Volume 164 Issue 11

For Debate The ACT heroin trial proposal: an overview The authors of the proposal describe the trial and its development Gabriele Bammer and Robert M Douglas MJA 1996; 164: 690-692 Introduction - Aims and outcome measures - Pilot studies - Full-scale clinical trial - Development of the proposal - The future - References - Authors' details - - More articles on Drugs and alcohol Introduction The proposal for a "heroin trial" in the Australian Capital Territory (ACT) builds on growing evidence that treatment is the most cost-effective approach to problems resulting from illicit drug use.1-4 A four-year feasibility study was undertaken after overwhelming encouragement from a national seminar of drug treatment and policy experts. It resulted in a proposal which addresses a key issue, is clinically workable, able to be rigorously evaluated and has minimal risks. The trial comprises two pilot studies and a full-scale clinical trial; evaluation is central and debate is welcomed. Aims and outcome measures The core of the proposed "heroin trial" is a clinical trial to compare a new treatment option against the current gold standard. In essence, it is a regular trial of a new treatment. The question to be asked is: If maintenance treatment for opioid dependence is expanded, so that both injectable diacetylmorphine (heroin) and oral methadone are available, is this more effective than current maintenance treatment with oral methadone alone? Measures of effectiveness are: Ability to attract dependent heroin users into treatment; Ability to prevent premature drop-out from treatment; Ability to improve health and well-being, including reducing drug use and criminal behaviour and improving social functioning; and Cost-effectiveness. Pilot studies The first step would be to conduct two six-month pilot studies in the ACT. First pilot study: This would involve 40 participants who meet the following eligibility criteria: Either currently or formerly on the ACT methadone program; and Able to prove ACT residence since 1993. Half would be drawn from volunteers currently receiving methadone treatment, who would prefer the expanded treatment option, and half from volunteers who have dropped out of methadone treatment. Equal numbers of men and women would be included from each of these groups. Participants would have a choice of treatments: injectable diacetylmorphine alone; injectable diacetylmorphine and oral methadone; and oral methadone alone. All could change treatments at will, within the limits of medical safety. To warrant moving to the second pilot study, the first would have to show that: A stable maintenance dose of injectable diacetylmorphine or injectable diacetylmorphine plus oral methadone could be found for more than half the participants; Participants could safely and easily move between the three treatment options; and There was improvement in at least half of the outcome measures for health and well-being. The first pilot study would also allow investigation of the pharmacokinetics and psychopharmacology of diacetylmorphine, especially effects on driving skills. Stability is a key issue for the first pilot study. Stabilised consumption within a defined therapeutic range was identified as a criterion for effective maintenance treatment by a meeting of experts on drug substitution organised by the World Health Organization in May 1995. Participants in the proposed trial would be able to attend the clinic to inject heroin up to three times a day. Current Swiss experience is that this works very well;5 those who cannot be stabilised on heroin under these conditions are prescribed a low dose of methadone as well. Second pilot study: This would be a small randomised controlled trial with 250 participants and the same eligibility criteria as the first pilot study. In contrast to the first pilot study, half the participants would be allocated to the choice of treatment options and half to oral methadone alone. The second pilot study would: Further investigate the questions addressed in the first pilot study; Begin to examine attraction into, and retention in, treatment; and Assess if randomisation is practicable for this group. A full-scale randomised controlled trial is the standard and most rigorous way to test a new treatment option. However, before launching such a full-scale trial, it is necessary to test whether it is practicable for dependent drug users. If not, there will be hard decisions about the value of less convincing forms of assessment. Alternatively, if drop-outs from the randomised pilot study are relatively few, then the sample size would be sufficient for statistically meaningful comparisons on outcome measures. Full-scale clinical trial This would involve: 1000 participants in three cities; and Volunteers drawn evenly from three groups: dependent heroin users who have never been in treatment; those who have dropped out of treatment; and