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Introduction: Germany is reforming its legal approach to cannabis, allowing the possession and cultivation of cannabis for recreational purposes. The objective of this study is to investigate the impact of the policy reform on (1) The prevalence of cannabis use in the general population and (2) Driving under the influence of cannabis (DUIC) among regular users., Methods and Analysis: A quasi-experimental research design will be employed, with repeated cross-sectional surveys on self-reported DUIC and cannabis use conducted at three measurement points in Germany (intervention group) and Austria (control group) over a 2-year observation period (2023-2025). Data will be collected from approximately 50 000 individuals aged between 18 years and 64 years. To minimise reporting biases in the measurement of DUIC, we will use direct and indirect assessments via crosswise model and motor vehicle accident data from official statistics. In a difference-in-difference framework, regression analyses and interrupted time series analysis will be carried out for hypothesis testing., Ethics and Dissemination: Participants will be informed about voluntary participation, data protection laws and the option to delete data on request. Ethical approval was obtained from the Local Psychological Ethics Committee of the Centre for Psychosocial Medicine in Hamburg, Germany (reference number: 0686). Findings will be disseminated through scientific networks and will be key for a comprehensive evaluation of the cannabis law reform. The findings will facilitate the design and implementation of road safety measures., Competing Interests: Competing interests: JM has worked as consultant for and received honoraria from public health agencies. All other authors do not declare any conflict of interest., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

With the enforcement of the Cannabis Act on 1 April 2024, Germany has adopted one of the most liberal legal approaches to cannabis on the continent. The German model prioritises a non-profit approach and precludes legal market mechanisms. We believe these are the main drivers for increasing cannabis use and related health problems, based on observations following cannabis legalisation in Canada and many states in the U.S. Although legalising cannabis possession and cultivation may not immediately eliminate the illegal market, it is expected to serve public health goals. Despite the overall positive evaluation of the Cannabis Act in Germany, there are three potential areas of concern: the potential for misuse of the medical system, the normalization of cannabis use, and the influence of the cannabis industry. The German model may herald the beginning of a new generation of European cannabis policies, but concerted efforts will be required to ensure that these policy reforms serve rather than undermine public health goals., Competing Interests: Unrelated to the present work, JM has worked as consultant for and received honoraria from various public health organizations (World Health Organization, European Monitoring Centre for Drugs and Drug Addiction, national non-governmental organisations) and has received payment for expert testimony in the German parliament. Moreover, all authors were involved in a research project on potential outcomes of cannabis legalisation based on empirical evidence from other countries funded by the German Ministry of Health., (© 2024 The Author(s).)

Background: To counteract the spread of new psychoactive substances (NPS) and to prevent the emergence of novel substances, specifically designed as a response to the legal control of individual substances, a new law was introduced in Germany in 2016: the New Psychoactive Substances Act (NpSG). The NpSG combines a generic approach with the waiver of criminal liability for the acquisition and possession of NPS for personal use, which is a novelty in German narcotics law. The present study aimed at exploring the impact of the introduction of the NpSG from three different perspectives-NPS users, staff of addiction care facilities, and members of law enforcement authorities-to better understand the dynamics surrounding such a change in legislation and to contribute to the body of international experience in dealing with NPS., Methods: Semi-structured narrative interviews were conducted with a total of 193 representatives of the three different groups affected by the law. These interviews included questions on perceived changes associated with the introduction of the NpSG as well as questions on opinions regarding legal and criminal policy issues. The analysis was carried out using qualitative content analysis according to Mayring., Results: Most interviewees welcomed the non-criminalisation approach of the NpSG but also noticed that, in practice, not much has changed for users. Nevertheless, the changes in legislation have had an impact on the market. For example, novel substances have emerged circumventing the new legislation. According to users, this has led some to reduce NPS use and others to adopt more hazardous consumption patterns. Overall, most respondents did not expect the introduction of the NpSG to bring any significant changes., Conclusions: Although the idea of non-criminalisation inherent to the NpSG is appreciated and the generic approach has been well implemented in the law, thus covering a wide range of substances, the introduction of the law-perhaps for that very reason-has also had unintended and negative consequences, taking the cat-and-mouse game to the next level. To end the game, or at least to defuse the game situation, a combination of different strategies will be necessary, with legislation always playing a key role., (© 2022. The Author(s).)

