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Addiction. 2011 Sep;106(9):1647-55. doi: 10.1111/j.1360-0443.2011.03463.x. Epub 2011 Jul 22.

Physical and mental health in severe opioid-dependent patients within a randomized controlled maintenance treatment trial.

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Centre for Interdisciplinary Addiction Research, University of Hamburg, Hamburg, Germany.



To evaluate physical and mental health and compare treatment outcomes in opiate-dependent patients substituted either with heroin or methadone.


Twelve-month open-label randomized controlled trial.


Out-patient substitution clinics in seven German cities.


A total of 1015 opiate-dependent individuals.


Opiate Treatment Index-Health Scale Score (OTI), Body Mass Index (BMI), serology for infectious diseases such as hepatitis B, C and human immunodeficiency virus as well as tuberculosis, Karnofsky Performance Scale (KPS), electrocardiogram (ECG), echocardiogram, Symptom Checklist 90-R (SCL-90-R), Global Assessment of Functioning (GAF), Modular System for Quality of Life and study medication-related serious adverse events (SAE).


Improvements were found in both heroin and methadone substituted patients regarding OTI, BMI, KPS, SCL-90-R, and GAF, but they were more pronounced for the heroin group (analysis of variance, all P = 0.000). The frequency of pathological echocardiograms decreased in the heroin group and increased in the methadone group (χ(2) test, <0.05). Markers for infectious diseases and frequencies of pathological ECGs did not differ between baseline and 12 months, or between treatment groups. Study medication-related serious adverse events, all of which were treated successfully, occurred 2.5 times more often in the heroin group. The majority of heroin-related SAEs (41 of 58) occurred within a few minutes of the injections.


The integration of severe injection drug users either in methadone or heroin-assisted maintenance treatment has positive effects on most physical and mental change-sensitive variables, with heroin showing superior results. Due to medication-related adverse events, patients should be observed for 15 minutes after a heroin injection.

[Indexed for MEDLINE]

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