those currently in methadone treatment. The trial would run for two years. In the first year it would be a randomised controlled trial, but in the second all participants would be given choice of treatment. At the end of the trial there could be evidence-based assessment of the role of diacetylmorphine in maintenance treatment, the subgroups in whom this treatment is most likely to be useful, and other indications and contraindications. This would allow a more balanced perspective on medical prescription of this drug. Development of the proposal The proposal resulted from a four-year feasibility study that concluded that the benefits of testing this new treatment option outweighed the risks. While all currently available options (such as methadone maintenance, detoxification, residential rehabilitation and counselling) are beneficial for some dependent users, none appear satisfactory for a further significant proportion. Additional options are needed. Diacetylmorphine is not the only potential new treatment; others include buprenorphine, levomethadyl acetate (LAAM), naltrexone and injectable methadone. However, the feasibility study focused on diacetylmorphine because it is the most controversial, among the least carefully studied and the preferred option for many dependent heroin users. Some of the controversy arises from uncertainties about whether prescribing diacetylmorphine can have positive outcomes, whether it can be cost-effective and whether stability is achievable on this short-acting opioid. These questions can be resolved only through empirical research and are the focus of the trial. Moral arguments about the value of maintenance treatment, about providing treatment for self-inflicted problems and about making a currently illicit substance available under carefully controlled conditions are not resolvable but are open to ethical debate (some issues are covered by Ostini et al.6). Finally, controversy arises because a trial has risks. These include that dependent heroin users may move to the ACT; a trial may lead to more permissive attitudes to illicit drug use; the trial drugs may cause road accidents or be diverted onto the black market; participants may congregate at the trial site; women in the trial may give birth to diacetylmorphine-affected babies; and a trial might further institutionalise or marginalise dependent heroin users. Much of the feasibility research involved working with critics of a trial, firstly to identify these risks and then to develop ways to minimise them. In summary, these include using well-defined eligibility criteria, not providing take-away doses of heroin, strictly supervising injection at the clinic, carefully monitoring participants before they leave and setting the trial within the current context of law enforcement and preventive activities. Potential risks would also be carefully monitored. The feasibility research was conducted in collaboration with the Australian Institute of Criminology. Well over 100 people have been involved -- as collaborators, assistants and advisers -- and many hundreds have provided feedback through workshops, seminars and discussions. Opinions have also been elicited from around 5000 members of the general community through ACT and national surveys. A wide range of options was initially explored. The development of a proposal that was clinically workable, able to be rigorously evaluated and minimised risks was an iterative process -- any one change to the protocol could have multiple ramifications. The process involved integrating both the findings of many disciplines (anthropology, clinical science and health care, criminology, demography, economics, epidemiology, law, pharmacology, philosophy, political science, policy analysis, psychology, sociology and statistics) and the insights of the key interest groups (people who are or have been dependent on heroin, police, people involved in providing treatment and other services to illicit drug users, the general community and policy makers). Heroin has long been prescribed for dependent users in the United Kingdom and, while there is evidence that this can be a useful option, it is contested. The same is true of historical evidence from the United States. No evaluation to date has been as rigorous as would now be required before introducing a new treatment. Other countries, most notably Switzerland and the Netherlands, are either undertaking, or about to undertake, "heroin trials".5,7 Much will be learnt from them, but many questions will remain unanswered and these are the focus of the ACT proposal. The future The future of the trial is now in the hands of the policy makers. The immediate stimulus for the feasibility research came from the deliberations of an ACT Legislative Assembly Select Committee on HIV, Illegal Drugs and Prostitution in early 1991.8 The final report and recommendations from the feasibility study9 were