Road safety implications of the partial legalisation of cannabis in Germany: protocol for a quasi-experimental study.

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.

Germany's cannabis act: a catalyst for European drug policy reform?

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.

Changes in Opioid Agonist Treatment Practice in Germany during the COVID-19 Pandemic: What Have Physicians Done, and What Would They Like to Keep Doing?

INTRODUCTION: Opioid agonist treatment (OAT) is the most common and most effective treatment option for persons with opioid use disorders (OUD). In Germany, the prescription of OAT medications is regulated by the Narcotic Drugs Prescription Ordinance. With the introduction of restrictions to contain the SARS-CoV-2 virus, the German OAT regulations have been amended to ensure a legal continuation of OAT for people with OUD. In this study, we aimed to examine the use of the OAT regulations in practice, the experience made by physicians prescribing OAT medications, and their perspective on OAT regulations. METHODS: Between September and December 2021, a questionnaire on the current situation and potential changes in the provision of OAT during the COVID-19 pandemic was sent out to 2,416 German physicians prescribing OAT medications. Differences between physicians with and without addiction medicine certification were analyzed. RESULTS: The response rate of physicians was 22.8%. Their average age was 57.4 (±10.1) years, and 62.3% were male. During the COVID-19 pandemic, take-home periods for stable patients have been extended by 48.2% of physicians, and 52.6% would like to maintain this prescribing practice in the future. Most physicians (71.6%) indicated that patients handled the extended take-home prescriptions predominantly responsibly. A total of 71.8% of the physicians generally did not use video consultation. A corona pandemic-related switch of the OST medication to depot buprenorphine injection did rather not occur, as 71.2% reported no patients treated with depot buprenorphine, and only 2.6% switched first-time or more patients to depot buprenorphine due to the COVID-19 pandemic. CONCLUSION: The corona situation opened up opportunities for physicians and patients and enabled change processes in OAT. Physicians had positive experiences implementing expanded take-home prescriptions for stable patients. Video contacts rarely took place, suggesting resistance to digital consultation. The number of depot buprenorphine prescriptions has not increased substantially since the pandemic's beginning and has remained at low levels. Further research is needed to assess to what extent the changes in OAT will be maintained over time and whether they will also lead to long-term benefits for OAT patients.

The impact of legal cannabis availability on cannabis use and health outcomes: A systematic review.

BACKGROUND: For alcohol, regulating availability is an effective way to reduce consumption and harm. Similarly, the higher availability of medical cannabis dispensaries has been linked to increased cannabis consumption and harm. For recreational cannabis markets, such a link is suspected but still poorly understood. METHODS: A systematic literature review (PROSPERO registration number 342357) was conducted on 1 July 2022 in common libraries (Medline, Web of Science, PsycInfo, Psyndex, CINAHL, Embase, SCOPUS, Cochrane) for publications since 2012. Studies linking variations in the availability of legal cannabis products to behavioral outcomes (cannabis use or related health indicators) were included, while studies focusing solely on the legalization of medical cannabis were excluded. The risk of bias was assessed using an adapted version of the Newcastle-Ottawa-Scale. RESULTS: After screening n = 6,253 studies, n = 136 were selected for full-text review, out of which n = 13 met the inclusion criteria, reporting on n = 333,550 study participants and n = 855,630 presentations to emergency departments. All studies were conducted in North America, with the majority from Western US states. Using longitudinal (n = 1), cross-sectional (n = 4), or repeated cross-sectional (n = 8) study designs, an increased availability of legal cannabis was linked to increased current cannabis use and health-related outcomes (vomiting, psychosis, or cannabis-involved pregnancies), regardless of the indicator employed to measure availability (proximity or density) among both adults and adolescents. The positive correlation between cannabis availability and consumption is most pronounced among those groups who have been less exposed to cannabis before legalization. The association between the availability of legal cannabis and risky use indicators was less consistent. CONCLUSIONS: Groups who have been least exposed to cannabis before legalization may be most susceptible to increased availability. In jurisdictions with legal cannabis markets, restrictions on the number of legal cannabis retailers, especially in densely populated areas, appear warranted.

