Cravv™ (Zpharm, Waterloo) is a natural health product licensed by Health Canada to assist with smoking cessation; each oral capsule contains 1.5mg of cytisine. The dosing is as follows: 6 capsules daily for the first 3 days; 5 capsules daily for days 4-12; 4 capsules daily for days 13-16; 3 capsules daily for days 17-20; and 1-2 capsules daily for days 21-25.

The Nicoderm® patch plus Nicorette® Lozenge will be provided to participants in the combination NRT group. Participants smoking less than 15 cigarettes per day will be provided with 14 mg patches while those smoking 15 or more cigarettes per day will receive 21 mg patches. Participants will be told to apply a new patch each morning. Participants will be instructed to use the lozenges as needed (up to 15 per day) to overcome nicotine cravings. Lozenges are available in both 2mg and 4mg strengths. For those who are smoking less than 15 cigarettes per day, they will be given the 2mg strength. For those who are smoking 15 or more cigarettes per day, they will receive the 4mg strength.

Smoking Cessation

Coronary Artery Disease

Cytisine is a plant-based smoking cessation medication. Cytisine acts by reducing the rewarding effect of nicotine and attenuating nicotine withdrawal symptoms. A recent review concluded that cytisine is the most promising future smoking cessation treatment. Cytisine is inexpensive to produce and is currently priced much lower than other cessation medications. It is well-tolerated by smokers and requires a shorter treatment period than conventional treatments. Because it is plant-based, cytisine may be attractive for smokers who prefer 'natural' medicines. Numerous placebo-controlled studies have demonstrated the safety and efficacy of cytisine. One high-quality pragmatic non-inferiority trial (n = 1310) found that cytisine was superior to nicotine replacement therapy (NRT) in improving self-reported continuous abstinence rates at 1 week, and 1, 2 and 6 months when both groups received minimal behavioural support.

Cytisine

The Nicoderm® patch plus Nicorette® Lozenge will be provided to participants in the combination NRT group. Participants will be instructed to apply a new patch each day. They will continue to wear patches for 25 days.

Nicoderm C-Q Transdermal Product

Participants in the NRT group will receive Nicorette Lozenges to use during their 25-day quit attempt. They will receive enough lozenges to last for the 25-day treatment period.

Nicorette Lozenge Product

University of Ottawa Heart Insitute - Prevention and Wellness Centre

Cytisine Compared to Combination NRT in Relapsed Smokers

Pilot RCT of Cytisine Compared to Combination Nicotine Replacement Therapy to Reduce Cigarette Consumption in Relapsed Smokers

will be feasible to recruit 10 relapsed smokers with CHD per month to a study of cytisine vs. combination NRT

Participants will complete at least 70% of their prescribed treatment

There will be less than 5% attrition over a 25-d treatment period

Cigarette consumption will drop by 5 cigs/d more in the cytisine group compared to the combination NRT group by the end of the 25-d treatment period

Arterial stiffness, as measured by pulse wave velocity, will improve in smokers who are able to achieve complete abstinence (i.e. smoking zero cigarettes per day).

This is a pilot study so datasets will not be shared until a written request is submitted to the PI.

Ottawa Heart Institute Research Corporation

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

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.

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

cytisine/kiharusi

Cytisine Compared to Combination NRT in Relapsed Smokers

Screening and Multiple Intervention on Lung Epidemics

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