presented to the ACT Chief Minister, Ms Kate Carnell, in June 1995; she has maintained that a trial will not proceed without support from other States and financing from outside the ACT. In the meantime, we welcome public and private critiques and debate on the proposal. If a trial does eventuate it must be as well conceived as possible. Opportunities for clinical trials are rare and justified only when there is a real research question, with doubt about the outcome. In addition, trials are expensive. We estimate the cost of the two pilot studies alone at $2.3 million. A trial cannot be paid for from funding currently allocated to drug treatment or research; there are too many other urgent priorities. New money will have to be allocated --ultimately, this is the real test of political will. Of necessity this overview must be brief. A more detailed proposal can be found in the 1995 report on feasibility of the heroin trial.9 The results of the feasibility research are presented in four reports, thirteen working papers and, to date, 16 peer-reviewed papers, which are available from the authors (for a selection see references 10-14). A detailed response to the critique by Dr Matt Gaughwin is also available from the authors. References Gerstein DR, Johnson RA, Harwood HJ, et al. Evaluating recovery services: The California drug and alcohol treatment assessment (CALDATA). General report submitted to the State of California, Department of Alcohol and Drug Programs by National Opinion Research Center at the University of Chicago and Lewin-VHI Inc, Fairfax Virginia. Sacramento: California Department of Alcohol and Drug Programs, 1994. National Institute in Drug Abuse. Drug abuse treatment. An economical approach to addressing the drug problem in America. Rockville MD: US Department of Health and Human Services, Public Health Service, Alcohol, Drug Abuse, and Mental Health Administration, 1991. Odyssey House. Drugs in our community. Unpublished report. Melbourne: Odyssey House. Rydell CP, Everingham SS. Controlling cocaine. Supply versus demand programs. Santa Monica: RAND Drug Policy Research Centre, 1994. Uchtenhagen A, Dobler-Mikola A, Gutzwiller F. Medically controlled prescription of narcotics: fundamentals, research plan, first experiences. In: Rihs-Middel M, Lewis DC, Clerc J, et al., editors. The medical prescription of narcotics: scientific foundations and practical experiences. Freiburg: Huber verlag. In press. Ostini R, Bammer G, Dance P, Goodin R. The ethics of experimental heroin maintenance. J Med Ethics 1993; 19: 175-182. Health Council of the Netherlands: Committee on Pharmacological Interventions in Heroin Addicts. The prescription of heroin to heroin addicts. The Hague: Health Council of the Netherlands, 1995. (Publication no. 1995/12E.) Legislative Assembly for the Australian Capital Territory. Select Committee on HIV, Illegal drugs and Prostitution. Second interim report. A feasibility study on the controlled availability of opioids. Canberra: Legislative Assembly for the Australian Capital Territory, 1991. Bammer, G. Report and recommendations of stage 2 feasibility research into the controlled availability of opioids. Canberra: National Centre for Epidemiology and Population Health, Australian National University and the Australian Institute of Criminology, 1995. Hartland N, McDonald D, Dance P, Bammer G. Australian reports into drug use and the possibility of heroin maintenance. Drug Alcohol Rev 1992; 11: 175-182. Bammer G. Should the controlled provision of heroin be a treatment option? Australian feasibility considerations. Addict 1993; 88: 467-475. Bammer G, Weekes S. Becoming an ex-user: insights into the process and implications for treatment and policy. Drug Alcohol Rev 1994; 13: 285-292. Bammer G, Stevens A, Dance P, et al. Controlled heroin availability in Australia? How and to what end? Int J Addict 1995; 30: 991-1007. Stevens A, Ostini R, Dance P, et al. Police opinions of a proposal for controlled availability of heroin in Australia. Policing Soc 1995; 5: 303-312. Authors' details National Centre for Epidemiology and Population Health, Australian National University, Canberra, ACT. Gabriele Bammer, PhD, Fellow. Robert M Douglas, MD, FAFPHM, Director. No reprints will be available. Correspondence: Dr G Bammer, National Centre for Epidemiology and Population Health, The Australian National University, Canberra, ACT 0200. Email: Gabriele. BammerATanu.edu.au

Gabriele Bammer · Robert M Douglas