Individual, Social, and Environmental Factors Associated with Different Patterns of Stimulant Use: A Cross-Sectional Study from Five European Countries.

INTRODUCTION: Amphetamine-type stimulants (ATSs) are the second most commonly consumed class of illicit drugs globally, but there is limited understanding of the precise factors associated with problematic versus controlled ATS consumption. This exploratory study aimed to identify which individual, social, and environmental factors are associated with different patterns of ATS use over time. METHODS: Cross-sectional surveys were conducted in Germany, England, The Netherlands, Poland, and the Czech Republic via face-to-face computer-assisted personal interviews to collect data on different user groups. 1,458 adults (18+) reported exposure to but no ATS use (n = 339); former rare/moderate ATS use (n = 242); current rare/moderate ATS use (n = 273); former frequent/dependent ATS use (n = 201); current frequent/dependent ATS use (n = 403). Extent of ATS/other substance use was assessed by number of consumption days (lifetime, past year, past month) and Severity of Dependence Scale. To identify factors associated with group membership, data were also collected on previous injecting drug use (IDU) and consumption setting/rules. Psychological distress was measured using the Brief Symptom Inventory, with additional data collected on self-reported adverse life events and physical/mental health. RESULTS: Currently, using frequent/dependent ATS users experienced more frequent unstable living conditions (27.5%) and psychological distress (59.8%) compared to other groups. A multinomial logistic regression showed that currently abstinent rare/moderate users were more likely to abstain from methamphetamine use {odds ratio (OR) = 2.48 (confidence interval [CI] = 1.32-4.68)} and from IDU (OR = 6.33 [CI = 2.21-18.14]), to avoid ATS use during working hours (OR = 6.67 [CI = 3.85-11.11]), and not to use ATS for coping reasons (OR = 4.55 [CI = 2.50-6.67]) compared to the reference group of currently using frequent/dependent users. CONCLUSIONS: People who use ATS frequently and/or at dependent levels are more likely to have experienced social and economic adversity compared to infrequent ATS users. On the other hand, there is a substantial share of users, which show a controlled use pattern and are able to integrate ATS use into their lives without severe consequences.

[Identification of Information Needs for Prevention of the Problematic Use of Benzodiazepines and Z-Drugs - A Focus Group Study]. / Identifikation von Informationsbedürfnissen zur Prävention des problematischen Konsums von Z-Substanzen und Benzodiazepinen ­ eine Fokusgruppenstudie.

OBJECTIVE: In order to develop demand-driven health information about z-drugs and benzodiazepines, we aimed to identify information needs of people at risk of dependency. METHODS: We conducted three focus groups with different target groups: Younger people with sleep disorders (N=7), middle-aged women with occasional/regular intake of z-drugs or benzodiazepines (N=6) and older people with regular drug intake. RESULTS: The information needs primarily refer to the areas "sleep disorders" (esp. alternative treatment options), "z-drugs and benzodiazepines" (esp. risks of intake) and "offers of assistance" (esp. contact points). CONCLUSION: The thematic overlaps indicate that all affected groups can profit from general information about sleep disorders, different treatment options and risks. Additionally, information services should also focus on guidance and referral in the help system.

Feasibility and Short-Term Effects of Low-Threshold Opioid Substitution Treatment during the COVID-19 Pandemic in Hamburg, Germany.

