Druckrey-Fiskaaen, Karl Trygve and Furulund, Einar and Daltveit, Jan Tore and Vold, Jørn Henrik and Lid, Torgeir Gilje and Madebo, Tesfaye and Fadnes, Lars Thore (2022) Integration of smoking cessation into standard treatment for patients receiving opioid agonist therapy who are smoking tobacco: protocol for a randomised controlled trial (ATLAS4LAR). Trials, 23, 663. doi: 10.1186/s13063-022-06560-x.
External website: https://trialsjournal.biomedcentral.com/articles/1...
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.
G Health and disease > State of health > Physical health
HJ Treatment or recovery method > Substance disorder treatment method > Substance replacement method (substitution) > Opioid agonist treatment (methadone maintenance / buprenorphine)
HJ Treatment or recovery method > Substance disorder treatment method > Cessation of tobacco use
J Health care, prevention, harm reduction and treatment > Patient / client care management
J Health care, prevention, harm reduction and treatment > Treatment and maintenance > Treatment factors
VA Geographic area > Europe > Norway
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