Objective: The aim of this pilot trial was to assess the feasibility of ASBI in primary health care units (PHCUs) in Kazakhstan. Methods: A two-arm cluster randomised trial in five PHCUs based on the RE-AIM framework for implementation studies was carried out. Patients with AUDIT-C scores ≥4 for females and ≥5 for males received a brief face-to-face intervention delivered by a trained physician plus information leaflet (intervention group, IG) or simple feedback including a leaflet (control group, CG). Results: Among 7327 patients eligible for alcohol screening according to the inclusion criteria 1148 patients were screened (15.7%, IG: 11.5%, CG: 27.3%). 12.3% (N = 141) were tested AUDIT-C positive (IG: 9.9%, CG: 15.1%). Out of 112 physicians invited, 48 took part in the ASBI training, 31 finally participated in the study, 21 in the IG (2 PHCUs), 10 in the CG (3 PHCUs). The majority of physicians did not have difficulties in performing the intervention. Conclusion: ASBI is feasible and can be implemented into PHC settings in Kazakhstan. However, the implementation depends on the willingness and interest of the PHCU and the physicians., Competing Interests: UV received speaker’s honoraria and travelling expenses from Mundipharma GmbH and received travelling expenses and an unrestricted educational grant from CAMURUS. BS received an unrestricted educational grant and travelling expenses from CAMURUS. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Verthein, Lahusen, Martens, Prilutskaya, Yussopov, Kaliyeva and Schulte.)

Introduction: Once-weekly or once-monthly injectable depot buprenorphine is a new opioid substitution treatment (OST) medication that provides clinically relevant plasma concentrations without daily peaks. Together with a high tolerability and acceptance reported by patients, the prolonged release of injectable depot buprenorphine might have beneficial implications on the patients' quality of life and social participation. The primary objective of this prospective non-interventional observational study is to evaluate the effects of subcutaneous injectable depot buprenorphine on the quality of life of patients in routine OST care in Germany. Secondary outcomes like illicit substance use, psychological distress, social participation and activity are assessed to provide an overall evaluation toward addiction recovery. Methods and Analysis: The present study is a non-randomized prospective observational study with a control group (treatment-as-usual). To ensure comparability between both patient groups, suitable control patients ( n = 213) from the same OST unit will be matched pairwise to each patient treated with injectable depot buprenorphine ( n = 213). Matching variables are gender, duration of OST, take-home prescription and psychosocial functioning (according to the Global Assessment of Functioning scale). Primary study endpoint is the difference of change in quality of life, assessed with the recently developed Opioid Substitution Treatment Quality of Life scale (OSTQOL), within the depot buprenorphine group between baseline and month 12. The primary analysis will be carried out according to the intention-to-treat principle (ITT) by comparing OSTQOL mean scores using dependent t -tests. For secondary analyses, group comparisons will be done by mixed model approaches with baseline OSTQOL score and the (pairwise) cluster term as covariates. Discussion: The study combines clinical, routine OST care data with relevant patient reported outcome data. The pairwise matching allows conclusions on effects of different OST medications. The study findings will provide new insights in the addiction recovery processes of OST patients treated with depot buprenorphine. Ethics and Dissemination: The study protocol has been approved by the Ethics Committee of the Hamburg Chamber of Physicians (Ärztekammer Hamburg) (reference number: PV7078). The study results will be disseminated through peer-reviewed publications and presentations on scientific conferences. Clinical Trial Registration: German Clinical Trials Register DRKS-ID: DRKS00020797., Competing Interests: BS had received an unrestricted educational grant from Camurus. UV received speaker's honoraria and traveling expenses from Mundipharma and received traveling expenses from Camurus. JR had served as consultant for Camurus, Indivior, Mundipharma, Sanofi-Aventis, was member of the speakers bureau for Camurus, Hexal, Indivior, and received unrestricted educational grants from Mundipharma. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2020 Schulte, Lehmann, Schmidt, Rühling, Weber, Schäfer, Reimer and Verthein.)

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., Competing Interests: Declaration of Competing Interest The study was conducted by the Centre for Interdisciplinary Addiction Research (University Medical Center Hamburg-Eppendorf, UKE) as an Investigator Initiated Trial (IIT) and was financially supported by the pharmaceutical company Mundipharma Deutschland GmbH & Co. KG (Frankfurt on the Main, Germany) (unrestricted educational grant). The funding body had no role in the study design and the collection, analysis and interpretation of data. Uwe Verthein received speaker's honoraria from Mundipharma Deutschland GmbH & Co. KG and travelling expenses from Camurus GmbH and Mundipharma Deutschland GmbH & Co. KG. Jens Reimer participates in the speaker's bureaus of Camurus GmbH, Hexal AG, Indivior PLC and Sanofi-Aventis Deutschland GmbH. Kirsten Lehmann received a reimbursement of travel expenses as well as the absorption of participation fees and accommodation costs from pcm scientific. The other authors declare no conflicts of interest., (Copyright © 2020 The Authors. Production and hosting by Elsevier B.V. All rights reserved.)