For Debate "Acculturating" heroin use Viewpoint: the proposed ACT heroin trial has not comprehensively considered the variability in the needs of heroin users Matt D Gaughwin MJA 1996; 164: 692-693 Introduction - References - Authors' Details - - More articles on Drugs and alcohol Acculturation: "The adoption and assimilation of an alien culture",1 used here to mean the mutual consideration of the viewpoints of two cultures (heroin users and non-users) for the benefit of each. Introduction Despite much thinking and talking about heroin, Australia, like most countries, has not come close to solving the problems associated with heroin use. The proposal by researchers at the National Centre for Epidemiology and Population Health (NCEPH) and the Australian Institute of Criminology (AIC) to conduct trials of the prescription of heroin is a welcome attempt to improve the lives of Australians who use heroin, their families and communities. The purpose of this article is to argue that the NCEPH/AIC proposal has prematurely focused on one way of providing heroin which is too narrow and too restrictive; that some of the criteria for "success" of the pilot studies seem to be arbitrary; and that some of the criteria for termination of the project are unreasonable. I also suggest some alternative approaches to providing heroin on a trial basis. The proposal is for two pilot studies, each of six months' duration, followed by a trial of two years. Each stage of the proposal is contingent on the "success" of the previous stage. The core of the proposal is to provide heroin for injection to users who attend a special clinic up to three times a day to receive heroin and/or methadone under close supervision. Any radical approaches to opiate dependence (such as providing heroin) will be constrained by political and practical considerations. At the outset the investigators associated their proposal with the prevalent paradigm, which seeks to contain heroin users by locking them up or treating them. Thus, the report on feasibility of the trial1 states that the project "must not be linked with permissive attitudes to illicit drug use and must be coupled with continuing law enforcement and prevention activity against illicit drug use". It seems reasonable to ask whether such views allow adequate exploration of alternative approaches to providing heroin. If these statements indicate undue sensitivity to the perceptions of those with negative views about heroin use, then it follows that any strategy for providing heroin would tend to be very restrictive. In stage 2 of the feasibility research into the views of dependent heroin users, most people questioned were clients of the ACT methadone program (209) and relatively few had never received treatment (14) or were treatment "drop-outs" (8).2There is little indication that a wide range of heroin users have been comprehensively questioned about possible methods of providing heroin or of evaluating the pilots or trial. By concentrating on clients of the ACT methadone program in which "in both 1993 and 1994, half the people who entered the program had dropped out within a few months",2 a premature and limited view of heroin and methadone provision may have been obtained. Criteria for success of the pilot studies have been established but are not necessarily justified. The first pilot study will be successful if a stable dose of heroin or heroin plus methadone is "found" for "more than half of the participants".2 These criteria seem arbitrary and restrictive -- should participants who do not receive stable doses of heroin but nevertheless have better lives (improved health, less involvement in crime) be regarded as unsuccessful? What is the rationale for concluding that the first pilot project is a success if 51% ("more than half") of participants achieve a stable dose of heroin? Why not 25% or 75%? The progression of the second pilot study to the full-scale trial is contingent on the acceptability to heroin users of being randomised to receive either their choice of heroin, methadone or both or, in the control group, to receive methadone alone. Again, this criterion seems too restrictive in that it gives preference to the design of a trial over improvements in the lives of heroin users. In my view, the latter should be given greatest weight as a criterion at all stages of the project, even if it means redesigning the full-scale trial. The relative lack of consideration for the potential variability in the needs of individual heroin users is taken to a logical but unreasonable conclusion in the criteria for termination of a trial. One criterion will be if prescribed heroin "has value for only a subgroup of dependent heroin users". This is unreasonable because, for example, if subgroups that were most likely to engage in crime or experience overdose benefited most, then continuing to prescribe heroin for them would surely be appropriate. Another model for provision of heroin in a pilot program might be decentralised prescription by selected specialist or general practitioners in a few regions, based primarily on individual assessment of needs and on potential risks to individuals and communities. One seeming advantage of the NCEPH/AIC proposal is the strategy of proceeding by incremental steps, each dependent on the satisfactory outcome of the previous one. However, with only a limited