2020 Guidelines for treating tobacco dependence English Edition 0roe occ fcn 2sae ebd non 0elig tpe 2uidtinde Ga e r t d Tobacco g-ensp.eu/ n n © 2020European Network for Smoking aPrevention aisbl (ENSP) Chaussée d’Ixelles 144 B-1050 Brussels, Belgium Tel.: +32 2 2306515 Fax: +32 2 2307507 E-mail: [email protected] Internet: www.ensp.orgE-learning platform: http://elearni ISBN: 978-2-930966-05-2 7890 3344444777889001111123 5666777778 Table of contents Acknowledgements .............................................................................................................................................................Declarations of Interests ....................................................................................................................................................Level of evidence of recommendations in the guidelines ................................................................................................Preface ...............................................................................................................................................................................1 PART ONE1.0 Assessment of tobacco use and tobacco dependence ..............................................................................................1 1.1 Tobacco use is a disease .....................................................................................................................................................1 1.2 Definitions, classifications, terms and specific explanations ....................................................................................... 1 1.2.1 Tobacco dependence: an acquired industrial disease ................................................................................................ 1 1.2.2 Mechanism of induction of tobacco dependence ......................................................................................................... 1 1.2.3 Nicotine is not the only driver of tobacco dependence ............................................................................................... 1 1.2.4 Nicotine dependence according to WHO ....................................................................................................................... 1 1.3 Smoking is a chronic relapsing disease .......................................................................................................................... 1 1.3.1 Relapse patterns .............................................................................................................................................................. 1 1.3.2 Treatment of tobacco dependence after cessation ...................................................................................................... 1 1.4 Routine identification of smokers is mandatory in current medical practice ............................................................ 1 1.5 Assessment/diagnosis of tobacco use and dependence .............................................................................................. 1 1.5.1. Clinical diagnosis of tobacco use and dependence .................................................................................................... 1 1.5.2 Analysis of previous quit smoking attempts ............................................................................................................... 2 1.5.3 Motivation to quit smoking .............................................................................................................................................. 2 1.5.4 Patient’s medical history ................................................................................................................................................. 2 1.5.5 Pregnancy/ Breast Feeding/ Contraception ................................................................................................................. 2 1.5.6 Patient’s anxiety and depression history ...................................................................................................................... 2 1.5.6.1 Initial Screening ............................................................................................................................................................. 2 1.5.6.2 Clinical Assessment of Anxiety and Depression ...................................................................................................... 2 1.5.7 Laboratory diagnosis of tobacco dependence ............................................................................................................. 2 References ................................................................................................................................................................................. 2 2.0 General recommendations for the treatment of tobacco use and tobacco dependence ........................................2 2.1 Tobacco use .......................................................................................................................................................................... 2 2.2 Tobacco dependence disease ............................................................................................................................................ 2 2.3 Smoking cessation ............................................................................................................................................................. 2 2.3.1 Therapeutic education ..................................................................................................................................................... 2 2.3.2 Behavioural support ........................................................................................................................................................ 2 2.3.3 Medications ....................................................................................................................................................................... 2 2.3.4 Tobacco cessation ............................................................................................................................................................ 2 2.4 Treatment of tobacco dependence after cessation ......................................................................................................... 2 2.5 Prevention of relapse .......................................................................................................................................................... 2 3 8 90001112 35569901112335567999900114455777 2 23333333 33333344444444444444455555555555 References ................................................................................................................................................................................. 0 Brief advice on stopping tobacco use .........................................................................................................................3.1 General recommendations ................................................................................................................................................ 3.2 Intervention plan for medical personnel involved in assisting smokers .................................................................... 3.3 Recommendations for general practitioners .................................................................................................................. 3.4 Recommendation for hospitalized patients .................................................................................................................... 3.5 Recommendation for pregnant women .......................................................................................................................... 