Background: Patient-reported outcomes (PROs) can help to reduce uncertainties about hepatitis C virus (HCV) treatment with direct-acting antivirals (DAAs) among people who inject drugs and increase treatment uptake in this high-risk group. Besides clinical data, this study analyzed for the first time PROs in a real-world sample of patients on opioid agonist treatment (OAT) and HCV treatment with DAAs., Methods: HCV treatment data including virological response, adherence, safety, and PROs of 328 German patients on OAT were analyzed in a pragmatic prospective cohort study conducted from 2016 to 2018. Clinical effectiveness was defined as sustained virological response (SVR) at week 12 after end of treatment and calculated in per-protocol (PP) and intention-to-treat (ITT) analyses. Changes over time in PROs on health-related quality of life, physical and mental health, functioning, medication tolerability, fatigue, concentration, and memory were analyzed by repeated-measures analyses of variances (ANOVAs)., Results: We found high adherence and treatment completion rates, a low number of mainly mild adverse events, and high SVR rates (PP: 97.5% [n = 285]; ITT: 84.5% [n = 328]). Missing SVR data in the ITT sample were mainly caused by patients lost to follow-up after treatment completion. Most PROs showed statistically significant but modest improvements over time, with more pronounced improvements in highly impaired patients., Conclusions: This real-world study confirms that DAA treatment among OAT patients is feasible, safe, and effective. PROs show that all patients, but particularly those with higher somatic, mental, and social burden, benefit from DAA treatment., (© The Author(s) 2020. Published by Oxford University Press on behalf of Infectious Diseases Society of America.)

Background: New approaches are required to slow down or reverse increasing trends of levels of delta-9-tetrahydrocannabinol (THC) and cannabis-attributable hospitalizations in Germany. Legal access to cannabis may constitute one viable effective policy response; however, available evidence does not suffice to inform a regulation model for Germany. The proposed study aims to reduce harm for cannabis users through legal access to herbal cannabis through pharmacies. Protocol: A quasi-experimental study comparing cannabis users with legal access to herbal cannabis (Berlin, intervention group) to those without legal access (Hamburg, control group) (total N=698). As the primary outcome, we hypothesize that: 1) illegal THC consumption will reduce by at least 50% in the intervention group and 2) total THC exposure in the intervention group will be reduced by at least 10% lower than that of the control group, taking into account baseline values. Secondary outcomes comprise measures of frequency of use, THC-impaired driving, and mode of administration. Paired t-tests and multilevel regression models will be performed for statistical analyses. Discussion: This study proposal is currently being reviewed by the 'Federal Institute for Drugs and Medical Devices' - the body responsible for approving research studies on classified substances, including cannabis. Upon approval and prior to the start of the study, a full ethical review will be undertaken. Results may inform a regulation model for Germany and other jurisdictions and are expected to deepen the understanding of the effects of legal access to cannabis. Pre-registration: German Clinical Trials Register (DRKS), DRKS00020829., Competing Interests: No competing interests were disclosed., (Copyright: © 2020 Manthey J et al.)

Background: Amphetamine-type stimulants (ATS) are the second most commonly used illicit drugs in Europe and globally. However, there is limited understanding of what shapes patterns of ATS use over the life course. The ATTUNE project "Understanding Pathways to Stimulant Use: a mixed methods examination of the individual, social and cultural factors shaping illicit stimulant use across Europe" aims to fill this gap. Here we report initial findings from the life course chart exercise conducted as part of qualitative interviews with ATS users and nonusers., Methods: Two hundred seventy-nine in-depth qualitative interviews were conducted with five ATS user groups (current and former dependent users;current and former frequent users;non-frequent users) and one group of exposed non-ATS users in five European countries (Germany, UK, Poland, Netherlands and Czech Republic). As part of the interviews, we used life course charts to capture key life events and substance use histories. Life events were categorised as either positive, neutral or negative, and associated data were analysed systematically to identify differences between user groups. We applied statistical analysis of variance (ANOVA) and analysis of covariance (ANCOVA) to test for group differences., Results: Out of 3547 life events documented, 1523 life events were categorised as neutral, 1005 life events as positive and 1019 life events as negative. Current and formerly dependent ATS users showed more negative life events for the entire life course after age adjustment. Although some group differences could be attributed to the individuals' life course prior to first ATS use, most negative life events were associated with periods of ATS usage. A detailed analysis of the specific life domains reveals that dominantly, the social environment was affected by negative life events., Conclusions: For non-dependent, frequent and non-frequent ATS users, negative life events from the period of ATS use do not become obvious in our analysed data. Besides preventing a pathway into ATS dependency, the aim of an intervention should be to reduce the harm by for example drug testing which offers also the opportunity for interventions to prevent developing a substance use dependency. For the group of dependent ATS users, our study suggests holistic, tailored interventions and specialist treatment services are needed, as a single, simple intervention is unlikely to cover all the life domains affected.

