Heroin is a Schedule I drug under the Controlled Substance Act—it is often abused, it is not accepted for medical use, and it is not considered safe under medical supervision. Using injectable naltrexone could help prevent relapse following incarceration, but how it is administered raises ethical questions.
Tuesday, November 25, 2008

The Impact of Modern Neuroscience on Treatment of Parolees

Ethical Considerations in Using Pharmacology to Prevent Addiction Relapse

By: Richard J. Bonnie J.D. Donna T. Chen M.D., M.P.H. and Charles P. O'Brien M.D., Ph.D.

Neuroscience is offering insights into addiction and providing scientists with pharmacological methods, such as the use of injectable naltrexone, for reducing relapse. Richard J. Bonnie, Donna T. Chen and Charles P. O’Brien consider the ethical and legal implications of different methods for administering naltrexone to convicted drug offenders.

As neuroscience advances our understanding of addiction, a drug called naltrexone offers the possibility of treating drug offenders, particularly those on probation or parole, and helping them avoid relapse. The Dana Foundation supported a pilot feasibility study on this approach, conducted by Charles P. O'Brien and colleagues. Here, Richard J. Bonnie, Donna T. Chen and O’Brien examine ethical and legal concerns related to various methods of administering naltrexone.

Until recently, the nation’s policymakers have seemed indifferent to the high costs of criminal punishment of drug-addicted individuals and the apparent failure of criminalization to reduce heavy drug use. Increasing frustration with the costs of criminalization has fueled renewed interest in treatment of addicted offenders and others with drug problems, especially at the state level. We see a major opportunity for the criminal justice system to take advantage of recent advances in the pharmacological treatment of opioid addiction—in particular by facilitating the use of an injectable drug called naltrexone to prevent relapse by individuals who are under community legal supervision (probation or parole). This initiative is an attractive first step because most of these individuals should be highly motivated to stay “clean” in order to stay out of prison, society has a strong interest in reducing addiction-related crime, and the extended-release formulation of naltrexone has been approved by the Food and Drug Administration for the treatment of alcoholism and soon may be approved for treatment of opioid addiction as well. But using naltrexone to prevent relapse and repeat offenses does raise ethical and legal concerns.

Background

The costs of criminal punishment for drug-addicted individuals are borne by these individuals, their families and friends, and society—members of the community who fall victim to drug-related crimes and others whose tax dollars pay for incarceration, a strategy that has repeatedly been shown to be ineffective in reducing personal and social problems caused by drug addiction. A 2001 report issued by the National Research Council of the National Academy of Sciences calls for more research on the effects of criminal sanctions against users, characterizing the government’s apparent indifference to the effects of its costly policies as “unconscionable.”1

A renewed interest in a therapeutic response to addicted offenders is reflected in the creation of specialized drug courts (numbering 2,147 at the end of 2007), legislation requiring treatment for nonviolent drug-involved offenders, and other programs.2 Surprisingly, however, this therapeutic movement has not taken full advantage of neuroscience advances in the understanding of addiction and associated pharmacological developments.

The drug treatment offered in the criminal justice system is largely educational and counseling-oriented. Few programs offer medications, even ones with significant evidence of effectiveness in reducing drug use and criminal behavior. Legislators and judges seem to us to be deeply skeptical of methadone maintenance for opioid addiction (believing that it only substitutes one addictive drug for another) and have generally overlooked other medications. These include buprenorphine (like methadone, this long-acting medication activates the opioid receptor, and it has been shown to decrease heroin craving) and naltrexone (a medication that blocks the effects of opioids at the receptor and thus blocks the high from heroin and other opioids). The gap between therapeutic opportunity and actual clinical practice in addiction treatment (not only in criminal justice populations) is about to widen with the introduction of extended-release versions of existing drugs and rapid advances now being made in the development of other anti-craving drugs and, potentially, vaccines targeted at drugs of abuse. In short, we appear to be on the threshold of major advances in the pharmacological management of addiction.

In choosing to focus on extended-release naltrexone in the setting of community legal supervision, we set aside many other ways that neuroscientific advances in understanding and treating behavioral problems such as addiction might affect criminal justice policy. For example, we do not engage the larger question of the appropriateness of criminalizing drug use by addicted offenders, although this broad issue is being considered by a new project on law and neuroscience supported by the John D. and Catherine T. MacArthur Foundation.3 Rather we focus narrowly on ethical, legal and practical aspects of how the criminal justice system might manage offenders who are addicted to heroin or other opioids by facilitating use of extended-release naltrexone.

