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. 2022 Aug 17;23(1):663.
doi: 10.1186/s13063-022-06560-x.

Integration of smoking cessation into standard treatment for patients receiving opioid agonist therapy who are smoking tobacco: protocol for a randomised controlled trial (ATLAS4LAR)

Karl Trygve Druckrey-Fiskaaen  1   2 , Einar Furulund  3   4   5 , Jan Tore Daltveit  3 , Jørn Henrik Vold  3   4   6 , Torgeir Gilje Lid  5 , Tesfaye Madebo  3   7 , Lars Thore Fadnes  3   4 ; ATLAS4LAR Study Group
Collaborators, Affiliations

Integration of smoking cessation into standard treatment for patients receiving opioid agonist therapy who are smoking tobacco: protocol for a randomised controlled trial (ATLAS4LAR)

Karl Trygve Druckrey-Fiskaaen et al. Trials. .

Abstract

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.

Keywords: Behavioural intervention; Nicotine replacement; Opiate substitution treatment; Smoking cessation; Substance abuse treatment centres.

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Timeline for nicotine replacement therapy component of the smoking cessation intervention. Remarks: The blue columns indicate evaluation points
See this image and copyright information in PMC

References

    1. Forouzanfar MH, Alexander L, Anderson HR, Bachman VF, Biryukov S, Brauer M, Burnett R, Casey D, Coates MM, Cohen A, et al. Global, regional, and national comparative risk assessment of 79 behavioural, environmental and occupational, and metabolic risks or clusters of risks in 188 countries, 1990-2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet. 2015;386(10010):2287–2323. doi: 10.1016/S0140-6736(15)00128-2. - DOI - PMC - PubMed
    1. Collaborators GBDCoD Global, regional, and national age-sex-specific mortality for 282 causes of death in 195 countries and territories, 1980-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2018;392(10159):1736–1788. doi: 10.1016/S0140-6736(18)32203-7. - DOI - PMC - PubMed
    1. Inoue-Choi M, Christensen CH, Rostron BL, Cosgrove CM, Reyes-Guzman C, Apelberg B, Freedman ND. Dose-response association of low-intensity and nondaily smoking with mortality in the United States. JAMA Netw Open. 2020;3(6):e206436. doi: 10.1001/jamanetworkopen.2020.6436. - DOI - PMC - PubMed
    1. Inoue-Choi M, Hartge P, Park Y, Abnet CC, Freedman ND. Association between reductions of number of cigarettes smoked per day and mortality among older adults in the United States. Am J Epidemiol. 2019;188(2):363–371. doi: 10.1093/aje/kwy227. - DOI - PMC - PubMed
    1. Hayes RD, Chang CK, Fernandes A, Broadbent M, Lee W, Hotopf M, Stewart R. Associations between substance use disorder sub-groups, life expectancy and all-cause mortality in a large British specialist mental healthcare service. Drug Alcohol Depend. 2011;118(1):56–61. doi: 10.1016/j.drugalcdep.2011.02.021. - DOI - PubMed

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