Background: Identifying and addressing heavy drinking represents a major public health priority worldwide. Whilst the majority of alcohol screening and brief intervention (ASBI) research has been conducted in western, high-income countries, evidence is growing that ASBI can also impact positively on heavy drinkers in low- and middle-income country populations. This mixed methods study aims to assess the feasibility of conducting a fully randomised controlled trial of the effectiveness of ASBI in primary care in Kazakhstan and explore the feasibility and acceptability of implementing ASBI in this setting from patients' and physicians' perspectives., Methods: Six primary health care units in the region of Pavlodar will be cluster randomised to either an intervention (WHO manualised 5 min alcohol brief intervention plus alcohol leaflet) or control group (simple feedback plus alcohol leaflet). Primary feasibility measures will be rates of participation at baseline and retention of eligible patients at the 3-month follow-up point. Patient/physician questionnaires and physician focus groups will assess additional dimensions of feasibility, as well as acceptability, according to the RE-AIM framework: Reach (rates of eligible patients screened/received advice); Effectiveness (change in AUDIT-C score); Adoption (rate/representativeness of participating physicians); Implementation (quality of ASBI/barriers and facilitators to delivery); and Maintenance (potential sustainability of intervention)., Discussion: This is the first trial of the feasibility and acceptability of ASBI in Kazakhstan. As the planning and assessment of implementation determinants is based on the RE-AIM framework, the project outcomes will be relevant for the future development, tailoring and implementation of ASBI in Kazakhstan., Trial Registration: DRKS, DRKS00015882, Registered 17 December 2018., Competing Interests: Competing interestsThe authors declare that they have no competing interests, (© The Author(s). 2020.)

Background: According to the German guidelines, people with severe alcohol use disorders (AUDs) should receive withdrawal treatment. Compared to somatic withdrawal treatment (SWT), extended duration and psychosocial elements of so-called "qualified withdrawal treatment" (QWT) aim to reduce relapse rates. Despite promising results of prospective studies on QWT, only few German inpatients seeking withdrawal treatment receive QWT. We estimated the potential effects on mortality and morbidity for higher proportions of treatment-seeking patients receiving QWT rather than SWT in the German city of Bremen., Methods: In 2016 and 2017, 2051 inpatients were admitted to two specialised hospitals for withdrawal treatment. The potential beneficial effects of QWT over SWT were estimated by simulating treatment outcomes taken from two prospective studies. Outcomes comprised number and length of all-cause hospitalisations within 5 years, as well as abstinence and all-cause mortality rates within 28 months. Outcomes were estimated for actual and increased rates of QWT (25, 50%) among inpatients seeking alcohol treatment., Results: In the selected hospitals, 170 patients (8%) received QWT. If 25% of AUD inpatients were to receive QWT, benefits in abstinence rates (+ 18%), the total number of hospitalisations (- 9%) and hospital days (- 10%) could be expected. If 50% of AUD inpatients were to receive QWT, benefits in abstinence rates (+ 45%), the total number of hospitalisations (- 23%) and hospital days (- 26%) were more pronounced, in addition to reductions in mortality (- 20%)., Conclusion: Increasing the proportion of people with severe AUD enrolled in extended withdrawal treatment programs (such as QWT) may contribute to reduce overall alcohol-attributable burden of disease. Randomised controlled trials or other prospective studies controlling for confounding factors are needed to determine the potential at the population level.

