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 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.
BackgroundFor people with opioid dependence in Norway, chronic hepatitis C virus (HCV) infections contribute to high mortality and high morbidity. Around 50% of patients in medically assisted rehabilitation (MAR) have been shown to have HCV, and the current prevention and control efforts have been mostly unsuccessful. Thus, there is a need for new strategies for people-centred service delivery and innovative methods to improve health outcomes.MethodsOver the last few years, the city of Bergen, Norway, has developed a cross-sector collaboration with substantial peer involvement in research and health provision related to substance use. User group representatives for people receiving MAR, addiction medicine health personnel, infectious disease specialists, policy makers in the municipality, low-threshold health care centres for people with substance use disorders in Bergen Municipality and researchers in the INTRO-HCV project have made concerted efforts in this regard. We will present here some of the strategies and steps we have taken.ResultsWe have established an integrated HCV treatment scheme for people who inject drugs or who have opioid dependence. More than 800 persons have been tested for HCV within these frames, and more than 250 persons have been given treatment for HCV within the project. The integrated treatment of HCV is offered both in MAR outpatient clinics, municipal low-threshold healthcare centres, and local and regional prisons. The preliminary results indicate an increase in HCV treatment uptake among those receiving integrated treatment (96% initiating treatment compared to 75%). The user group organisation ProLAR Nett has established an outreach service to screen for HCV, increase awareness and reduce the proportion of people unknowingly living with HCV while informing and motivating people to receive treatment. Together with the other stake holders, peer user group, health care, research planning, concert events, and policy panels have been held.ConclusionsPeer involvement seems to have increased testing rates for HCV and acknowledgment of its importance. This seems to have improved health care for people with opioid dependence in Bergen over the last few years, particularly relating to the treatment of HCV. These experiences might be helpful in the planning of integrated policies in other settings that seek to eliminate the HCV endemic.
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