International Journal of Drug Policy 19 (2008) 79–89
Policy analysis
Informed consent to opioid agonist maintenance treatment:Recommended ethical guidelines
Adrian Carter a,∗, Wayne Hall b,1
a Queensland Brain Institute, School of Biomedical Sciences, The University of Queensland, Brisbane, QLD 4072, Australiab School of Population Health, The University of Queensland, Herston, QLD 4066, Australia
Received 24 May 2007; received in revised form 30 August 2007; accepted 3 September 2007
bstract
ackground: Some bioethicists have questioned whether opioid addicted individuals are able to provide free and informed consent to opioidgonist maintenance treatment. Conflicting motives for providing such treatment (e.g. improving the personal health of addicts and protectingublic health and order) can also influence what individuals are required to consent to, and how that consent is obtained. We discuss bothssues and attempt to specify the conditions for obtaining informed consent to agonist maintenance treatment for opioid addiction.
ethods: We briefly review the neuroscientific literature on the effects of addiction on the autonomy and decision-making capacity of opioidependent individuals, and ascertain how informed consent to the treatment of opioid addiction should be obtained. We also provide an ethicalnalysis of the competing social and medical forces that influence the consent process and make some recommendations on how to ensurehat individuals enter maintenance treatment that is provided in an effective and ethical way.esults: Our analysis shows that whilst the autonomy of opioid dependent individuals is impaired by their addiction, they do retain the ability
o consent to treatment provided they are not in acute withdrawal or intoxication. These symptoms should have abated, either by supervisedithdrawal or stabilisation on agonist maintenance, before they are asked to consent to a detailed treatment contract. Once stabilised, individuals
hould be provided with detailed information about the risks and benefits of all treatments, and restrictions and regulations under which they
re provided.onclusion: Informed consent is an important part of the treatment process that should be obtained in ways that increase the autonomy andecision-making capacity in opioid addicts.
2007 Elsevier B.V. All rights reserved.
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eywords: Informed consent; Opioids; Addiction; Autonomy; Agonist mai
Consenting to treatment of addiction, particularly agonistaintenance treatment of opioid addiction, raises a number
f ethical issues. Most centre around the fact that treatmentf addiction involves the management of behaviour that isonsidered criminal, that creates adverse consequences foroth the individual and the rest of society, and is increasinglynderstood to be neurobiologically driven to some degree.
hen opioid dependent individuals seek treatment, they are
ften in desperate social, financial and health circumstances.hey may also be neurocognitively impaired and are often
nder some degree of duress or external coercion to enterreatment. There is often conflict between the interests of theddict seeking treatment and the community who regularlyund treatment programmes and decide how they are run.hese tensions may influence what people are required toonsent to when they enter treatment, and how their consents obtained.
In this paper we analyse the issues involved in obtainingnformed consent, and the role that it plays in produc-ng positive treatment outcomes. We briefly review recentesearch on the neurobiological changes that underlie addic-
ive behaviours (e.g. compulsion and craving). We illustratehe impact that this has had on some bioethicists’ thinkingbout the capacity of addicted individuals to give free ornternally uncoerced consent to participate in harm reduction
Table 1The four requirements necessary for informed consent to agonist mainte-nance treatment of opioid dependence
Informed consentrequirement
Description
1. Capacity The decision-making and cognitive capacities tounderstand a treatment, and to communicate anintention or preference (e.g. cognition,decision-making, comprehension).
2. Freedom The ability to make a choice without being coerced,internally or externally, and for that decision to beable to be apprehended in terms of their long-termgoals and values of the individual (voluntarism,autonomy and authenticity, apprehension).
3. Information To have all available information regarding the risksand benefits of treatment, and those of otheralternatives, as well as rules and requirements oftreatment.
4. Options/access Equal access to all forms of effective treatment,
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reatments, such as agonist maintenance therapies. We alsonalyse some of the competing ethical, social and politi-al forces that affect how agonist maintenance treatment isrovided. We conclude with some guidelines for ethicallycceptable and effective treatment of opioid addicted individ-als within a harm reduction framework. These guidelinesim to improve public health and safety, whilst maximis-ng the opportunity for positive treatment outcomes for thendividual.
Whilst we will focus on agonist maintenance treatment ofpioid addiction, similar ethical issues arise in the treatmentf addiction to other substances, different treatment strategiesnd philosophies (e.g. abstinence, antagonist maintenance orelapse prevention), and in different treatment contexts (e.g.rivately funded, coerced). We illustrate this by providingbrief analysis of the implications that our ethical analysisas for consent to abstinence-oriented forms of treatment forpioid dependence.
he role of informed consent in addiction treatment
Informed consent is the process by which individualsgree to enter treatment in the full knowledge of its pos-ible risks and benefits, and in the absence of duress oroercion. Informed consent is commonly taken to requirehat the individual: (1) has the capacity to understand treat-
ent and communicate their wishes, (2) is free to makeecisions (i.e. internally or externally uncoerced), and (3)s fully informed of the risks and benefits of treatment, asell as those of other treatment options (Faden, Beauchamp,King, 1986; Roberts, 2002b; Walker, Logan, Clark, &
eukefeld, 2005). We suggest including a fourth guidelinehat is neglected in traditional characterisations of informedonsent, namely, (4) that patients have equal access to allffective forms of treatment, where treatment is appropriatelyperated and resourced. We believe that this is particularlyelevant in the provision of opioid dependence treatmenthere there are competing social and political forces thatetermine what treatment options are made available, andhe manner in which these treatments are provided (seeable 1).