INTRODUCTION: After rapidly opening up a low-threshold clinic to support heavily opioid-dependent persons at the beginning of the COVID-19 pandemic in April 2020 in Hamburg (Germany), this non-interventional study evaluated the feasibility and short-term effects of opioid substitution treatment (OST). The low-threshold concept was customized for the pandemic situation and is the first of its kind in Germany. METHODS: Patients who had already begun treatment were questioned in two assessments, at T1 shortly after beginning treatment and at T2 6 months later. The primary outcome criterion was their quality of life using the OSTQOL. Secondary criteria included retention rate, their mental and physical health (measured by the BSI-18 and the OTI Health Scale), social situation, drug use, COVID-19 status, and satisfaction with treatment. RESULTS: Out of 84 patients included in the study, 51 participated in both assessments, resulting in a 6-month retention rate of 60.7%. 27.5% were females, and 72.5% were males. The feasibility question of the low-threshold OST clinic can clearly be answered positively. During the course of the study over 6 months, the situation mainly remained stable regarding quality of life, physical and mental health, and days of drug consumption. Patients significantly reduced the time they spent on the drug scene from 8.5 (SD = 7.56) to 6.1 (SD = 6.71) hours a day between the beginning of OST and T2 (p = 0.020). While 56.9% answered to be homeless at the beginning of OST, only 33.3% answered not to have found an accommodation by T2 (p = 0.012). The number of patients having contact to social workers increased from 51.0% to 74.5% (p = 0.004). Almost 2 fifths of the patients took part in PCR testing for COVID-19 (that only being done if they had symptoms), and none of the tests were positive. DISCUSSION/CONCLUSIONS: Overall, the low-threshold OST clinic has been successfully implemented in order to help a vulnerable group of people navigate through a global pandemic and support the public health sector. Further conclusions on effects are limited by the short study period and the small number of patients, which calls for further research studies in a larger setting.

Taking the cat-and-mouse game to the next level: different perspectives on the introduction of the German New Psychoactive Substances Act.

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.

Alcohol Screening and Brief Intervention in Primary Health Care in Kazakhstan-Results of a Cluster Randomised Pilot Study.

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.

The Universal and Primary Prevention of Foetal Alcohol Spectrum Disorders (FASD): A Systematic Review.

Foetal alcohol spectrum disorder (FASD) comprises multiple neurodevelopmental disorders caused by alcohol consumption during pregnancy. With a global prevalence rate of 7.7 per 1000 population, FASD is a leading cause of prenatal developmental disorders. The extent of physical, mental, and social consequences for individuals with FASD can be vast and negatively affect their social environment, daily life, school, relationships, and work. As treatment for FASD is labour- and cost-intensive, with no cure available, prevention is key in reducing FASD prevalence rates. As most systematic reviews conducted so far have focused on specific FASD risk groups, we investigated the effectiveness of universal FASD prevention and primary preventive strategies. We identified a total of 567 potentially pertinent records through PubMed, Cochrane Library, EBSCO, PubPsych, and DAHTA published from 2010 to May 2020, of which 10 studies were included in this systematic review. Results showed a substantial heterogeneity in the studies' quality, although all preventive measures, except one, proved effective in both increasing knowledge and awareness of FASD, as well as decreasing the risk of an alcohol exposed pregnancy. Limiting factors such as small sample sizes and a lack of behavioural change testing require further studies to support existing evidence for FASD prevention and its implementation, as well as detecting the best course of action for FASD prevention when creating and implementing prevention and intervention approaches.

[Opioid agonist therapy and the German Narcotic Drugs Prescription Ordinance from the pharmacist's perspective]. / Opioidsubstitutionstherapie im Rahmen der neuen Betäubungsmittel-Verschreibungsverordnung aus Sicht von Apothekerinnen und Apothekern.

