Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

Keynote webinar | Spotlight on medication adherence

LIVE: Thursday 27th June 2024, 18:00-19:30 (CEST)
Join our expert panel to discover why you need to understand the drivers of non-adherence in your patients, and how you can optimize medication adherence in your clinics to drastically improve patient outcomes.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2022

Open Access 01-12-2022 | Opioids | Study protocol

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

Authors: Karl Trygve Druckrey-Fiskaaen, Einar Furulund, Jan Tore Daltveit, Jørn Henrik Vold, Torgeir Gilje Lid, Tesfaye Madebo, Lars Thore Fadnes, for the ATLAS4LAR Study Group

Published in: Trials | Issue 1/2022

Login to get access

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
Literature
1.
Forouzanfar MH, Alexander L, Anderson HR, Bachman VF, Biryukov S, Brauer M, 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):2287–323.CrossRefPubMed
2.
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):1736–88.CrossRef
3.
Inoue-Choi M, Christensen CH, Rostron BL, Cosgrove CM, Reyes-Guzman C, Apelberg B, et al. Dose-response association of low-intensity and nondaily smoking with mortality in the United States. JAMA Netw Open. 2020;3(6):e206436.CrossRefPubMedPubMedCentral
4.
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):363–71.CrossRefPubMed
5.
Hayes RD, Chang CK, Fernandes A, Broadbent M, Lee W, Hotopf M, et al. 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.CrossRefPubMed
6.
Lewer D, Jones NR, Hickman M, Nielsen S, Degenhardt L. Life expectancy of people who are dependent on opioids: a cohort study in New South Wales, Australia. J Psychiatr Res. 2020;130:435–40.CrossRefPubMed
7.
Rehm J, Manthey J, Shield KD, Ferreira-Borges C. Trends in substance use and in the attributable burden of disease and mortality in the WHO European Region, 2010-16. Eur J Public Health. 2019;29(4):723–8.CrossRefPubMed
8.
Westman J, Wahlbeck K, Laursen TM, Gissler M, Nordentoft M, Hällgren J, et al. Mortality and life expectancy of people with alcohol use disorder in Denmark, Finland and Sweden. Acta Psychiatr Scand. 2015;131(4):297–306.CrossRefPubMed
9.
Aas CF, Vold JH, Skurtveit S, Lim AG, Ruths S, Islam K, et al. Health-related quality of life of long-term patients receiving opioid agonist therapy: a nested prospective cohort study in Norway. Subst Abuse Treat Prev Policy. 2020;15(1):68.CrossRefPubMedPubMedCentral
10.
Guydish J, Passalacqua E, Pagano A, Martinez C, Le T, Chun J, et al. An international systematic review of smoking prevalence in addiction treatment. Addiction. 2016;111(2):220–30.CrossRefPubMed
11.
Bech AB, Clausen T, Waal H, Delaveris GJM, Skeie I. Organ pathologies detected post-mortem in patients receiving opioid agonist treatment for opioid use disorder: a nation-wide 2-year cross-sectional study. Addiction. 2022;117(4):977–85.CrossRefPubMed
12.
Mehta S, Parmar N, Kelleher M, Jolley CJ, White P, Durbaba S, et al. COPD and asthma in patients with opioid dependency: a cross-sectional study in primary care. NPJ Prim Care Respir Med. 2020;30(1):4.CrossRefPubMedPubMedCentral
13.
Apollonio D, Philipps R, Bero L. Interventions for tobacco use cessation in people in treatment for or recovery from substance use disorders. Cochrane Database Syst Rev. 2016;11:CD010274.PubMed
14.
Guydish J, Kapiteni K, Le T, Campbell B, Pinsker E, Delucchi K. Tobacco use and tobacco services in California substance use treatment programs. Drug Alcohol Depend. 2020;214:108173.CrossRefPubMedPubMedCentral
15.
16.
Yee A, Hoong MC, Joyce YC, Loh HS. Smoking cessation among methadone-maintained patients: a meta-analysis. Subst Use Misuse. 2018;53(2):276–85.CrossRefPubMed
17.
Notley C, Gentry S, Livingstone-Banks J, Bauld L, Perera R, Hartmann-Boyce J. Incentives for smoking cessation. Cochrane Database Syst Rev. 2019;7(7):CD004307.PubMed
18.
Lindson-Hawley N, Thompson TP, Begh R. Motivational interviewing for smoking cessation. Cochrane Database Syst Rev. 2015;3:CD006936.
19.
Patnode CD, Henderson JT, Coppola EL, Melnikow J, Durbin S, Thomas RG. Interventions for tobacco cessation in adults, including pregnant persons: updated evidence report and systematic review for the US Preventive Services Task Force. Jama. 2021;325(3):280–98.CrossRefPubMed
20.
Park ER, Perez GK, Regan S, Muzikansky A, Levy DE, Temel JS, et al. Effect of sustained smoking cessation counseling and provision of medication vs shorter-term counseling and medication advice on smoking abstinence in patients recently diagnosed with cancer: a randomized clinical trial. Jama. 2020;324(14):1406–18.CrossRefPubMedPubMedCentral
21.
Hall SM, Humfleet GL, Gasper JJ, Delucchi KL, Hersh DF, Guydish JR. Cigarette smoking cessation intervention for buprenorphine treatment patients. Nicotine Tob Res. 2018;20(5):628–35.CrossRefPubMed