An ongoing challenge in treating opioid addiction is pro-iding an ideal level of treatment in the face of shrinkingudgets and increasing numbers requiring treatment, par-icularly in developing countries. In many countries agonist
aintenance is prohibited by law. Such constraints limit thextent to which those who provide opioid dependence treat-ent may be able to meet our ideal standards for obtaining
nformed consent. From the perspective of those providingreatment (e.g. care givers), individuals should have accesso all effective forms of treatment that are possible within
he political and economic context in which treatment isoverned. Access to treatment should not be determined byhe moral attitudes towards addiction of those operating thereatment programme.
Hhat
where treatments are appropriately operated andresourced.
There has been very little research into the process ofnformed consent in the treatment of mental health, and in par-icular, substance abuse and addiction (Sugarman et al., 1999;
alker et al., 2005). Most of our understanding of capacityo consent is derived from studies of consent to participaten research or clinical trials, where there has been a longngagement with these issues. Many of the ethical issues thatre relevant to consent to treatment, are also central to con-enting to research and clinical trials. This is particularly truef addiction where the line between research and treatments often blurred.
A systematic review in 1999 found only two studies of con-ent in substance abuse treatment settings (Sugarman et al.,999). The literature on consent to participate in research onubstance abuse is also limited. One study found that inject-ng drug users (IDUs) had the capacity and comprehensiono consent to a clinical trial of an HIV vaccine (Harrison,lahov, Jones, Charron, & Clements, 1995). Another studyemonstrated that capacity to consent in these individualsould be enhanced by the use of audiovisual aids (Fureman,eyers, McLellan, Metzger, & Woody, 1997). Whilst such
tudies suggest that opioid dependent drug users have theognitive capacities to comprehend and communicate therocess of consent, they do not shed light on the ability ofpioid addicts to provide free and internally uncoerced con-ent to participate in research, clinical trials or treatmentshat involve the consumption of their drug of addiction or angonist with similar effects (e.g. methadone). More researchs required in this regard. There have been some studies inecent years which have attempted to measure the decision-aking capacity of dependent drug users (Cairns et al., 2005;azelton, Sterns, & Chisholm, 2003; Hotopf, 2005; Smith,
orton, Saitz, & Samet, 2006). Further research may not onlyelp in ensure that consent is both free and informed; it maylso assist in providing more effective treatments that areailored to an individual’s specific needs.
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The highly regulated and institutionalised nature ofnformed consent has seen the process reduced to a medico-egal event, epitomised by the signing of a consent form. Thispproach to consent is more valid in medical research andurgical procedures, where the concept of informed consentas initially developed. It is less applicable in the treatmentf mental disorders and addiction. There is great variabil-ty in the degree of addiction, and the social and cognitiveapacities of individuals presenting for addiction treatmentRoberts, 2002b), as well as differences in their willingnesso change (Walker et al., 2005). The narrow and rigid struc-ure of the informed consent form can gloss over the complexature of consent, particularly in the case of substance abusehere it is more difficult to ascertain whether consent is free
nd informed, and where the capacity to consent may changeramatically over time. As we will show, adopting too nar-ow a view of the consent process can also lead to poorerreatment outcomes.
o addicts have the autonomy and capacity toonsent to agonist maintenance treatment?
By definition, addiction is a disorder in which an individ-al’s control over their drug use is impaired. People with anddiction continue to use drugs in the face of enormous neg-tive consequences, and despite often expressing a wish thathey could stop. This folk or common perspective is codifiedn the DSM-IV diagnostic criteria for substance dependencer addiction, which characterises addiction in terms of a “lossf control” over drug use, where drug taking becomes “com-ulsive” and consumes a great deal of an individual’s time andesources, to the detriment of other activities, such as work-ng or caring for children (American Psychiatric Association,994).
Some bioethicists have argued that by virtue of theirondition, addicts are unable to refuse their drug of addic-ion and are therefore unable to provide free and internallyncoerced consent to any addiction treatment that involveshe provision of an opiate, such as methadone or buprenor-hine maintenance treatment (Caplan, 2006; Charland, 2002;ohen, 2002; Elliott, 2002; Roberts, 2002a). This argu-ent, if accepted, could affect the way in which treatment
s provided, the strength of the carer–patient relationship, theegree of involvement individuals have in decisions regard-ng their treatment, and therefore the likelihood of treatmentuccess. It may also have significant implications for howpioid addicts are thought of in society and the social poli-ies we adopt to treat addiction and drug use (Carter & Hall,007).
