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Precommitment Devices: A Defensible Treatment for Opioid Addiction?

Published online by Cambridge University Press:  01 January 2021

Rebecca Dresser
Rebecca Dresser*
Affiliation:
Washington University in St. Louis
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American Journal of Law & Medicine , Volume 46 , Issue 2-3: Emerging Issues in Bioethics , May 2020 , pp. 189 - 202
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Copyright © 2020 American Society of Law, Medicine & Ethics Boston University School of Law

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References

1 See Bell, Kirsten, Thwarting the Diseased Will: Ulysses Contracts, the Self, and Addiction, 39 Culture Med. & Psychiatry 380, 386-87 (2015)CrossRefGoogle ScholarPubMed.

2 Precommitment agreements are sometimes called Ulysses contracts, in reference to Homer's story of Ulysses and the Sirens. In the story, Ulysses directed his crew to bind him to the mast so that he could hear the Sirens' song without yielding to temptation. See generally id.; Rebecca S. Dresser, Ulysses and the Psychiatrists: A Legal and Policy Analysis of the Voluntary Commitment Contract, 16 Harv. C.R.–C.L. L. Rev. 777 (1982).

3 See generally Harriet Standing & Rob Lawlor, Ulysses Contracts in Psychiatric Care: Helping Patients to Protect Themselves from Spiralling, 45 J. Med. Ethics 693 (2019) (presenting four reasons why Ulysses contracts should be followed for individuals with certain illnesses); Ryan Spellecy, Reviving Ulysses Contracts, 13 Kennedy Inst. Ethics J. 373 (2003) (arguing that the enforcement of some Ulysses contracts may be justified).

4 See FDA Approves Six Month Implant for Treatment of Opioid Dependence, Nat'l Inst. on Drug Abuse (May 26, 2016), https://www.drugabuse.gov/news-events/news-releases/2016/05/fda-approves-six-month-implant-treatment-opioid-dependence.

5 Researchers at Columbia Psychiatry Begin Study to Evaluate OLANI for Treatment of Opioid Use Disorders, Colum. U. Dep't of Psychiatry (Apr. 15, 2019), https://www.columbiapsychiatry.org/news/researchers-columbia-psychiatry-begin-study-evaluate-olani-treatment-opioid-use-disorders [hereinafter Colum. U. Dep't of Psychiatry].

6 Australian physician George O'Neil developed the implant (OLANI stands for O'Neil Long-Acting Naltrexone Implant). The first phase of the research will investigate the implant's effects in healthy volunteers. Later investigations will evaluate how the implant works in people with opioid use disorder. See id.; Isabella Kwai, An Australian Doctor's Dream: Curing America's Opioid Curse, N.Y. Times (June 6, 2019), https://www.nytimes.com/2019/06/06/world/australia/opiate-opioid-treatment-naltrexone.html?searchResultPosition=1.

7 See, e.g., Royal Australasian C. of Physicians, The Use of Sustained Release Formulations of Naltrexone in Opioid Dependence: Position Statement 3 (2013), https://www.racp.edu.au//docs/default-source/advocacy-library/the-use-of-sustained-release-formulations-of-naltrexone-in-opioid.pdf?sfvrsn=25aa2f1a_10; Philipp Lobmaier et al., Sustained-Release Naltrexone for Opioid Dependence, Cochrane Database of Systematic Rev. no. 2, 2008 at 3.

8 Precommitment issues arise in the context of health decisions that can be altered over time. Many medical interventions are irreversible, of course. In those cases, it is particularly important for people to understand and appreciate their inability to revoke a choice to accept the intervention.

9 My analysis considers voluntary implant use in the context of research and medical care. I do not address the additional issues that would be raised if implant use were compelled in the context of the criminal justice or mental health treatment systems. See Amelia Pang, Did a Drug Company Illegally Experiment on a Louisiana Prisoner?, New Republic (Oct. 31, 2019), https://newrepublic.com/article/155553/drug-company-illegally-experiment-louisiana-prisoner (raising questions about naltrexone implant testing in prison setting).

10 See Compton, Wilson M. & Volkow, Nora D., Improving Outcomes for Persons With Opioid Use Disorders, 316 JAMA 277, 277 (2016)CrossRefGoogle ScholarPubMed.

11 For a description of the diagnostic criteria for substance use disorder, see Am. Psychiatric Ass'n, Diagnostic & statistical manual of mental disorders (5th ed., 2013).