Background: An estimated 1.4 to 2.6 million people in German suffer from drug dependence. Most of them are long-term users of benzodiazepines (BZD), Z drugs (ZD), or opioid analgesics (OA)., Methods: This analysis is based on prescription data from patients of the national statutory health insurance system in the German federal states of Schleswig-Holstein, Hamburg, Bremen, and Lower Saxony. Drug-taking trends, duration, dosage, and long-term use of BZD, ZD, and OA in the years 2006 to 2015 are analyzed; prevalences are estimated for the years 2006 to 2016., Results: In 2006, 7.7% of patients received at least one prescription for a BZD, ZD, or OA; in 2016, 7.0% did. Over the period of analysis, a marked drop was seen in prescriptions of BZD and a slight fall in prescriptions of ZD (2006: BZD 3.5%, ZS 1.1%; 2016: BZD 2.0%, ZS 0.8%), but there was also an increase in prescriptions of OA, from 4.2% to 4.9%. The number of defined daily doses (DDD) prescribed per year fell for both BZD and ZD. For OA, the number of DDD prescribed per year rose from 2006 to 2009 and decreased by a small amount in subsequent years. The proportions of BZD and ZD patients who had long-term prescriptions fell over time, while the corresponding percentage of OA patients rose., Conclusion: Nearly one-fifth of all prescriptions for BZD were long-term prescriptions for an entire year, in violation of the relevant guidelines. The rising prevalence of OA use was in the expected range in view of the aging population, but the number of prescriptions rose among younger patients as well. This trend toward more common treatment with opioid analgesics should be critically examined.

Introduction: Amphetamine-type stimulants (ATS) including amphetamine, methylenedioxymethamphetamine/'ecstasy', methamphetamine, synthetic cathinones and 'Ritalin' are the second most commonly used illicit drugs globally. Yet, there is little evidence on which factors are associated with the development of different patterns of ATS use over the life course. This study aims to examine which individual, social and environmental factors shape different pathways and trajectories of ATS consumption. The study will be conducted in five European countries: Germany, the Netherlands, Poland, Czech Republic and the UK., Methods and Analysis: We will use a sequential mixed-methods study design to investigate the multiple factors (familial, social and occupational situation, critical life events, general risk behaviour, mental and physical health, satisfaction with life) that shape individual ATS use pathways. A systematic literature review will be performed to provide an overview of the current academic literature on the topic. In module 1, qualitative semistructured interviews (n=ATS users and non-users) will be conducted to explore individual experiences of, and perspectives on, dynamics of change in stimulant consumption patterns. In module 2, structured questionnaires (n=2000 ATS users and non-users) will be administered via tablet computers to validate and enhance the generalisability of the interview findings. Data integration will take place at two key points. First, during the study, where the findings from the first qualitative interviews will inform the design of the structured questionnaire. Second, at the end of the study, where mixed methods data will be brought together to generate an in-depth, contextualised understanding of the research topic., Ethics and Dissemination: The study has been approved by the respective responsible ethics committee in each participating country. Data will be treated confidentially to ensure participants' anonymity. Findings will be disseminated in peer-reviewed scientific journals, national and international conferences, and in briefings for policy and practice., Competing Interests: Competing interests: UV received a speaker’s honoraria and travelling expenses from Mundipharma GmbH. AOD was funded by an NIHR School for Primary Care Research Fellowship between October 2015 and September 2017., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ.)

Background: Opioid addiction is one of the most common substance-related disorders worldwide, and morbidity and mortality due to opioid addiction place a heavy burden on society. Knowing the size of the population that is addicted to opioids is a prerequisite for the development and implementation of appropriate health-policy measures., Methods: Our estimate for Germany for 2016 is based on an enumeration of opioid-addicted persons who were entered in a registry of persons receiving substitution therapy, an enumeration of persons receiving outpatient and inpatient care for addiction without substitution therapy, an extrapolation to all addiction care facilities, and an estimation of the number of opioid-addicted persons who were not accounted for either in the substitution registry or in addiction care., Results: The overall estimate of the number of opioid-addicted persons in Germany in 2016 was 166 294 persons (lower and upper bounds: 164 794 and 167 794), including 123 988 men (122 968 to 125 007) and 42 307 women (41 826 to 42 787). The estimates for each German federal state per 1000 inhabitants ranged from 0.1 in Brandenburg to 3.0 in North Rhine-Westphalia and 5.5 in Bremen. The average value across Germany was 3.1 per 1000 inhabitants., Conclusion: Comparisons with earlier estimates suggest that the number of persons addicted to opioids in Germany has hardly changed over the past 20 years. Despite methodological limitations, this estimate can be considered highly valid. Nearly all persons who are addicted to opioids are in contact with the addiction care system.

