Switching opioid-dependent patients in substitution treatment from racemic methadone, levomethadone and buprenorphine to slow-release oral morphine: Analysis of the switching process in routine care

Since 2015 slow-release oral morphine (SROM) is approved for opioid substitution treatment (OST) in Germany. The SROMOS study (efficacy and tolerability of slow-release oral morphine in opioid substitution treatment) evaluates the efficacy and safety of SROM in routine care. This article describes the switching process from racemic methadone, levomethadone and buprenorphine to SROM.Between July 2016 and November 2017 180 patients in 23 study centers in Germany were included in the prospective, non-interventional, naturalistic observational study. Patients were already in OST and switched from a previous medication to SROM. The switching process was analyzed during a period of fourteen days.Data were available for 169 participants. The switching process had a different progression depending on premedication and pre dosage. On the fourteenth day of SROM treatment patients switched from racemic methadone took an average dosage of 922.2 mg/day, from levomethadone 801.0 mg/day and from buprenorphine 626.7 mg/day. Average conversion ratio racemic methadone to SROM was 1:11.8, levomethadone to SROM 1:17.4 and buprenorphine to SROM 1:58.0.This study provides the first data on the switching process from buprenorphine to SROM. Average dose ratio racemic methadone to SROM on the fourteenth day of treatment was considerably higher than recommended in the prescribing information

Is Heroin-Assisted Treatment Effective for Patients with No Previous Maintenance Treatment? Results from a German Randomised Controlled Trial

Background/Aims: Until now, the medical prescription of diamorphine (heroin) has been suggested as suitable for patients who have failed previous maintenance treatments. The aim of this paper is to assess the effects of diamorphine on opioid-dependent patients with no previous maintenance treatment experience (NPME). Methods: The German heroin trial compared diamorphine versus methadone maintenance treatment and included 107 patients with NPME. This paper is a sub-analysis of these patients. Results: When comparing this subsample with the rest of the participants in the study, large baseline differences were found, showing a more severe drug use profile in patients with NPME. However, no differences were found in terms of treatment outcome and treatment retention. In the subsample with NPME, outcome measures on the reduction of illicit drug use were significantly better under diamorphine compared to methadone treatment, while there was no difference in health outcomes. Conclusion: Controlled studies are now necessary to examine whether diamorphine treatment could be considered as one of several options in treating severely opioid-dependent patients, regardless of previous maintenance treatment experience

Effects of Psychiatric Comorbidity on Treatment Outcome in Patients Undergoing Diamorphine or Methadone Maintenance Treatment

Background: Comorbid psychiatric disorders among opioid-dependent patients are associated with several negative outcome factors. However, outcomes of maintenance treatment have not been sufficiently established, and no evidence is available with respect to heroin-assisted treatment (HAT). Methods: For patients in the German heroin trial outcome measures were analyzed for HAT versus methadone maintenance treatment (MMT) both for patients with and without a comorbid diagnosis according to CIDI. Results: 47.2% of the sample had at least one comorbid psychiatric diagnosis, mainly neurotic, stress-related or somatoform (F4) or affective (F3) disorders. HAT had a better outcome than MMT concerning improvement of health and reduction of illicit drug use in both comorbid and non-comorbid patients, but weaker effects were found in the comorbid group. Conclusions:The better outcome of HAT also in comorbid patients suggests that psychiatric comorbidity should be an inclusion criterion for HAT. The weaker advantage of HAT may be due to pharmacological or methodological reasons

Measuring quality of life in opioid dependent people : a systematic review of assessment instruments

Purpose Opioid dependence is a chronic relapsing disorder. Despite increasing research on quality of life (QOL) in people with opioid dependence, little attention has been paid to the instruments used. This systematic review examines the suitability of QOL instruments for use in opioid-dependent populations and the instruments’ quality. Methods A systematic search was performed in the databases Medline, PsycInfo, The Cochrane Library, and CINAHL. Articles were eligible if they assessed QOL of opioid-dependent populations using a validated QOL instrument. Item content relevance to opioid-dependent people was evaluated by means of content analysis, and instrument properties were assessed using minimum standards for patient-reported outcome measures. Results Eighty-nine articles were retrieved, yielding sixteen QOL instruments, of which ten were assessed in this review. Of the ten instruments, six were disease specific, but none for opioid dependence. Two instruments had good item content relevance. The conceptual and measurement model were described in seven instruments. Four instruments were developed with input from the respective target population. Eight instruments had low respondent and administrator burden. Psychometric properties were either not assessed in opioid-dependent populations or were inconclusive or moderate. Conclusions No instrument scored perfectly on both the content and properties. The limited suitability of instruments for opioid-dependent people hinders accurate and sensitive measurement of QOL in this population. Future research is in need of an opioid dependence-specific QOL instrument to measure the true impact of the disease on people’s lives and to evaluate treatment-related services

Effects of heroin-assisted treatment on alcohol consumption: findings of the German randomized controlled trial

Alcohol has been suggested to be a risk factor for opioid-dependent patients in methadone maintenance treatment (MMT). Literature shows that MMT has limited effects on alcohol use. Nevertheless, a decrease in alcohol use was detected in the Swiss heroin-assisted treatment (HAT) study. In this article, we carry out an in-depth analysis of the German HAT trial with the aim of determining whether alcohol use was affected among patients undergoing HAT and MMT. Analysis was carried out using self-reported data on consumption units of alcohol used (CU), Addiction Severity Index composite scores (ASI CSs), and carbohydrate-deficient transferrin (CDT) measures. Results suggest significant reduction of CU and CDT in both groups, yet larger effects in the HAT group. ASI CS significantly decreased in the HAT but not in the MMT group. The greater benefit of HAT in reducing alcohol use may be due to the greater daily frequency of dispensing heroin coupled with a requirement of sobriety at each dosing occasion

