PMID- 21489005 OWN - NLM STAT- MEDLINE DCOM- 20111027 LR - 20131121 IS - 1360-0443 (Electronic) IS - 0965-2140 (Linking) VI - 106 IP - 9 DP - 2011 Sep TI - Physical and mental health in severe opioid-dependent patients within a randomized controlled maintenance treatment trial. PG - 1647-55 LID - 10.1111/j.1360-0443.2011.03463.x [doi] AB - 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 (chi(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. CI - (c) 2011 The Authors, Addiction (c) 2011 Society for the Study of Addiction. FAU - Reimer, Jens AU - Reimer J AD - Centre for Interdisciplinary Addiction Research, University of Hamburg, Hamburg, Germany. reimer@uke.de FAU - Verthein, Uwe AU - Verthein U FAU - Karow, Anne AU - Karow A FAU - Schafer, Ingo AU - Schafer I FAU - Naber, Dieter AU - Naber D FAU - Haasen, Christian AU - Haasen C LA - eng PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20110722 PL - England TA - Addiction JT - Addiction (Abingdon, England) JID - 9304118 RN - 0 (Analgesics, Opioid) RN - 70D95007SX (Heroin) RN - UC6VBE7V1Z (Methadone) SB - IM CIN - Addiction. 2011 Sep;106(9):1656-7. PMID: 21815927 MH - Adult MH - Analgesics, Opioid/adverse effects/*therapeutic use MH - Analysis of Variance MH - Body Mass Index MH - Echocardiography MH - Electrocardiography MH - Female MH - Germany MH - Health Status MH - Health Status Indicators MH - Heroin/adverse effects/therapeutic use MH - Humans MH - Male MH - Mental Health/*statistics & numerical data MH - Methadone/adverse effects/therapeutic use MH - Opiate Substitution Treatment/adverse effects/*methods MH - Opioid-Related Disorders/epidemiology/psychology/*rehabilitation MH - Quality of Life/psychology MH - Serologic Tests MH - Severity of Illness Index MH - Substance Abuse Treatment Centers MH - Substance Abuse, Intravenous/epidemiology/psychology/*rehabilitation MH - Treatment Outcome MH - Young Adult EDAT- 2011/04/15 06:00 MHDA- 2011/10/28 06:00 CRDT- 2011/04/15 06:00 PHST- 2011/04/15 06:00 [entrez] PHST- 2011/04/15 06:00 [pubmed] PHST- 2011/10/28 06:00 [medline] AID - 10.1111/j.1360-0443.2011.03463.x [doi] PST - ppublish SO - Addiction. 2011 Sep;106(9):1647-55. doi: 10.1111/j.1360-0443.2011.03463.x. Epub 2011 Jul 22.