3.6 Recommendation for patients with elective surgery ..................................................................................................... References .................................................................................................................................................................................. ART TWO0 Standard tobacco treatment interventions ................................................................................................................4.1. Therapeutic interventions for tobacco use and tobacco dependence ........................................................................ 4.1.1 Therapeutic intervention to stop smoking is mandatory ........................................................................................... 4.1.2 Standard approach to quitting smoking ....................................................................................................................... 4.1.3 Effectiveness of treatment for tobacco use and dependence (Assist ....................................................................... 4.1.4 Follow-up Support (Arrange .......................................................................................................................................... 4.1.5 Health care systems approach for tobacco use and dependence treatments ....................................................... 4.1.6 Types of smoking cessation interventions ................................................................................................................... 4.1.6.1 Minimal (brief advice .................................................................................................................................................... 4.1.6.2 Specialized individual interventions towards stopping smoking ........................................................................... References ................................................................................................................................................................................. 4.2 Behavioural Counselling .................................................................................................................................................... 4.2.1 Psychological support for smoking cessation ............................................................................................................. References ................................................................................................................................................................................. 4.2.2 Cognitive-behavioural therapy (CBT) ............................................................................................................................. References ................................................................................................................................................................................. 4.2.3 Motivational interviewing (MI .......................................................................................................................................... References ................................................................................................................................................................................. 4.2.4 Delivery Format ................................................................................................................................................................ 4.2.4.1 Individual smoking cessation counselin.................................................................................................................... 4.2.4.2 Group smoking cessation counseling ....................................................................................................................... References ................................................................................................................................................................................. 4.2.4.3 Telephone support and quit lines ............................................................................................................................... References ................................................................................................................................................................................. 4.2.4.4 Self-help materials ....................................................................................................................................................... References ................................................................................................................................................................................. 4.2.4.5 Computer/web-based .................................................................................................................................................. References ................................................................................................................................................................................. 4.3 Pharmacological treatment of tobacco dependence ..................................................................................................... 4.3.1. Treatment with NRT ........................................................................................................................................................ 4.3.1.1 Indications .......................................................................................................................................................................4.3.1.2 Mechanism of action ...................................................................................................................................................... 4 3. P4. 89012347780111222567811124577912223445558 94 4.3.1.3 Clinical evidence for the efficacy of NRT .....................................................................................................................54.3.1.4 NRT Patch ........................................................................................................................................................................54.3.1.5 Oral nicotine replacement.............................................................................................................................................64.3.1.6 Prescribing instructions ................................................................................................................................................64.3.1.7 Contra-indications ..........................................................................................................................................................64.3.1.8 Adverse effects, precautions, warnings, drug interactions .....................................................................................64.3.2 Treatment with bupropion SR ........................................................................................................................................ 64.3.3 Treatment with varenicline ............................................................................................................................................. 