Mental and behavioral disorders due to use of tobacco (nicotine). Tobacco dependence, tobacco withdrawal syndrome in adults: clinical guidelines

List of Abbreviations

BI – Brinkman index

mg – milligram

mcg – microgram

ICD-10 – International Classification of Diseases, 10th Revision

NRT – nicotine replacement therapy

FEV1 – forced expiratory volume in 1 second during a forced expiratory spirometry test

PEF – peak expiratory flow during peak expiratory flow rate measurement or a forced expiratory spirometry test

FVC – forced vital capacity during a forced expiratory spirometry test

CNS – central nervous system

ENDS – electronic nicotine delivery systems

HTP – heated tobacco products

CO – carbon monoxide

ppm – unit of measurement for relative values, representing the number of parts of a given substance per million parts of the analyzed mixture

GATS – Global Adult Tobacco Survey

Terms and Definitions

Tobacco products – products entirely or partially made of tobacco leaf as a raw material processed so as to be used for smoking, sucking, chewing, or snuffing^[1].

Smoking tobacco products – tobacco products intended for smoking (cigarette, cigar, cigarillo, papirosy, hookah tobacco, pipe tobacco, bidi, kretek, etc.)

Nicotine-containing products – products containing nicotine (including that obtained by synthesis) or its derivatives, including nicotine salts, intended for nicotine consumption and its delivery via sucking, chewing, snuffing, or inhalation, including heated tobacco products, solutions, liquids, or gels containing liquid nicotine in a volume of at least 0.1 mg/ml, nicotine-containing liquid, powders, mixtures for sucking, chewing, snuffing, and not intended for food consumption (excluding medical devices and drugs registered in accordance with the legislation of the Russian Federation, food products containing naturally occurring nicotine, and tobacco products)^[2];

Hookah – a device used to generate aerosol, vapor, or smoke arising from the smoldering and/or heating of tobacco or products not containing tobacco leaf, and in which the aerosol, vapor, or smoke passes through a vessel filled with liquid²

Devices for the consumption of nicotine-containing products – electronic or other devices used to obtain nicotine-containing or non-nicotine aerosol or vapor inhaled by the consumer, including electronic nicotine delivery systems and heated tobacco products, as well as their components and parts (excluding medical devices and drugs registered in accordance with the legislation of the Russian Federation)².

Heated tobacco products (or HTP) – a nicotine consumption device that heats tobacco to a temperature lower than the combustion temperature of tobacco in a traditional cigarette

Electronic cigarette (or ENDS) – an electronic device that creates

a highly dispersed vapor (aerosol) intended for inhalation.

Non-smoking tobacco products (smokeless tobacco) – these include tobacco products intended for sucking, chewing, or snuffing and other methods of consumption not related to smoking – sucking tobacco (snus), chewing tobacco, snuff, naswar, and other tobacco products¹.

Tolerance – a decrease in response to the repeated administration of medications, drugs, or psychoactive substances; adaptation of the body, which necessitates progressively larger doses to achieve the effect inherent to the substance.

Nicotinic acetylcholine receptor (nicotine-sensitive cholinergic receptor, n-cholinergic receptor, nACh-receptor) – a subtype of acetylcholine receptors that mediates nerve impulse transmission across synapses and is activated by acetylcholine as well as nicotine

Bronchial obstruction syndrome – a clinical symptom complex caused by impaired air passage through the bronchi due to narrowing or occlusion of the airways, followed by an increase in airway resistance to the inhaled airflow.

Bronchial hyperreactivity – a state of the airways manifested by their increased response to various chemical, physical, or pharmacological stimuli, where bronchospasm develops in response to an exposure that does not cause such a reaction in most healthy individuals.

^[1] Federal Law No. 268-FZ dated December 22, 2008 – "Technical Regulations for Tobacco Products"

^[2] Federal Law No. 15-FZ "On Protecting Citizens' Health from Exposure to Environmental Tobacco Smoke, the Consequences of Tobacco Consumption, or Nicotine-Containing Product Consumption"

1. Brief information on the disease or condition

1.1 Definition of the disease or condition

Tobacco (nicotine) dependence syndrome – a cluster of behavioral and mental disorders characterized by a strong urge to smoke or consume nicotine-containing products, the development of tolerance, the emergence of withdrawal symptoms upon cessation of use, and the inability to quit tobacco (nicotine) despite harmful health consequences and social pressure [1]. Given that certain tobacco pyrolysis products possess some psychoactive activity and contribute to the pathoplastic features of withdrawal syndrome while causing most of the serious somatic complications associated with smoking, they are not the cause of the dependence syndrome itself; therefore, using the terms "nicotine dependence" and "nicotine withdrawal syndrome" is more accurate [2].

Tobacco (nicotine) withdrawal syndrome – a group of symptoms of varying nature and severity that occur after a reduction or cessation of nicotine intake in a dependent individual. It includes craving for tobacco or other nicotine-containing products, anxiety, decreased concentration, irritability or restlessness, malaise and weakness, dysphoric mood, increased cough, aphthous stomatitis, increased appetite, and insomnia. The duration of withdrawal syndrome ranges from 7 days to several weeks, rarely months [1, 2].

Medical and social consequences of tobacco smoking and nicotine-containing product consumption. Tobacco smoking is considered one of the leading causes of preventable mortality in most countries. The harm of tobacco smoking is primarily due to smoke inhalation, with nicotine being largely responsible for habituation and the development of tobacco dependence. Smoking and tobacco consumption result in diseases of virtually all human organs and systems. Complex inflammatory processes and immune system alterations are crucial in the pathogenesis of smoking-related diseases, such as chronic obstructive pulmonary disease (COPD), pulmonary emphysema, lung cancer, and atherosclerosis. Heart and vascular diseases, respiratory, digestive, and endocrine disorders, and osteoporosis most commonly develop with smoking. Cigarette smoke can cause atherosclerosis, thrombosis, increased insulin resistance, and the development of metabolic syndrome [2-5].

1.2 Etiology and pathogenesis of the disease or condition (group of diseases or conditions)

The main cause of tobacco dependence syndrome and tobacco withdrawal syndrome is the consumption of tobacco or nicotine-containing products. Their consumption delivers nicotine into human arterial blood. On average, it takes about 7 seconds after inhaling tobacco smoke, vapor, or aerosol for nicotine to reach the brain. The development of dependence is based on the interaction of nicotine with alpha-4-beta-2 acetylcholine receptors in the brain, resulting in the release of dopamine and other neurotransmitters, which serves as positive reinforcement for nicotine addiction. Upon cessation of this interaction, withdrawal symptoms develop, the severity of which is clinically significant and leads to a relapse of product use in most individuals attempting to quit tobacco/nicotine on their own [3].

