Background About 85% of patients receiving opioid agonist therapy (OAT) for opioid dependence are smoking tobacco. Although smoke-related pulmonary diseases are significant contributors to morbidity and mortality, few smoking cessation interventions are evaluated within this group, and few OAT patients are offered smoking cessation as an integrated part of their addiction treatment. This study protocol describes an integrated smoking cessation intervention aimed at patients receiving OAT and smoking tobacco. Methods This is a multicentre, randomised controlled clinical trial that will recruit 266 daily tobacco smoking patients receiving OAT in OAT outpatient clinics in Bergen and Stavanger, Norway. The patients randomised for the intervention arm will be offered smoking cessation therapy consisting of weekly brief behavioural interventions and prescription-free nicotine replacement products. In the control arm, patients will receive standard care without any added interventions related to smoking cessation. The smoking cessation intervention includes psychoeducational techniques with components from motivational interviewing, and nicotine replacement products such as nicotine lozenges, patches, and chewing gum. The duration of the intervention is 16 weeks, with the option of extending it by a further 8 weeks. The main outcomes are measured at 16 weeks after initiation of the intervention, and sustained effects are evaluated 1 year after intervention initiation. The primary outcome is smoking cessation verified by carbon monoxide (CO) levels or at least a 50% reduction in the number of cigarettes smoked. Secondary outcomes are changes in psychological well-being, biochemical inflammation markers, changes in physical health, quality of life, and fatigue. Discussion Integration of other treatments to standard OAT care improves adherence and completion rates providing another rationale for integrated smoking cessation treatment. Thus, if integrated smoking cessation treatment is superior to standard care, this trial provides important information on further scale-up. Trial registration ClinicalTrials.gov NCT05290025. Registered on 22 March 2022
Background: High alcohol intake has been associated with increased risk of hospital admission, increased complication rates, and prolonged hospital stay. Thus, hospital admission may present a relevant opportunity for alcohol intervention. To understand the potential of alcohol interventions we need knowledge about patients' drinking patterns. The aim of this study was therefore to determine the drinking patterns in a Norwegian hospital population. Methods: A multicentre cross-sectional survey was carried out at three university hospitals. Patients were asked about alcohol intake one month prior to admission/outpatient treatment. The questionnaire included weekly alcohol intake calculated by frequency X quantity as well as episodes of binge drinking (drinking more than 5 AU during a single day). AUDIT-C was used to determine the frequency of patients having a hazardous drinking pattern during the 12 months prior to hospital treatment. Results: In total we assessed 2,932 patients for eligibility. A total of 2,350 patients fulfilled the inclusion criteria. We included 1,522 patients (65%) in the analyses. Six percent of the women and 11% of the men reported drinking more than the weekly limits of nine alcohol units (AU) for women and 14 AU for men. Fourteen percent of the women and 29% of the men reported binge drinking during the last month. The frequency of women scoring more or equal to 4 points on AUDIT-C was 20%. The frequency of men scoring more or equal to 5 points was 25%. Conclusion: Hazardous drinking among Norwegian hospital patients may be more prevalent than what has been reported for the Norwegian population in general. Binge drinking is the dominant drinking pattern.
Background People with substance use disorders generally have unhealthy diets, including limited intake of fruit and vegetables. Evidence shows substantial health benefits from increasing fruit and vegetable consumption on various indicators and possibly also psychological distress. A pilot study has indicated that supplementation with fruit smoothie could be promising also among people receiving opioid agonist therapy for opioid dependence. FruktBAR will compare the efficacy of added fruit smoothie supplementation to people receiving opioid agonist therapy compared to standard treatment without added supplementation. Methods FruktBAR is a multicentre, randomised controlled trial. The trial will aim to recruit 302 patients receiving opioid agonist therapy. The intervention involves daily supplementation with 250 ml fruit smoothie including a variety of fruits such as apple, pineapple, mango, bananas, orange, blueberries, passion fruit, coconut, lime, and blackcurrant. The main endpoints are 16 weeks after intervention initiation. Participants will be included and followed up during and after the intervention. The target group will be patients with opioid dependence receiving opioid agonist therapy from involved outpatient clinics in Bergen and Stavanger, two of the largest cities in Norway. The main outcome is psychological distress assessed with Hopkins Symptom Checklist (SCL-10) at the end of the intervention period 16 weeks after initiation, and will be compared between the intervention and control arms. Secondary outcome measures are changes in fatigue, physical functioning assessed with a 4-minute step-test, health-related quality of life, biochemical indicators of inflammation, and biochemical indicators of fruit intake. Discussion This study will inform on the relative advantages or disadvantages of fruit supplementation in addition to the current medically and psychologically oriented treatment of people receiving opioid agonist therapy. If the supplementation is efficacious, it can be considered for further scale-up. Trial registration Registered 2022-02-08 in ClinicalTrials.gov, identifier NCT05229770.
Background: About 85% of patients receiving opioid agonist therapy (OAT) for opioid dependence are smoking tobacco. Although smoke-related pulmonary diseases are significant contributors to morbidity and mortality, few smoking cessation interventions are evaluated within this group, and few OAT patients are offered smoking cessation as an integrated part of their addiction treatment. This study protocol describes an integrated smoking cessation intervention aimed at patients receiving OAT and smoking tobacco.Methods: This is a multicentre, randomised controlled clinical trial that will recruit 266 daily tobacco smoking patients receiving OAT in OAT outpatient clinics in Bergen and Stavanger, Norway. The patients randomised for the intervention arm will be offered smoking cessation therapy consisting of weekly brief behavioural interventions and prescription-free nicotine replacement products. In the control arm, patients will receive standard care without any added interventions related to smoking cessation.The smoking cessation intervention includes psychoeducational techniques with components from motivational interviewing, and nicotine replacement products such as nicotine lozenges, patches and chewing gum. The duration of the intervention is 16 weeks, with the option of extending it with a further eight weeks. The main outcomes are measured at 16 weeks after initiation of the intervention, and sustained effects are evaluated one year after intervention initiation. The primary outcome is smoking cessation verified by carbon monoxide (CO)-levels or at least a 50% reduction in the number of cigarettes smoked. Secondary outcomes are changes in psychological well-being, biochemical inflammation markers, changes in physical health functioning, quality of life and fatigue. Discussion: Integration of other treatments to standard OAT care improves adherence and completion rates providing another rationale for integrated smoking cessation treatment. Thus, if integrated smoking cessation treatment is superior to standard care, this trial provides important information on further scale-up. Trial registration: ClinicalTrials.gov NCT05290025, Date of registry 22. March 2022
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