BACKGROUND: Opioid agonist therapy (OAT) has been established to be the most important therapy option for improving health and social burdens of people with opioid dependence. Pharmacies provide drug substitutes to substitution practices or outpatient clinics and administer drugs to substituted patients (medication under visual control) or supply prescriptions for unsupervised, at-home use by patients. Given the gaps in medical care, the relevance of pharmacies for the comprehensive treatment of opioid-dependent patients will become even more important in the future. The 3rd Revision of the Narcotic Drugs Prescription Ordinance (NDPO) adopted sweeping reforms to the framework of OAT in 2017. This paper examines the impact of this reform from the pharmacist's perspective. METHODS: Between November 2020 and March 2021, pharmacists in the German federal states of Hamburg, North-Rhine Westphalia, Saxony, and Bavaria were informed by their State Chambers of Pharmacists about participation in this online study. A total of 480 questionnaires were evaluated. The analysis differentiates between pharmacists who are currently involved in the substitution of opioid-dependent patients (54.2%), pharmacists who were involved in the past (21.4%), and those who have never been involved in opioid substitution (24.4%). RESULTS: Pharmacists involved in OAT have not seen any positive changes resulting from the 3rd Revision of the NDPO. According to 97.9% of the pharmacists, remuneration for administering medication under visual control should be analogous to remuneration in doctors' practices. Mixed prescriptions (prescription of take-home dose and intermediate medication under visual control) increase the administrative workload and have been rejected by a quarter of the pharmacists. Non-involved pharmacists significantly overestimated the occurrence of critical situations with substituted patients in the pharmacy. While only 2.7% of pharmacists involved in OAT reported drug emergencies, 23.1% of non-involved pharmacists expressed such concerns. 39.3% of the pharmacists felt they could be motivated to participate in OAT if they were approached directly, and 73.9% of the pharmacists who are currently involved in OAT said they could provide substitution medication under visual control to additional opioid-dependent patients. CONCLUSIONS: The 3rd Revision of the NDPO has no influence on the situation and willingness of pharmacists to be involved in OAT. However, to ensure that pharmacists continue to be actively involved in OAT and attract new substituting pharmacies, their importance for comprehensive OAT must be upgraded. This includes, and not least, the funding of pharmacists' administration of substitution drugs under visual control. In addition, knowledge about OAT, attitudes toward opioid-dependent patients, and contact anxiety could be addressed by promoting educational awareness and training.

[Screening for Problematic Alcohol Consumption - A Survey on Guideline Implementation in Transdisciplinary Health Care of a Model Region]. / Screening auf problematischen Alkoholkonsum ­ Erhebung zur Umsetzung der S3-Leitlinienempfehlungen in der transdisziplinären Versorgung einer Modellregion.

AIM: Recording the frequency of screenings for problematic alcohol consumption by professionals involved in the health care of respective patients. The German S3-guideline "screening, diagnosis and treatment of alcohol-related disorders" recommends the use of questionnaire-based screenings for all patients in all settings. METHODS: Cross-sectional survey on screening frequency among general practitioners, gynecologists, psychiatrists, child- and adolescent therapists, psychotherapists, social workers and midwives. Logistic regression was used to explore how healthcare professionals' attributes were associated with the implementation of screenings. RESULTS: With response rates of about 20%, health care professionals reported using screening instruments for an average of 6.9% of all patients during the previous four weeks. Most of the time, custom-made questions were used instead of the recommended instruments (AUDIT, AUDIT-C). Higher screening rates were reported for patients with newly diagnosed hypertension (21.2%), alcohol-related disorders (43.3%) and mental disorders (39.3%). Knowledge of the guideline was associated with implementation of screenings (OR=4.67; 95% KI 1.94-11.25, p<0.001). CONCLUSIONS: Comprehensive screening for problematic alcohol use with questionnaire-based instruments in accordance with guidelines is far from being routinely implemented in the studied health care settings. Measures to increase the knowledge of the guidelines are necessary in order to increase the frequency of alcohol screening in health care.

Amphetamine-Type Stimulant Dependence and Association with Concurrent Use of Cocaine, Alcohol, and Cannabis: A Cross-Sectional Study.

