PMID- 34134867 OWN - NLM STAT- MEDLINE DCOM- 20210805 LR - 20210805 IS - 1873-6483 (Electronic) IS - 0740-5472 (Linking) VI - 127 DP - 2021 Aug TI - Substitution treatment for opioid dependence with slow-release oral morphine: Retention rate, health status, and substance use after switching to morphine. PG - 108350 LID - S0740-5472(21)00076-3 [pii] LID - 10.1016/j.jsat.2021.108350 [doi] AB - INTRODUCTION: Since April 2015, slow-release oral morphine (SROM) has been approved for opioid agonist treatment (OAT) in Germany. Experimental studies show that benefits of SROM over methadone include less heroin craving, better tolerability, and higher patient satisfaction and mental stability. The SROMOS study (Efficacy and Tolerability of Slow-Release Oral Morphine in Opioid Substitution Treatment) aims to investigate the long-term effects (effectiveness and safety) of morphine substitution under routine care in Germany. MATERIAL AND METHODS: This is a prospective, noninterventional, naturalistic, observational study. Between July 2016 and November 2017, this study recruited patients in OAT who decided to switch to SROM from 23 outpatient addiction treatment centers in Germany. The study collected data on mental health (Brief Symptom Inventory - BSI-18), substance use, somatic health (Opiate Treatment Index Health-Symptoms-Scale - OTI-HSS), opioid craving (visual analogue scale), and withdrawal symptoms (Short Opiate Withdrawal Scale) at baseline (t0) and after 3 (t3), 6 (t6) and 12 (t12) months. Physicians documented side effects as adverse events (AEs) and adverse drug reactions (ADRs). RESULTS: Three-quarters of the enrolled study participants (N = 180) were male. The average age was 44.4 years. Patients were opioid-dependent for 23 years and had been in OAT for almost seven years on average. After 12 months, 60.6% were still being treated with SROM. Mental health improved significantly under SROM treatment between t0 and t12. The intention-to-treat (ITT), as well as the per-protocol (PP) analysis, shows a statistically significant improvement of the mean Global Severity Index (GSI) of the BSI-18 value of 20% (ITT) and 24% (PP). Physical health also improved significantly under SROM treatment. There were no statistically significant changes in the use of cannabis, cocaine, amphetamines, and tranquillizers in the past 30 days, but heroin use, intravenous consumption, and the number of drinking days significantly decreased. CONCLUSIONS: This study provides some of the first long-term data on OAT with SROM under routine care conditions. SROM treatment is an effective alternative for a subgroup of opioid-dependent patients with an unsatisfactory course of OAT or in cases where undesirable side effects due to alternative substances have occurred. ETHICAL STATEMENT: The study protocol was approved by the Ethics Committee of the Chamber of Physicians in Hamburg in March 2016 (No. PV5222). The study was conducted by following the Declaration of Helsinki and is registered with the German Register of Clinical Trials (DRKS, ID: DRKS00010712). CI - Copyright (c) 2021 Elsevier Inc. All rights reserved. FAU - Lehmann, Kirsten AU - Lehmann K AD - Centre for Interdisciplinary Addiction Research of Hamburg University (CIAR), University Medical Center Hamburg-Eppendorf, Department of Psychiatry and Psychotherapy, Martinistr. 