Substitution treatment for opioid dependence with slow-release oral morphine: Retention rate, health status, and substance use after switching to morphine

• Published in: Journal of substance abuse treatment Vol. 127; p. 108350
• Main Authors: Lehmann, Kirsten, Kuhn, Silke, Baschirotto, Cinzia, Jacobsen, Britta, Walcher, Stephan, Görne, Herbert, Backmund, Markus, Scherbaum, Norbert, Reimer, Jens, Verthein, Uwe
• Format: Journal Article
• Language: English
• Published: Elmsford Elsevier Inc 01-08-2021; Elsevier Limited
• Subjects: Addictions; Amphetamines; Clinical research; Clinical trials; Cocaine; Craving; Critical incidents; Drug addiction; Drug use; Drug withdrawal; Drugs; Efficacy; Ethics; Health status; Heroin; Long term; Marijuana; Medical treatment; Mental health; Methadone; Morphine; Narcotics; Opioid agonist treatment; Opioid dependence; Opioids; Outpatient treatment; Patient satisfaction; Physicians; Side effects; Slow-release oral morphine; SROM; Substance abuse; Substance abuse treatment; Treatment retention; Germany; Opioid dependence; Opioid agonist treatment; SROM; Treatment retention; Slow-release oral morphine; Mental health
• ISSN: 0740-5472; 1873-6483
• DOI: 10.1016/j.jsat.2021.108350

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.
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).
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.
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.
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).
•First long-term data on opioid agonist treatment with SROM in routine care•The retention rate was 61% after twelve months of medication with SROM.•Switching to SROM led to an improvement in mental and physical health.•Alcohol consumption decreased significantly during SROM treatment.•First data on successful switching from levomethadone and buprenorphine to SROM