Matching of treatment-resistant heroin-dependent patients to medical prescription of heroin or oral methadone treatment: Results from two randomized controlled trials

Abstract

Aims: To investigate which baseline patient characteristics of treatment-resistant heroin addicts differentially predicted treatment response to medical heroin prescription compared to standard methadone maintenance treatment. Design: Two open-label randomized controlled trials; pooled data. Setting: Methadone maintenance programmes and heroin treatment centres in six cities in the Netherlands. Participants: Four hundred and thirty heroin addicts. Intervention: Methadone plus injectable heroin or methadone plus inhalable heroin compared to methadone alone prescribed over 12 months: heroin maximum 1000 mg per day, methadone maximum 150 mg per day. Main outcome measure: Dichotomous, multi-domain response index, including validated indicators of physical health, mental status and social functioning. Findings: Data of the inhalable and injectable heroin trials were pooled. Intention-to-treat analysis showed that treatment with medically prescribed heroin plus methadone was significantly more effective (51.8% response) than standard methadone maintenance treatment (28.7%) (95% CI of response difference: 14.1-32.2%). Multivariate logistic regression analyses showed that only one of all baseline characteristics was predictive of a differential treatment effect: patients who had previously participated in abstinence-orientated treatment responded significantly better to heroin-assisted treatment than to methadone treatment (61% versus 24%), while patients without experience in abstinence-orientated treatment did equally well in heroin-assisted or methadone maintenance treatment (39% and 38%, respectively). Conclusions: The effect of heroin-assisted treatment is not dependent on clinical characteristics, with the exception of previous abstinence-orientated treatment: medical prescription of heroin is most effective for those patients who have previously participated in abstinence-orientated treatment.