52, 20246 Hamburg, Germany. Electronic address: k.lehmann@uke.de. FAU - Kuhn, Silke AU - Kuhn S AD - Centre for Interdisciplinary Addiction Research of Hamburg University (CIAR), University Medical Center Hamburg-Eppendorf, Department of Psychiatry and Psychotherapy, Martinistr. 52, 20246 Hamburg, Germany. Electronic address: skuhn@uke.de. FAU - Baschirotto, Cinzia AU - Baschirotto C AD - University of Florence, Department of Psychiatry, AOU Careggi, Largo Brambilla, 3, 50134 Florence, Italy. Electronic address: cinziabaschirotto@hotmail.com. FAU - Jacobsen, Britta AU - Jacobsen B AD - Centre for Interdisciplinary Addiction Research of Hamburg University (CIAR), University Medical Center Hamburg-Eppendorf, Department of Psychiatry and Psychotherapy, Martinistr. 52, 20246 Hamburg, Germany. Electronic address: jacobsen@zis-hamburg.de. FAU - Walcher, Stephan AU - Walcher S AD - CONCEPT, Addiction Medicine Munich, Kaiserstrasse 1, 80801 Munich, Germany. Electronic address: kontakt@moviemed.de. FAU - Gorne, Herbert AU - Gorne H AD - MediZentrum Hamburg, Rahlstedter Str. 29, 22149 Hamburg, Germany. Electronic address: goerne@medizentrum-hamburg.net. FAU - Backmund, Markus AU - Backmund M AD - Ludwig-Maximilians-University and Praxiszentrum im Tal, Tal 9, 80331 Munich, Germany. Electronic address: markus.backmund@p-i-t.info. FAU - Scherbaum, Norbert AU - Scherbaum N AD - LVR-Hospital Essen, University of Duisburg-Essen, Department of Psychiatry and Psychotherapy, Virchowstrasse 174, 45147 Essen, Germany. Electronic address: norbert.scherbaum@uni-due.de. FAU - Reimer, Jens AU - Reimer J AD - Centre for Interdisciplinary Addiction Research of Hamburg University (CIAR), University Medical Center Hamburg-Eppendorf, Department of Psychiatry and Psychotherapy, Martinistr. 52, 20246 Hamburg, Germany. Electronic address: reimer@uke.de. FAU - Verthein, Uwe AU - Verthein U AD - Centre for Interdisciplinary Addiction Research of Hamburg University (CIAR), University Medical Center Hamburg-Eppendorf, Department of Psychiatry and Psychotherapy, Martinistr. 52, 20246 Hamburg, Germany. Electronic address: u.verthein@uke.uni-hamburg.de. LA - eng SI - DRKS/DRKS00010712 PT - Journal Article PT - Observational Study PT - Research Support, Non-U.S. Gov't DEP - 20210304 PL - United States TA - J Subst Abuse Treat JT - Journal of substance abuse treatment JID - 8500909 RN - 0 (Analgesics, Opioid) RN - 0 (Delayed-Action Preparations) RN - 0 (Narcotics) RN - 76I7G6D29C (Morphine) RN - UC6VBE7V1Z (Methadone) SB - IM MH - Adult MH - Analgesics, Opioid/adverse effects MH - Delayed-Action Preparations/therapeutic use MH - Germany MH - Health Status MH - Humans MH - Male MH - Methadone/therapeutic use MH - *Morphine/adverse effects MH - Narcotics/therapeutic use MH - Opiate Substitution Treatment MH - *Opioid-Related Disorders/drug therapy MH - Prospective Studies MH - Treatment Outcome OTO - NOTNLM OT - Mental health OT - Opioid agonist treatment OT - Opioid dependence OT - SROM OT - Slow-release oral morphine OT - Treatment retention EDAT- 2021/06/18 06:00 MHDA- 2021/08/06 06:00 CRDT- 2021/06/17 05:48 PHST- 2020/09/24 00:00 [received] PHST- 2020/12/16 00:00 [revised] PHST- 2021/03/01 00:00 [accepted] PHST- 2021/06/17 05:48 [entrez] PHST- 2021/06/18 06:00 [pubmed] PHST- 2021/08/06 06:00 [medline] AID - S0740-5472(21)00076-3 [pii] AID - 10.1016/j.jsat.2021.108350 [doi] PST - ppublish SO - J Subst Abuse Treat. 2021 Aug;127:108350. doi: 10.1016/j.jsat.2021.108350. Epub 2021 Mar 4.