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Heroin-assisted treatment for opioid dependence: Randomised controlled trial

  • Christian Haasen (a1), Uwe Verthein (a1), Peter Degkwitz (a1), Juergen Berger (a2), Michael Krausz (a3) and Dieter Naber (a3)...
Abstract
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.

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Copyright
Corresponding author
Dr Christian Haasen, Centre for Interdisciplinary Addiction Research, Department of Psychiatry, University Medical Centre Eppendorf, Martinistrasse 52, 20246 Hamburg, Germany. Email: haasen@uke.uni-hamburg.de
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Declaration of interest

None. Funding detailed in Acknowledgements.

Footnotes
References
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Heroin-assisted treatment for opioid dependence: Randomised controlled trial

  • Christian Haasen (a1), Uwe Verthein (a1), Peter Degkwitz (a1), Juergen Berger (a2), Michael Krausz (a3) and Dieter Naber (a3)...
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eLetters

Response to letter �Important findings for heroin treatment but treatment retention not one of them"

Christian Haasen, psychiatrist
07 September 2007

Dr. Al-Adwani raises an important issue in evaluating the outcome of maintenance treatment, namely how to evaluate the retention rate in an unblinded trial. The special incentive for patients randomised into methadone treatment was the option to switch into the heroin group after completing one year of treatment. Considering the fact that retention is considered one of the main outcome measures for maintenance treatment, ourtrial shows that heroin-assisted treatment (HAT) has two advantages, namely that it reaches a higher number of potential patients (% initiatingtreatment) and that the retention rate of those initiating treatment also is significantly higher for HAT (68.3 vs. 56.3%; LogRank=14.1, p<0.001). Therefore, it is incorrect to say that “retention rates wouldpossibly differ insignificantly”: the difference is certainly less, but still significant. ... More

Conflict of interest: None Declared

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Important findings for heroin treatment but treatment retention not one of them

Andrew Al-Adwani, Consultant Psychiatrist
05 July 2007

Haasen et al (2007) report highly significant findings in their trialof heroin plus methadone maintenance. A small problem is that the heroinplus methadone group were, to a large extent, self-selected with only 2.3%failing to initiate treatment in this group versus 28.8% in the methadone only arms. They state that this “limiting effect is minimised” by randomisation and intention to treat (ITT) analysis. ITT makes their already significant findings even more impressive but randomisation is limited by the unavoidable self-selection in a necessarily unblinded trial. The paper goes on to say “retention was higher in the heroin group, with 67.2% completing the 12 month treatment compared with 40% of the methadone group”, but later this is given as 56.3% for the methadone only group when the 28.8% who did not initiate treatment were excluded. The retention rate would rise again if the dropout (“discontinued”) rate was calculated using the same reduced denominator and therefore retention rates would possibly differ insignificantly. Taking this into consideration would also explain the almost equal numbers of discontinued subjects in the two main arms of the trial.

The findings of this aspect of the trial are not surprising and without doubt it would be difficult to devise a control with the reinforcing power of heroin. Injectable methadone, financial incentives or pleasurable activities might approximate a substitute and produce more accurate retention figures. With the high cost of freeze-dried heroin, asused in the UK, adding these incentives might attract funding for a suitably modified study conducted here. Given that high retention rates are today’s centrally defined most desirable outcome in the UK, this sort of study might be even more attractive within these shores.

Christian Haasen, Uwe Verthein, Peter Degkwitz, Juergen Berger, Michael Krausz, and Dieter Naber (2007) Heroin-assisted treatment for opioid dependence: Randomised controlled trial. British Journal of Psychiatry, 191, 55-62.
... More

Conflict of interest: None Declared

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