In addition to nicotine, tobacco smoke contains water, alkaloids, and tars. Tobacco smoke contains about 7,000 different chemicals, many of which are risk factors for human diseases: nicotine, benzopyrene, and others

polycyclic hydrocarbons, N-nitrosonornicotine, P-naphthylamine, polonium-210, nickel, cadmium, arsenic, and lead. The gas phase of tobacco smoke contains carbon monoxide, acetaldehyde, acetone, methanol, nitrogen oxides, hydrogen cyanide, acrolein, ammonia, benzene, formaldehyde, nitrosamines, and vinyl chloride. Tobacco smoke exhibits an exceptionally strong oxidative potential. High concentrations of free radicals are found in both the gas phase and the tars [4]. Aerosols of electronic nicotine delivery systems (ENDS) and heated tobacco products (HTPs) also contain chemicals such as formaldehyde, acetaldehyde, acrolein, and metals. Many components of tobacco smoke are subject to regulatory sanitary and hygienic standards due to their toxic effects. Diseases of various organs and systems develop as a result of local damage to the bronchopulmonary tract and the systemic absorption of toxic substances from tobacco smoke [5]. Inhaled tobacco smoke penetrates through the respiratory tract into the alveoli. As the smoke penetrates deep into the respiratory tract, soluble gases are absorbed, while particles are deposited in the airways and alveoli. As a result, tobacco product users rather quickly develop pathological processes in the bronchopulmonary system [5] and other smoking-related diseases of various organs and systems.

The chemical complexity of the vast number of liquids for ENDS requires ongoing toxicological investigation of each liquid ingredient and health risk assessment. The main components present in almost all e-liquids are capable of causing specific toxicological reactions depending on the varying ratios of propylene glycol and glycerin solvents, free-base nicotine, organic acids, nicotine salts, and flavorings [6].

When using HTPs, a subset of chemicals is formed, but the content of detectable toxic components in the HTP aerosol is significantly lower compared to the control cigarette. The structure of the tobacco blend is a decisive factor in determining the resulting chemical composition of HTP aerosols [7].

1.3 Epidemiology of the Disease or Condition

In the Russian Federation, despite significant positive changes achieved, the prevalence of tobacco use remains very high. In 2016, under the leadership of the Russian Ministry of Health, a representative epidemiological study was conducted: the Global Adult Tobacco Survey (GATS) [8]. According to the study, 30.5% (36.4 million) of all adults constantly used tobacco in any form (49.8% among men and 14.5% among women). Smoked tobacco was used by 30.3% (36.3 million) (49.5% among men and 14.4% among women). The proportion of daily smokers among adults was 26.1% (31.2 million) (43.9% among men and 11.3% among women). In recent years, the consumption of ENDS has begun to spread intensively. The survey showed that in 2016, the proportion of adults who had ever heard of electronic cigarettes was 79.9%, and 3.5% of adults used them regularly. However, among adults aged 15 to 24 years, 91.2% had ever heard of electronic cigarettes and 9.7% were regular electronic cigarette users. The intensity of smoking among tobacco consumers is very high. Of the total number of smokers, 29.9% (35.8 million) of adults regularly smoked cigarettes (48.8% among men and 14.2% among women), and 25.7% of adults smoked cigarettes daily (43.1% among men and 11.3% among women). On average, daily smokers smoked 16.3 cigarettes per day (17.1 among men and 13.7 among women). The average age of initiation of daily cigarette smoking among all adults was 17.0 years (16.8 years among men and 17.2 years among women). The result of such intensive tobacco consumption was the development of high and very high degrees of nicotine dependence in the majority of smokers: 64.0% of daily tobacco smokers smoked their first cigarette within 30 minutes of waking up.

According to the Sample Survey of the Population's Health State conducted by Rosstat in 2023 [9], the prevalence of tobacco use among the total population was 21.1%, among men – 34.6%, and among women – 10.1% (excluding ENDS). Recently, there has been a decrease in the prevalence of not only active smoking, but also passive smoking [10].

1.4 Features of Coding the Disease or Condition

F17.2 – Mental and behavioural disorders due to use of tobacco. Dependence syndrome

F17.3 – Mental and behavioural disorders due to use of tobacco. Withdrawal state

Withdrawal state is coded separately when it is the direct reason for seeking specialist medical care.

1.5 Classification of the disease or condition

The symptomatology of nicotine dependence in tobacco or nicotine-containing product use is assessed clinically, and its severity is evaluated using the Fagerström test (for nicotine-containing products, the modified Fagerström test is used, Appendix G1).

For practical purposes, tobacco dependence syndrome and tobacco withdrawal syndrome with harmful effects of tobacco product consumption are also distinguished:

• Tobacco dependence syndrome and tobacco withdrawal syndrome with bronchopulmonary symptoms.

• Tobacco dependence syndrome and tobacco withdrawal syndrome with bronchopulmonary syndromes.

Comments: With prolonged use of tobacco products, under the influence of harmful substances from tobacco smoke or aerosol, including nicotine, changes occur in the bronchopulmonary system, manifesting as various symptoms and syndromes. Bronchopulmonary symptoms include cough, sputum, and dyspnea. Bronchopulmonary syndromes include bronchial hyperreactivity and bronchial obstruction [11, 12, 13].

1.6 Clinical presentation of the disease or condition

1.6.1 Tobacco (nicotine) dependence syndrome

With the development of nicotine dependence, it becomes difficult to control the consumption of tobacco and/or nicotine-containing products, continued use is noted despite emerging harmful consequences; preference for tobacco or nicotine use to the detriment of other activities and fulfillment of duties; an increase in the number of cigarettes smoked or other nicotine-containing products. Depending on the intensity, duration of consumption, and the type of tobacco and nicotine-containing products, the clinical presentation of the dependence syndrome, as well as the risks of developing complications, will vary somewhat [1, 2, 3].

1.6.2 Tobacco withdrawal syndrome.

It is characterized by the presence of nicotine dependence and manifests upon partial or complete cessation of tobacco and/or nicotine-containing product consumption by the rapid development of withdrawal symptoms: craving for tobacco and/or nicotine, anxiety, decreased concentration, irritability or restlessness, malaise and weakness, dysphoric mood, increased cough, increased appetite, insomnia.

The duration of withdrawal symptoms ranges from 7 days to several weeks, sometimes months [1, 2, 3].

1.6.3 Tobacco dependence syndrome and tobacco withdrawal syndrome with bronchopulmonary symptoms

The clinical picture is manifested by the presence of nicotine dependence symptoms and/or withdrawal symptoms described in paragraphs 1.6.1 and 1.6.2, as well as the following bronchopulmonary symptoms: cough, sputum, dyspnea

1.6.4. Tobacco dependence syndrome and tobacco withdrawal syndrome with bronchopulmonary syndromes

The clinical picture is manifested by the presence of nicotine dependence symptoms and/or withdrawal symptoms described in paragraphs 1.6.1 and 1.6.2, as well as the following bronchopulmonary syndromes: bronchial hyperreactivity syndrome, bronchial obstruction syndrome [11, 12, 13].