Background: Although long-term use of benzodiazepines (BZDs) and Z drugs is associated with various side effects, they remain popular among the older population. Possible reasons for this phenomenon could be ineffective ways of transmitting information on the health risks associated with long-term use, and communication gaps between patients and healthcare professionals., Aim: The aim was to investigate the views of patients, physicians, nurses, and pharmacists regarding long-term BZD and Z drug use., Design & Setting: The qualitative study design used focus group interviews with physicians, pharmacists, and nurses in Hamburg. Patient interviews were conducted in Lippstadt, Germany., Method: The interviews were audiotaped with each participant's permission, transcribed, and thematically analysed using a software program for qualitative research (MAXQDA)., Results: The data from the four focus groups consisting of 28 participants were analysed. Patients indicated lack of knowledge about risks and side effects, difficult access to alternatives, and fears of ceasing drug use without professional support. Although the physicians were reported to be cautious about prescribing BZDs and Z drugs, the psychosocial problems of older patients are often considered to be complex and treatment knowledge, experience, and resources are frequently unsatisfactory. Nurses described that when BZDs were prescribed, they did not feel it was their responsibility to evaluate their effects. Pharmacists were reported to be strongly ambivalent in informing patients about the risks, which may contradict the prescription advice provided by the physician., Conclusion: Patients, physicians, nurses, and pharmacists reported differences in the perception of long-term BZD and Z drug use. Nevertheless, all of the participants described lack of information and expressed the need for greater communication exchange., Competing Interests: The authors declare that no competing interests exist.

Background: Knowledge of health-related quality of life (HRQOL) of patients receiving opioid substitution treatment (OST) is limited and fragmented. The present study examines the HRQOL of a large national sample of OST patients in Germany and sociodemographic and clinical correlates., Methods: Cross-sectional data on the HRQOL of 2176 OST patients was compared with German general population norms. Patients were recruited from 63 OST practices across Germany. To identify correlates of HRQOL, as measured with the SF-12, we performed bi- and multivariate analyses with sociodemographic and clinical variables, including patient- and clinician-reported outcomes on physical and mental health., Results: Patients' HRQOL was significantly poorer than in the general population, especially their mental HRQOL. Factors associated with lower physical HRQOL were older age, longer duration of opioid dependence, hepatitis C virus infection, and HIV infection. Benzodiazepine use was associated with lower mental HRQOL, and amphetamine use with higher physical HRQOL, compared to non-use of these substances. For both mental and physical HRQOL, the factor with the strongest positive association was employment and the factors with the strongest negative associations were physical and mental health symptom severity, psychiatric diagnosis, and psychopharmacological medication., Conclusions: Compared to the general population, we found substantially lower HRQOL in OST patients, especially in their mental HRQOL. OST programs can benefit from further improvement, particularly with regard to mental health services, in order to better serve their patients' needs. Clinicians may consider the use of patient-reported outcome measures to identify patients' subjective physical and psychological needs. Further research is needed to determine if employment is a cause or consequence of improved HRQOL., Trial Registration: ClinicalTrials.gov: NCT02395198 , retrospectively registered 16/03/2015.

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., Competing Interests: The authors declare that they have no competing interests.

Introduction: The long-term use of benzodiazepines (BZD) and z-drugs in older populations is associated with a variety of sociodemographic and health-related factors. Recent studies reported that long-term BZD and z-drugs use is associated with increased age, female sex, and severe negative psychological (e.g., depression) and somatic (e.g., chronic disease) factors. The current study explores the sociodemographic and health-related factors associated with long-term BZD and z-drugs use in the elderly., Methods: We conducted a cross-sectional survey among randomly selected patients of one health insurance plan ("AOK North-West") with BZD and z-drugs prescriptions in the past 12 months. The sample was stratified by appropriate German prescription guidelines (yes vs. no) and age (50-65 vs. >65 years). To examine the association of selected sociodemographic and psychological variables (e.g., sex, employment status, quality of life, depression) with long-term use, a binary logistic regression analysis was conducted., Results: In total, data from 340 patients were analyzed. The mean age was 72.1 ( SD  = 14.5) years, and the most commonly used substances were zopiclon (38.1%), oxazepam (18.1%), and lorazepam (13.8%). The mean defined daily dose (DDD) was 0.73 ( SD  = 0.47). Insomnia was the main reason for prescribing BZD and z-drugs. The long-term use of BZD and z-drugs was significantly associated with unemployment ( OR  = 2.9, 95% CI [1.2-7.1]) and generally problematic medication use ( OR  = 0.5, 95% CI [0.2-1.0])., Discussion: Unemployment status and problematic medication use had a significant association with the patient-reported, long-term use of BZD and z-drugs. Divergent prescription patterns might suggest problematic patterns of BZD and z-drugs use. The causal connection between the identified factors and problematic BZD and z-drugs prescription is not discussed in this paper. Nevertheless, employment status and possible evidence of general problematic drug use may be a warning signal to the prescribers of BZD and z-drugs., Competing Interests: The authors declare there are no competing interests.