Patient-centered care interventions to reduce the inappropriate prescription and use of benzodiazepines and z-drugs: a systematic review

Background Benzodiazepines (BZDs) and z-drugs are effective drugs, but they are prescribed excessively worldwide. International guidelines recommend a maximum treatment duration of 4 weeks. Although these drugs are effective in the short-term, long-term BZD therapy is associated with considerable adverse effects, the development of tolerance and, finally, addiction. However, there are different interventions in terms of patient-centered care that aim to reduce the use of BZDs and z-drugs as well as assist health care professionals (HCPs) in preventing the inappropriate prescription of BZDs. Aim The aim of this systematic review was to identify interventions that promote patient-centered treatments for inappropriate BZD and z-drug use and to analyze their effectiveness in reducing the inappropriate use of these drugs. Methods To identify relevant studies, the PubMed, EMBASE, PsycINFO, Psyndex, and Cochrane Library databases were searched. Studies with controlled designs focusing on adult patients were included. Trials with chronically or mentally ill patients were excluded if long-term BZD and z-drug use was indicated. Study extraction was performed based on the Cochrane Form for study extraction. To assess the quality of the studies, we used a tool based on the Cochrane Collaboration’s tool for assessing the risk of bias in randomized trials. Results We identified 7,068 studies and selected 20 for systematic review. Nine interventions focused on patients, nine on HCPs, and two on both patients and HCPs. Intervention types ranged from simple to multifaceted. Patient-centered interventions that provided patient information effectively increased the appropriate use of BZDs. The educational approaches for HCPs that aimed to achieve appropriate prescription reported inconsistent results. The methods that combined informing patients and HCPs led to a significant reduction in BZD use. Conclusions This is the first review of studies focused on patient-centered approaches to reducing the inappropriate prescription and use of BZDs and z-drugs. The patient-centered dimension of patient information was responsible for a decrease in BZD and z-drug consumption. Further, in some studies, the patient-centered dimensions responsible for reducing the prescription and use of BZDs and z-drugs were the clinician’s essential characteristics and clinician-patient communication

Benzodiazepine use among patients in heroin-assisted vs. methadone maintenance treatment: findings of the German randomized controlled trial

Benzodiazepine (BZD) use has been found to be associated with poorer psychosocial adjustment, higher levels of polydrug use and more risk-taking behaviors among opioid dependent patients. The aim of this paper is to analyze the correlation between BZD use, BZD prescription and treatment outcome among participants in the German trial on heroin-assisted treatment. 1015 patients who participated in the study comparing heroin-assisted and methadone maintenance treatment (HAT & MMT) for 12 months were included in the analysis. Analyses were carried out to assess the association of treatment outcome with baseline BZD use, with ongoing BZD use and with different patterns of BZD prescription. Baseline BZD use correlated with lower retention rates but not with poorer outcome. Ongoing BZD use correlated with poorer outcomes. Significantly better outcomes were found in the course of phobic anxiety symptomatology for those with regular prescription of BZD. The percentage of BZD positive urine tests decreased more in HAT than in MMT. Poorer outcome for benzodiazepine users may be mediated by a higher severity of addiction. Cautious prescribing of benzodiazepines may be beneficial due to the reduction of overall illicit use

Civil society involvement in drug policy in EU Member States. Assessment report.

On the European Union level, the issue of how to strengthen the civil society involvement (CSI) in drug policy has increasingly attracted attention over the last few years, starting with the presentation of the “Green Paper on the role of Civil Society in Drugs Policy in the European Union” by the European Commission (2006) and the subsequent establishment of the “Civil Society Forum on Drugs” as a platform for regular dialogue on policy development and implementation between the Commission and representatives of European civil society. How the Civil Society Forum on Drugs is to be involved in EU drugs policy is further defined in the current EU Action Plan on Drugs 2017-2020 (Council of Europe 2017). However, the current action plan does not only refer to civil society involvement on the EU level, but also calls for action on the national level to “promote and strengthen dialogue with, and involvement of, civil society and the scientific community in the formulation, implementation, monitoring and evaluation of drug policies”. The successful implementation of best practice in drug demand reduction in the member states, is further hinged (among other indicators) on the “involvement of civil society in the implementation of the standards, including in planning and introduction”. This assessment report will focus on the involvement of civil society in the national drug policies of the EU member states. Its objective is to gain a better insight and create a better understanding of the nature and extent of civil society involvement in drug policy at the national level. The assessment will reflect the status of CSI as condensed in national drug policy documents, analyse the levels of CSI in different drug policy fields, identify and quantify different type of civil society stakeholders in the member states and size up the impact of civil society participation in the decision making process. Furthermore it will analyse barriers and facilitators for CSI and give conclusions and recommendations for promoting and strengthening CSI in the member states. This introduction will be followed by a description of the methods used to reach the above mentioned objectives. Subsequently, the limitations of these methods will be declared before the results of the assessment will be presented. Finally, the main results of the assessment will be discussed against the background of the EUs call for strengthening civil society involvement in the member states