INTRODUCTION: Amphetamine-type stimulants (ATSs) are the second most commonly used class of illegal substances in Europe. Although concurrent substance use has been subject to research, little is known about associations between concurrent use of cocaine, alcohol, or cannabis and ATS dependence. We expect that the concurrent use of any of the substance, especially cannabis and cocaine, is associated with ATS dependence. METHODS: Cross-sectional data were gathered within the European ATTUNE study in 2018/2019. Participants (N = 721) were asked about their consumption patterns and social, psychological, and economic situation. Multivariate logistic regressions were carried out for associations between ATS dependence and use combinations of frequent cocaine, alcohol, or cannabis, with the reference group of no frequent concurrent use (model 1). Model 2 calculated associations for ATS dependence with lifetime methamphetamine use for respective use combinations. RESULTS: The study population was on average 28.9 years old (SD = 7.7), with the majority being male (63.5%). In model 1, the adjusted odds ratio (aOR) for frequent alcohol use was 0.70 (confidence interval [CI] 0.41-1.20). Similar results were shown for model 2 (aOR 0.82, CI 0.42-1.62). Frequent cannabis use significantly reduced the chance for ATS dependence by 50% in adjusted model 1 (aOR 0.50, CI 0.28-0.89) and by 62% in model 2 (aOR 0.38, CI 0.18-0.82). For frequent cocaine use, models 1 and 2 report an aOR at 1.37 (CI 0.58-3.25) and 2.39 (CI 0.77-7.43), although not statistically significant. Frequent users of all 3 substances had a significant 3-fold chance for ATS dependence (model 1: aOR 2.98, CI 1.16-7.63; model 2: aOR 2.95, CI 1.02-8.58). DISCUSSION: Against initial hypotheses, frequent concurrent use of alcohol or cannabis generally decreased chances for ATS dependence. An explanation could be the study population, which consists of many irregular users of ATS, who mainly consume alcohol or cannabis. Cocaine generally increased chances, although results were not significant. The frequent use of all 3 substances together with ATS in the last year was significantly associated with dependence, thus reporting important information for treatment services. Further research is needed for disentangling causal relationships underlying these associations and for pinpointing consequences for relapse prevention and retention success.

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

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).

Impact of opioid agonist treatment on mental health in patients with opioid use disorder: a systematic review and network meta-analysis of randomized clinical trials.

Background: There is a knowledge gap in systematic reviews on the impact of opioid agonist treatments on mental health.Objectives: We compared mental health outcomes between different opioid agonist treatments and placebo/waitlist, and between the different opioids themselves.Methods: This meta-analysis of randomized clinical trials (RCTs) was pre-registered at PROSPERO (CRD42018109375). Embase, MEDLINE, PsychInfo, CINAHL Complete, and Web of Science Core Collection were searched from inception to May 2020. RCTs were included if they compared opioid agonists with each other or with placebo/waitlist in the treatment of patients with opioid use disorder and reported at least one mental health outcome after 1-month post-baseline. Studies with psychiatric care, adjunct psychotropic medications, or unbalanced psychosocial services were excluded. The primary outcome was overall mental health symptomatology, e.g. Symptom Checklist 90 total score, between opioids and placebo/waitlist. Random effects models were used for all the meta-analyses.Results: Nineteen studies were included in the narrative synthesis and 15 in the quantitative synthesis. Hydromorphone, diacetylmorphine (DAM), methadone, slow-release oral morphine, buprenorphine, and placebo/waitlist were among the included interventions. Based on the network meta-analysis for primary outcomes, buprenorphine (SMD (CI95%) = -0.61 (-1.20, -0.11)), DAM (-1.40 (-2.70, -0.23)), and methadone (-1.20 (-2.30, -0.11)) were superior to waitlist/placebo on overall mental health. Further direct pairwise meta-analysis indicated that overall mental health improved more in DAM compared to methadone (-0.23 (-0.34, -0.13)).Conclusions: Opioid agonist treatments used for the treatment of opioid use disorder improve mental health independent of psychosocial services.

[Opioid Substitution Treatment in Germany: Physicians' View on the Effects of the 3rd Revision of the Narcotic Drugs Prescription Ordinance]. / Die Substitutionstherapie Opioidabhängiger in Deutschland: Auswirkungen der 3. BtMVVÄndV aus der Sicht substituierender Ärztinnen und Ärzte.