For much of the 20th century, opioid dependent per-ons were seen as autonomous, self-governing individuals
ho wilfully, knowingly, and voluntarily engaged in crimi-al and immoral behaviour (Dalrymple, 2006; Szasz, 1997).he presumed autonomy and responsibility of such individ-als has been called into question by recent genetic and
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of Drug Policy 19 (2008) 79–89 81
euroscientific research on addiction conducted primarilyt the US National Institute on Drug Abuse (NIDA) andhe National Institute on Alcohol Abuse and AlcoholismNIAAA) (Leshner, 1997; Volkow & Li, 2004). The directorsf these Institutes have argued that addiction is a “chronic,elapsing brain disease” (Leshner, 1997, p. 45) caused byhronic self-administration of drugs that produces enduringhanges in brain neurotransmitter systems that leave addictsulnerable to relapse after abstinence has been achievedVolkow & Li, 2005b).
The brain disease model of addiction challenges the tra-itional belief that drug use is always a voluntary choicey arguing that prolonged drug use results in long-lastinghanges in brain structure and function that undermineoluntary control (Leshner, 1997; Volkow & Li, 2004). Neu-oimaging studies have shown that chronic drug use producessignificant decrease in dopaminergic activity that is involved
n the disruption of limbic and prefrontal regions (VolkowLi, 2005a). Adaptations in limbic regions emphasize the
ewarding effects of drugs and make addicted individualsess sensitive to the rewarding effects of natural reinforcerseveryday stimuli such as food, work and relationships).isruption of functioning in the prefrontal regions focuses
ddicts’ attention on drug use and impairs their ability toontrol impulses to use drugs (Volkow & Fowler, 2000;olkow, Fowler, & Wang, 2003). These neuroadaptations canersist for months after abstinence, possibly years (Volkow
Li, 2004). Neurocognitive studies have also shown thatddicted individuals display cognitive deficits in decision-aking tasks (Bechara, 2001, 2005; Fillmore, 2003; Grant,ontoreggi, & London, 2000; Jentsch & Taylor, 1999; RogersRobbins, 2001; Yucel & Lubman, 2007).These results are used to support a neurophysiological
icture of how addictive drugs subvert endogenous rewardircuits that are essential to survival, thereby giving drug usen over-riding motivational salience that works to the detri-ent of all other goal directed activities (Dackis & O’Brien,
005). According to proponents of the brain disease model,hese brain changes also explain: why addicts continue to userugs despite tolerance to their pleasurable effects and in theace of serious adverse consequences; and why addicts haveifficulty in understanding or considering the long-term con-equences of drug use and have a diminished ability to controlheir drug use as a result of neuropharmacological changesn their brains. When taken literally, the model of addictionrising from this research has been used by some bioethicistso argue that those with an addiction fail the first two testsf informed consent—(1) the capacity to understand and (2)he ability to make free and autonomous choices.
Recently, some ethicists have been prompted by themerging neurobiological conception of addiction to ques-ion the capacity of opioid dependent individuals to consent to
ome forms of treatment for their dependence (Caplan, 2002;harland, 2002; Cohen, 2002; Elliott, 2002; Roberts, 2002a).ccording to these ethicists, heroin addicts are, by definition,nable to make rational decisions about whether to accept an
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ffer of heroin either in the setting of a research study (Cohen,002), or in a clinical trial of heroin maintenance treatmentCharland, 2002). In the case of heroin maintenance, if a treat-ent can only be offered to patients if there is evidence of its
afety and efficacy provided by a randomised controlled trial,hen the acceptance of Charland’s argument would preventhe completion of the randomised controlled trials requiredo assess its safety and efficacy, and hence would precludets clinical use. Moreover, if these arguments were accepted,hey would raise similar doubts about the capacity of opi-id addicts to freely consent to any treatment that involvedeing maintained on an agonist, such as methadone or partialgonist like buprenorphine; arguably two of the most effec-ive pharmacological treatments that are currently availableGowing, Ali, & White, 2006; Mattick, Breen, Kimber, &avoli, 2003).Charland (2002) argues that heroin addicts are unable to
ive free and informed consent to participate in heroin pre-cription trials. Heroin addicts, he argues, are incapable ofaying “no” to the offer of free heroin. The warrant for thisrgument is the testimony of one former heroin addict andtatements by neuroscience researchers that the brains ofpioid dependent individuals are so altered by opioids thathey are unable to consider the risks of taking it. In usingrugs, Charland argues, “[t]heir decision is not truly theirs”Charland, 2002, p. 43) and hence, opioid addicts are unableo consent to participate in trials of injectable heroin.
