Please select the eligibility criteria that correspond to the clinical trial below.
Title: Randomised Controlled Trial Investigating the Efficacy and Safety of an Electronic Nicotine Delivery Device (E-Cigarette) in Smokers
Brief Summary: The study's major aim is to investigate the ability of a commercial Electronic Nicotine Delivery Device (E-Cigarette) to induce long-term smoking reduction/abstinence in smokers unwilling to quit. Secondary aims are to investigate changes in withdrawal symptoms and cravings and to examine whether concomitant use of the E-Cigarette and smoking is safe.

The study will monitor smoking reduction/abstinence effects, changes in withdrawal symptoms, and adverse events of a currently marketed device in Italy ("Categoria" electronic cigarette - "ORIGINAL" 7.2 mg nicotine cartridges).

The primary hypothesis is that the E-Cigarette is a safe device that allows smoking reduction or abstinence in smokers possibly by suppressing withdrawal symptoms and cravings.


Options:
A: Inclusion Criteria: healthy smokers unwilling to quit, between 18 and 60 years of age. They should report a cigarette intake of ≥ 15 cig/day for at least 5 years. At screening they must provide a CO level of ≥ 15 ppm and an FTND ≥ 5.

Exclusion Criteria: alcohol and illicit drug use, breastfeeding, or pregnancy. Individuals who report current attempts to quit smoking and previous experience with electronic cigarettes will be also excluded.
B: Inclusion Criteria:

1. Over 60 years of age,
2. Have smoked 100 cigarettes in their lifetime and currently smoke five or more cigarettes a day on average,
3. Have an address in a rural census tract defined by a RUCA code of 4-10,
4. Interested in participating in a cessation program,
5. Own a phone that has texting ability and free texting,
6. Have general knowledge of text messaging and
7. Are willing to receive and respond to text messages from the study teams, throughout the duration of the study.

Exclusion Criteria:

1. criteria include non-English speaking patients
2. already participating in a smoking cessation intervention study.
C: Inclusion Criteria:

* Male and female cigarette smokers over the age of 18 years who are not willing/able to quit smoking within the next month but who are willing to attempt to reduce their smoking to work toward a quit attempt within the next 3 months.
* Subjects must have smoked an average of at least 10 cigarettes per day during the past year and during the month prior to the screening visit, with no continuous period of abstinence greater than 3 months in the past year and who have an exhaled carbon monoxide (CO) \>10 ppm at screening.
* Subjects with mild to moderate depression or anxiety may be included if their condition is stable.

Exclusion Criteria:

* Subjects with a history of a suicide attempt or any suicidal behavior in the past two years.
* Subjects with severe depression or anxiety.
* Subjects with psychosis, panic disorder, bipolar disorder, post traumatic stress disorder (PTSD), or schizophrenia.
* Subjects with alcohol or substance abuse or dependence (except nicotine) unless in full remission for at least 12 months.
D: Inclusion Criteria:

* Male and female smokers in good general health aged 20-65 years regularly smoking \>10 cigarettes per day for more than 1 year who are motivated to reduce or quit smoking

Exclusion Criteria:

* Subjects with uncontrolled hypertension, history of coronary heart disease or other significant heart condition
* History of other significant medical condition that might interfere with study procedures
* Pregnant or nursing mother
* Current drug abuse.

Answer: A