Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Multicenter, Double Blind, Placebo Controlled Study Evaluating The Efficacy Of Varenicline In Cessation Of Oral Smokeless Tobacco Use
Brief Summary: The primary goal of this study is to compare efficacy of varenicline to placebo for cessation of use of smokeless tobacco.


Options:
A: Inclusion Criteria:Healthy smokers 18-60 years old, smoking ≥15 conventional cigarettes per day (cig/day) for at least 10 years were recruited using anti-smoking leaflets and by an approved kiosk located in the atrium of the university hospital (AOU 'Policlinico-V. Emanuele') promoting the smoking cessation services of the CPCT (Centro per la Prevenzione e Cura del Tabagismo, Università di Catania, Italy).

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Exclusion Criteria:history of alcohol and illicit drug use, major depression or other psychiatric conditions. We also excluded subjects who reported recent myocardial infarction, angina pectoris, essential hypertension (\>140mmHg systolic and/or \>90mmHg diastolic), diabetes mellitus, severe allergies, poorly controlled asthma or other airways diseases

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B: Inclusion Criteria:

* Male or female daily smokeless tobacco users aged 18 years and older, who are motivated to stop use of all tobacco products.
* Subjects must be daily users of nicotine containing smokeless tobacco and using smokeless tobacco on at least 8 occasions per day averaged over a week.
* Have used smokeless tobacco for at least 1 year prior to screening with no period of abstinence \>3 months in the past year.

Exclusion Criteria:

* Subjects using nicotine containing products (including smoking tobacco) other than smokeless tobacco for 3 months prior to screening.
* Subjects with exhaled Carbon Monoxide (CO) \>10 ppm at baseline.
* Subjects who have used varenicline, bupropion, or NRT within 3 months of screening.
* Subjects currently or within the past 12 months requiring treatment for depression or have a current or prior history of panic disorder, psychosis, bipolar disorder or any other serious mental illness.
C: Inclusion Criteria:

Subjects must meet all of the following inclusion criteria to be eligible for enrolment into the study:

1. Able to comply with the study procedures
2. Male or female healthy smokers aged ≥19
3. Smoking at least 10 cigarettes a day
4. Smoking for at least one year
5. Not currently attempting to quit smoking or wishing to do so in the next 30 days (this will be verified at screening by the answer ''NO'' to both questions ''Do you intend to quit in the next 30 days?'' and ''Are you interested in taking part in one of our smoking cessation programs?'')
6. Female smokers not planning to become pregnant are using an acceptable form of contraception.

Exclusion Criteria:

The presence of any of the following will exclude a subject from study enrolment:

1. Use of smokeless tobacco, or any other tobacco products (including e-cigarettes, cigars, chewing tobacco, snus, etc.) within the last 3 months, at baseline and during the whole study.
2. Use of nicotine replacement therapy or other smoking cessation therapies within the last 3 months and at baseline.
3. Self-reported pregnancy, planned pregnancy or breastfeeding.
4. Tobacco industry employees and 1st degree relatives will be excluded in order to safeguard independence of the study

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D: Inclusion Criteria:

* Men and women
* 18 to 75 yrs old
* Motivated to stop smoking
* Smoke at least 10 cigarettes/day

Exclusion Criteria:

* Active psychiatric disease
* Severe or unstable cardiovascular or pulmonary disease
* Current or recent treatment to stop smoking
* Previous use of varenicline

Answer: B