Naltrexone for Prevention of Relapse in Parolees

Heroin-addicted individuals commit many crimes to support their habits. Although these are usually nonviolent crimes, addicted offenders are typically sentenced to prison terms. Despite not using opioids for a long period, incarcerated opioid addicts relapse at an alarming rate following their release from custody, even when they are under the supervision of a parole officer. It may be thought that the period of incarceration would “get the opioids out of their system” and “teach them a lesson,” but this is apparently not enough to prevent re-addiction and re-incarceration in a majority of opioid-addicted offenders. The availability of naltrexone may provide real benefits to these individuals, the criminal justice system and the public at large.

Studies conducted in the 1990s suggested that daily ingestion of a naltrexone pill taken by mouth reduced the frequency of relapse in parolees. Naltrexone has a high affinity for opiate receptors and prevents the high from heroin or other opioids by blocking their access to the receptor. In the only randomized, controlled clinical trial of probationers with a history of opioid addiction, Dr. James Cornish and colleagues in Philadelphia found that 59 percent of opioid-addicted parolees who received standard parole supervision—but not naltrexone—relapsed and were re-incarcerated within a year of their release. In contrast, a randomly assigned group of similar parolees who received both standard parole supervision and naltrexone from a research nurse stationed at the parole office had a relapse rate of only 25 percent.4 

Notably, treatment with oral naltrexone was approved by the FDA in 1985 and is not considered experimental. It does not require stringent ethics reviews and heightened informed consent procedures any more than does the use of any other FDA-approved medication. It is not addicting, has few side effects and is not considered to be a dangerous drug. It does have a “black box” warning in the package insert about the potential for liver damage, but this warning was based on patients in the 1970s who received seven times the recommended dose in an effort to reduce appetite. Clinicians consider it to be a safe medication.

Adherence and the New Naltrexone Formulations

One of the problems associated with oral naltrexone is the low rate of adherence to daily ingestion. Patients forget to take the pill or resist taking it—thus limiting its potential effectiveness. Beyond these general factors, which are common to most medications and patient populations, special circumstances limit naltrexone adherence. First, many opioid-addicted patients have disorganized lives, which can lead to forgetting. Second, naltrexone prevents the euphoria from heroin or other opioids—which, consciously or unconsciously, the individual may not wish to give up. Finally, there are no reinforcing pharmacological effects from taking naltrexone as one gets from taking methadone or buprenorphine—it doesn’t make the patient feel good.

Various companies have been working to develop sustained-release versions of naltrexone (“depot naltrexone”) to reduce adherence problems. A single injection given every 30 days provides continuous, steady-state medication throughout this time period. The extended-release form of naltrexone was approved by the FDA in 2006 for the treatment of alcoholism and is expected to be approved for the prevention of relapse to opioid addiction in the near future.

The National Institute on Drug Abuse (NIDA) has recently funded a five-site study of recently released parolees with a history of opioid addiction to be treated with either extended-release naltrexone or treatment as usual for six months. This study will be completely voluntary, as described below. Beginning the treatment in the community is a good first step. However, we believe that the most efficient and effective way to use this medication would be to initiate the treatment prior to an addicted individual’s release from prison—in pilot studies, most of those volunteering for treatment after release had already relapsed and had to be detoxified before starting naltrexone.

Options for Criminal Justice Policy

Assuming that the FDA approves the use of extended-release naltrexone for opioid addiction relapse prevention, there are three approaches that criminal justice policymakers could take toward facilitating its use:5 (1) a “voluntary” approach, in which the treatment is not linked to the offender’s status in the criminal justice system and the offender’s decision to participate (or not) in treatment and to take (or not) naltrexone is unequivocally voluntary; (2) a “leveraged” approach, in which the offender agrees to undertake the treatment in return for a more favorable disposition of the case; and (3) a “no choice” approach, in which the offender is simply ordered by the court to take the drug. Each of these approaches raises distinct ethical concerns.