2. Diagnostics, medical indications and contraindications for diagnostic methods

Clinical diagnosis, consisting of collecting complaints, anamnesis, and evaluating the Fagerström test, including its modified version, is of primary importance in diagnosing nicotine dependence syndrome or nicotine withdrawal syndrome. Other types of diagnostics play a secondary role.

Criteria for diagnosing the disease/condition:

Criteria for tobacco (nicotine) dependence syndrome in ICD-10 include 3 or more symptoms from the 6 symptoms listed below, observed over a period of 12 months [1]:

1. A strong desire or sense of compulsion to take tobacco or nicotine-containing products;

2. A reduced ability to control tobacco (nicotine)-using behavior in terms of its onset, termination, or levels of use. Tobacco (nicotine) is often taken in larger amounts or over a longer period than intended;

3. A withdrawal state: a) characteristic withdrawal criteria for nicotine; b) tobacco or nicotine-containing products are used with the intention of relieving or avoiding withdrawal symptoms;

4. Evidence of tolerance, such as: a) lack of nausea, dizziness, and other characteristic symptoms despite the use of significant amounts of nicotine; b) a markedly diminished effect with continued use of the same amount of tobacco or nicotine-containing products;

5. A great deal of time is spent in activities necessary to obtain tobacco or nicotine-containing products;

6. Continued tobacco or nicotine-containing products use despite clear evidence of overtly harmful consequences, as evidenced by chronic use with actual or presumed awareness of the nature and extent of harm.

Criteria for tobacco (nicotine) withdrawal syndrome:

There must be conformity with the general criteria for withdrawal states (F1x.3).

The following signs may be present: strong desire to use tobacco (or other nicotine-containing products); feeling unwell or weakness; dysphoria; irritability or anxiety; insomnia; increased appetite; severe cough; difficulty concentrating. [1]

2.1 Complaints and Anamnesis

Complaints of inability to control the consumption of tobacco or nicotine-containing products, continued use despite harmful consequences, and the occurrence of irritability, anxiety, weakness, sleep disturbances, strong craving for tobacco or nicotine-containing products, impaired concentration, and increased appetite upon reducing or stopping consumption. Complaints characteristic of bronchopulmonary pathology: cough, sputum production, difficulty breathing, shortness of breath.

Taking the anamnesis includes establishing the age of onset of tobacco and/or nicotine-containing product use, the duration, intensity, and methods of their use, the presence of attempts to quit tobacco and nicotine-containing products, and why they were unsuccessful. If respiratory diseases develop, it is necessary to clarify the presence of official diagnoses and therapy.

2.2 Physical Examination

Although physical examination is an important part of diagnostics in general, it has low diagnostic informativity for detecting or ruling out tobacco (nicotine) dependence syndrome and withdrawal syndrome; peripheral blood pressure measurement, pulse examination, respiratory rate measurement, and pulse oximetry are performed to assess the patient's general condition and the safety of the prescribed therapy [4].

2.3 Laboratory Diagnostics

Although laboratory diagnostic tests are an important part of diagnostics in general, they are not informative for detecting or ruling out tobacco (nicotine) dependence syndrome or tobacco (nicotine) withdrawal syndrome. Existing rapid tests (immunochromatographic cotinine test) are not objective quantitative analyses. They can only indicate the presence or absence of cotinine in the body.

2.4 Instrumental Diagnostics

Comments: At the diagnosis stage, determining the carbon monoxide (CO) content in exhaled breath using a gas analyzer makes it possible to determine the smoking intensity of tobacco products, as well as to use it to enhance motivation to quit smoking. During the treatment stage, this indicator makes it possible to monitor complete cessation of tobacco smoking. Exhaled CO values from 6 ppm to 10 ppm are characteristic of mild smoking, from 11 ppm to 20 ppm – moderate smoking, and over 21 ppm – heavy smoking.

Comments: At the diagnosis stage, assessing the functional state of the lungs makes it possible to establish the presence of bronchial hyperreactivity syndrome or bronchial obstruction syndrome and determine the degree of its reversibility. During the treatment stage, this study makes it possible to detect exacerbation of bronchial hyperreactivity or bronchial obstruction. The presence of bronchial hyperreactivity can be assessed by performing weekly monitoring of morning and evening peak expiratory flow (PEF) values. The criterion for the presence of bronchial hyperreactivity is a difference between the minimum morning and maximum evening PEF values of more than 20%. The presence of bronchial obstruction is determined using a spirometer during a forced expiration test with the calculation of the parameters "forced expiratory volume in 1 second" (FEV1), "forced vital capacity" (FVC), and the FEV1/FVC ratio. A decrease in the FEV1 indicator by more than 20% indicates the development of bronchial obstruction in the patient. A decrease in the FEV1/FVC ratio below 0.7 indicates the development of severe bronchial obstruction in the patient. Personalized information about spirometry results and brief recommendations increase the likelihood of prolonged abstinence from tobacco use [14].

Comments: To assess the reversibility of bronchial obstruction, a study of respiratory volumes using medications is carried out (spirometry with a bronchodilation test), where short-acting β2-adrenergic agonists (selective beta2-adrenomimetics ATC R03AC) are most often used. An increase in the FEV1 indicator by 12% or 200 ml or more indicates the presence of reversible bronchial obstruction in the patient.

2.5 Other Procedures

Comments: If the patient at the time of examination has reduced or completely stopped the consumption of tobacco and/or nicotine-containing products, then when answering the questions of the questionnaire, they should describe the situation at the time of tobacco consumption in full before reducing or completely stopping its consumption.

Comments: The Prochaska questionnaire makes it possible to assess the patient's readiness to quit tobacco and/or nicotine use.

Comments: The SI calculation must be performed for every smoking patient visiting a doctor or admitted to a hospital, and the assessment result must be recorded in the medical documentation. The SI reflects smoking intensity and makes it possible to determine the prognosis of smoking cessation. If the patient has reduced or completely stopped cigarette smoking at the time of examination, the SI calculation uses the number of cigarettes smoked per day at the time of their full consumption before reducing or completely stopping smoking. Patients with an SI > 5 find it harder to quit smoking on their own.

3. Treatment, including drug and non-drug therapies, diet therapy, and pain management

Treatment of nicotine dependence is carried out taking into account its severity and readiness to quit nicotine and includes pharmacotherapy and cognitive-behavioral therapy, which can be carried out either separately or in combination [18]. If bronchopulmonary symptoms or syndromes are detected in the patient, symptomatic treatment of bronchopulmonary disorders is added to the treatment of nicotine dependence and withdrawal syndrome [12]. In tobacco and nicotine-containing product dependence syndrome, additional pharmacological drugs may be prescribed to eliminate withdrawal symptoms. Treatment is effective if it provides a period of abstinence from tobacco products for at least 6 months.

3.1 Pharmacotherapy

Comments: Drugs used for nicotine dependence and nicotine replacement ("nicotine replacement" therapy – NRT). NRT is first-line therapy for tobacco/nicotine cessation in motivated and unmotivated patients.