64.3.3.1 Mechanism of action ......................................................................................................................................................64.3.3.2 Clinical evidence for efficacy of varenicline ................................................................................................................64.3.3.3 Varenicline in combination pharmacotherapy ..........................................................................................................74.3.3.4 Varenicline and counselling .........................................................................................................................................74.3.3.5 Indications .......................................................................................................................................................................74.3.3.6 Clinical use ......................................................................................................................................................................74.3.3.7 Contraindications............................................................................................................................................................74.3.3.8 Precautions imposed by varenicline therapy .............................................................................................................74.3.3.9 Tolerability and safety ....................................................................................................................................................74.3.4 Treatment with clonidine ................................................................................................................................................. 74.3.5 Treatment with nortriptyline ........................................................................................................................................... 74.3.6 Cytisine................................................................................................................................................................................7References ................................................................................................................................................................................. 74.4 Individualized therapeutic schemes ................................................................................................................................. 84.4.1 Combination of pharmacological therapies ................................................................................................................. 84.4.1.1 General principles of combination pharmacotherapy ..............................................................................................84.4.1.2 Combination of nicotine replacement therapy (NRT) ................................................................................................8References ................................................................................................................................................................................. 84.4.2 Recommendations for prolonging treatment duration .............................................................................................. 8References ................................................................................................................................................................................. 84.5 Available evidence on other interventions to support tobacco cessation ................................................................... 8References ................................................................................................................................................................................. 84.6 Recommendations for the smoking reduction approach ............................................................................................. 94.6.1 Smoking reduction with nicotine replacement ............................................................................................................ 94.6.2 Smoking reduction with varenicline.............................................................................................................................. 9References ................................................................................................................................................................................. 94.7 Treatment recommendations to prevent relapse to smoking ..................................................................................... 9References ................................................................................................................................................................................. 94.8 Treatment recommendations in special situations and population groups at risk .................................................. 94.8.1. Treatment recommendations for pregnant women .................................................................................................. 9References ................................................................................................................................................................................. 94.8.2. Treatment recommendations for young people under 18 ........................................................................................ 9References ................................................................................................................................................................................. 94.8.3. Treatment recommendations for smokers with respiratory, cardiovascular, psychiatric, cancer and other comorbidities ......................................................................................................................... 9References ............................................................................................................................................................................... 10 5 4.8.4 Recommendations to approach post-smoking cessation weight gain ................................................................. 105References ............................................................................................................................................................................... 106 0 Research and Scientific Recommendations for Evaluating Smoking Cessation ...................................................1075.1. Criteria for clinical research in smoking cessation .................................................................................................... 1085.2 Cost-effectiveness of tobacco dependence therapies ................................................................................................. 108References ............................................................................................................................................................................... 1105.3 Recommendations about implementation of smoking cessation guidelines ......................................................... 110References ............................................................................................................................................................................... 1115.4 Recommended Scientific Literature Resources on Smoking Cessation .................................................................. 111 ART THREE0 Recommendations to train health professionals in the treatment of tobacco use and dependence anduality standards for tobacco cessation specialists and tobacco cessation services ................................................1136.1 Recommendations for criteria of standard smoking cessation expertise training................................................. 1166.2 Recommendations to develop smoking cessation curricula for medical university graduates in Europe ......... 1176.3 Recommendations to develop smoking cessation curricula for medical university postgraduates in Europe – Certificate Programme ........................................................................................................... 119References ............................................................................................................................................................................... 