22.
Strand BH, Dalgard OS, Tambs K, Rognerud M. Measuring the mental health status of the Norwegian population: a comparison of the instruments SCL-25, SCL-10, SCL-5 and MHI-5 (SF-36). Nord J Psychiatry. 2003;57(2):113–8.CrossRefPubMed
23.
Vieira EB, Degani-Costa LH, Amorim BC, Oliveira LB, Miranda-Silva T, Sperandio PC, et al. Modified BODE index to predict mortality in individuals with COPD: the role of 4-min step test. Respir Care. 2020;65(7):977–83.CrossRefPubMed
24.
Peak J, Goranitis I, Day E, Copello A, Freemantle N, Frew E. Predicting health-related quality of life (EQ-5D-5 L) and capability wellbeing (ICECAP-A) in the context of opiate dependence using routine clinical outcome measures: CORE-OM, LDQ and TOP. Health Qual Life Outcomes. 2018;16(1):106.CrossRefPubMedPubMedCentral
25.
Vold JH, Gjestad R, Aas CF, Meland E, Johansson KA, Fadnes LT. Validation of a three-item Fatigue Severity Scale for patients with substance use disorder: a cohort study from Norway for the period 2016-2020. Health Qual Life Outcomes. 2021;19(1):69.CrossRefPubMedPubMedCentral
26.
Hajiro T, Nishimura K, Tsukino M, Ikeda A, Koyama H, Izumi T. Analysis of clinical methods used to evaluate dyspnea in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 1998;158(4):1185–9.CrossRefPubMed
27.
Craig CL, Marshall AL, Sjöström M, Bauman AE, Booth ML, Ainsworth BE, et al. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003;35(8):1381–95.CrossRefPubMed
28.
Calvert M, Kyte D, Mercieca-Bebber R, Slade A, Chan AW, King MT, et al. Guidelines for inclusion of patient-reported outcomes in clinical trial protocols: the SPIRIT-PRO extension. Jama. 2018;319(5):483–94.CrossRefPubMed
29.
Welch VA, Norheim OF, Jull J, Cookson R, Sommerfelt H, Tugwell P. CONSORT-Equity 2017 extension and elaboration for better reporting of health equity in randomised trials. Bmj. 2017;359:j5085.CrossRefPubMed
30.
Moher D, Schulz KF, Altman DG. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials. Lancet. 2001;357(9263):1191–4.CrossRefPubMed
31.
Hartmann-Boyce J, Chepkin SC, Ye W, Bullen C, Lancaster T. Nicotine replacement therapy versus control for smoking cessation. Cochrane Database Syst Rev. 2018;5(5):Cd000146.PubMed
32.
Nahvi S, Adams TR, Ning Y, Zhang C, Arnsten JH. Effect of varenicline directly observed therapy versus varenicline self-administered therapy on varenicline adherence and smoking cessation in methadone-maintained smokers: a randomized controlled trial. Addiction. 2021;116(4):902–13.CrossRefPubMed
33.
Fadnes LT, Aas CF, Vold JH, Leiva RA, Ohldieck C, Chalabianloo F, et al. Integrated treatment of hepatitis C virus infection among people who inject drugs: a multicenter randomized controlled trial (INTRO-HCV). PLoS Med. 2021;18(6):e1003653.CrossRefPubMedPubMedCentral
34.
Vijayaraghavan M, Elser H, Frazer K, Lindson N, Apollonio D. Interventions to reduce tobacco use in people experiencing homelessness. Cochrane Database Syst Rev. 2020;12(12):CD013413.PubMed
35.
36.
Metadata
Title
Integration of smoking cessation into standard treatment for patients receiving opioid agonist therapy who are smoking tobacco: protocol for a randomised controlled trial (ATLAS4LAR)
Authors
Karl Trygve Druckrey-Fiskaaen
Einar Furulund
Jan Tore Daltveit
Jørn Henrik Vold
Torgeir Gilje Lid
Tesfaye Madebo
Lars Thore Fadnes
for the ATLAS4LAR Study Group
Publication date
01-12-2022
Publisher
BioMed Central
Keywords
Opioids
Opioids
Published in
Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-022-06560-x

Other articles of this Issue 1/2022

Trials 1/2022 Go to the issue

Study protocol

Effect of mobile-based cognitive behavior therapy (CBT) on lowering of blood lipid levels in atherosclerotic cardiovascular disease (ASCVD) patients: study protocol for a multicenter, prospective, randomized controlled trial

Study protocol

Effect of electroacupuncture on discomfort during gastroscopy: a study protocol for a randomized controlled trial

Study protocol

A multicomponent family support intervention in intensive care units: study protocol for a multicenter cluster-randomized trial (FICUS Trial)

Study protocol

A socio-ecological approach to reduce the physical activity drop-out ratio in primary care-based patients with type 2 diabetes: the SENWI study protocol for a randomized control trial

Study protocol

A double-blind clinical trial to compare the efficacy and safety of a multiple amino acid-based ORS with the standard WHO-ORS in the management of non-cholera acute watery diarrhea in infants and young children: “VS002A” trial protocol

Study protocol

Study protocol for comparing Screening, Brief Intervention, and Referral to Treatment (SBIRT) to referral as usual for depression in African American churches