STUDY AIM: Opioid substitution treatment (OST) is the most effective drug treatment for opioid dependence worldwide. This form of therapy is also well established in Germany. Nevertheless, there are gaps in the provision of care, especially in rural areas and some states, due to a decreasing number of physicians involved in implementing the substitution programs. The 3rd revision of the Narcotic Drugs Prescription Ordinance (NDPO), which came into force in 2017, transferred medical therapeutic tasks of OST to the policy-making power of the German Medical Association. This comprehensive reform of the general conditions for OST led to greater legal certainty for this form of treatment. The present study aimed to analyze the effects of the 3rd revision of the Narcotic Drugs Prescription Ordinance from the providers' perspective. METHODS: Between August and December 2019, a questionnaire on individual experiences with the changes implemented in 3rd revision of the Narcotic Drugs Prescription Ordinance was sent by the Federal Opium Agency and the Associations of Statutory Health Insurance Physicians of the chosen federal states to 2,503 physicians implementing the substitution program in Germany as well as 563 physicians in Hamburg, Bavaria, North Rhine-Westphalia and Saxony who were not or no longer involved in this field of medical practice.The evaluation distinguished between physicians with and without further training in addiction medicine and between urban and rural districts. RESULTS: The response rate of physicians was 34.1%. The average age was 57.9 (±8.7) years, and 64.5% were male. The most relevant changes of the NDPO revision were found to be no time limit for achieving opioid abstinence (85.3%), new assessment and treatment using additional psychotropic substances (71.0%), extending take-home regulation to a maximum of 30 days (70.0%) and greater legal certainty (66.2%). Widening of consultative care up to 10 patients met with little approval (14.8%); 36.7% did not believe that care of substituted patients was assured either now or in the future. CONCLUSIONS: The NDPO revisions were considered to be relevant in terms of increased legal certainty and treatment liberties. Information was needed in rural areas, among physicians who carried out substitution therapy without advanced training in addiction medicine and physicians no longer involved in substitution therapy.

Internalizing and externalizing subtypes in female patients with co-occurring post-traumatic stress disorder and substance use disorders.

BACKGROUND: Research has described subtypes with more internalizing and more externalizing symptoms in samples of patients with post-traumatic stress disorder (PTSD) and samples of patients with substance use disorders (SUD). OBJECTIVE: This study sought to examine the respective subtypes in female PTSD-SUD patients and potential relationships with substance use characteristics. METHODS: We performed a latent class analysis (LCA) in 343 adult female participants of a multisite therapy trial on PTSD and SUD. We derived externalizing symptoms from the Assessment of DSM-IV Personality Disorders (ADP-IV) questionnaire. We assessed internalization using the Symptom Checklist-27 (SCL-27) and the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I). We collected substance use-related information using the Addiction Severity Index-Lite (ASI-lite). RESULTS: LCA suggested four latent classes including an externalizing (10.8%), a moderately internalizing class (31.0%), and a highly internalizing class (22.0%), as well as a class with a low severity of psychological symptoms (36.3%). Externalizing participants used more substances than any other class, while the duration of substance use did not differ between groups. Regular use started at a significantly younger age among the members of the highly internalizing subgroup compared to the moderately internalizing and low severity participants, but at an older age compared to the externalizing group members. CONCLUSIONS: The finding of two internalizing subgroups along with an externalizing and a low severity class emphasizes the heterogeneity and complexity of populations with PTSD and SUD. This heterogeneity bears implications for research among this group of patients, but also for their treatment, especially considering our results on differences in substance use.

Predictors of attendance in outpatient group treatment for women with posttraumatic stress disorder and substance use disorder.

Objective: The present study investigated predictors of treatment attendance among 226 women with posttraumatic stress disorder (PTSD) and substance use disorder (SUD). Participants received either an integrated intervention for PTSD and SUD ("Seeking Safety") or a relapse prevention training (RPT) as part of a multicenter randomized controlled trial. Method: Beta-binomial regression was conducted to investigate baseline sociodemographic, motivational, mental health and substance use predictors of session attendance. Treatment by predictor interactions were included to identify treatment-specific predictors. Results: Session attendance was predicted by employment status, drug use severity and abstinence status. Higher drug use severity and unemployment were associated with less session attendance. The effect of abstinence status was treatment-specific, with abstinent participants in RPT attending most sessions. Conclusions: Considering individual characteristics could enhance session attendance in outpatient treatment for women with PTSD and SUD. This might include matching treatment concepts to abstinence status, the identification of attendance barriers in unemployed women and more intensive treatment settings for those with severe drug use.

Addiction Recovery Among Opioid-Dependent Patients Treated With Injectable Subcutaneous Depot Buprenorphine: Study Protocol of a Non-randomized Prospective Observational Study (ARIDE).

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.

Controlled administration of cannabis to mitigate cannabis-attributable harm among recreational users: a quasi-experimental study in Germany.

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.