Charland’s claim that heroin users are unable to say “no”o an offer of heroin is empirically false because the Swisseroin trials were not inundated with untreated heroin addictseeking “free heroin”. This was clearest in a randomisedontrolled trial of immediate vs. delayed entry to heroin main-enance (with the delayed entry group given access to usualreatment, methadone maintenance or abstinence) (Perneger,iner, Del Rio, & Mino, 1998). The researchers intended
o recruit 40 patients in each group but only recruited 24nd 27 patients, respectively. Moreover, when those whoere allocated to delayed entry to heroin treatment wereffered the choice at the end of six months, two thirds ofhe group decided against receiving heroin (Perneger et al.,998). Severely dependent treatment refractory Swiss heroinddicts were thus capable of saying “no” to an offer of pre-cribed heroin.
The arguments of Charland and Cohen interpret the DSM-V criteria that describe loss of control and compulsiveehaviour in absolute terms, as reflecting an incapacity toontrol drug use rather than as describing varying degrees ofmpaired control over drug use in varying situations. TheSM-IV criteria that they rely on are simply descriptive
erms, and in themselves do not constitute evidence. Manyddicts, for example, are able to control their drug use in par-icular settings when experiencing serious difficulties. They
ay, and often do, stop using drugs without assistance forarying periods, either to reduce their tolerance or to takeime out from the rigours of their life style. The fact that
any opioid addicts stop using in response to changes in life
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of Drug Policy 19 (2008) 79–89
ituation, such as a birth of a child or input from friends,amily and colleagues indicates that addictive behaviour isore than a simple neurochemical drive (Dalrymple, 2006).he experience of returning Vietnam veterans who were able
o quit opioid use without treatment once back in the U.S. isurther evidence that opioid addiction is a more complex con-ition than simplistic neuropharmacological models allowGerstein & Harwood, 1990).
In order for “addiction” to plausibly forestall autonomyn individuals with an opioid dependence, the internal andxternal forces must be demonstrably irresistible and abso-ute. It is clear from behavioural and observational studies thathis is generally not the case. Also, the evidence some ethi-ists cite from the neuroscience literature is less compellinghan they might think. It is unclear that when neuroscientistsefer to the brains of the addicted as being “hijacked” by arug, that they mean it in the literal and absolute sense inhich Charland, Cohen and Elliot seem to. A closer readingf the neuroscientific literature would suggest that addictioneurobiologists were highlighting the fact that addiction is aeal neurophysiological disorder, that required more humanereatment than was the norm.
Evidence for compulsive drug use in neuroscientificesearch emerged from highly controlled laboratory animaltudies (Olds & Milner, 1954). These animal studies have
limited application to the study of human compulsiveehaviour, and the contexts in which humans typically userugs (Foddy & Savulescu, 2006). Human neuroimaging andeurocognitive research show that addicts as a group haveore evidence of disruptions in brain function that are asso-
iated with a reduced ability to control drug use and poorererformance on neurocognitive tests of decision-making thano non-addicts. But these changes in brain function andeurocognitive deficits do not necessarily and absolutelyndermine capacity to consent. These studies find a tendencyor some addicts to have diminished neurocognitive capac-ty and function compared to non-addicts. Significantly, notll those who are addicted display these deficits whilst someon-addicted controls do (Bechara, 2001, 2005).
In summary, neuroscience research on addiction does notrove that addicts lack autonomy: whilst their autonomy isn some instances clearly impaired, particularly during acuteithdrawal or intoxication (see below), addicts retain someegree of control over their drug use and some degree ofutonomy. The aim of treatment should be to increase patientecision-making capacity and autonomy (Spriggs, 2005),ather than preventing addicts from participating in researchnd treatment that may be of benefit to them.
apacity to consent to abstinence-oriented treatment
Bioethicists’ concerns about capacity to consent have been
electively raised about pharmacological maintenance treat-ent. Cohen and Charland, for example, seem to implicitly
ssume that the only free and informed decision that an addicts capable of making is the decision to enter abstinence-
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riented treatment. But, by the same type of reasoning,here are grounds for arguing that decisions in favour ofhis treatment type may not be truly free or informed. Manyddicts enter abstinence-oriented treatment under some formf coercion, such as the threat of criminal prosecution, orhe loss of employment or a relationship. Heroin addictsho enter such treatment may overestimate their capac-
ty to achieve abstinence, underestimate the difficulties ofemaining abstinent, and may not appreciate the risks of suchreatment (e.g. increased risk of a fatal overdose on relapseo heroin use in a condition of opioid naivete (Mattick &all, 1996). Abstinence-oriented treatment programmes, no
ess than agonist maintenance treatment, must also meet eth-cal obligations to inform patients of the low success rate ofheir treatment, the increased risk of fatal overdose in thehort term that they assume in entering such treatment, andhe availability of other approaches to treatment, includinggonist maintenance treatment.