Various forms of medicinal products used for nicotine dependence containing nicotine are registered in the Russian Federation (INN: nicotine, ATC: N07BA01):

• transdermal patch with prolonged nicotine release (16 hours) in dosages: 16-hour patch – 10, 15, and 25 mg;

• medicinal chewing gum – 2 and 4 mg.

• metered-dose oral mucosa spray [mint], [fruit and mint] 1 mg/dose.

• mint film-coated lozenges, – 2 and 4 mg.

• fruit film-coated lozenges, – 2 and 4 mg.

Both monotherapy using a single product and a combination of multiple products can be used.

The Nicotine Replacement Therapy (NRT) regimen is developed individually, taking into account the degree of nicotine dependence, the number of cigarettes smoked per day, and the degree of motivation to quit tobacco and/or nicotine. The treatment course ranges from 3 to 6 months. In cases of very high nicotine dependence, treatment may be extended up to 12 months. Treatment starts immediately after the complete cessation of tobacco and/or nicotine-containing products. For patients with a very high degree of nicotine dependence, therapy may be initiated prior to complete cessation of tobacco and/or nicotine use (for no more than 6 weeks)..

In mild nicotine dependence (2-4 points on the Fagerström test) not accompanied by clinically significant withdrawal symptoms, pharmacotherapy is not indicated.

Comments: Partial agonists of the nicotinic acetylcholine receptor with high affinity and selectivity (ATC: N07BA drugs used for nicotine dependence) bind to alpha-4 beta-2 nicotinic acetylcholine receptors in the brain, acting both as partial agonists (though to a lesser extent than nicotine) and as antagonists in the presence of nicotine. Cytisine is a natural alkaloid found in several plant genera, available as oral tablets containing 1.5 mg of the active substance.

Comments: Currently, among anxiolytics, fabomotizole is used – a domestic selective anxiolytic without hypnosedative and myorelaxant properties; it is not an agonist of the benzodiazepine or barbiturate sites of GABA receptors and therefore lacks the drawbacks of drugs in this class. Tetramethyltetraazabicyclooctandione is also used.,

Psychological support

For anyone planning to stop using nicotine-containing products or tobacco, motivation and readiness for cessation are of vital importance. Psychological support from a physician of any specialty enhances the patient's motivation to quit smoking [25]. During the consultation, the physician (or paramedic) assesses readiness to quit smoking, explains the treatment, discusses the quit date with the patient, selects therapy considering all factors, informs about potential complications and difficulties, provides recommendations on physical activity [26] and diet if necessary, answers questions, and schedules a follow-up visit. Three types of psychological support are used: brief intervention, motivational interviewing, and cognitive behavioral therapy (Appendix A3).

Comments: A brief intervention (brief counseling) is conducted by physicians of all specialties as well as mid-level medical personnel, lasting 3 minutes or more, and includes: 1) determining smoking status; 2) personalized advice to quit smoking; 3) determining the most effective assistance. The results of the brief intervention must be recorded in the patient's medical documentation.

The methodology for conducting a brief intervention is presented in Appendix A3.

Comments: Two goals of motivational interviewing are distinguished: 1) to enhance motivation to quit tobacco and/or nicotine use in patients with low motivation for cessation (5R methodology); 2) to support the patient throughout the course of nicotine dependence treatment (5A methodology).

The methodology of motivational counseling is presented in Appendix A3.

Comments: Cognitive behavioral therapy can be used in the treatment of nicotine dependence as monotherapy for mild and very mild nicotine dependence (according to the Fagerström test). In cases of high and very high nicotine dependence, cognitive behavioral therapy is used in combination with pharmacological therapy.

Cognitive behavioral therapy is conducted throughout the entire treatment period and is based on the following principles: 1) identifying and testing thoughts about tobacco or nicotine use; 2) modifying relevant beliefs and identifying triggers that increase the likelihood of using these substances; 3) teaching skills for abstaining from tobacco or nicotine use; 4) relapse prevention. It is recommended to use a range of cognitive therapy techniques, including problem-solving, decision-making, activity monitoring and planning, distraction and shifting attention, and successive approximation.

Cognitive behavioral therapy sessions are conducted for 3 to 6 months with a frequency of once a week for the first month, then once every 2 weeks for the second month, and thereafter once a month.

Longer cognitive behavioral therapy does not increase the rate of remission. This may be explained by decreased adherence to long-term or extended therapy due to treatment fatigue [29].

3.3 Other Treatment

Comments: The use of mucolytic and expectorant drugs (acetylcysteine**, ambroxol**, and combined expectorant drugs) aims to clear sputum from the airways. They have different mechanisms of action.

Mucolytic drugs act directly on the gel phase of bronchial secretions and effectively thin sputum without significantly increasing its volume. Expectorant drugs act on receptors to cause reflex contraction of the bronchial musculature, inducing a cough that facilitates the removal of bronchial secretions.

Various registered mucolytic and expectorant drugs may be used. The choice of drug is made taking into account whether the patient has a dry (non-productive) or wet (productive) cough.

Comments: Drugs for the treatment of obstructive airway diseases (ATC R03) – a pharmacological group of symptomatic medicines that directly relieve bronchospasm by blocking it through various pathways:

Selective beta-2 agonists (ATC R03AC),

Anticholinergic agents (ATC R03BB).

Adrenergic agents in combination with anticholinergic agents (ATC R03AL)

The speed of onset and duration of the bronchodilator effect of the drug, as well as the magnitude and duration of the bronchoprotective effect, are of great importance. Therapy is prescribed individually depending on the severity of the impairment. If a patient exhibits bronchial hyperreactivity or reversible bronchial obstruction, treatment is initiated with monotherapy using one of the selective beta2-adrenergic agonist or anticholinergic drug groups. Preference is given to long-acting (prolonged) agents. In cases of severe bronchial obstruction or inefficacy of monotherapy, it is advisable to prescribe a combination of adrenergic agents with anticholinergic agents. Preference is given to fixed combinations of drugs. In individuals with previously diagnosed COPD who received bronchodilator therapy as monotherapy, it should be intensified by switching to a fixed combination. The recommended duration of treatment is 1–3 months, followed by a reassessment of pulmonary function and clinical symptoms to identify bronchopulmonary disorders or COPD requiring the continuation of bronchodilator therapy.

4. Medical Rehabilitation and Sanatorium-Resort Treatment

Rehabilitation is not required for this disease.

5. Prevention and Dispensary Observation

Dispanserization (active clinical monitoring) is not required for this disease. Prevention in this disease should aim at preventing the resumption of tobacco/nicotine use and be conducted both with the patient and their immediate social environment. Upon completion of the treatment course, it is advisable to conduct a preventive discussion, including reviewing triggers that previously led to tobacco or nicotine use, in order to prevent relapse or breakdown.

