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J Subst Abuse Treat. 2014 Oct;47(4):275-81. doi: 10.1016/j.jsat.2014.05.012. Epub 2014 Jun 10.

Safety and tolerability of slow-release oral morphine versus methadone in the treatment of opioid dependence.

Author information

1
Universitäre Psychiatrische Dienste Bern, CH-3010 Bern, Switzerland. Electronic address: haemmig@spk.unibe.ch.
2
Bürgerhospital, D-60316 Frankfurt am Main, Germany.
3
Asklepios Klinik Nord Ochsenzoll, D-22765 Hamburg, Germany.
4
Private practice, D-34117 Kassel, Germany.
5
Private practice, D-80331 Munich, Germany.
6
Integrierte Psychiatrie Winterthur, CH-8408 Winterthur, Switzerland.
7
Zentralinstitut für Seelische Gesundheit, D-68159 Mannheim, Germany.
8
Private practice, D-13357 Berlin, Germany.
9
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.
10
Zentrum für Interdisziplinäre Suchtforschung, Universität Hamburg, D-20246 Hamburg, Germany.
11
Interdisciplinary Centre for Clinical Trials (IZKS), University Medical Centre of the Johannes Gutenberg University of Mainz, D-55131 Mainz, Germany.

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.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT01079117.

KEYWORDS:

Opioid dependence; Opioid substitution treatment; QTc-interval; Safety; Slow-release oral morphine

PMID:
25064422
DOI:
10.1016/j.jsat.2014.05.012
[Indexed for MEDLINE]

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