mplications
Acute intoxication with opioids can significantly impair anndividual’s cognitive and behavioural capacities, and there-ore significantly reduce their autonomy (Curran, Kleckham,earn, Strang, & Wanigaratne, 2001; Mintzer, Copersino, &titzer, 2005). Other drugs which are also commonly abusedy individuals entering treatment, such as alcohol and benzo-iazepines, produce similar cognitive deficits (Curran, 1991;innigan & Hammerslay, 1992). The symptoms of acuteithdrawal can also lead to severe cognitive impairments
Lyvers & Yakimoff, 2003; Rapeli et al., 2006). A com-only held (and we believe reasonable) view has been that
rug dependent people are able to give free and informedonsent if they are not intoxicated or suffering acute with-rawal symptoms at the time when consent is requestedAdler, 1995; Gorelick, Pickens, & Benkovsky, 1999; Grisso
Applebaum, 1998).There is a great deal of variability in opioid dependent
ndividual’s response to drugs, and the degree of impairmenthat they produce. Impairment may differ depending on theype of drug being abused (e.g. stimulants have been shown tomprove cognition on some measures), the route of adminis-ration, the severity of the addiction and the level of tolerance,nd the amount of time since last drug use. A non-abstinentpioid dependent individual can spend time between peri-ds of acute intoxication and withdrawal in which they areot severely cognitively impaired. As yet, there is no way toeasure or define the effect of these symptoms in a clinical
etting in a clear-cut and objective fashion (Dunn, Nowrangi,almer, Jeste, & Saks, 2006). Given that there are circum-tances associated with drug use, in addition to the cycle ofithdrawal and intoxication that can impact on their ability to
ake far-reaching decisions about treatment, we believe thatclient should only be asked to consider detailed treatment
equirements once they have become stabilised in treatment.atients should therefore not be asked to sign a detailed treat-
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of Drug Policy 19 (2008) 79–89 83
ent contract on admission to treatment. The worst of drugithdrawal symptoms should be reduced by medication (orave abated) before they are required to make long-term orar-reaching decisions that are implied by signing a treatmentontract which may have significant physical and financialamifications.
Addiction may therefore affect addicts’ ability to consento treatment in the short term and their capacity to choose
specific treatment from the types available. We shouldonetheless assume that addicts possess decision-makingapacity and attempt to engage them as much as possiblen making their own decisions rather than making decisionsor them, or worse still, over-ridding their wishes by com-elling them to enter treatment. This is the presumption thats made by the courts in holding addicts responsible for theirctions (rather than exculpating on the grounds of their addic-ion). It seems reasonable to make the same assumptions inhe treatment setting when we seek their consent to treatment.
The specific nature of addiction means that givingnformed consent to treatment is considerably more compli-ated than signing a legally binding consent form. Treatmentust engage with the individual and validate their experience,
reate trust, be flexible, and aim to enhance their autonomynd increase their decision-making capacity. Research hashown that successful addiction treatment depends upon theuality of the clinician–client relationship (Bell, Chan, &uk, 1995). Treatment which engages with the client and
osters control over drug use may be more effective than treat-ent which limits the autonomy of the addict by using rigid
reatment protocols.In dealing with heroin addicts in desperate physical and
ental states, treatment services must acknowledge the veryeal neurobiological changes that affect addicts’ ability toontrol their drug use and to make decisions about them-elves. These facts can be acknowledged whilst recognisinghat opioid dependent persons who are not in these states stillossess a capacity to make decisions about their treatment.his capacity should be nurtured and developed, through bothedication and therapy so that those addicted can play an
ctive role in their treatment and recovery. Once addicts havetabilised, it is important that treatment services provide accu-ate information about the likely success, risks and benefits ofhe different treatment options, and the rules and obligationsntailed in accepting these treatments.
onflicting aims in harm reduction treatment ofpioid addiction
The treatment of opioid dependence is complicated byhree issues. First, many opioid addicts who seek treatmentre involved in the criminal justice system because they have
een arrested for offences committed to fund their drug use.hey may be coerced into treatment to reduce the adverseffects that their behaviour has on society. Second, many opi-id dependent persons are not able to pay the costs of their
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tawtomstaff that operate the treatment programmes. Individuals whoreceive support and counselling must have access to appro-priate pharmacological drugs if required, whilst those inmaintenance and relapse prevention programmes should not
Table 2The minimum requirements for acquiring free and fully informed consentto opioid agonist maintenance treatment (adapted from Walker et al., 2005)
Minimum requirements for informed consent to opioid addictiontreatment, include providing information to clients about:
1. Clinical characteristics and diagnosis2. Treatment recommendations3. Risks and benefits of treatment4. Costs of treatment5. Programme rules—rights and obligations
4 A. Carter, W. Hall / International
reatment. These programmes are generally funded on therounds that they reduce the social costs of opioid addiction,ith the largest cost savings arising from the fact that theserogrammes substantially reduce crime whilst opioid depen-ent persons remain in treatment (Hall, Doran, Degenhardt,
Shepard, 2006; Ward, Mattick, & Hall, 1998). Thirdly,ong-term opioid agonist treatment presents risks to both thendividual – in terms of overdose risk – and to society inerms of their potential diversion to the illicit drug market andonsequent spread of illicit drug use. The fact that agonistaintenance treatment of opioid dependence serves mixed
ersonal, public health and public order goals complicateshe provision of treatment.
