title: Physical and mental health in severe opioid-dependent patients within a randomized controlled maintenance treatment trial.
abstract: OBJECTIVE
  To evaluate physical and mental health and compare treatment outcomes in opiate-dependent patients substituted either with heroin or methadone.
  
  
  METHODS
  Twelve-month open-label randomized controlled trial.
  
  
  METHODS
  Out-patient substitution clinics in seven German cities.
  
  
  METHODS
  A total of 1015 opiate-dependent individuals.
  
  
  METHODS
  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).
  
  
  RESULTS
  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.
authors.affiliation: Centre for Interdisciplinary Addiction Research, University of Hamburg, Hamburg, Germany. reimer@uke.de
authors.forename: Jens
authors.initials: J
authors.lastname: Reimer
authors.forename: Uwe
authors.initials: U
authors.lastname: Verthein
authors.forename: Anne
authors.initials: A
authors.lastname: Karow
authors.forename: Ingo
authors.initials: I
authors.lastname: Schäfer
authors.forename: Dieter
authors.initials: D
authors.lastname: Naber
authors.forename: Christian
authors.initials: C
authors.lastname: Haasen
mesh_terms: D000328:Adult; D000701:Analgesics, Opioid / Q000009:adverse effects / Q000627:therapeutic use*; D000704:Analysis of Variance; D015992:Body Mass Index; D004452:Echocardiography; D004562:Electrocardiography; D005260:Female; D005858:Germany; D006304:Health Status; D006305:Health Status Indicators; D003932:Heroin / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008603:Mental Health / Q000706:statistics & numerical data*; D008691:Methadone / Q000009:adverse effects / Q000627:therapeutic use; D058850:Opiate Substitution Treatment / Q000009:adverse effects / Q000379:methods*; D009293:Opioid-Related Disorders / Q000453:epidemiology / Q000523:psychology / Q000534:rehabilitation*; D011788:Quality of Life / Q000523:psychology; D012698:Serologic Tests; D012720:Severity of Illness Index; D016320:Substance Abuse Treatment Centers; D015819:Substance Abuse, Intravenous / Q000453:epidemiology / Q000523:psychology / Q000534:rehabilitation*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000701:Analgesics, Opioid; D003932:Heroin; D008691:Methadone