Smoking cessation through the administration of Cytisine (in standard and prolonged administration) + reduction of inflammatory status through the administration of Acetylsalicylic acid, diet modification and physical activity increase + standard treatment for early lung cancer detection (ultra low dose CT) + spirometry with CO test + anthropometic data collection + blood test

Smoking cessation through the administration of Cytisine (in standard and prolonged administration) + standard treatment for early lung cancer detection (ultra low dose CT) + spirometry with CO test + anthropometic data collection + blood test

reduction of inflammatory status through the administration of Acetylsalicylic acid, diet modification and physical activity increase + standard treatment for early lung cancer detection (ultra low dose CT) + spirometry with CO test + anthropometic data collection + blood test

standard treatment for early lung cancer detection (ultra low dose CT) + spirometry with CO test + anthropometic data collection + blood test

Inflammation

Smoking Cessation

Diet Modification

Physical Activity

Lung Cancer

Cytisine administration will be randomized 1:1 in standard (40 days)and prolonged treatment (84 days).
Subjects will be educated on how to take the product and informed about possible adverse effects.

Cytisine

The treatment will consist of Acetylsalicylic acid at 100mg once a day

Acetylsalicylic acid

It will be proposed:
an optimal diet with the aim of favoring control of weight, abdominal fat and adequate nutritional status without increasing the levels of IGF-I and inflammatory factors or glycemic peaks, with periodic verification of the results
a regular and sustainable physical activity program with periodic verification of the results.

Diet Modification and Physical Activity Increase

standard treatment for early lung cancer detection with ultra low dose CT

early lung cancer detection

spirometry with CO test

anthropometic data collection

blood test to assess the metabolic and inflammatory profile

blood test

World Cancer Research Fund / American Institute for Cancer Research. Food, Nutrition, Physical Activity, and the Prevention of Cancer: a Global Perspective

WHO report on the global tobacco epidemic, 2015

Ministero della Salute, Istituto Superiore di Sanità. Linee guida cliniche per promuovere la cessazione dell'abitudine al fumo. Guida breve per la realizzazione degli interventi.

AIRC. Fumo: le domande più frequenti. Perché si insiste tanto sui rischi del fumo?

IARC. IARC monogrpah on the evaluation of carcinogenic risks to humans. Volume 100E. A review of human carcinogens - Personal habits and indoor combustions

Detels R, Gulliford M, Karim QA, Tan CC. Oxford Textbook of Global Public Health (6 ed.)

Fondazione IRCCS Istituto Nazionale dei Tumori

Screening and Multiple Intervention on Lung Epidemics

Multifactorial Intervention of Primary Prevention in High Risk Subjects: a Randomized Trial

Reduction in the percentage of subjects with CRP>=2 mg/L

Dietary intakes are collected by a self reported food frequencies questionnaire and data are expressed as the average daily/weekly consumption of foods and food groups.
Servings size is defined as "natural unit" (e.g. 1 glass of soft drinks, 1 teaspoon of sugar) or as an average serving (e.g. 80 g of pasta or rice, 30 g of dried fruits).
The frequency of serving size is reported as continuous measure. Data will be collected as continuous measures and will be analyzed by performing statistical models to investigate a potential relationship among changes in dietary habits and anthropometric parameters (BMI, waist circumference..), socio-demographic characteristics (gender, smoking status, physical activity), biochemical parameters (CRP blood levels), drugs assumption and the risk of chronic diseases, such as lung cancer.

Increase in the physical activity measured by the validate short form IPAQ questionnaire (International Physical Activity Questionnaire) The items in the short IPAQ form were structured to provide separate scores on walking, moderate-intensity and vigorous-intensity activity. Computation of the total score requires summation of the duration (in minutes) and frequency (days) of each activity.
METs are multiples of the resting metabolic rate and a MET-minute is computed by multiplying the MET score of an activity by the minutes performed:
Walking MET-minutes/week = 3.3 * walking minutes * walking days
Moderate MET-minutes/week = 4.0 * moderate-intensity activity minutes * moderate days
Vigorous MET-minutes/week = 8.0 * vigorous-intensity activity minutes * vigorous-intensity days
Total physical activity MET-minutes/week = sum of Walking + Moderate + Vigorous MET-minutes/week scores

Weight and height will be combined to report BMI in kg/m^2. Reduction in BMI

Reduction in waist circumference expressed in centimeters

Enhancement in blood glucose, total cholesterol, LDL, HDL and triglycerides

Reduction in lung cancer specific and overall mortality

Ugo Pastorino

Head of Thoracic Surgery Division

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Istituto Di Ricerche Farmacologiche Mario Negri

Study participants will receive active varenicline and be instructed to take the medication for 12 weeks; participants will also receive a placebo Nicotine Replacement Therapy mouth spray for 8 weeks.

Study participants will receive placebo varenicline and be instructed to take the placebo medication for 12 weeks; participants will also receive an active Nicotine Replacement Therapy mouth spray for 8 weeks.

Study participants will receive active cytisine and be instructed to take the medication for 25 days; participants will also receive a placebo Nicotine Replacement Therapy mouth spray for 8 weeks.

Study participants will receive placebo cytisine and be instructed to take the medication for 25 days; participants will also receive an active Nicotine Replacement Therapy mouth spray for 8 weeks.

HIV Infection

Alcohol Use

Smoking

1 week starter kit followed by 1mg twice daily for 12 weeks.

Varenicline

Multi-daily dosing, range 3-9 mg daily for 25 days.

Mouth spray dosing based on standard recommendations tapered over 8 weeks.

Nicotine Replacement Therapy

1 week starter kit followed by 1 pill twice daily for 12 weeks.

Varenicline Placebo

Cytisine Placebo

Nicotine Replacement Therapy Placebo

URBAN ARCH, a member of NIAAA CHAART (Consortiums for HIV/AIDS & Alcohol Research Translation) initiative, conducts and disseminates interdisciplinary research on how alcohol impacts people with HIV and develops interventions to reduce related outcomes.

First St. Petersburg Pavlov State Medical University

Studying Partial-agonists for Ethanol and Tobacco Elimination in Russians With HIV (St PETER HIV)

URBAN ARCH 4/5 Russia Cohort-Targeting HIV-comorbidities With Pharmacotherapy to Reduce Alcohol and Tobacco Use in HIV-infected Russians

Self-reported past 30-day alcohol consumption obtained via the Timeline Followback (TLFB) method, heavy drinking defined by NIAAA definition

Measured by the Penn Alcohol Craving Scale

Self-reported 7-day point prevalence abstinence and a carbon monoxide measured in end-expired air threshold of <10 ppm.

cytisine/inflammation

Screening and Multiple Intervention on Lung Epidemics

Studying Partial-agonists for Ethanol and Tobacco Elimination in Russians With HIV (St PETER HIV)

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