6. Organization of Medical Care

The attending physician is obliged to provide any patient who seeks medical care at a medical organization, regardless of the reason for the visit, with recommendations to cease the consumption of tobacco or nicotine-containing products and

to provide necessary information on the medical care that can be provided^[1].

At the outpatient level, physicians of all specialties must question the patient about the use of tobacco and/or nicotine-containing products, identify the presence of the disease, establish a diagnosis, and enter all information into the patient's medical documentation.

An example of an insert sheet for medical documentation is given in Appendix G2.

Upon identifying the disease, the physician must conduct a brief intervention (Section 3.2.2). If the patient's motivation is low, the physician should conduct repeated brief interventions at each patient visit. If the patient has a high degree of motivation to quit tobacco/nicotine, the physician must either draw up a patient treatment plan or refer them to specialists

providing this medical care.

At the inpatient level, medical care for tobacco dependence syndrome and tobacco withdrawal syndrome pursues several goals:

1. Motivating tobacco/nicotine users to completely quit consumption.

2. Providing medical care aimed at stopping tobacco/nicotine consumption during the patient's stay in the hospital.

3. Providing medical care for the treatment of tobacco dependence syndrome and tobacco withdrawal syndrome.

Upon admission to the hospital for any illness, the patient is questioned about the use of tobacco and/or nicotine-containing products, the presence of the disease is identified, a diagnosis is established, and all information is recorded in the medical documentation. An example of an insert sheet for medical documentation is given in Appendix A3. The attending physician must conduct a motivational interview and recommend therapy either for the temporary cessation of tobacco/nicotine consumption during the hospital stay or for complete cessation of tobacco/nicotine.

^[1] Order of the Russian Ministry of Health No. 104n dated February 26, 2021, "On Approval of the Procedure for Providing Medical Care to the Adult Population for the Cessation of Tobacco or Nicotine-Containing Product Consumption, Treatment of Tobacco (Nicotine) Dependence, and Consequences of Tobacco or Nicotine-Containing Product Consumption".

7. Additional Information

Interventions that are effective in smoking cessation can be used in all nicotine-dependent individuals, except for cases where there are contraindications to the use of specific drugs, or when there is insufficient evidence for the use of pharmacotherapy during pregnancy, in children and adolescents, and in patients with severe respiratory, cardiovascular, psychiatric, oncological, and other comorbid conditions.

Since tobacco/nicotine use carries a high health risk for both the woman and the fetus, it is necessary to conduct motivational interviews for quitting tobacco/nicotine and to treat nicotine dependence. Despite the fact that the maximum positive effect is observed when quitting tobacco/nicotine in early pregnancy (the first trimester of pregnancy), it is important to motivate cessation throughout the entire gestational period. In treating nicotine dependence in pregnant women, a standard algorithm with enhanced psychological support is used. As pharmacological therapy for nicotine dependence, only NRT is used [40, 41].

The prevalence of tobacco/nicotine use among patients with mental disorders is higher than in the general population. Treatment of nicotine dependence in this category of patients has no fundamental differences and should be carried out by a psychiatrist-narcologist and/or a psychiatrist [42].

Smokers with cardiovascular diseases should be strongly advised to quit smoking, especially during the acute phase of the disease. Patients with any risk of developing cardiovascular disease should receive smoking cessation instructions, with therapy selected using NRT taking risk-benefit assessment into account [43, 44].

In COPD, smoking cessation is a necessary therapeutic intervention utilizing pharmacotherapy and ongoing psychological support [12, 30].

Criteria for Evaluating the Quality of Medical Care

References

Appendix A1. Working Group Composition

Authors:

Sakharova G.M. Dr.Sc. (Medicine), Professor, Member of the Russian Respiratory Society

Antonov N.S. Dr.Sc. (Medicine), Member of the Russian Respiratory Society

Salagay O.O. State Secretary – Deputy Minister of Health of the Russian Federation

Avdeev S.N. Academician of the RAS, Dr.Sc. (Medicine), Professor, Member of the Russian Respiratory Society

Ergeshov A.E. Corresponding Member of the RAS, Dr.Sc. (Medicine), Professor, Member of the Russian Respiratory Society

Romanov V.V. Dr.Sc. (Medicine), Professor, Member of the Russian Respiratory Society

Rusakova L.I. Dr.Sc. (Medicine), Member of the Russian Respiratory Society

Nadezhdin A.V. Cand.Sc. (Medicine), Member of the Russian Society of Psychiatrists

Tetenova E.Yu. Cand.Sc. (Medicine), Member of the Russian Society of Psychiatrists

Working group

Co-Chairs:

Klimenko Tatyana Valentinovna Dr.Sc. (Medicine), Prof. Krupitsky Evgeny Mikhailovich Dr.Sc. (Medicine), Prof.

Secretary:

Gubanov, Georgy Alexandrovich

Working Group Members:

Agibalova Tatyana Vasilyevna Dr.Sc. (Medicine), Prof.

Buzik Oleg Zhanovich, Doctor of Medical Sciences, Professor

Vinnikova Maria Alekseevna, Doctor of Medical Sciences, Professor

Mikhailov Mikhail Albertovich, D.Sc. in Medicine

Arkus, Maxim Leonidovich, PhD

Korchagina, Galina Alexandrovna, MD, Prof.

Ilyuk Ruslan Dmitrievich, D.Sc. in Medicine

Lobacheva Anna Stanislavovna, Ph.D. in Medicine

Rybakova Ksenia Valeryevna, D.Sc. in Medicine

Shevtsova Yulia Bronyusovna, Candidate of Medical Sciences

Utkin Sergey Ionovich, Candidate of Medical Sciences

Poplevchenkov Konstantin Nikolaevich, Ph.D. in Medicine

Nenastyeva Anna Yuryevna, PhD

The authors and members of the Working Group have confirmed no financial support / conflict of interest.

Appendix A2. Methodology for Developing Clinical Guidelines

These Guidelines are a revision of the Clinical Guidelines for Tobacco Dependence Syndrome and Tobacco Withdrawal Syndrome approved in the Register of Clinical Guidelines (Treatment Protocols) of the Russian Ministry of Health in 2018 (ID601).

Target audience of these clinical guidelines:

1. Psychiatrist-narcologist

2. District psychiatrist-narcologist

3. General Practitioner

4. Pulmonologist

5. Cardiologist

6. General Practitioner (Family Doctor)

7. Psychiatrist

8. District psychiatrist

9. Psychotherapist

10. Medical psychologist

The following information resources were used in the development of these clinical guidelines:

• Order of the Russian Ministry of Health dated February 28, 2019, No. 103n (as amended on June 23, 2020) "On approval of the procedure and timelines for the development of clinical guidelines, their revision, the standard form of clinical guidelines and requirements for their structure, composition and scientific validity of the information included in clinical guidelines" (with amendments and additions that entered into force on August 4, 2020).

