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

A Sad State of Affairs: Psychostimulant Addiction Treatment Leaves Much to be Desired

The authors of a new paper, published ahead of a special issue of Neuropharmacology, give the reader a good look at the current state of psychostimulant substance use disorder treatment - and the results are disappointing. Starting with behavioral treatments and ending with a review of medications, the clear fact remains that there is no single treatment that outperforms most others.

Meta-analyses of behavioral interventions for the treatment of cocaine use disorder have shown modest benefits; while one review found, "there is currently no evidence for a differential treatment effect of any psychosocial treatment in the management of" cocaine or amphetamine use disorders. CBT and Contingency Management (CM) remain the mainstay of psychostimulant treatment, and the authors cite data suggesting a combination of CM plus Community Reinforcement Approach might produce the best outcomes.

In terms of pharmacological treatments, researched medications include antagonist therapy, agonist therapy, medications to treat withdrawal symptoms and medications to treat co-occurring psychiatric symptoms or disorders; and the authors of the present paper devote the bulk of their attention to weighing the evidence of such options.

Naltrexone, they note, has shown some promise in laboratory studies, as it has been shown to weaken amphetamine- and cocaine-related effects in some subjects in both human and animal trials. Because it also seems to weaken the subjective euphoric effects of methylphenidate (Ritalin), one area of promise could be in the combination of naltrexone and methylphenidate to limit the abuse potential of an agonist-like treatment.

Disulfiram (aka Antabuse) has also shown some promise in the lab, but mainly in the treatment of cocaine-use disorders. It was shown to increase the brain ratio of dopamine to norepinephrine and to prevent stress-induced cocaine reinstatement. In pilot studies, disulfiram was shown to be effective in reducing cocaine use in patients with cocaine use disorders (CUD), and among buprenorphine-maintained polydrug users. However, in a more recent study, disulfiram showed less promise reducing cocaine use among methadone-maintained patients. The authors of the review point to evidence that disulfiram may only be effective among CUD patients with specific genotypes - and may be more effective among men than women.

Agonist-like treatments are also reviewed by the authors, and appear to offer some of the more exciting, and possibly effective, interventions for psychostimulant addiction. D-amphetamine has been shown to improve treatment retention and reduce illicit cocaine use in early trials; while a later study showed a reduction in withdrawal and craving, but a failure to reduce methamphetamine use. Not mentioned in the review, but a small study we wrote about in 2012 appeared to show promising results in the combination of mixed amphetamine salts (Adderall) and topiramate (Topamax)

For its part, sustained-release methamphetamine has been tested as a maintenance agent for CUD, and appeared to significantly reduce cocaine-positive urine samples and cocaine craving. The familiar medication, methylphenidate, has been shown to be non-superior to placebo in some studies for meth/amphetamine use and cocaine use, but appears to warrant further research at improved dosages. The other agonist-like medication discussed, modafanil, seems to be an interesting candidate for maintenance treatment. Known to be a cognitive enhancer, modafanil may be useful in addressing the impairments in a range of cognitive functions that can result from psychostimulant addiction; but studies have thus far produced more "equivocal" results in most trials as treatments for cocaine or for methamphetamine - even when combined with D-amphetamine. Post-hoc analysis of the available data does, however, suggest efficacy in the less severe cases of addiction.

Additionally, researchers in Latin America have argued in favor oral coca for the treatment of cocaine use disorder. Their "Handbook on Oral Cocaine as Agonist Therapy for Cocaine Dependence" is an intriguing read, and the authors of the review posit that political, cultural and commercial barriers - not scientific ones - are likely to blame for the "lack of follow-up on this line of research".

A host of other medications have been tried and tested for psychostimulant use disorders, with little success. Vaccines, on the other hand, are now gaining momentum in the field and are being used in multiple studies at various phases. A vaccine that that produces antibodies to prevent cocaine from crossing the blood-brain barrier has performed well in Phase I and Phase II trials. A methamphetamine vaccine is still in preclinical development, but initial results have shown good levels of antibodies in animal models and a Phase I  trial is scheduled to begin in 2015.

Considering the vast global toll which is the result of psychostimulant addiction, treatment for these disorders is as desperately needed as ever. If there is one thing that this review makes clear, it's the fact that we still have a long way to go before we can say that we have effective treatment options for the consumer. A question for readers of this blog: what are the techniques and interventions that you have found to be helpful stimulant use disorders? Is there a particular line of research that you feel would be important to investigate further? Do you see the utility of agonist-like medications? Your thoughts are always appreciated.