12 Nat'l Inst. on drug abuse, Nat'l Inst. of health, principles of drug addiction treatment: a research-based guide 42 (3d ed. 2018).

13 See Volkow, Nora D. et al., Medication-Assisted Therapies — Tackling the Opioid-Overdose Epidemic, 370 New Eng. J. Med. 2063, 2064 (2014)CrossRefGoogle ScholarPubMed.

14 See generally Nat'l Health & Med. Research Council, Naltrexone Implant Treatment for Opioid Dependence 4 (2010).

15 There is a philosophical debate over whether dependence on methadone and buprenorphine is a problem. Although some characterize it as simply another form of drug addiction, others compare it to the long-term maintenance therapy provided to people with chronic conditions like diabetes. See Jessica Glenza, Russia's “Cold Turkey” Approach Highlights Global Divide over Drug Treatment at UN, Guardian (Apr. 20, 2016 6:22 PM), https://www.theguardian.com/world/2016/apr/20/ungass-russia-drug-treatment-heroin-methadone.

16 See Ling, Walter et al., Buprenorphine Implants for Treatment of Opioid Dependence, 304 JAMA 1576, 1581-82 (2010)CrossRefGoogle ScholarPubMed.

17 See Sullivan, Maria A. et al., A Randomized Trial Comparing Extended-Release Injectable Suspension and Oral Naltrexone, Both Combined With Behavioral Therapy, for the Treatment of Opioid Use Disorder, 176 Am. J. Psychiatry 129, 134 (2019)CrossRefGoogle ScholarPubMed. Another positive is that naltrexone is not regulated under the Controlled Substances Act. This law sets demanding requirements for clinicians prescribing methadone and buprenorphine, limiting the drugs' availability. See Colum. U. Dep't of Psychiatry, supra note 5.

18 For example, in one study of naltrexone, half the people enrolled were unable to complete the detoxification process. See Sullivan et al., supra note 17, at 132. The two other drugs can be started at an earlier time, when people are in “mild-to-moderate withdrawal.” See Lee, Joshua et al., Comparative Effectiveness of Extended-Release Naltrexone Versus Buprenorphine-Naloxone for Opioid Relapse Prevention (X:BOT): A Multicentre, Open-Label, Randomised Controlled Trial, 391 Lancet 309, 310 (2018)CrossRefGoogle ScholarPubMed. For a vivid account of the withdrawal experience, see generally Travis Rieder, In Pain: A Bioethicist's Personal Struggle With Opioids (2019).

19 See Ed Holt, Russian Injected Drug Use Soars in Face of Political Inertia, 376 Lancet 13 (2010).

20 Nat'l Health & Med. Research Council, supra note 14, at 5.

21 Id. at 4.

22 Cf. Hulse, Gary K. et al., Improving Clinical Outcomes in Treating Heroin Dependence, 66 Archives Gen. Psychiatry 1108, 1113 (2009)CrossRefGoogle ScholarPubMed.

23 Krupitsky, Evgeny et al., Randomized Trial of Long-Acting Sustained-Release Naltrexone Implants vs Oral Naltrexone or Placebo for Preventing Relapse in Opioid Dependence, 69 Archives Gen. Psychiatry 973, 974 (2012)CrossRefGoogle ScholarPubMed [hereinafter Krupitsky et al. I].

24 See, e.g., Sullivan et al., supra note 17, at 129 (after six months, study group receiving injections was twice as likely to remain in treatment as group receiving daily pills).

25 See Colum. U. Dep't of Psychiatry, supra note 5.

26 See id.

27 An FDA-approved six-month buprenorphine implant offers the benefit of long-term drug delivery, but this option doesn't meet the needs of people seeking to avoid dependence on maintenance drugs. Cf. Compton & Volkow, supra note 10, at 277.

28 See generally Krupitsky et al. I, supra note 23.

29 Cf id. at 980 (discussing the limitations of naltrexone implants, including potential implant removal by patients).

30 Kelty, Erin & Hulse, Gary, Examination of Mortality Rates in a Retrospective Cohort of Patients Treated With Oral or Implant Naltrexone for Problematic Opioid Use, 107 Addiction 1817, 1818 (2012)CrossRefGoogle Scholar.

