Injection drug users (IDUs) frequently suffer from somatic and mental co-morbidity. The effects of different opioid maintenance protocols on these parameters have not been systematically studied yet.

This study was conducted as a 12-month open-label multi-centre randomised controlled trial to test a heroin- vs. methadone based protocol.

515 patients were randomised to the heroin-assisted and 500 to the methadone-assisted treatment program. Baseline scores were as follows: OTI-HSS 19.0 (±5.2), BMI 22.6 (±3.5), pathologic electro-/echocardiogram 20.4% (n=582) / 13.9% (n=491), positive HBV-, HCV- and HIV-serology 65.7% (n=863) / 86.5% (n=855) / 9.2% (n=951), positive tuberculin test 9.1% (n=318), KPS 71.4 (±12.9), Global Severity Index (GSI; SCL-90-R) 69.2 (±10.6), GAF 53.6 (±11.7) (all parameters not significant between treatment groups). Improvement after 12 months of treatment differed significantly between treatment groups (heroin vs. methadone): OTI-HSS 8.1 (±5.2) vs. 10.6 (±6.4), BMI 24.5 (±4.3) vs. 23.7 (±4.1), KPS 78.2 (±12.8) vs. 74.2 (±13.3), GSI 58.6 (±13.7) vs. 62.0 (±13.2), GAF 63.0 (±13.3) vs. 56.2 (±15.0) (ANOVA, all p=.000). The frequency of pathologic echocardiograms after 12 months was significantly lower in the heroin compared to the methadone group. Within the heroin group, completers benefited stronger than drop-outs. The remaining parameters did not differ between baseline and 12 months and between treatment groups.

Integration of severe injection drug users either in methadone or heroin assisted maintenance treatment has positive effects on most change sensitive physical and mental variables. In this patient group heroin assisted treatment showed superior results compared to methadone.