Treatment for opioid dependence often involves interac-ions between the health and criminal justice systems. Theseystems have different aims and motivations for providingpioid dependence treatment, and different ideas about whatonstitutes effective or successful treatment. The same can berue for conflicts between public health and personal medicalare professionals. The use of pharmacological treatmentsnsures that maintenance treatment falls under the umbrellaf medicine as these drugs must be prescribed by physicians.et the justification for public funding of agonist mainte-ance treatment for opioid dependence often depends uponhe fact that they improve public health (via reduced bloodorne virus (BBV) infection) and public order (via reducedriminal activity and drug use) (Hall, 2006). The differentrofessional groups working in these areas (e.g. law enforce-ent, the judiciary, clinical staff, and public health) also
ave different ethical priorities and approaches to opioidddiction treatment which can influence how treatment isrovided.
Public ambivalence about the ethical acceptability ofaintaining addicts on opioids often leads to the imposition
f restrictive rules and regulations on pharmacological treat-ent. Some regulations are intended to minimise the risk of
on-addicted persons entering treatment (e.g. by demandingvidence of an extensive history of dependence and docu-ented failure at abstinence treatment). Other regulations
im to prevent the diversion of pharmaceutical opioids tohe black market where they may be used inappropriatelynd result in overdose deaths and addiction. Some pro-rammes specify the frequency of urine testing and requirehat patients be excluded from programmes if they provideeveral “dirty” urine samples. Others place time limits onreatment or insist upon a goal of abstinence from all opioidseing achieved within some arbitrary period (e.g. one or twoears). The unintended effects of these types of regulationsay include: discouraging opioid dependent persons from
eeking treatment until their condition is chronic, decreasingrogramme retention because of the onerous requirementsade of patients, and forcing stable patients to withdraw from
reatment and return to illicit opioid use (Ward, Mattick, &all, 1992).Programmes that are structured to serve public welfare
oals, often at the expense of the best interests of the patient
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of Drug Policy 19 (2008) 79–89
nd the chances of successful treatment, can also lead to anver use of urine screening, where positive results are usedo punish individuals by reducing maintenance dose or takeway privileges. The impact of competing treatment aimss most clearly seen in the setting of dosage. The agonistose is often the source of much contention and disagreementetween the client and the programme, and is sometimes useds a tool to manipulate an individual’s behaviour. Rather thaneing set to meet the individual’s medical needs, maintenanceosage may be reduced in order to punish noncompliantehaviour. However, a positive urine sample may in facte an indication that the maintenance dosage is too low toeduce craving, and eliminate the cycle of intoxication andithdrawal.Most significantly, urine screening can affect how the
atient is viewed by staff, and can undermine the carer–clientelationship. Apart from dosage, the carer–patient rela-ionship is the most single important aspect of treatment.uccessful treatment requires the development of a trustingnd empathic carer–patient relationship (Bell et al., 1995).ocussing too heavily on the public welfare and criminal
ustice goals of treatment can be an impediment to the devel-pment of such relationships. Conflicting treatment aims canlso impact on what pharmacological treatments are madevailable (e.g. methadone or buprenorphine) and in what set-ing (e.g. specialist clinic or primary care) they are prescribed.
mplications
Ethically acceptable and effective agonist maintenancereatment of opioid dependence requires programme rulesnd regulations that balance patient and community safetyhilst permitting patients to remain in and benefit from
reatment. Ethical and effective treatment must address allf the needs of the individual. It is important that treat-ent is not limited by the ideological viewpoints of the
. Alternative services and interventions
. Freedom to choose and refuse treatment
hilst these guidelines were developed for harm reduction treatments, theyroadly apply to the process of obtaining consent to all forms of addictionreatment.