Background: Opioid maintenance treatment with methadone is regarded as gold standard in the therapy of opioid dependence. Identification of the 'right' methadone dose, however, remains challenging. We wanted to explore if the Opiate Dosage Adequacy Scale (ODAS) is a helpful instrument in methadone titration., Methods: Within this 12-months prospective naturalistic cohort study patients in stable maintenance treatment with methadone (Eptadone®) were included. Sociodemographic and clinical data were gathered at baseline, and months 3, 6, and 12. At the same points in time, the instruments ODAS, European Addiction Severity Index (EuropASI), and Derogatis Interview for Sexual Functioning-Self Report (DISF-SR) were applied., Results: Five hundred fifteen patients were enrolled, 129 patients prematurely terminated substitution treatment (treatment failure), in 108 patients substitution medication was changed, likely due to bitter taste of Eptadone®. Complete longitudinal ODAS and EuropASI data sets were available for 229 patients. The frequency of adequate methadone doses (ODAS) increased (60.9 % at baseline, 85.3 % at month 12) as well as the average daily methadone dose (63.8 (±30.8) mg/day at baseline to 69.6 (±36.0) mg/day at month 12). Inadequacy of methadone dose was not associated with treatment failure (RR 1.019; CI 95 % 0.756-1.374). Addiction severity decreased statistically significantly. Compared to adequately dosed patients, inadequately dosed patients benefited more, in that they showed greater improvements in ODAS scores, had higher increases in methadone dose, and partially experienced more advanced sexual functioning., Conclusion: Application of ODAS was associated with improved methadone dose adequacy and addiction severity parameters as well as increased methadone doses. Its usefulness should be corroborated in a controlled trial.

Background: Hepatitis C virus infection is highly prevalent among people who inject drugs. Opioid substitution therapy, the standard treatment for opioid dependence, provides an excellent opportunity for the treatment of hepatitis C virus infection due to the close and regular contact between patients and clinicians. However, there is little research on the impact of opioid substitution therapy on the prevalence of the hepatitis C virus at a national level. This paper describes the protocol for the Epidemiology of Hepatitis C Virus Infection among People Receiving Opioid Substitution Therapy (ECHO) study. The aim of this study is to estimate the national prevalence and incidence of hepatitis C virus infection among people receiving opioid substitution therapy in Germany and to describe factors associated with hepatitis C treatment uptake and seroconversion., Methods/design: An observational, longitudinal, multicentre study is being conducted between 2014 and 2016 in a representative sample of approximately 2500 people receiving opioid substitution therapy from about 100 clinicians providing opioid substitution therapy in Germany. Data will be collected during routine patient care and by means of patient and clinician questionnaires at baseline and 12-month follow-up. Stratified sampling will be performed to obtain a representative sample of clinicians providing opioid substitution therapy. The strata will be constructed based on the distribution of the total sample of clinicians providing opioid substitution therapy in Germany according to German Federal State and the number of patients per clinician., Discussion: Opioid substitution therapy may be an important strategy to prevent the spread of hepatitis C virus in opioid dependent populations, but its effectiveness may be diminished by our limited understanding of factors associated with treatment uptake and seroconversion. The present study will provide important information for developing strategies to address hepatitis C virus-related disease burden in people receiving opioid substitution therapy., Trial Registration: ClinicalTrials.gov: NCT02395198.