• Order of the Russian Ministry of Health No. 104n dated February 26, 2021, "On Approval of the Procedure for Providing Medical Care to the Adult Population for Cessation of Tobacco or Nicotine-Containing Product Consumption, Treatment of Tobacco (Nicotine) Dependence, and Consequences of Tobacco or Nicotine-Containing Product Consumption"

• Analysis of scientific literature sources and other data, as well as internet resources over the past 10 years:

- domestic: guidelines for physicians, scientific publications in periodicals, eLIBRARY scientific electronic library, State Register of Medicines,

Register of Medicines, Federal State Statistics Service of the Russian Federation;

- foreign: Cochrane Library, Medline, MedScape, PubMed, National Institute on Alcohol Abuse and Alcoholism (NIAAA), Substance Abuse and Mental Health Services Administration (SAMHSA), European Monitoring Centre for Drugs and Drug Addiction (EMCDDA)

- Regulatory documents of the Government of the Russian Federation and the Ministry of Health of the Russian Federation.

Rating schemes for assessing the levels of evidence certainty (1, 2, 3, 4, 5) and the levels of recommendation consensus (A, B, C) were used in the development of these clinical guidelines.

Appendix A2.1 – Levels of Evidence (LoE) Grading Scale for diagnostic methods (diagnostic interventions)

Appendix A2.2 – Level of Confidence (LoC) grading scale for methods of prevention, treatment, and medical rehabilitation, including those based on the use of natural therapeutic factors (preventive, therapeutic, and rehabilitative interventions)

Appendix A2.3 – Level of Evidence (LoE) grading scale for recommendations on methods of prevention, diagnostics, treatment, and medical rehabilitation, including those based on the use of natural therapeutic factors (preventive, diagnostic, therapeutic, and rehabilitative interventions)

Procedure for updating clinical guidelines.

The mechanism for updating clinical guidelines provides for their systematic revision at least once every three years, as well as upon the emergence of new evidence-based medicine data on the diagnosis, treatment, prevention, and rehabilitation of substance use disorders (SUD), and in the presence of justified additions/comments to previously approved clinical guidelines, but no more frequently than once every 6 months.

Clinical guidelines are updated every 3 years.

Appendix A3. Reference Materials

Information on indications for use, contraindications, methods of administration, and dosages of medicinal products is publicly available on the website of the State Register of Medicines grls.rosminzdrav.ru

1. Brief intervention

Methodology of the physician's brief intervention:

1. Ask the patient about the use of tobacco and/or nicotine-containing products and document their use status in medical records. The question about use must be more complex than simply asking: "Do you use tobacco

and/or nicotine-containing products?". For example, many smokers who do not smoke cigarettes

every day do not consider themselves smokers and are most likely to answer "No" to this question. Therefore, the question should be complex, identifying the following categories of smoking status:

a. Non-smoker / non-user: does not use tobacco and/or nicotine-containing products at all.

b. Regular user: For cigarette smokers: has smoked at least 100 cigarettes in their lifetime and has smoked at least 1 cigarette in the last 30 days. For users of other tobacco and/or nicotine-containing products: has used them at least once in the last 30 days.

c. Former smoker: has smoked at least 100 cigarettes in their lifetime, but has not smoked a single cigarette in the last 30 days.

2. Advise quitting the use of tobacco and/or nicotine-containing products and, if possible, personalize this advice using identified clinical symptoms and the patient's functional status assessment.

3. Strongly recommend treatment for nicotine dependence to the patient and, upon their agreement, either initiate such treatment using cognitive-behavioral and pharmacotherapy, or refer them to a medical facility where they can receive appropriate medical care

2. Motivational interviewing

Motivational interviewing includes the 5A strategy for patients with high motivation to quit tobacco and/or nicotine-containing products and the 5R strategy for patients with low motivation.

5A strategy methodology:

Step 1 – Ask: Substantiate the harm of tobacco/nicotine use. Sometimes users temporarily suspend the use of tobacco and/or nicotine-containing products due to health problems. Such individuals should be identified and actively encouraged to continue quitting.

Step 2 – Advise: The physician should discuss immediate and long-term positive outcomes of quitting tobacco/nicotine with the patient. In addition, the health hazards of tobacco/nicotine use may also be discussed, especially if the patient already has any impairments.

Step 3 – Assess. Determine the patient's readiness to continue or quit tobacco/nicotine use.

Step 4 – Assist. For patients who are ready to quit tobacco/nicotine use, the physician should explain and offer individual treatment programs aimed at reducing withdrawal symptoms and building the ability to resist urges.

Step 5 – Arrange. The physician should schedule follow-up visits for supportive counseling.

5R strategy methodology:

Step 1 – Relevance. At this stage, the conversation should be tailored to the individual patient, and the physician must substantiate the harm of tobacco/nicotine use using medical information about their health status.

Step 2 – Risks. The physician should ask the patient to identify the negative consequences of continued tobacco/nicotine use and emphasize that, for example, reducing smoking intensity, switching to lower-nicotine and lower-tar cigarettes, or replacing cigarettes with another tobacco product will not eliminate the risk of developing diseases.

Step 3 – Rewards. The physician should ask the patient to identify potential positive health changes resulting from quitting tobacco/nicotine use.

Step 4 – Roadblocks. The physician should ask the patient to identify barriers and difficulties in quitting tobacco/nicotine (withdrawal symptoms, fear of failure, weight gain, lack of support, depression, loss of pleasure from tobacco/nicotine use, smoking social environment, relaxation associated with tobacco and/or nicotine product use).

Step 5 – Repetition. Motivational counseling should be conducted every time the patient visits the physician at a medical facility. Patients who have failed to quit tobacco/nicotine should be supported and encouraged to make repeated attempts, explaining that most people make several attempts to quit tobacco/nicotine before achieving success.

3. Cognitive-behavioral therapy

Cognitive-behavioral therapy techniques are described in the following reference materials:

• Beck, Judith S. Cognitive Therapy: Basics and Beyond: Trans. from English. - M.: LLC "I.D. Williams", 2006. - 400 p.: ill.

• Clark, D.A., Beck, A.T. Anxiety and Worry: A Cognitive-Behavioral Approach: Transl. from English. - M.: Dialektika, 2020, 448 p.: ill.

4. Related Documents

1. Federal Law No. 15-FZ of February 23, 2013 "On the Protection of Citizens' Health from the Effects of Environmental Tobacco Smoke, Consequences of Tobacco Consumption or Consumption of Nicotine-Containing Products" (as amended)

2. Federal Law No. 303-FZ of July 31, 2020 "On Amending Certain Legislative Acts of the Russian Federation on the Protection of Citizens' Health from the Consequences of Nicotine-Containing Product Consumption"

3. Federal Law No. 323-FZ of November 21, 2011 "On the Fundamentals of Healthcare Protection in the Russian Federation"

4. Order of the Russian Ministry of Health No. 203n dated May 10, 2017 "On Approval of Criteria for Assessing the Quality of Medical Care" (Registered with the Ministry of Justice of Russia on May 17, 2017, No. 46740). Order of the Ministry of Health of the Russian Federation No. 916n dated November 15, 2012 "On Approval of the Procedure for Providing Medical Care to the Population in the Profile 'Pulmonology'"

5. Order of the Russian Ministry of Health No. 1034n dated December 30, 2015, "On approval of the Procedure for providing medical care in the field of 'psychiatry-narcology' and the Procedure for dispensary monitoring of individuals with mental disorders and/or behavioural disorders associated with the use of psychoactive substances" (with amendments and addenda).