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Table 3The main features of agonist maintenance treatment that individuals entering treatment will be required to consent to
Practical guidelines for opioid agonist maintenance treatment:
ConsentInformed consent is a critical part of conveying information and options, as well as endeavouring to engage patient and increase autonomy and
decision-making capacities
Treatment issues:• Individuals may be in social, financial and cognitive situation, including intoxication or withdrawal, that diminishes ability to make completely
free and autonomous decisions• Treatment presents considerable risks to individual and society• Treatment requires strict rules and obligations, some of which may be intrusive, violate freedom, and carry long-term risks
Recommendations:• Individuals entering treatment should not be required to consent to a detailed treatment contract until they have been stabilised on treatment
medication, or completed withdrawal• Once stabilised in treatment, individuals should be informed of all their treatment options, and the risk, benefits and obligations of each• Patients should be aware that treatment is a long-term process, and be aware of the risks of stopping treatment• Consent should be a process which engages individuals in treatment, and aims to increase autonomy and decision-making capacity• Individuals must have the right to refuse treatment
DosageThe amount of opioid agonist prescribed can be difficult to titrate. It is often the point of contention between recipient, dispenser and the programme
as it highlights the conflicting motivations for treatment. The dosage prescribed must meet patients needs without causing further harm tothe individual (overdose) or society (diversion)
Treatment issues:• Varies from person to person• Can lead to overdose during stabilisation• Can be diverted to black market negatively impacting on society• Sometimes used as a form of punishment (e.g. in response to a positive urine sample)• Needs to be high enough to reduce the cycle of withdrawal and intoxication, and to attenuate craving and emotional disturbances
Recommendations:• Set in consultation with patient• Be flexible to meet the patient’s changing needs (e.g. maintenance vs. detoxification)• Set with the aim of reducing illicit opioid use, not as a form of punishment• Research has shown that doses of methadone of 60 mg and over are effective (Trafton, Minkel, & Humphreys, 2006)
Urine testingTesting patients for drug use is an important part of setting dose—positive urine samples can often be a sign of the fact that the maintenance dosage is
not adequate enough to reduce the effects of craving and emotional disturbance. It is also a critical instrument in evaluating the effectivenessof the treatment programme, or the use of other drugs which may be counter-indicated with treatment drug
Treatment issues:• Necessary to ensure the safety of individuals during stabilisation period• Can be an onerous intrusion in to individual’s privacy• Can undermine trust and the carer–patient relationship• Can be used, or perceived to be used, to punish individuals• There are questions over the validity and accuracy of urine testing in determining drug use—most abused drugs have a short half-life;
self-report as effective when a positive test does not entail a punitive response• Often used to test for drugs that are unrelated to the treatment• Testing can be expensive• Testing can deter some from entering or remaining in treatment, whilst expelling individuals for positive samples can lead to a reuptake of illicit
opioid abuse
Recommendations:• Convey the need for testing to individuals, both in order to protect society and to prevent an overdose during stabilisation• Introduce a tiered or evolving testing system, where testing is frequent during the initial stabilisation period• Use a less frequent testing protocol for stabilised and compliant patients, as part of positive reinforcement programme• Do not use positive urine tests to punish individuals—can often be a sign that the dose is inadequate, or that individuals require more therapy
and support
Choice of drug (methadone vs. buprenorphine)The two most common drugs used in agonist maintenance programmes are methadone (opioid agonist) and buprenorphine (a partial agonist). Each has
its own advantages and particular applications
Treatment issues:• Methadone has a greater potential for overdose—generally more restricted in the way that is dispensed (e.g. daily dosing, highly supervised)• Buprenorphine has less overdose potential—less frequent dosing, take away doses, and less supervision required (e.g. primary carer)• Methadone is reported to be better at reducing craving and emotional disturbances, and possibly higher retention rates
86 A. Carter, W. Hall / International Journal of Drug Policy 19 (2008) 79–89
Table 3 (Continued )
Recommendations:• More research is required to establish the relative superiority of one over the other, and in which circumstances• Buprenorphine appears to be better for those that require more flexible delivery of maintenance treatment, and do not require the increased
agonist action that methadone provides• The choice of drug should be based on individual’s needs
Legal coercion and the criminal justice systemTreatment is often offered as an alternative to imprisonment in order to have legal sanctions deferred, reduced or lifted, or as a condition of parole,
with the threat of imprisonment if these conditions are not met
Treatment issues:• Compromises individuals ability to give free consent• Effective in reducing negative social impacts of drug use (e.g. crime, BBV, etc.)• Types of treatment offered often limited; stigmatisation of participants• Allows for confusion between treatment aims—may be seen as part of a punitive response
Recommendations:• Legally coerced treatment should only be offered after due process• Treatment must be effective and aimed at treating the individual, not as part of a punishment• The individual must be offered a variety of effective treatment options• The individual must be free to refuse treatment, and face the judicial system
Setting and dispensingWhere drugs are dispensed, by whom and how often is can often be an impediment to an individuals ability to reintegrate back into society, and affect
retention in treatment in the long term
Treatment issues:• Control over the number of doses prescribed at one time, and the situation in which it is dispensed is critical in ensuring that treatment does not
result in any additional harms to society, through diversion of medication on the black market or overdose• Daily dosing can be difficult to manage for individuals attempting to reintegrate back into society• Large treatment centres require strict treatment rules which can be inflexible for individuals changing needs, and result in some leaving treatment• More flexible treatment options (e.g. via primary care) do not provide the same degree of security over medication prescriptions as large
treatment centres• Allowing for multi-dose prescriptions makes it easier for individuals to reintegrate back in to society
Recommendations:• Setting and dispensing to reflect progress of patient—those stabilised and compliant to receive greater freedom and dosing privileges• Increased use of prescription by well trained primary health care givers• Utilisation of newer treatment medications, such as buprenorphine, which are less amenable to overdose and can be given in larger doses,
therefore requiring less frequent dosing• Research and development of new drug formulations (e.g. depot medications and vaccines)
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e include a list of the issues that can emerge in treatment and cause probthical and effective.
e limited to pharmacological strategies. Treatment mustlso recognise the changing circumstances of the patient asreatment progresses, and be flexible enough to meet theseeeds.