The Voluntary Approach

The voluntary approach does not link participation in drug treatment to an individual’s criminal justice status. An offender on probation or parole is legally obligated to remain clean and may be subject to periodic urine testing. However, unless the court or parole agency specifically makes treatment a condition of probation or parole, the offender is not legally required to participate in treatment, much less to take naltrexone, and he or she may choose not to do so.

The voluntary option is theoretically appealing because it fits into fundamental notions of ethical health care and basic human rights. It recognizes that most offenders should have a strong motivation to stay clean, knowing that relapse will lead to re-incarceration. And, if sufficiently motivated, they will seek out drug treatment, including naltrexone, on their own. Experience has shown, however, that not all drug offenders have, or can sustain, this type of internal motivation, and even when they do, internal motivation is often not enough when it comes to sticking with treatment and staying clean. The underlying problem is that the desire for the high in the short term can all too often overwhelm the addicted person’s genuine wish to make himself better off in the long run.

Research shows that removing impediments to treatment—and even offering incentives—are associated with higher rates of treatment participation. In the context of voluntary use of naltrexone by addicted offenders, the long-acting preparation is extremely promising because of convenience: staying clean would not require daily decisions to stay with the program in the face of temptation. However, even if an offender is psychologically committed, cost may be a barrier. Consider the challenge faced by indigent offenders and their families if they seek out treatment upon release from prison and find that it will cost them $500 to $700 per month in out-of-pocket expenses because they have no insurance. Even if they are fortunate enough to have insurance, lack of coverage for naltrexone or unaffordable insurance copays could very well make the drug financially inaccessible.

Because most individuals in the criminal justice system likely will not have the resources to obtain naltrexone on their own, particularly early in its patent life, a significant policy matter—and indeed a significant ethical matter—is whether such treatment should be subsidized for any addicted offender who wants it. The NIDA-funded study mentioned earlier, which is using extended-release naltrexone with offenders who are under community supervision and who have volunteered to participate, will help inform policymakers about the effectiveness of this policy option in reducing relapse and repeat offenses.

It is not clear how many drug offenders would take advantage of naltrexone under a purely voluntary approach—at least in the absence of a major commitment by the criminal justice system to subsidize it. Some will decline because they believe they can beat the addiction on their own, others because they are unable to harness the psychological commitment needed to become and/or stay clean. Here, too, research shows that when people are able to prod themselves into initiating treatment, they often have difficulty sustaining participation on their own. But external pressure, ranging from informal nudging on the part of a spouse, to more formal interventions by employers, to legally mandated treatment through a court order, can help people do what they know is in their long-term interest even if they are unable to do it in the face of strong short-term desires. Just think of all the strongly motivated people who relapse while trying to quit smoking, even after being clean for months. Studies suggest that individuals pressured into treatment do as well as those who seek it voluntarily, and some develop the internal motivation to remain in treatment and/or stay clean after initially being pressured into treatment.

The Leveraged Approach

Leveraged approaches to inducing acceptance of drug treatment already exist. A leveraged agreement connects a person’s legal status in the criminal justice system with participation in drug treatment, typically through plea bargaining for a probationary sentence in the community instead of incarceration (or, for someone who is already incarcerated, through agreement to participate in return for early release on parole). Variations on this basic legal arrangement typically used by drug courts include participation in treatment in return for eventual dismissal of the criminal charge or the expungement of a guilty plea. Under such a leveraged agreement, a person might agree to participate in treatment with or without agreeing specifically to take naltrexone.

Leveraged participation in drug treatment generally includes frequent monitoring of compliance with the treatment program’s requirements (e.g., attendance at counseling sessions) and of drug use (e.g., clean urine samples), as well as use of incentives to reward adherence and sanctions to penalize undesired behaviors. At issue, then, is whether extended-release naltrexone could be part of such a treatment program.

Some civil libertarians and treatment providers oppose leveraged use of extended-release naltrexone because they regard leveraged agreements in the criminal justice system to be inherently coercive. We do not agree with this point of view. Rather, we believe that offering drug-addicted individuals treatment instead of incarceration expands their options and that acceptance of treatment, though leveraged, is not coerced. Similarly, we believe that a leveraged agreement to take extended-release naltrexone, even though it precludes trying methadone and some other medications for at least a month, is not coerced.

