PMID- 25064422 OWN - NLM STAT- MEDLINE DCOM- 20150421 LR - 20151214 IS - 1873-6483 (Electronic) IS - 0740-5472 (Linking) VI - 47 IP - 4 DP - 2014 Oct TI - Safety and tolerability of slow-release oral morphine versus methadone in the treatment of opioid dependence. PG - 275-81 LID - S0740-5472(14)00094-4 [pii] LID - 10.1016/j.jsat.2014.05.012 [doi] AB - Opioid substitution treatment (OST) for opioid dependence may be limited by adverse events (AEs). Increasing the range of therapeutic options optimizes outcomes and facilitates patient management. An international, multi-center, two-phase study investigated the efficacy and safety of slow-release oral morphine (SROM) versus methadone in patients receiving methadone therapy for opioid dependence. In phase 1 (two way cross-over, 11 weeks each period) patients were randomized to SROM or methadone oral solution. In phase 2 (25 weeks), patients continued treatment with SROM (group A) or switched from methadone to SROM (group B). In total, 211 out of 276 completed phase 1 and 198 entered phase 2 (n=95 group A, n=103 group B). Treatment with both SROM and methadone was well tolerated. However, the mean QTc-interval associated with methadone was significantly longer than that under SROM. Higher treatment satisfaction, fewer cravings for heroin, and lower mental stress were reported with SROM. This study adds a significant further weight of evidence that SROM is an effective and well tolerated long-term maintenance treatment for opioid dependence with a beneficial risk profile compared to methadone regarding cardiac effects and supports its clinical utility. CI - Copyright (c) 2014 Elsevier Inc. All rights reserved. FAU - Hammig, Robert AU - Hammig R AD - Universitare Psychiatrische Dienste Bern, CH-3010 Bern, Switzerland. Electronic address: haemmig@spk.unibe.ch. FAU - Kohler, Wilfried AU - Kohler W AD - Burgerhospital, D-60316 Frankfurt am Main, Germany. FAU - Bonorden-Kleij, Karin AU - Bonorden-Kleij K AD - Asklepios Klinik Nord Ochsenzoll, D-22765 Hamburg, Germany. FAU - Weber, Bernd AU - Weber B AD - Private practice, D-34117 Kassel, Germany. FAU - Lebentrau, Karin AU - Lebentrau K AD - Private practice, D-80331 Munich, Germany. FAU - Berthel, Toni AU - Berthel T AD - Integrierte Psychiatrie Winterthur, CH-8408 Winterthur, Switzerland. FAU - Babic-Hohnjec, Lucija AU - Babic-Hohnjec L AD - Integrierte Psychiatrie Winterthur, CH-8408 Winterthur, Switzerland. FAU - Vollmert, Christian AU - Vollmert C AD - Zentralinstitut fur Seelische Gesundheit, D-68159 Mannheim, Germany. FAU - Hopner, Doris AU - Hopner D AD - Private practice, D-13357 Berlin, Germany. FAU - Gholami, Najibulah AU - Gholami N AD - Psychiatric University Hospital of Zurich, Clinic of Social and General Psychiatry, Research Group on Substance Use Disorders, Switzerland; Arud, Centres for Addiction Medicine, Zurich, Switzerland. FAU - Verthein, Uwe AU - Verthein U AD - Zentrum fur Interdisziplinare Suchtforschung, Universitat Hamburg, D-20246 Hamburg, Germany. FAU - Haasen, Christian AU - Haasen C AD - Zentrum fur Interdisziplinare Suchtforschung, Universitat Hamburg, D-20246 Hamburg, Germany. FAU - Reimer, Jens AU - Reimer J AD - Zentrum fur Interdisziplinare Suchtforschung, Universitat Hamburg, D-20246 Hamburg, Germany. FAU - Ruckes, Christian AU - Ruckes C AD - Interdisciplinary Centre for Clinical Trials (IZKS), University Medical Centre of the Johannes Gutenberg University of Mainz, D-55131 Mainz, Germany. LA - eng SI - ClinicalTrials.gov/NCT01079117 SI - EudraCT/2008-002185-60 PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20140610 PL - United States TA - J Subst Abuse Treat JT - Journal of substance abuse treatment JID - 8500909 RN - 0 (Delayed-Action Preparations) RN - 76I7G6D29C (Morphine) RN - UC6VBE7V1Z (Methadone) SB - IM MH - Administration, Oral MH - Adult MH - Cross-Over Studies MH - Delayed-Action Preparations MH - Europe MH - Female MH - Humans MH - International Cooperation MH - Male MH - Methadone/administration & dosage/adverse effects/*therapeutic use MH - Morphine/administration & dosage/adverse effects/*therapeutic use MH - *Opiate Substitution Treatment MH - Opioid-Related Disorders/*drug therapy MH - Treatment Outcome OTO - NOTNLM OT - Opioid dependence OT - Opioid substitution treatment OT - QTc-interval OT - Safety OT - Slow-release oral morphine EDAT- 2014/07/30 06:00 MHDA- 2015/04/22 06:00 CRDT- 2014/07/28 06:00 PHST- 2014/02/16 00:00 [received] PHST- 2014/05/13 00:00 [revised] PHST- 2014/05/26 00:00 [accepted] PHST- 2014/07/28 06:00 [entrez] PHST- 2014/07/30 06:00 [pubmed] PHST- 2015/04/22 06:00 [medline] AID - S0740-5472(14)00094-4 [pii] AID - 10.1016/j.jsat.2014.05.012 [doi] PST - ppublish SO - J Subst Abuse Treat. 2014 Oct;47(4):275-81. doi: 10.1016/j.jsat.2014.05.012. Epub 2014 Jun 10.