It is ethically desirable that the treatment of opioid depen-ence be governed by the primary aim of treating the opioidddict. Most of the obstacles to effective treatment are theesult of different understandings of the nature of opioidddiction and confusion over the aims of treatment (Bell,998). Often the regulations and policies that guide treatmentre aimed at controlling, and even punishing an individual.ot only are such approaches ethically unsound – in that theyiolate the individual’s right to safe and effective treatment –hey are also ineffective from the utilitarian ethical perspec-ive that often motivates the provision of treatment for opioid
ependence in that they may reduce the public health bene-ts of treatment. Treatment that aims to produce a therapeuticenefit for the individual is more effective if it engages theatient in treatment (Bell et al., 1995).
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e also provide some recommendations for ensuring that treatment is both
uidelines when entering individuals into addictionreatment
When opioid dependent individuals enter treatment, theyre often in a desperate state. They may be willing to agreeo almost anything in order to get into treatment (e.g. to endheir withdrawal symptoms or avoid the negative social con-equences of their addiction). For these reasons, individualsn this situation should not be asked to provide detailed con-ent to a treatment programme, apart from indicating theircceptance of the immediate offer of assistance. A client cannly begin to think about treatment after they have either beentabilised on a longer acting opioid, or they have completedupervised opioid withdrawal.
When choosing what sort of treatment to enter, it is impor-
ant that the client understand the likely effectiveness of thereatment, the benefits and risks of completing treatment, andhe requirements of the programme. The treatment that ishosen should reflect the aims of the individual rather than
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hose of the staff or the wider community. The staff member’sesponsibility is to ensure that the client is well informedbout the treatment options that are available, their goals,isks and benefits, and what the expectations are of them inntering the programme. This will include discussions abouthe pros and cons of abstinence vs. maintenance treatmentoals, as well as an honest appraisal of the risks and the like-ihood of benefiting from both types of treatment. Refer toable 2.
Informed consent to a detailed treatment contract will statehe rules and regulations of treatment and an individual’sbligations. This may include information on drug testingegimes, responses to positive urine samples, the intendedength of treatment, costs, where and how often drugs are toe dispensed, other treatment requirements, the involvementf the criminal justice system, and rights to privacy and con-dentiality, including informing participants of the limits ofonfidentiality (e.g. that it is mandatory to report child abuser homicide). These rules and obligations should be aimed athe treatment of the individual, whilst still protecting societyrom harm. A summary of the practical issues involved inroviding agonist treatment of opioid dependence and somereatment recommendations are summarised in Table 3.
onclusion
In many developed countries it is generally a legal obliga-ion in medical and psychiatric treatment to obtain a signedreatment “consent form” during intake. The process of gain-ng consent is important not only to satisfy legal and ethicalequirements; it plays a crucial role at the beginning of treat-ent. Unlike traditional consent procedures such as those
ound in medical research, the effect that addiction has onndividual’s decision-making capacities, means that informedonsent is itself a critical part of successful treatment. Obtain-ng consent should be a process that engages the patient andreates a strong and trusting carer–patient relationship; onehat validates the patient’s experiences and aims to encouragebelief, willingness, and capacity to change (Walker et al.,005). Informed consent as a single event of unilateral flowf information can undermine such a positive and productivereatment process.
Little attention has been given to investigating what isequired for informed consent to treatment for opioid depen-ence and how this is best obtained (Sugarman et al., 1999).ore research is needed on this topic, as are studies of atti-
udes and understanding of the issue of consent by physicians,arers and researchers (Forman et al., 2002; McCrady & Bux,999). Better training of staff is desirable, not just to meetegal requirements or provide the minimum of rights, but toacilitate better treatment. Research in to the development of
ools to better assess the capacity of opioid dependent individ-als may aid in their treatment, not just to establish consent,ut to better understand what the deficits are, and their extentCairns et al., 2005; Hotopf, 2005). Whilst their usefulness in
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he clinical setting is uncertain, it is clear that ethical treatmentf opioid dependence should aim to improve an individual’secision-making capacity and ability to make autonomoushoices rather than override or undermine them.
There is an enormous variability in the physical, socialnd psychological circumstances of opioid dependent indi-iduals who enter treatment and varying degrees of intentionnd capacity to change. This is a major challenge in the pro-ision of opioid dependence treatment that highlights themportance of an engaged consent process that addresses anndividual’s needs. A better understanding of the neurocog-itive changes that underpin these differences, and tools toeasure them, may prove useful in this task (Dunn & Jeste,
001).This paper is the result of a project funded by the World
ealth Organisation, however the views expressed are thosef the authors. Adrian Carter is supported by a scholarshiprom the National Health and Medical Research Centre, Aus-ralia (No. 456331).
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