Background Heroin-assisted treatment has been found to be effective for people with severe opioid dependence who are not interested in or do poorly on methadone maintenance.

Aims To study heroin-assisted treatment in people on methadone who continue intravenous heroin and in those who are heroin dependent but currently not in treatment.

Method In an open-label multicentre randomised controlled trial, 1015 people with heroin dependence received a variable dose of injectable heroin (n=515) or oral methadone (n=500) for 12 months. Two response criteria, improvement of physical and/or mental health and decrease in illicit drug use, were evaluated in an intent-to-treat analysis.

Results Retention was higher in the heroin (67.2%) than in the methadone group (40.0%) and the heroin group showed a significantly greater response on both primary outcome measures. More serious adverse events were found in the heroin group, and were mainly associated with intravenous use.

Conclusions Heroin-assisted treatment is more effective for people with opioid dependence who continue intravenous heroin while on methadone maintenance or who are not enrolled in treatment. Despite a higher risk, it should be considered for treatment resistance under medical supervision.

INTRODUCTION
Germany has an estimated 150 000 people with opioid dependence, mainly heroin dependence, among a population of 80 million (Bu"hringer et al, 1997). Less than half (50 000–60 000) at any given time are on opioid maintenance treatment. None the less, the mortality rate only decreased slightly after the widespread introduction of maintenance treatment in the early 1990s (Raschke et al, 2000), which is in accordance with other long-term follow-up studies (Rathod et al, 2005). This opened the discussion for modification of maintenance treatment, especially for people who either dropped out or who continued treatment but also illicit opioid use.

A large (n=1969) cohort study was initiated in Switzerland in 1994, and ascertained the feasibility, safety and potential efficacy of offering injectable heroin to people with dependence who were not responding sufficiently to maintenance treatment (Rehm et al, 2001). The study showed a high retention rate (70% after 12 months) as well as positive effects with respect to illegal drug use, physical and mental health and social outcomes. However, assessment of the Swiss trial by the World Health Organization was unable to determine if the positive effects were a result of the prescription of heroin, the extensive psychosocial counselling and care, or the combination of both (Ali et al, 1999). A small randomised controlled trial (n=51) comparing injectable heroin with a standard treatment (mainly methadone maintenance) showed significantly better functioning in those receiving heroin after 6 months (Perneger et al, 1998). However, those people also received additional, mandatory psychosocial care, which may have influenced the results.

In 1998 two randomised controlled trials in The Netherlands assessed the effectiveness of the co-prescription of inhalable (n=375) and injectable (n=174) heroin in people with opioid dependence and chronic resistance to methadone treatment. Results showed that heroin-assisted treatment was feasible, more effective and probably as safe as methadone alone in reducing physical, mental and social problems (van den Brink et al, 2003; Blanken et al, 2005). Co-prescription of heroin was cost-effective compared with methadone treatment alone (Dijkgraaf et al, 2005). A limitation of these trials was that psychosocial treatments were not standardised and were uncontrolled. Furthermore, the larger of the two trials used inhalable heroin, which is used by the majority (75–90%) of street heroin users in The Netherlands, but not in Germany.

A recent Cochrane review (Ferri et al, 2005) found that the Swiss and Dutch studies do not allow a definite conclusion to be drawn about the overall effectiveness of heroin prescription because of a lack of comparability. We therefore examined the effectiveness of medically prescribed and supervised heroin injection in an open-label randomised controlled trial in two groups of people with heroin dependence: those not responding sufficiently to methadone maintenance treatment and those currently not in substance misuse treatment. To control for the impact of psychosocial treatment, participants in each group were randomised to one of two types of psychosocial care.

Christian Haasen, MD, Uwe Verthein, PhD and Peter Degkwitz, PhD
Centre for Interdisciplinary Addiction Research, University Medical Centre Eppendorf, Hamburg

Juergen Berger, PhD
Institute for Medical Biometrics and Epidemiology, University Medical Centre Eppendorf, Hamburg

Michael Krausz, MD and Dieter Naber, MD
Centre for Interdisciplinary Addiction Research, University Medical Centre, Eppendorf, Hamburg, Germany

Correspondence: Dr Christian Haasen, Centre for Interdisciplinary Addiction Research, Department of Psychiatry, University Medical Centre Eppendorf, Martinistrasse 52, 20246 Hamburg, Germany. Email: .(JavaScript must be enabled to view this email address)

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