31 Id. at 1820-21. See also Hulse et al., supra note 22, at 1108; Ngo, Hanh T. et al., Comparing Drug-Related Hospital Morbidity Following Heroin Dependence Treatment With Methadone Maintenance or Naltrexone Treatment, 65 Archives Gen. Psychiatry 457, 457 (2008)CrossRefGoogle ScholarPubMed.

32 Nikolaj Kunoe et al., Naltrexone Implants After In-Patient Treatment for Opioid Dependence: Randomised Controlled Trial, 194 Brit. J. Psychiatry 541 (2009).

33 Id. at 544.

34 Ngo et al., supra note 31, at 461.

35 See Kunoe et al., supra note 32, at 545.

36 Russian authorities have banned the use of methadone and buprenorphine on grounds that they simply replace one form of drug dependence with another. See Krupitsky et al., Slow-Release Naltrexone Implant versus Oral Naltrexone for Improving Treatment Outcomes in People With HIV Who Are Addicted to Opioids: A Double-Blind, Placebo-Controlled, Randomised Trial, 6 Lancet HIV e221 (2019) [hereinafter Krupitsky et al. II]; Holt, supra note 19, at 13.

37 Krupitsky et al. I, supra note 23, at 973.

38 Krupitsky et al. II, supra note 36, at e225-27.

39 Id. at e227.

40 Holt, supra note 19, at 14. See also Krupitsky et al. II, supra note 36, at e227.

41 Holt, supra note 19, at 13-14.

42 Journalists covering the OLANI's use in Australia have reported that “the desire to take drugs while on the implant can be so great that some have even tried highly risky do-it-yourself removals of the implant.” Id. at 14. In an online comment on a New York Times report about the OLANI study, a reader referred to a naltrexone implant that a New Jersey physician had been offering to patients. According to the writer, “the craving to get high was so forceful for some [patients] that they would cut their own implant out to get high. Addiction is a terrible thing and people will go to extremes to get high sometimes, even if it means cutting an implant out.” See Kwai, supra note 6, Reader Comment from Sara.

43 See, e.g., 45 C.F.R. § 46 (2019).

44 See Charles P. Sabatino, Advance Directives and Advance Care Planning: Legal and Policy Issues 7-14 (2007) (discussing the historical development of advance directives).

45 45 C.F.R. § 46.116 (2019).

46 45 C.F.R. § 46.116 (a) (4) (2019).

47 45 C.F.R. § 46.116 (b) (2) (2019).

48 45 C.F.R. § 46.116 (b) (8) (2019).

49 45 C.F.R. § 46.116 (a) (6) (2019).

50 See generally Terrance McConnell, The Inalienable Right to Withdraw from Research, 38 J.L. Med. & Ethics 840 (2010) (describing and defending this right); Robertson, John A., Precommitment Issues in Bioethics, 81 Tex. L. Rev. 1849, 1859 (2003)Google ScholarPubMed (noting that a “mainstay of research ethics has been the right of subjects to withdraw from research at any time, regardless of the reason or the cost to researchers”).

51 See Biros, Michelle, Capacity, Vulnerability, and Informed Consent for Research, 46 J.L. Med. & Ethics 72, 73 (2018)Google ScholarPubMed.

52 Id.

53 45 C.F.R. § 46.102 (i) (2019).

54 See Biros, supra note 51, at 76.

55 Erin S. DeMartino et al., Who Decides When a Patient Can't? Statutes on Alternate Decision Makers, 376 New Eng. J. Med 2 (2017); see also Wittich, Christopher M. et al., Ten Common Questions (and Their Answers) about Off-Label Drug Use, 87 Mayo Clinic Proceedings 982, 986 (2012)CrossRefGoogle ScholarPubMed (noting that the FDA does not regulate the practice of medicine).

56 45 C.F.R. § 46.116 (b) (8) (2019).

57 See Jessica W. Berg et al., Informed Consent: Legal Theory and Clinical Practice 41-129 (2d. ed. 2001).

58 See Clausen, Judy A., Making the Case for a Model Mental Health Advance Directive Statute, 14 Yale J. Health Pol'y, L. & Ethics 1, 24-25 (2014)Google Scholar.

59 See generally Rebecca Dresser, Autonomy and Its Limits in End-of-Life Law, in Oxford Handbook of U.S. Health Law 399, 403 (I. Glenn Cohen, Allison K. Hoffman, and William M. Sage, eds., 2017).

