Evaluation of heroin-assisted treatment in Norway: protocol for a mixed methods study.

BACKGROUND: Opioid agonist treatment (OAT) for patients with opioid use disorder (OUD) has a convincing evidence base, although variable retention rates suggest that it may not be beneficial for all. One of the options to include more patients is the introduction of heroin-assisted treatment (HAT), which involves the prescribing of pharmaceutical heroin in a clinical supervised setting. Clinical trials suggest that HAT positively affects illicit drug use, criminal behavior, quality of life, and health. The results are less clear for longer-term outcomes such as mortality, level of function and social integration. This protocol describes a longitudinal evaluation of the introduction of HAT into the OAT services in Norway over a 5-year period. The main aim of the project is to study the individual, organizational and societal effects of implementing HAT in the specialized healthcare services for OUD. METHODS: The project adopts a multidisciplinary approach, where the primary cohort for analysis will consist of approximately 250 patients in Norway, observed during the period of 2022-2026. Cohorts for comparative analysis will include all HAT-patients in Denmark from 2010 to 2022 (N = 500) and all Norwegian patients in conventional OAT (N = 8300). Data comes from individual in-depth and semi-structured interviews, self-report questionnaires, clinical records, and national registries, collected at several time points throughout patients' courses of treatment. Qualitative analyses will use a flexible inductive thematic approach. Quantitative analyses will employ a wide array of methods including bi-variate parametric and non-parametric tests, and various forms of multivariate modeling. DISCUSSION: The project's primary strength lies in its comprehensive and longitudinal approach. It has the potential to reveal new insights on whether pharmaceutical heroin should be an integral part of integrated conventional OAT services to individually tailor treatments for patients with OUD. This could affect considerations about drug treatment even beyond HAT-specific topics, where an expanded understanding of why some do not succeed with conventional OAT will strengthen the knowledge base for drug treatment in general. Results will be disseminated to the scientific community, clinicians, and policy makers. TRIAL REGISTRATION: The study was approved by the Norwegian Regional Committee for Medical and Health Research Ethics (REK), ref.nr.:195733.

Who receives heroin-assisted treatment? A comparison of patients receiving opioid maintenance treatment in Denmark.

BACKGROUND: Since 2010, heroin-assisted treatment (HAT) has been one of the treatment options available to people with opioid use disorder (OUD) in Denmark. This study aimed to characterize HAT patients at treatment start and compare their individual characteristics to those of patients entering traditional opioid maintenance treatment (OMT) with methadone or buprenorphine during the same period. METHODS: Patients who initiated HAT or OMT with methadone or buprenorphine in Denmark from 2010 to 2018 were included (n=6798). Multiple national registers were linked to compare treatment groups in terms of socio-demographic variables, previous OUD treatment episodes, hospital-based care, and criminal conviction history. RESULTS: Nearly all HAT patients had a history of methadone treatment (91%) and half had residential treatment experience (48%). In the year previous to admission, HAT patients recorded the highest percentages of non-fatal overdoses (12%) and chronic hepatitis C diagnoses (16%), and the lowest percentages of psychiatric disorders (11%) compared to traditional OMT patients. Criminal convictions were also common: 39% of the HAT group had committed a property crime and 18% a drug-related crime the year before HAT entry. During the study period, an overall reduction in OMT enrollments for each year was recorded. The HAT proportion to the total remained fairly stable (4%-10%), while the buprenorphine proportion increased. CONCLUSIONS: In Denmark, OMT patients exhibited numerous vulnerabilities at treatment start, and among the patient groups, HAT patients were the most burdened. HAT seems to reach the target group and adhere to formulated eligibility criteria.

Adolescents' Psychoactive Substance Use During the First COVID-19 Lockdown: A Cross Sectional Study in Italy.

Background: Italy was one of the first European countries to be affected by Covid-19. Due to the severity of the pandemic, the Italian government imposed a nationwide lockdown which had a great impact on the population, especially adolescents. Distance-learning, moving restrictions and pandemic-related concerns, resulted in a particularly stressful situation. Objective: This cross-sectional study aims to analyse substance consumption and its associated factors during the Covid-19 lockdown imposed by the Italian government. Methods: ESPAD is a questionnaire that is administered yearly in Italian high schools. In 2020, it was administered online during dedicated hours of distance learning, collecting data from 6027 Italian students (52.4% were male) aged 15-19. Data collected from the 2020 questionnaire was matched with that collected in 2019, in order to make them comparable. Results: The prevalence of consumption of each substance decreased during the restriction period, and the most used substance during the lockdown period was alcohol (43.1%). There were some changes in factors associated with psychoactive substance use, especially painkillers and non-prescription drugs. For instance, unlike what was observed in the 2019 model, in 2020 spending money without parental control was associated with painkillers and non-prescription drug use while risk perception was not. Conclusions: The restrictions and the increased difficulties in obtaining psychoactive substances did not prevent their consumption, and students with particular risk factors continued to use them, possibly changing the substance type of substance. This information is useful in order to better understand adolescents' substance use during the ongoing pandemic.

Efficacy of intravenous tramadol treatment for reducing pain during office diagnostic hysteroscopy.

OBJECTIVE: To assess whether IV tramadol before outpatient hysteroscopy could reduce procedure-related pain. DESIGN: A randomized double-blind placebo controlled trial. SETTING: Outpatient Hysteroscopy Centre in the Department of Obstetrics and Gynaecology of Cagliari University. PATIENT(S): Fifty healthy, parous, women who underwent outpatient diagnostic hysteroscopy and endometrial biopsy. INTERVENTION(S): Random IV infusion of tramadol or placebo before hysteroscopy and endometrial biopsy were performed. MAIN OUTCOME MEASURE(S): Visual analogue scale of pain was measured both immediately after and 15 minutes after the procedure. Stress hormones (ACTH, cortisol), blood pressure, and heart frequency were evaluated before, during, and 15 minutes after the procedure. RESULT(S): In the tramadol group, the visual analogue scale of pain was significantly lower than in the placebo group both immediately after the procedure and 15 minutes later. Basal levels of ACTH and cortisol did not differ between the groups. In both groups, the ACTH levels remained unchanged during the study, and the cortisol levels were higher 15 minutes after the procedure than before the procedure. Procedure time, heart frequency, blood pressure, and adverse effects did not differ between the groups. CONCLUSION(S): In parous women without uterine malformations, a treatment with tramadol before hysteroscopy and endometrial biopsy appears to be capable of reducing the pain and discomfort that are associated with this procedure.