Medicine at the University of Pennsylvania. Dr. Childress and colleagues previously found that subliminal drug "reminder cues" (the sights, sounds, smells, and memories of the drug) could activate the brain's reward circuit. "Now, we wanted to understand whether a medication could inhibit these early brain responses," said Childress.

Kimberly Young, PhD, an NIH/NIDA Post-doctoral Fellow at Penn, and first author of the study explained that, "Drug reward and motivation is largely mediated by dopamine transmission in the brain's reward circuit -- even drug "reminder cues" can cause dopamine release. Since baclofen and similar medications reduce these effects in laboratory animals, we wanted to examine whether it could prevent drug-cue induced activation in the human brain."

The study tested baclofen, which was approved by the U.S. Food and Drug Administration in 1977 for spasm, on 23 cocaine-dependent men, ages 18 to 55. Each reported using cocaine on at least eight of 30 days before screening. Inclusion in the study required that they stay for up to 10 days in a supervised inpatient drug treatment facility, be drug-free for the duration, not be on any medication affecting dopamine or neurotransmitter response, and have no history of psychosis, seizures, or brain syndromes unrelated to cocaine use.

Upon admission, patients were randomized to receive baclofen or placebo. Over the first six days, patients in the baclofen group received the medication in increasing dosage to 60 mg. While on the full 60 mg dose of baclofen, patients were placed in an fMRI and shown a series of images, to measure their neural responses to "ultra-brief" pictures of cocaine or other comparison pictures. Each of the ultra-brief 33 msec "target" pictures was immediately followed by longer picture of non-drug objects or scenes. Under these conditions, the participants are aware of the longer pictures, but the ultra-brief target pictures remain completely outside conscious awareness -- they are "backward-masked."

"We wanted to present the key stimulus: images of drug use and preparation, sexual images, and other aversive images in a way such that the brain could not consciously process them, but so that we could measure their earliest, subconscious effect on the brain," said Childress.

What the team found was that the patients who were treated with baclofen showed a significantly lower response in the reward and motivational circuits to subliminal cocaine cues versus neutral cues, as compared to the placebo-treated control group. In addition, no difference was seen in the active versus the control group in their response to sexual and aversive cues, indicating that the effects of baclofen on cue-induced brain activation were specific to drug cues.

"These findings suggest that the brain response to drug cues presented outside of awareness can be pharmacologically inhibited, providing a mechanism for baclofen's potential therapeutic benefit in addiction," says Young. "Further studies will show whether the prevention of these early brain responses is associated with reduced rates of craving and relapse in cocaine-dependent patients," added Childress. 

Source: http://www.sciencedaily.com/releases/2014/04/140401172914.htm

This could be exciting news for one of the most difficult substance use disorders to treat. Does anyone have experience using baclofen with patients with cocaine use disorders?