60 See Clausen, supra note 58, at 29.

61 Id. at 29-33.

62 Id. at 29-30 (majority of state mental health directive statutes limit revocation to patients with capacity).

63 Va. Code Ann. § 54.1-2986.2 (B) (2019).

64 Id.

65 Va. Code Ann. § 54.1-2982 (2019).

66 Va. Code Ann. § 54.1-2986.1 (B) (2019).

67 Id. § 54.1-2982. Apparently these laws are not used very often. See Berghmans, Ron & Zanden, Marja van der, Choosing to Limit Choice: Self-Binding Directives in Dutch Mental Health Care, 35 Int'l J.L. & Psychiatry 11, 15 (2012)Google ScholarPubMed (describing low usage rate for legally authorized self-binding mental health directives in the Netherlands); Zelle, Heather et al., Advance Directives in Mental Health Care: Evidence, Challenges and Promise, 14 World Psychiatry 278, 278-79 (2015)CrossRefGoogle ScholarPubMed (describing low usage rates of psychiatric advance directives).

68 See, e.g., Chrisoula Andreou, Making a Clean Break: Addiction and Ulysses Contracts, 22 Bioethics 25 (2008) (discussing precommitment and addiction).

69 Id. at 27.

70 Id. at 27-29.

71 Id. at 28.

72 Andreou does not offer a defense of legally binding precommitment, instead focusing on informal precommitment agreements, see generally id.

73 Caplan, Arthur, Denying Autonomy in Order to Create It: The Paradox of Forcing Treatment Upon Addicts, 103 Addiction 1919, 1919 (2008)Google ScholarPubMed. See also Berghmans & van der Zanden, supra note 67, at 11 (“compulsory force resulting from addiction” can interfere with autonomy).

74 Caplan, supra note 73, at 1919. See also Arthur Caplan, Ethical Issues Surrounding Forced, Mandated, or Coerced Treatment, 31 J. Substance Abuse Treatment 117 (2006).

75 Hall, Wayne et al., The Use of Depot Naltrexone Under Legal Coercion: The Case for Caution, 103 Addiction 1922, 1922 (2008)Google ScholarPubMed.

76 See id.

77 See id.

78 Bell, supra note 2, at 395.

79 For an alternative conception of addiction, see Pickard, Hanna, Responsibility Without Blame for Addiction, 10 Neuroethics 169, 171-72 (2017)CrossRefGoogle ScholarPubMed (describing evidence that addiction fails to deprive people of control over their harmful behavior).

80 See Brock, Dan W., Precommitment in Bioethics: Some Theoretical Issues, 81 Tex. L. Rev. 1805, 1816-17 (2003)Google ScholarPubMed.

81 Id. at 1818.

82 Id.

83 Id. at 1821. “Different selves” questions can arise in other contexts, too, such as criminal punishment. See Rebecca Dresser, Personal Identity and Punishment, 70 B.U. L. Rev. 395 (1990).

84 See Andreou, supra note 68; Caplan, supra note 73.

85 See Cohen, Peter J., Untreated Addiction Imposes an Ethical Bar to Recruiting Addicts for Non-Therapeutic Studies of Addictive Drugs, 30 J.L. Med. & Ethics 73, 76 (2002)Google ScholarPubMed.

86 See, e.g., Brock, supra note 80, at 1805, 1818.

87 Savulescu, Julian & Dickenson, Donna, The Time Frame of Preferences, Dispositions, and the Validity of Advance Directives for the Mentally Ill, 5 Phil. Psychiatry & Psychol. 226, 233-34 (1998)Google Scholar.

88 Id. at 232-35.

89 Davis, John K., How to Justify Enforcing a Ulysses Contract When Ulysses is Competent to Refuse, 18 Kennedy Inst. Ethics J. 87, 98 (2008)Google ScholarPubMed.

90 See Spellecy, Ryan, Reviving Ulysses Contracts, 13 Kennedy Inst. Ethics J. 373, 384 (2003)CrossRefGoogle ScholarPubMed.

91 Id. Other scholars justify binding treatment agreements on different grounds. See, e.g., Standing & Lawlor, supra note 3 (presenting four reasons why Ulysses contracts should be followed); Widdershoven, Guy & Berghmans, Ron, Advance Directives in Psychiatric Care: A Narrative Approach, 27 J. Med. Ethics 92, 93 (2001)CrossRefGoogle ScholarPubMed (directives are a highly significant “part of a process of finding ways of living one's own life”).

