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

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


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

Design: Twelve-month open-label randomized controlled trial.

Setting: Out-patient substitution clinics in seven German cities.

Participants: A total of 1015 opiate-dependent individuals.

Measurements: 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).

Findings: 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.

Conclusions: 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.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Analgesics, Opioid / adverse effects
  • Analgesics, Opioid / therapeutic use*
  • Analysis of Variance
  • Body Mass Index
  • Echocardiography
  • Electrocardiography
  • Female
  • Germany
  • Health Status
  • Health Status Indicators
  • Heroin / adverse effects
  • Heroin / therapeutic use
  • Humans
  • Male
  • Mental Health / statistics & numerical data*
  • Methadone / adverse effects
  • Methadone / therapeutic use
  • Opiate Substitution Treatment / adverse effects
  • Opiate Substitution Treatment / methods*
  • Opioid-Related Disorders / epidemiology
  • Opioid-Related Disorders / psychology
  • Opioid-Related Disorders / rehabilitation*
  • Quality of Life / psychology
  • Serologic Tests
  • Severity of Illness Index
  • Substance Abuse Treatment Centers
  • Substance Abuse, Intravenous / epidemiology
  • Substance Abuse, Intravenous / psychology
  • Substance Abuse, Intravenous / rehabilitation*
  • Treatment Outcome
  • Young Adult


  • Analgesics, Opioid
  • Heroin
  • Methadone