1216.4 Recommendations to develop smoking cessation curricula for other categories of professionals involved in delivering smoking cessation in Europe: psychologists, nurses, health policy-makers ......................... 121References ............................................................................................................................................................................... 1216.5. Training standards for tobacco cessation clinicians ................................................................................................... 1226.6 Quality standards in tobacco dependence treatment .................................................................................................. 123References ............................................................................................................................................................................... 1266.7 Requirements for accreditation of specialized tobacco cessation service ............................................................... 12626.7.1 Three levels of tobacco cessation services ............................................................................................................... 1266.7.2 Accreditation of specialized tobacco cessation units ................................................................................................ 127References ............................................................................................................................................................................... 130 ART FOUR0 Smoking Cessation on high risk population groups .....................................................................................................7.1 Health Effects of Smoking in Pregnancy ..............................................................................................................................References ......................................................................................................................................................................................7.2 Smoking Cessation among Adolescents ..............................................................................................................................References ......................................................................................................................................................................................7.3 Smoking Cessation in patients with diabetes ......................................................................................................................References ......................................................................................................................................................................................7.4 Smoking Cessation in Patients with Chronic Obstructive Pulmonary Disease (COPD) .................................................7.5 Smoking Cessation in Patients with Cardiovascular Disease ...........................................................................................References ...................................................................................................................................................................................... 6 5. P6.q P7. Constantine Vardavas, MD, RN, MPH, PhD, FCCP, Associate Director of the Institute of Public Health (IPH) of the American College of Greece.st ENSP likewise wishes to thank the Board of Reviewers of the 1edition for their kind contributions: Maria Sofia Cattaruzza, head of UNITAB, Sapienza University, Rome, Italy; ăţFlorin Dumitru Mihlan, Professor of Pneumology, M. Nasta National Institute of Pneumology, President of the Romanian Society of Pneumology, Bucharest, Romania; Manfred Neuberger, O. Univ.-Prof. M.D., Vienna, Austria; Biagio Tinghino, President of the Società Italiana di Tabaccologia (SITAB), co-ordinator of the working group on SITAB Guidelines, head of the Smoking Cessation Centre, ASL Monza e Brianza, Italy; Paulo D. Vitόria, Psychologist, PhD, Professor of Preventive úMedicine at Faculdade de Ciências da Sade – Universidade da Beira Interior. Member of the Coordination Team at Portuguese Quitline. Member of the Steering Board at Portuguese Society of Tabacology (SPT), Portugal; Vincenzo Zagà, editor-in-chief of Tabaccologia, Società Italiana di Tabaccologia (SITAB), Bologna, Italy; Witold A. Zatoski, Professor, M.D, PhD. Director Division of Epidemiology and Cancer Prevention, Director WHO Collaborating Centre, Warsaw, Poland. Cornel Radu-Loghin,ENSP is indebted to the ENSP General Secretary, for initiating and managing the project. 7 Acknowledgements The 2020 (4th) edition was coordinated and revised by Dr. Sophia Papadakis and Dr Constantine Vardavas stnd rdENSP wishes to thank the Editorial Board of the 1, 2and 3 version for their kind contributions: Panagiotis K. Behrakis, MD, PhD (McGill), FCCP, Chair of the Scientific Committee of ENSP, Director of the Institute of Public Health of the American College of Greece and a Researcher at the Biomedical Research Foundation of the Academy of Athens, Greece; Nazmi Bilir, Professor of Public Health, Hacettepe University, Faculty of Medicine, Department of Public Health, Ankara, Turkey; Luke Clancy, BSc, MB, MD, PhD, FRCPI, FRCP (Edin), FCCP, FFOM, respiratory physician and Director General, TobaccoFree Research Institute Ireland (TFRI); Bertrand Dautzenberg, Professor of Chest Medicine at Pitié-Salpêtrière hospital, Paris and Chair of Office français de prévention du tabagisme (OFT), Paris, France; Andrey Konstantinovich Demin, M.D., D.Polit.Sci., Professor of Public Health at I.M. Sechenov 1st Moscow State Medical University and N.I. Pirogov National Medical Surgical Centre, and President of Russian Public Health Association, Moscow, Russia; Sophia Papadakis, PhD, MHA, is a Scientist, Division of Prevention and Rehabilitation at the University of Ottawa Heart Institute, Adjunct Professor in the Faculty of Medicine at the University of Ottawa and Visiting Scientist in the Clinic of Social and Family Medicine of the School of Medicine of the University of Crete, Greece; Hans Gilljam, MD, Professor of Public Health, Karolinska Institute, Stockholm, Sweden; Antigona Trofor, M.D. Ph.D., Associate Professor of Pulmonology at the șUniversity of Medicine and Pharmacy Gr. T. Popa, Iai and Respiratory șPhysician at the Clinic of Pulmonary Diseases, Iai, Romania; Antigona Trofor has received regular paid consultancy funds for clinical research work from Novartis Pharma Services Romania SRL, CROM Research Org. SRL, INC Research and Glaxo SmithKline during 2011-2012 and has received fees for occasional lectures from the European Commission, AstraZeneca, Servier Pharma SRL, Glaxo SmithKline and Pierre-Fabre during 2011-2012; Sophia Papadakis declares that her institute has been awarded educational grants by Pfizer; but has refused anypersonal fees from pharmaceutical companies or other agencies; Constantine Vardavas declares that his institute has been awarded educational grants by Pfizer; but has refused any personal fees from pharmaceutical companies or other agencies. Declarations of Interests The members of the Editorial Board of the ENSP Guidelines for Treating Tobacco Dependence declare the following declarations of interest: Panagiotis K. Behrakis declares to have no conflict of interest with any pharmaceutical company; Luke Clancy declares that his institute was awarded a research grant by Pfizer in 2010; he received consultancy feesfrom Pfizer and Pierre Fabre 2010, 2011, 2012; he received lecture fees from Pfizer and Novartis in 2010, 2011, 2012; Bertrand Dautzenberg has collaborated for the past three years, but has refused any personal fees from Pfizer,GlaxoSmithKline; Hans Gilljam declares that he has no relation to the pharmaceutical industry; 8