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||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:
The first step would be to conduct two six-month pilot studies in the
First pilot study: This would involve 40 participants who meet the following eligibility criteria:
To warrant moving to the second pilot study, the first would have to show that:
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:
Full-scale clinical trial
This would involve:|
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 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.
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.
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