Please select the eligibility criteria that correspond to the clinical trial below.
Title: The Appeal and Impact of E-cigarettes in Smokers With Serious Mental Illness
Brief Summary: This study will evaluate behavioral and psychological appeal, toxicity, and effect of e-cigarettes on smoking behavior and nicotine addiction in chronic smokers with serious mental illness (SMI) who have failed to quit smoking. A total of 240 participants will be enrolled and randomly assigned to either receive a supply of e-cigarettes for 8 weeks plus assessments (baseline \& weeks 2, 4, 6, 8, 13, \& 26) or assessments only. This single-blinded study will provide e-cigarettes and instructions on their safe use. Level of appeal will be inferred from carefully assessed use of e-cigarettes and reduction in combustible tobacco. Qualitative data will also be collected from participants assigned to e-cigarettes, given that unanticipated issues will almost certainly arise in connection with e-cigarette use that can only be captured within a qualitative debriefing at the conclusion of participants' time in the study.


Options:
A: Inclusion Criteria:

* Daily smokers who live in New Zealand
* Aged ≥18 years
* Motivated to quit smoking within the next two weeks
* Able to provide consent
* Have daily access to a mobile telephone that can text
* Have access to the internet via a computer or smart phone
* Are willing to use cytisine or an e-cigarette or both products to help quit smoking

Exclusion Criteria:

* Have another person in their household currently enrolled in the study
* Are pregnant/breastfeeding, or are women trying to become pregnant in the next three months
* Are currently using smoking cessation medication (including using e-cigarettes daily for the last month)
* Are enrolled in another cessation programme/trial
* Have a known hypersensitivity to cytisine or nicotine e-cigarettes
* Self-report moderate/severe renal impairment
* Are undergoing treatment for active/latent tuberculosis
* Have experienced a myocardial infarction, stroke, or severe angina within the previous two weeks
* Have uncontrolled high blood pressure (\>150 mmHg systolic, \>100 mmHg diastolic)
* Have a history of seizures / epilepsy
* Have a strong preference to use or not to use cytisine and/or e-cigarettes in their quit attempt.
* Have a history of severe allergy and/or poorly controlled asthma.
B: Inclusion Criteria:

* Self-identified African American
* Smokes ≥ 1 cigarette per day (cpd)
* Smoke on ≥ 25 days of the past 30 days
* Functioning telephone
* Interested in quitting smoking
* Interested in taking 3 months of varenicline
* Willing to complete all study visits

Exclusion Criteria:

* Renal impairment
* Evidence or history of clinically significant allergic reactions to varenicline
* A cardiovascular event in the past month
* History of alcohol or drug dependence in the past year
* Major depressive disorder in the last year requiring treatment
* History of panic disorder, psychosis, bipolar disorder, or eating disorders
* Use of tobacco products other than cigarettes in past 30 days
* Use of pharmacotherapy in the month prior to enrollment, including prior use of varenicline
* Pregnant, contemplating getting pregnant, or breastfeeding
* Plans to move from Kansas City during the treatment and follow-up phase
* Another household member enrolled in the study
* Evidence of current severe major depressive disorder or suicidal ideation
C: Inclusion Criteria:

1. Type 2 diabetic patients (≤ 75 years of age) who are regular smokers (≥10 cigs/day during the past year, with no period of abstinence greater than three months in the past year) and willing to quit.
2. Females of non childbearing potential (surgically sterilized or at least 2 years postmenopausal) who are not nursing may be included. Females of childbearing potential may be included provided that they are not pregnant, not nursing, and are practicing effective contraception.
3. Subjects must be able to be outpatients and be assessed in a clinic setting.
4. Participating subjects must be able to provide written informed consent.

Exclusion Criteria:

1. Subjects currently or within the past 12 months requiring treatment for depression. Subjects with a past or present history of panic disorder, psychosis, or bipolar disorder;
2. Subjects with a current or recent (within the past 12 months) history of alcoholism;
3. Subjects with a requirement to use other medications during the study that might interfere with the evaluation of the study drug (e.g., nicotine replacement therapy);
4. Subjects with a body mass index (BMI) less than 15 or greater than 38, wearing indoor clothing without shoes and determined using the Body Mass Index (BMI);
5. Subjects with evidence or history of clinically significant allergic (except for seasonal allergies at time of dosing), endocrine, gastrointestinal, hematological, hepatic, neurologic, pulmonary, or renal disease or a history of cancer (excluding treated basal cell carcinoma and squamous cell carcinoma). Exceptions to this exclusion may include subjects with a history of mild chronic obstructive pulmonary disease, and stable thyroid disease.
6. Subjects with a history of clinically significant cardiovascular disease. In addition, subjects with uncontrolled hypertension or a screening or baseline systolic blood pressure greater than 160 mm Hg or a diastolic blood pressure greater than 95 mm Hg will be excluded.
D: Inclusion Criteria:

* Diagnosis of Schizophrenia, Schizoaffective Disorder, or Bipolar Disorder
* Enrolled in services at the research site for a minimum of 3 months
* Regular smoker (approximately 10 cigarettes for the past 5 years) with a history of at least 1 quit attempt
* Fluent in English

Exclusion Criteria:

* Regular use of e-cigarettes in the past month
* Current interest/plan to quit smoking
* Regular use of nicotine replacement therapy to quit smoking or use of bupropion or varenicline to quit smoking
* Use of emergency room or hospitalization for psychiatric reasons in the past 30 days

Answer: D