6. Order of the Ministry of Health and Social Development of the Russian Federation No. 543n dated May 15, 2012, Moscow "On Approval of the Regulations on the Organization of Primary Health Care for the Adult Population"

7. State Program of the Russian Federation "Healthcare Development". Approved by Decree of the Government of the Russian Federation No. 394 of March 31, 2017

8. Order of the Ministry of Health of the Russian Federation No. 140n dated February 26, 2021 "On Approval of the Procedure for Providing Medical Care to the Adult Population for Cessation of Tobacco or Nicotine-Containing Product Consumption, Treatment of Tobacco (Nicotine) Dependence, and Consequences of Tobacco or Nicotine-Containing Product Consumption"

5. Example of an insert into medical documentation regarding a patient consuming tobacco and/or nicotine-containing products.

Assessment of Tobacco and Nicotine Product Use Status Full Name Age Date

1. The patient consumes:

2. Duration of use: years

3. When smoking conventional cigarettes:

Smoking index (pack-years):

(SI = (number of cigarettes smoked per day) × Number of years of smoking / 20)

4. Assessment of the degree of nicotine dependence (underline as appropriate):

5. Assessment of withdrawal symptoms:

Does the patient develop at least one of the following conditions when abstaining from the product:

6. Diagnosis:

a. In the absence of withdrawal symptoms: Tobacco dependence syndrome (F17.2) b. In the presence of withdrawal symptoms: Tobacco (nicotine) withdrawal state (F17.3)

Appendix B. Physician Action Algorithms

Appendix C. Patient Information

Information to motivate the patient to quit tobacco: "5 Steps to Success"

Step 1 – Obtaining Information:

Carefully review scientific data on the health effects of tobacco smoking (cigarettes, papirosy, cigars, pipes, hookahs, self-rolled cigarettes, etc.), ENDS, and HTPs. Do not disregard proven facts, as they are derived from rigorous scientific research.

Scientific studies have proven:

• Tobacco smoking affects almost every organ in a smoker's body. This leads to disease and loss of health.

• Quitting smoking reduces the risk of tobacco-related diseases and death and significantly improves health.

• Low-tar and low-nicotine cigarettes are not safe.

• The list of diseases caused by tobacco smoking is constantly growing and now includes cervical, pancreatic, kidney, and stomach cancers, aortic aneurysm, leukemia, cataracts, pneumonia, and gum disease.

Tobacco smoking causes cancer:

• Tobacco smoking causes cancer of the oral cavity, larynx, pharynx, lung, esophagus, pancreas, kidney and urinary bladder, stomach, cervix, and acute myeloid leukemia.

• In most cases, tobacco smoking is the cause of lung cancer. The risk of developing lung cancer in smokers is increased 20-fold compared to non-smokers. Tobacco smoking is responsible for 90% of lung cancer deaths in men and 80% in women.

• Cigarette smoking combined with alcohol abuse causes laryngeal cancer.

• Smoking low-tar cigarettes does not reduce the risk of lung cancer and other organ cancers.

Tobacco smoking causes cardiovascular diseases:

• The risk of death from coronary heart disease in smokers is increased by 4 times.

• Despite treatment, 25% of men and 38% of women die within a year after a myocardial infarction if they continue smoking.

• Tobacco smoking leads to the development of atherosclerosis and arterial narrowing.

• Tobacco smoking leads to the development of coronary heart disease.

• Smoking low-tar and low-nicotine cigarettes does not reduce the risk of developing coronary heart disease.

• Tobacco smoking is a cause of stroke.

• Tobacco smoking causes aortic aneurysm (thinning and ballooning of the aorta in the abdominal area).

Tobacco smoking causes lung diseases:

• Tobacco smoking damages the bronchi and lungs, leading to fatal chronic obstructive pulmonary disease.

• The likelihood of developing infectious lung diseases is significantly higher in smokers than in non-smokers.

• Smoking pregnant women harm the lungs of their infant.

• Smoking in adolescence leads to lung underdevelopment and decreased lung function at a young age.

• Tobacco smoking leads to chronic cough, wheezing, and bronchial asthma in children and adolescents.

• Tobacco smoking leads to chronic cough and wheezing in adults.

Tobacco smoking impairs reproductive function in women:

• Tobacco smoking leads to decreased fertility in women.

• Smoking during pregnancy increases the risk of sudden infant death syndrome by 4 times.

• Smoking during pregnancy leads to placenta previa and placental abruption. These disorders can lead to premature birth.

• Nicotine and carbon monoxide contained in tobacco smoke lead to reduced oxygen delivery to fetal tissues.

• Smoking during pregnancy impairs fetal development and leads to low birth weight.

Tobacco smoking leads to a decline in the smoker's health:

• Smokers are less healthy than non-smokers.

• After surgeries, smokers are more likely to develop complications associated with poor wound healing and respiratory diseases.

• Smoking women during menopause are more likely to develop osteoporosis (decreased bone density).

• Smokers have an increased risk of bone fractures.

• Tobacco smoking causes periodontitis, serious gum infections, and tooth loss in 50% of cases.

• Tobacco smoking can cause impotence in men.

• Tobacco smoking increases the risk of cataracts leading to blindness by 3 times.

• Tobacco smoking increases the risk of peptic ulcer disease of the stomach and duodenum. In severe cases, this disease can be fatal.

It is currently proven that electronic cigarettes, vapes, and other types of ENDS produce an aerosol containing the following toxic substances:

• Nicotine is a highly addictive substance that negatively affects adolescent brain development (the brain develops until the age of 25).

• Propylene glycol is a common food additive; it is also used to produce substances such as antifreeze, paint thinner, and artificial smoke in fog machines.

• Acrolein (a carcinogen) is a herbicide mainly used to kill weeds and can cause irreversible lung damage.

• Acetaldehyde and formaldehyde (carcinogens) are cancer-causing chemicals.

• Diacetyl (a flavoring agent) is a chemical associated with a lung disease called bronchiolitis obliterans, also known as "popcorn lung".

• Diethylene glycol is a toxic chemical used in antifreeze, associated with lung diseases.

• Nickel, tin, lead are heavy metals.

• Cadmium is a metal found in traditional cigarettes that causes breathing problems and kidney disease.

• Benzene is a volatile organic compound found in car exhaust.

• Ultrafine particles are particles less than 2 microns in size that can penetrate deep into the lungs.