92 See Clausen, supra note 58, at 22 (person with decision-making capacity “should always be able to revoke her Ulysses arrangement”).

93 Davis, supra note 89, at 93. See also Brock, supra note 80, at 1820 (notion that precommitting “evaluative self” presents best picture of person's wishes and behavior doesn't leave room for people to change their minds).

94 See Berghmans & van der Zanden, supra note 67, at 14 (describing difficulties in applying this criterion to cases considered under Dutch mental health directive law).

95 See, e.g., Gergel, Tania & Owen, Gareth S., Fluctuating Capacity and Advance Decision-Making in Bipolar Affective Disorder – Self-Binding Directives and Self-Determination, 40 Int'l J. L. & Psychiatry 92, 95 (2015)Google ScholarPubMed.

96 See Biros, supra text accompanying note 52 (describing this definition).

97 See Clausen, supra note 58, at 33 (“When a patient's irrevocable directive consents to treatment that the patient refuses when he arrives at the hospital, the refusal itself is evidence of incapacity”); Widdershoven & Berghmans, supra note 91, at 95 (patient should be able to determine what counts as later incompetency sufficient to overrule wishes in favor of directive).

98 Some endorse a less drastic approach in which a person's refusal of previously accepted treatment would trigger a capacity evaluation. See, e.g., Gergel & Owen, supra note 95, at 95 (behaviors person names as triggering precommitment agreement are “key indicators that [decision-making capacity] may have been lost and requires assessment”).

99 Brodoff, Lisa, Planning for Alzheimer's Disease with Mental Health Advance Directives, 17 Elder L.J. 239, 294 (2009)Google Scholar. See also Gergel & Owen, supra note 95, at 96 (advance directive “would create an opportunity for detailed reflection and engagement between the patient and their clinical team”).

100 Brodoff, supra note 99, at 294. See also Gergel & Owen, supra note 95.

101 See Zelle et al., supra note 67, at 278. There is some empirical support for this claim. One study found a lower rate of involuntary medication and other coercive interventions among people who had completed a psychiatric advance directive than among those who had not. Jeffrey W. Swanson et al., Psychiatric Advance Directives and Reduction of Coercive Crisis Interventions, 17 J. Mental Health 255 (2009).

102 Clausen, supra note 58, at 20. See also Pam Belluck, Now Mental Health Patients Can Specify Their Care Before Hallucination and Voices Overwhelm Them, N.Y. Times (Dec. 3, 2018), (interviews with people experiencing this benefit).

103 Gergel & Owen, supra note 95, at 99.

104 LaFond, John Q. & Srebnik, Debra, The Impact of Mental Health Advance Directives on Patient Perceptions of Coercion in Civil Commitment and Treatment Decisions, 25 Intl J. L. & Psychiatry 537, 552-54 (2002)Google Scholar. See also Gergel & Owen, supra note 95, at 97.

105 Widdershoven & Berghmans, supra note 91, at 95.

106 See LaFond & Srebnik, supra note 104, at 547.

107 In line with this requirement, researchers conducting the most recent naltrexone implant study in Russia included the right to withdraw in the disclosure materials given to prospective subjects. Krupitsky et al. II, Supplementary Appendix, supra note 36, at 3.

108 See supra notes 40-42 and accompanying text.

109 See Zelle et al., supra note 67.

110 The consent form for the most recent implant study in Russia addressed removal requests as follows: “We strongly advise you not to try to remove the implant after it is inserted…. If you wish to have it removed, please make an appointment with the research staff to discuss the situation.” Krupitsky et al. II, Supplementary Index, supra note 36, at 8. Study investigators also required prospective study participants to pass a quiz measuring their understanding of study information before signing the consent form. Id. at 2.

111 See, e.g., Krupitsky et al. II, supra note 36, at e223 (counseling for study subjects “focused on providing support, encouraging adherence to prescribed medication, dealing with craving, avoiding situations associated with drug use and behaviours that spread HIV, providing help for psychiatric and psychosocial problems, and documenting adverse events”).

112 Herbert D. Kleber, Pharmacologic Treatments for Opioid Dependence: Detoxification and Maintenance Options, 9 Dialogues in Clinical Neuroscience 455 (2007).

113 See Nat'l Health & Med. Research Council, supra note 14, at 5, 15 (long-term benefit of naltrexone treatment greatest for “highly motivated patients”).