initial model of heroin provision and restricted concepts of progress or "success", any potential convergence to some "ideal" model or, indeed, divergence to more than one, is restricted. If there were several initial models, there would be more opportunity to select those that are effective. The impetus for the project arose, in part, from concerns that current approaches to the problems associated with heroin use "might not be effective".2 It follows that one focus could be on those for whom current approaches are not effective. If we see heroin users as individuals with individual needs, we might be led to alternative ways of making heroin available and of evaluating its usefulness. If we focus first on the things that heroin users and their communities want to change (e.g., crime, disease risk, cost, overdose) and only later on methods of delivery, it seems to me we will have a better chance of making a substantive contribution that will help ameliorate the problems of heroin use. Arguably, heroin and heroin users are seen as alien by most Australians. By showing people that heroin users are their fellow Australians, sometimes with a particular set of difficulties, we might begin their "acculturation" and not confine them in prisons and clinics or drive them to extremes of behaviour and thereby disable them. In conclusion, I urge the NCEPH/AIC to consider revising its approach to heroin prescription, and politicians, bureaucrats and others to support more comprehensive consideration of how to solve the problems associated with heroin use. The Commonwealth, States and Territories need to keep this issue on the public health agenda and to provide mechanisms and resources to enable the discussions and research to continue. References Burchfield R W, editor. A Supplement to the Oxford English Dictionary. Oxford, Oxford University Press, 1972. Bammer G. Report and recommendations of stage 2 feasibility research into the controlled availability of opioids. Canberra: National Centre for Epidemiology and Population Health, Australian National University and the Australian Institute of Criminology, 1995. Author's DetailsDrugs and Alcohol Resource Unit, Royal Adelaide Hospital, Adelaide SA. Matt D Gaughwin,PhD, FAFPHM, Acting Director. Correspondence: Dr M D Gaughwin, Drugs and Alcohol Resource Unit, Royal Adelaide Hospital, North Terrace, Adelaide, SA 5000.

Matt D Gaughwin

For Debate The heroin trial we had to have Viewpoint: the climate of prohibition has prevented dispassionate scientific assessment of the trial Nick Crofts MJA 1996; 164: 694-695 Introduction - References - Authors' details - - More articles on Drugs and alcohol Introduction That we treat heroin as a special drug is one of the great anomalies of this dark age of drug prohibition and the so called "War on Drugs". This is the one-sided policy that attempts to reduce consumption of illicit drugs by reducing supply through interdiction and incarceration. The war is being waged by policy makers, law enforcement and the military throughout the world. The effects of this social policy pervade the daily lives of all citizens, whether they know it (through the drug-related death of a friend or relative or through being burgled) or not (through taxes which pay for the imprisonment of drug users or through increased insurance premiums because of drug-related crime). It is scarcely credible in this era of sceptical rationality that a social policy with such far-reaching effects is based on little more than an almost religious faith in the doctrine of prohibition -- a policy based on racism, commercial exploitation, colonialism and the worldwide export of United States domestic policy.1 The proposed trial of medical prescription of heroin to heroin-dependent people in the Australian Capital Territory (ACT) would provide important data for more informed decision-making about heroin policy. Prohibition has the effect of demonising heroin and dehumanising heroin users. Objections to limited, scientific attempts to obtain information for rational debate about the best, least harmful method of integrating heroin and other opium use into our society eventually derive from the absolute need to defend the essentially untenable position of prohibition. Such objections have been vigorously raised about the proposed ACT trial. Were the proponents of prohibition sure of their position, they would have nothing to lose from such trials, which could adduce only further evidence of the need to direct every effort towards abstinence. On the other hand, objections to the proposed methods of the trial need careful consideration. Objections that the trial will not answer multiple questions about heroin use and treatment overlook the specificity of its aims. Indeed, the modest aims and careful development of realistic outcome indicators are outstanding features of the proposed trial. Equally, the objection that such a