How do we determine which contractual decisions are voluntary and which are the product of duress or coercion? The standard view is that threats coerce, but offers do not. And the crux of the distinction between a threat and an offer is that succumbing to a threat would make someone worse off than he previously was (“your money or your life”), while rejecting an offer (“I’ll leave you stranded on the highway with your broken-down car unless you pay me $100”) will leave the person no worse off than the baseline position he was already in.

Is treatment with naltrexone under these circumstances coerced? Assuming that a person has been fairly charged by the prosecutor, a tendered plea agreement is an offer (which expands the defendant's choices, though they remain constrained), not a threat. In the context of a prosecutorial offer of probation conditioned on taking extended-release naltrexone (in lieu of recommending a more severe sentence authorized by law for the defendant’s offense), the defendant who accepts the offer has made a voluntary choice. To be sure, the baseline against which this offer is made (incarceration) is unappealing, and the offender’s choice (to plead guilty and comply with treatment each month) has been leveraged by the possibility of imprisonment, but both of these choices are voluntary in a legal sense, as the Supreme Court has properly ruled, and in a moral sense. This is not to say that people so treated won’t feel that they “had no choice” and have been pressured to choose an option they might otherwise never have chosen. However, the psychological experience of feeling coerced by circumstances is a phenomenon of everyday life, particularly among people who have few choices to begin with, and it is not the same as coercion in a legal or moral sense.

In a related sphere, addicted physicians who face losing their licenses to practice medicine frequently embrace the option to participate in drug treatment, including use of naltrexone. Interestingly, there is little opposition to offering them these types of leveraged choices. These doctors’ circumstances are legally and ethically equivalent to those of addicted offenders, except that one offer is made by a criminal court while the other is tendered, in effect, by a licensing agency. The physicians are faced with the prospect of losing their licenses due to misconduct (their “baseline”), and they are offered the opportunity to keep their licenses by agreeing to treatment with naltrexone; this is equivalent to the offer made to offenders facing a jail term to avoid prison by participating in drug treatment and accepting naltrexone.

Although we believe that a leveraged agreement to take naltrexone is legally and ethically permissible, we also believe that it would be ethically preferable to offer offenders a range of clinically effective drug treatment modalities, including naltrexone as well as other pharmacological (for example, methadone maintenance treatment) and non-pharmacological treatments (for example, drug counseling, case management, etc.). This approach would be properly respectful of the principle of informed choice in medical decisions, which should be honored when possible, even for addicted offenders. (We do not enter into the debate about whether drug addicts make informed, ethically meaningful decisions about their addiction and drug treatment options. It is enough for present purposes to acknowledge that these individuals can make informed, ethically meaningful decisions even if they do not always exercise this ability.)

If naltrexone use were shown to be substantially more cost-effective among criminal offenders than the other treatment modalities, the criminal justice system might be justified in offering only naltrexone as an element of the leveraged agreement. Right now, however, the evidence regarding effectiveness for drug offenders under criminal justice supervision is scanty, not only for naltrexone but also for other pharmacotherapies. That is why it is imperative for criminal justice agencies to commit themselves not only to increasing the availability and use of pharmacotherapies for addicted offenders but also to study the effectiveness of those therapies when they are used to treat this important population.

The No-Choice Approach

The no-choice approach simply orders the offender to participate in treatment whether or not he wants to do so; in fact, it might even authorize forcible administration of the medication. For example, a court might sentence someone to a term of probation and order him or her to take naltrexone as a condition of probation, or the parole agency might release the individual and order him or her to take naltrexone, subject to immediate revocation of parole for failure to do so. The development of injectable naltrexone makes it feasible to enforce such an order by administering naltrexone over objection—from a practical standpoint, injections are more feasible to administer over objection than a pill form of any medication; with oral medication, even under mandated conditions, there is some small semblance of volition in swallowing the pill.

Mandated naltrexone injection is ethically and legally problematic, of course, only if the person does not want it and objects to it. If he or she wanted the medication, mandated treatment would be unnecessary but not technically coercive. However, within the framework of medical treatment, and indeed of human rights, any sort of mandated pharmacological treatment over the objection of the individual is ethically and legally controversial.