Aerosol from all types of electronic cigarettes and vapes is equally harmful. Flavored and unflavored electronic cigarettes are also equally harmful. A single electronic cigarette cartridge can contain as much nicotine as a pack of regular cigarettes.

It is currently proven that the use of electronic cigarettes, vapes, and other ENDS leads to the following health disorders in consumers:

• memory, concentration, learning ability, self-control, attention, and mood are impaired;

• seizures may develop;

• teenagers who use electronic cigarettes are 4 times more likely to transition to cigarette smoking; electronic cigarettes rapidly cause inflammation in the lungs, throat, and eyes;

• electronic cigarette users get colds and pneumonia more often;

• electronic cigarettes do not help quit tobacco use because nicotine addiction persists when using them.

Step 2 – Assess your health:

Consider that tobacco or nicotine-containing products may also have a harmful effect on your health. Analyze whether you have any symptoms of health disorders resulting from use: cough, sputum, high blood pressure, stomach pain, premature facial wrinkles, shortness of breath, constant fatigue. Perhaps the most important thing you can do for your health is to quit tobacco or nicotine use.

Your health will begin to improve the very minute you quit smoking:

• In 20 minutes your heart rate and blood pressure will drop.

• In 24 hours, your risk of a heart attack will decrease.

• In 2 days, your normal sense of taste and smell will return.

• In 2–3 weeks, your lung function will normalize, blood circulation will improve, and it will become easier for you to walk.

• In 1 year, the risk of a heart attack will be cut in half, and in 15 years it will drop to the level of non-smokers.

  In 5 years:

• the risk of cancer of the oral cavity, throat, and esophagus will be cut in half,

• the risk of stroke and myocardial infarction will become virtually the same as that of a non-smoker (within 5-15 years).

• In 10 years, your risk of dying from lung cancer will become virtually the same as that of a non-smoker.

• Quitting tobacco smoking reduces the risk of death from chronic obstructive pulmonary disease.

• The risk of developing bladder cancer is halved a few years after quitting tobacco smoking.

• If a woman quits smoking during the first trimester of pregnancy, the risk of giving birth to a low birth weight baby decreases to the level of a non-smoking woman.

Step 3 – Identify your reasons for quitting tobacco/nicotine:

1. Live a healthier life.

   Your health will begin to improve immediately after quitting tobacco or nicotine-containing products.

2. Live longer.

   Tobacco/nicotine use literally "eats you alive." For example, smokers killed by tobacco die about 14 years earlier than non-smokers.

3. Break free from dependence.

   Nicotine is one of the most addictive substances; smokers develop a disease known as tobacco (nicotine) dependence.

4. Improve the health of those around you.

   Secondhand tobacco smoke kills. It causes cancer, heart disease, respiratory and digestive system diseases, and other illnesses. Children whose parents smoke have a higher probability of developing bronchitis, bronchial asthma, ear infections, and pneumonia.

5. Save money.

   Calculate how much money per year you spend on cigarettes or other tobacco or nicotine-containing products, as well as lighters, coffee, and other smoking paraphernalia. You can spend this money on something much more useful for yourself and your family.

6. Feel better.

   You will get rid of your cough, it will become easier for you to breathe, and you will stop feeling unwell all the time. You will also look better – those who quit smoking have younger-looking skin, whiter teeth, and more energy.

7. Improve your quality of life.

   Your clothes, car, and home will no longer have an unpleasant odor. Food will taste better.

8. Have a healthy baby.

   Babies born to women who use tobacco or nicotine-containing products have a higher probability of being born with low birth weight and having poor health throughout their lives.

9. Improve your sexual and reproductive health.

   Men who use tobacco or nicotine may experience problems achieving and maintaining an erection. Women who smoke have a harder time conceiving and maintaining a pregnancy.

Step 4 – Making a Decision:

Focus on the reasons why you want to quit smoking or using other tobacco and nicotine-containing products. Prepare yourself to quit using them.

Step 5 – Action:

Now we will fight your disease together. Choose the day you will quit smoking, and we will create your treatment plan with you.

1. From the day you quit — not a single puff!

   Throw away ashtrays, lighters, and all cigarettes or other tobacco or nicotine-containing products.

2. Do not allow smoking in your car and at home.

   This will create a healthier environment for others and also help you resist the urge to smoke.

3. Secure support and approval from those around you.

   Tell your family members, friends, and coworkers that you are quitting smoking and ask for their support.

4. Find someone else who wants to quit smoking.

   It is easier to quit smoking with someone else. Invite a smoking acquaintance or smoking relative to quit smoking with you.

5. Identify what triggers the irresistible urge to smoke.

   Alcohol, coffee, and stress can trigger the urge to smoke. This urge can also be triggered by seeing people smoke — ask your smoking acquaintances not to light up in front of you.

Do not give up:

• Most people made several attempts to quit smoking before they succeeded. If you start smoking again, do not lose hope – make a new attempt.

• You have not failed – you have learned which factors and situations make you reach for a cigarette.

• The next attempt to quit smoking will be easier.

• It is never too late to quit smoking.

Appendix G. Assessment Scales, Questionnaires, and Other Evaluation Tools

Appendix G1.

1. Assessment of nicotine dependence in tobacco smoking. Fagerström Test.

Russian title: Fagerström Test

Original title (if any): Fagerstrom Test for Nicotine Dependence (FTND)

Source (official developer website, validation publication): Heatherton

TF, Kozlowski LT Frecker RC (1991). The Fagerstrom Test for Nicotine Dependence: A revision of the Fagerstrom Tolerance Questionnaire. British Journal of Addiction, 1991, 86:1119-27.

Type (underline):

• rating scale

• index

• questionnaire

• other (specify)

Purpose: Assessment of the intensity of physical dependence on nicotine.

Content (template): When smoking cigarettes

When using nicotine-containing products:

Key (interpretation): Conclusion based on the total score:

0–2 – Very low dependence.

3–4 – Low dependence.

5 – Moderate dependence.

6–7 – High dependence.

8–10 – Very high dependence.

Note: For a rapid assessment of the degree of nicotine dependence, it is possible to use responses to the first question only: 0 – Low, 1 – Moderate, 2 – High, 3 – Very high

Appendix G2.

2. Assessment of motivation to quit tobacco and/or nicotine-containing products (Prochaska questionnaire)

Russian title: Prochaska Questionnaire

Original title (if applicable): Test of Prochaska

Source (official developer website, validation publication): Budd, R. J., & Rollnick, S. The structure of the Readiness to Change Questionnaire: A test of Prochaska & DiClemente's transtheoretical model. British Journal of Health Psychology, 1996, 1(Part 4), 365-376. https://doi.org/10.1111/j.2044-8287.1996.tb00517.x

Type (underline):

• rating scale

• index

• other (specify)

Purpose: Assessment of the patient's readiness to quit tobacco and/or nicotine-containing products.

Content (template):

Key (interpretation): Conclusion based on the total score:

6 or more – high motivation,

3–5 – low motivation,

2 and lower – lack of motivation.