trial will equate to, or advance, the legalisation of heroin is fundamentally flawed. The medical prescription of heroin to those who are heroin-dependent maintains the current problematic view of heroin use -- the problem is simply medicalised. This, I would argue, is actually a retrograde step for legalisation, as medicalisation will make medical (rather than legal or moral) arguments paramount and very difficult to counter. We should have sufficient experience with methadone maintenance treatment to recognise this, but the voice of the methadone consumer has generally been silenced. For instance, maintenance therapy is often justified and used as a form of social control, particularly for reducing crime by heroin users, while masquerading as a medical treatment. There should, of course, be multiple options for those dependent on opiates and having trouble with this dependence. One option is oral methadone and others could include injectable heroin and buprenorphine. Each needs careful, controlled scientific examination; this is extraordinarily difficult in the context of prohibition, which creates so many confounders (e.g., necessary involvement of the heroin user in a criminal milieu, enormously inflated cost of drugs on the black market and resulting peer pressure to participate in crime). Information from properly planned and conducted scientific research is desperately needed to underpin policy and treatment approaches; the ACT trial will clearly provide a very important piece of this information. It would enable us (as a society) to assess the best methods of delivering injectable heroin in cooperation, rather than in competition, with other substitution approaches. It is an unfortunate reality that the ACT researchers must operate within a prohibitionist framework. Although prohibition has been shown to be harmful,2 legalisation has not as yet been convincingly shown to be less harmful. This needs an incremental approach, an adducement of evidence until the balance of judgement is swayed from supporting prohibition to regulation. The ACT researchers must be in a bind about the cost of the trial. On the one hand, the trial and its results will be so intensely scrutinised that it must be, and be seen to be, totally credible scientifically. This is expensive and leads to the charge that one small trial, on one small aspect of our relationship with heroin, will expend an inordinate proportion of our drug research budget. The researchers have made it clear that funding for the trial must be "new" money, raising the question of the trial's viability in the current political climate. However, the potential returns are so great as to outweigh this objection -- few other areas of research are likely to return so much, especially by attracting a wider range of the heroin-dependent into treatment that is cheap in comparison with imprisonment. The issue of morality often underlies the arguments. Moral arguments have their place, but are meaningful only when based on accurate information. The morality that rejects a place for opiates in this society because they are dangerous, when the danger demonstrably comes more from their illegality than from the drugs themselves, is flawed. I have often pondered why it is heroin that we have demonised and suspect that such violent reactions must be extremely attractive to those waging the War on Drugs. The obverse of approaches considered to "condone" heroin use are those which make it as dangerous as possible. It is a strange morality which argues for so many deaths to prevent the use of a substance that is relatively harmless under controlled conditions -- a morality that has given us enormous epidemics of HIV infection among children of heroin users in the United States and elsewhere. This is a morality which I suspect most people would not support without the intense social conditioning of the War on Drugs. The proposed trial would not provide all the information about heroin that is needed as a basis for public policy. It cannot, and should not, tackle holistic questions about the "best" (least harmful, most beneficial) relationship between heroin and society. Answering these questions needs data on more than the medical aspects of the relationship. However, this trial will provide some key data; what more should be required from a single study? References McCoy A. A historical review of opium and heroin production. Washington DC: Office of Special Technology, US Department of Defence, 1994. Wodak A, Owens R. Drug prohibition: a call for change. Sydney: UNSW Press, 1996. Authors' details Epidemiology and Social Research, Macfarlane Burnet Centre for Medical Research, Melbourne, VIC. Nick Crofts, MB BS, MPH, FAFPHM, Head. No reprints will be available from the author. Correspondence: Dr N Crofts, Epidemiology and Social Research, Macfarlane Burnet Centre for Medical Research, PO Box 254, Fairfield, VIC 3078.

Nick Crofts