Bergen Addiction Research, Department of Addiction Medicine, Haukeland University Hospital, Bergen, Norway.
Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway.
Trials. 2022 Aug 17;23(1):663. doi: 10.1186/s13063-022-06560-x.
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.
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.
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.
ClinicalTrials.gov NCT05290025. Registered on 22 March 2022.
大约 85%接受阿片类激动剂治疗（OAT）的阿片类药物依赖患者吸烟。尽管与吸烟有关的肺部疾病是发病率和死亡率的重要原因，但在这一人群中很少评估戒烟干预措施，也很少将戒烟作为其成瘾治疗的一个综合部分提供给 OAT 患者。本研究方案描述了一种针对接受 OAT 且吸烟的患者的综合戒烟干预措施。
这是一项多中心、随机对照临床试验，将在挪威卑尔根和斯塔万格的 OAT 门诊招募 266 名每天吸烟的接受 OAT 的烟草使用者。随机分配到干预组的患者将接受每周一次的简短行为干预和非处方尼古丁替代产品的戒烟治疗。在对照组中，患者将接受标准护理，而不会进行任何与戒烟相关的额外干预。戒烟干预措施包括来自动机访谈的心理教育技术以及尼古丁贴片、尼古丁咀嚼胶等尼古丁替代产品。干预持续 16 周，可选择再延长 8 周。主要结局在干预开始后 16 周测量，持续效果在干预开始后 1 年评估。主要结局是通过一氧化碳（CO）水平或吸烟量至少减少 50%来验证的戒烟。次要结局是心理幸福感、生化炎症标志物、身体健康变化、生活质量和疲劳的变化。
将其他治疗方法整合到标准 OAT 护理中可提高依从性和完成率，为综合戒烟治疗提供了另一个理由。因此，如果综合戒烟治疗优于标准护理，那么这项试验提供了关于进一步推广的重要信息。
ClinicalTrials.gov NCT05290025。于 2022 年 3 月 22 日注册。
