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1.7 Rationale for the study

The review of the available information regarding the results of methadone maintenance treatment in the Netherlands indicates that, although heroin addicts have a wide range of treatment modalities at their disposal and the treatment provided is adequate for a large number of addicts, there is also a considerable number of addicts for whom stabilization or improvement is difficult or impossible, despite intensive participation in methadone maintenance and/or other treatment. From a total of 24,000 heroin addicts in the Netherlands, it was estimated that approximately 8,000 addicts fall into this category (Driessen, 1990).
To meet the treatment needs of these addicts, for whom previous treatment has not yielded sufficient results, supplementary types of treatment are needed. On a limited scale, experiments have been conducted with injectable morphine, injectable methadone and oral Palfium, but these interventions lacked a scientific evaluation, and produced inconsistent results (morphine) or were aimed at palliation (injectable methadone and Palfium). Another option which has been under consideration is the prescription of increased dose levels of oral methadone, but since heroin addicts in the Netherlands generally reject high methadone dosages (Korf et al., 1998), this approach holds the risk of low compliance. To investigate the effects of such an approach, a randomized study is currently being conducted in the Netherlands into the effectiveness of medically prescribed oral methadone in dose levels of at least 80 mg a day in chronic, treatment-resistant heroin addicts (Driessen, 2000), the results of which are expected to be available in the year 2002. Prior to the start of the current study, there have been no experiences with the medical prescription of heroin to heroin addicts in the Netherlands.

Nearly all of the experience with the prescription of heroin stems from the United Kingdom and Switzerland. In the United Kingdom, however, the randomized trial by Hartnoll and his colleagues involved a small number of participants, who were quite young (mean age of 24 years), had a short addiction career (average of six years), and who all injected their heroin. In addition, the study was conducted in the early 1970's, when the heroin epidemic was at a much earlier stage, and methadone maintenance treatment was a new type of treatment. In the following decades and up till recently, only a small proportion of the heroin users in the United Kingdom received heroin maintenance treatment. In addition, the results of these treatments have been poorly documented, and no systematic scientific evaluation has taken place. The Swiss experiment has indicated that medical prescription of heroin is feasible and potentially effective in highly dysfunctional opiate addicts, but questions remain with regard to the causal attribution of the improvements, the relative contributions of the heroin component and the psychosocial component to the results of the combined treatment, and the effectiveness of medical treatment with inhalable heroin.

Given the existence of a sizeable group of heroin addicts in the Netherlands whose treatment needs are insufficiently met, and against the background of the positive experiences obtained in Switzerland, the medical prescription of heroin to treatment-resistant heroin addicts merits further investigation in a randomized controlled study. Starting points of this study are the utilization of randomized group assignment and subsequent comparison of patients in oral methadone maintenance treatment with similar patients in oral methadone and co-prescribed heroin treatment, who receive a similar offer of psychosocial counseling and support in both treatment conditions. In addition, given the predominance of heroin inhalation among Dutch heroin addicts, a new effort should be made to study the effectiveness of the medical prescription of inhalable heroin to non-injecting heroin addicts. Finally, it is important to note that neither in the United Kingdom, nor in Switzerland, nor in the sparse literature on treatment with heroin in earlier years, any indications have been found that the prescription of heroin to heroin addicts on a medical basis would harm those involved to such an extent that an experiment with this type of treatment would be ethically unacceptable.