Background: Data of the Central Bureau of Statistic of Nepal from 2008 show a total of more than 46,000 illegal drug users, out of which 61% are injecting drug users (IDU). An injecting mix of medicines like opioids, benzodiazepines and antihistamines (the so-called South Asian cocktail) was prevalent. Furthermore, it is estimated that about 70,000 people are living with human immunodeficiency virus (HIV). The government of Nepal has started realizing and recognizing drug use and HIV as significant health and social issues. Harm reduction programs such as needle syringe exchange and opioid substitution treatment are being implemented., Methods: The aim of this study is to obtain specific knowledge on the drug use behaviour and the health status of drug users with a focus on HIV in drug users with concurrent injection of opioids, benzodiazepines and antihistamines. After an initial mapping of Kathmandu Valley, 300 drug users in contact with different treatment and counselling centres were randomly chosen for the interviews. The research questionnaire was designed according to the European Addiction Severity Index (EuropASI) and Maudsley Addiction Profile standards., Results: Ninety-one percent of the respondents are male and 9% female. Mean age is 28.7 years. Ninety-five percent are injecting drug users with a mean of 8.7 years of drug use history. Eighty-six percent are injecting different 'cocktails', usually made of buprenorphine, diazepam, promethazine and/or other substances (30-day prevalence). Similarly, 48% use heroin, whereas only 2% take cocaine/crack. Among those tested for HIV (N = 223), 33% are positive (25% of the sample population). Compared to the other drug users (mainly heroin), the cocktail users show a higher HIV infection rate and more co-infections. Furthermore, risk behaviour, as e.g. needle sharing, is much more common among the cocktail users., Conclusion: Currently, the mixture of medicines, opioids, benzodiazepines and antihistamines, is the predominant drug in Nepal; the pharmaceutical drugs needed to prepare the cocktail are less expensive than heroin and relatively easy to acquire. The cocktail users show a higher risk behaviour regarding the transmission of HIV than heroin drug users. It needs to be considered which HIV prevention measures are necessary to target the specific needs of drug users who inject a mixture of opioids, benzodiazepines and antihistamines, since the available services (such as needle syringe exchange) do not seem to cover their specific needs (high percentage of needle sharing).

Background: Opioid replacement treatment (ORT) with methadone is regarded as gold standard in the treatment of opioid addiction. Treatment doses of 60 mg methadone per day and above are associated with better treatment retention and reduction in the use of heroin and cocaine. However, an absolute dose level cannot function as parameter for adequate dosing. This study aims to determine dose adequacy in a sample of patients on stable methadone treatment, and to relate dose adequacy to disease severity., Methods: This study was designed as open prospective cohort study over 12 months, with baseline data reported here. Patients on stable substitution treatment with methadone (Eptadone®) were consecutively included. Medical and socio-demographic data were gathered and the instruments Opiate Dosage Adequacy Scale (ODAS), European Addiction Severity Index (EuropASI) and the Derogatis Interview for Sexual Functioning - Self Report (DISF-SR) were applied., Results: Five hundred and sixteen subjects, who received on average 60.3 (±30.4) mg methadone per day, were included. According to ODAS, 40.6% suffered from an inadequate dosing, and 59.4% had an adequate dose. Patients with an adequate dose received on average 57.8 (±27.5) mg methadone per day, whilst patients with an inadequate dose received on average 70.6 (±33.0) mg per day. The frequencies of patients with methadone doses of less than 60 mg per were 45.4% in the inadequate and 60.6% in the adequate group. The inadequate group suffered from a statistically significant higher burden of addiction related problems in all EuropASI domains. Sexual functioning did not differ by adequacy group, but women suffered from more pronounced sexual dysfunction as compared to men., Conclusion: A high frequency of inadequate dosing was found in this sample of patients on ORT. Higher disease severity should alert for possible need of even higher methadone doses. The tendency to low methadone doses warrants further research in the treatment system. Higher methadone doses are not related to increased sexual dysfunction. Sexual dysfunction, especially in women, should be considered in treatment.

This study examines the relationship between heroin-assisted treatment versus methadone maintenance and the criminal activity of 1,015 individuals participating in a German model project. The main objective is to investigate how these treatments contribute to a decline of criminal behavior. The analyses are based upon self-reported criminal offence and police data on alleged criminals. Logistic regression is employed to explain the variance in the 12-month prevalence 1 year after program admission. The results clearly show a decline of criminal offences among participants receiving maintenance treatment; this decline was significantly greater in the heroin group with respect to property crimes and drug offences. The multivariate analysis reveals that the effects are due to a decrease of illegal drug use and absence from the drug scene.

Background: Heroin-assisted treatment has been found to be effective for people with severe opioid dependence who are not interested in or do poorly on methadone maintenance., Aims: To study heroin-assisted treatment in people on methadone who continue intravenous heroin and in those who are heroin dependent but currently not in treatment., Method: In an open-label multicentre randomised controlled trial, 1015 people with heroin dependence received a variable dose of injectable heroin (n=515) or oral methadone (n=500) for 12 months. Two response criteria, improvement of physical and/or mental health and decrease in illicit drug use, were evaluated in an intent-to-treat analysis., Results: Retention was higher in the heroin (67.2%) than in the methadone group (40.0%) and the heroin group showed a significantly greater response on both primary outcome measures. More serious adverse events were found in the heroin group, and were mainly associated with intravenous use., Conclusions: Heroin-assisted treatment is more effective for people with opioid dependence who continue intravenous heroin while on methadone maintenance or who are not enrolled in treatment. Despite a higher risk, it should be considered for treatment resistance under medical supervision.