title: Safety and tolerability of slow-release oral morphine versus methadone in the treatment of opioid dependence.
abstract: 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.
authors: Universitäre Psychiatrische Dienste Bern, CH-3010 Bern, Switzerland. Electronic address: haemmig@spk.unibe.ch.
authors: Robert
authors: R
authors: Hämmig
authors: Bürgerhospital, D-60316 Frankfurt am Main, Germany.
authors: Wilfried
authors: W
authors: Köhler
authors: Asklepios Klinik Nord Ochsenzoll, D-22765 Hamburg, Germany.
authors: Karin
authors: K
authors: Bonorden-Kleij
authors: Private practice, D-34117 Kassel, Germany.
authors: Bernd
authors: B
authors: Weber
authors: Private practice, D-80331 Munich, Germany.
authors: Karin
authors: K
authors: Lebentrau
authors: Integrierte Psychiatrie Winterthur, CH-8408 Winterthur, Switzerland.
authors: Toni
authors: T
authors: Berthel
authors: Integrierte Psychiatrie Winterthur, CH-8408 Winterthur, Switzerland.
authors: Lucija
authors: L
authors: Babic-Hohnjec
authors: Zentralinstitut für Seelische Gesundheit, D-68159 Mannheim, Germany.
authors: Christian
authors: C
authors: Vollmert
authors: Private practice, D-13357 Berlin, Germany.
authors: Doris
authors: D
authors: Höpner
authors: 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.
authors: Najibulah
authors: N
authors: Gholami
authors: Zentrum für Interdisziplinäre Suchtforschung, Universität Hamburg, D-20246 Hamburg, Germany.
authors: Uwe
authors: U
authors: Verthein
authors: Zentrum für Interdisziplinäre Suchtforschung, Universität Hamburg, D-20246 Hamburg, Germany.
authors: Christian
authors: C
authors: Haasen
authors: Zentrum für Interdisziplinäre Suchtforschung, Universität Hamburg, D-20246 Hamburg, Germany.
authors: Jens
authors: J
authors: Reimer
authors: Interdisciplinary Centre for Clinical Trials (IZKS), University Medical Centre of the Johannes Gutenberg University of Mainz, D-55131 Mainz, Germany.
authors: Christian
authors: C
authors: Ruckes
mesh_terms: D000284:Administration, Oral; D000328:Adult; D018592:Cross-Over Studies; D003692:Delayed-Action Preparations; D005060:Europe; D005260:Female; D006801:Humans; D007391:International Cooperation; D008297:Male; D008691:Methadone / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D009020:Morphine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D058850:Opiate Substitution Treatment; D009293:Opioid-Related Disorders / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D003692:Delayed-Action Preparations; D009020:Morphine; D008691:Methadone
keywords: Opioid dependence; Opioid substitution treatment; QTc-interval; Safety; Slow-release oral morphine