Compulsory treatment is prima facie unacceptable and must meet a heavy burden of justification. Nevertheless, it is widely accepted that mandated drug treatment can be legally and ethically justified under some circumstances if due process is respected, the treatment is known to be safe and effective, and less-restrictive interventions have proven unsuccessful. Examples include anti-psychotic drugs for psychiatric patients who lack decisional capacity or who are dangerous to themselves or others, and mandated directly observed treatment for patients with multidrug-resistant TB who are non-adherent under less coercive circumstances. In recent years, several federal courts have upheld forcible administration of anti-psychotic drugs as a condition of release on parole.

Mandated naltrexone may also be ethically and legally justifiable under specific circumstances; however, given the current state of the science, mandated treatment with extended-release naltrexone is unsupportable from an ethical standpoint, mainly because there is insufficient evidence of effectiveness. For example, at this point in time it is unknown whether extended-release naltrexone is effective for opioid addiction relapse prevention. To be sure, the formulation would successfully perform its pharmacological action to block the opioid receptor, but how that translates into preventing relapse and re-incarceration is still unknown. Further, in the absence of definitive evidence of effectiveness, residual uncertainty about long-term risks counsels caution, especially as we incorporate lessons learned from delayed understanding of harms from the long-term use of medications such as VIOXX and hormone replacement therapy. And even if the safety and effectiveness of extended-release naltrexone were supported by well-conducted research studies, coercing someone to use it should be regarded as a last resort after other interventions have failed to prevent relapse and reoffending. Even then, coercion may not be justifiable, but before then it clearly is not. And for now we have at least two other policy options that should be tried, and evaluated, first.

Conclusion

Neuroscientific advances leading to improved understanding of the biological and behavioral correlates of addiction and associated pharmacological developments may well revolutionize the way our society approaches drug addiction. In particular, the development of extended-release naltrexone may prove to be a safe, effective, and politically acceptable pharmacological addition to drug addiction treatment options in the criminal justice system. It is possible that the criminal justice system will move rapidly to incorporate use of naltrexone when it is FDA-approved for prevention of relapse into opioid addiction. We hope that criminal justice agencies will subsidize treatment with naltrexone by addicted offenders on probation and parole and will make affirmative efforts to offer naltrexone and other medications such as methadone or buprenorphine to them, either without any connection to their legal status or as a condition of probation or parole in accord with an agreement voluntarily accepted by the offender. Furthermore, as criminal justice policymakers move forward to take full advantage of these advances, it is important to expand treatment opportunities for all people who want to escape the grip of addiction. People with addictions should be able to access treatment when they need it. It would be perverse indeed if committing a crime became the primary gateway to addiction treatment.

References

1. National Research Council, Informing America’s Policy on Illegal Drugs: What We Don’t Know Keeps Hurting Us. Committee on Data and Research for Policy on Illegal Drugs. Charles F. Manski, John V. Pepper and Carol V. Petrie, eds. Committee on Law and Justice and Committee on National Statistics. Commission on Behavioral and Social Sciences and Education (Washington, DC: National Academy Press, 2001).

2. C. W. Huddleston III, D. B. Marlowe, and R. Casebolt, Painting the Current Picture: A National Report Card on Drug Courts and Other Problem-Solving Court Programs in the United States. National Drug Court Institute Report , vol. 2, no. 1 (May 2008) (available at http://www.ncjrs.gov/App/Publications/abstract.aspx?ID=245618).

3. MacArthur Foundation Law and Neuroscience Project, http://www.lawandneuroscienceproject.org/.

4. J. W. Cornish, D. Metzger, G. E. Woody, D. Wilson, A. T. McLellan, B. Vandergrift, and C. P. O'Brien, “Naltrexone Pharmacotherapy for Opioid Dependent Federal Probationers,” Journal of Substance Abuse Treatment 14 (1997): 529–534.

5. R. J. Bonnie, “Judicially Mandated Treatment with Naltrexone by Opiate-Addicted Criminal Offenders,” Virginia Journal of Social Policy and the Law 13 (2005): 6488.



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Scientific Advisory Board
Joseph T. Coyle, M.D., Harvard Medical School
Kay Redfield Jamison, Ph.D., The Johns Hopkins University School of Medicine
Pierre J. Magistretti, M.D., Ph.D., University of Lausanne Medical School and Hospital
Robert Malenka, M.D., Ph.D., Stanford University School of Medicine
Bruce S. McEwen, Ph.D., The Rockefeller University
Donald Price, M.D., The Johns Hopkins University School of Medicine

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