Please select the eligibility criteria that correspond to the clinical trial below.
Title: Extended Varenicline for Smoking Cessation: A Pilot Study
Brief Summary: The purpose of this study is to explore the use of an prolonged alternative dosing schedule using varenicline for smoking cessation leading to greater quit rates and higher rates of continuous abstinence.


Options:
A: Inclusion Criteria:

1. Subject is at least 18 years of age;
2. Subject has provide written informed consent;
3. Subject is smoking greater than or equal to 10 cigarettes per day for at least 6 months;

3) Subject is able to complete all study visits 4) Subject is in good health as determined by the investigator 5) Subject has the ability to participate fully in all aspects of the study and keep scheduled appointments 6) Subject is motivated to stop smoking.

Exclusion Criteria:

Female and were pregnant, lactating or likely to become pregnant during the trial and not able nor willing to use contraception or had:

1. an unstable medical condition;
2. another household member participating in the study;
3. bupropion or varenicline allergy;
4. current use (previous 30 days) of a tobacco dependence treatment and unable or unwilling to discontinue use;
5. an unstable medical condition or unstable angina, myocardial infarction, or coronary angioplasty (past 3 months) or an untreated cardiac dysrhythmia;
6. a history of renal failure or were on renal dialysis;
7. a history of seizures;
8. as defined by the C-SSRS (Columbia-Suicide Severity Rating Scale), current non-specific suicidal thoughts or lifetime history of a suicidal attempt (defined as "potentially self-injurious act committed with at least some wish to die, as a result of act");
9. a history of closed head trauma associated with \> 30 minutes of loss of consciousness, amnesia, skull fracture, subdural hematoma, or brain contusion;
10. a history or psychosis, bipolar disorder, bulimia or anorexia nervosa;
11. current moderate or severe depression as assessed by a score of ≥ 20 on the Beck Depression Inventory, Second Edition (BDI-II) 10;
12. active substance abuse other than nicotine;
13. current (past 14 days) use of an antipsychotic, monoamine oxidase inhibitors, or drugs known to interact with bupropion SR;
14. a recent dose change of their antidepressant (within last 3 months);
15. untreated hypertension or baseline systolic blood pressure \> 180 or diastolic \> 100;
16. current treatment with another investigational drug for tobacco dependence (previous 30 days); or
17. current use of bupropion or varenicline (previous 30 days).
B: Inclusion Criteria:

1. Between the ages of 18 and 75.
2. Smoking 5 or more cigarettes per occasion at least 3 times per week.
3. Fewer than 3 months of smoking abstinence in the past year.
4. Motivated to stop smoking.
5. Report exceeding maximum weekly drinking limits every week in the past 4 weeks and exceeding maximum daily drinking limits on at least 1 occasion in the past 4 weeks. Weekly heavy drinking is defined as 8 or more drinks for women and 15 or more drinks for men. Daily heavy drinking is defined as 4 or more drinks for women and 5 or more drinks for men on an occasion.

Exclusion Criteria:

1. Exhibit current, clinically significant physical disease or abnormality on the basis of medical history, physical examination, or routine laboratory evaluation
2. Any unexplained elevations in liver enzymes (i.e., transaminases, bilirubin)
3. Clinically significant cardiovascular disease
4. Uncontrolled hypertension
5. Hepatic or renal impairment
6. Severe chronic obstructive pulmonary disease
7. Diabetes mellitus requiring insulin or oral hypoglycemic medications.
8. Baseline systolic blood pressure higher than 150 mm Hg or diastolic blood pressure higher than 95 mm Hg
9. History of cancer (except treated basal cell or squamous cell carcinoma of the skin).
10. History of clinically significant allergic reactions.
11. Exhibit serious psychiatric illness (i.e., schizophrenia, bipolar disorder, severe major depression, panic disorder, borderline personality disorder, organic mood or mental disorders, or substantial suicide or violence risk) by history or psychological examination)
12. Have a current diagnosis of DSM-IV drug dependence other than nicotine or alcohol.
13. Have a current Diagnostic and Statistical Manual Diploma in Social Medicine IV (DSM-IV) diagnosis of alcohol dependence that is clinically severe defined by a) a history of seizures, delirium, or hallucinations during alcohol withdrawal, b) a Clinical Institute Withdrawal Assessment scale (Sullivan et al., 1989) score of \> 8, c) report drinking to avoid withdrawal symptoms, or d) have had prior treatment of withdrawal.
14. Use of another investigational drug within 30 days.
15. Intention to donate blood or blood products during the treatment phase of the study.
16. Use of tobacco products other than cigarettes or use of marijuana.
17. Use of nicotine replacement therapy, clonidine, varenicline, bupropion, or nortriptyline within the month prior to enrollment or intention to use medication that might interfere with study medication.
18. Body Mass Index (calculated as weight in kilograms divided by the square of height in meters) less than 15 or greater than 38 or weight less than 45 kg.
19. Females of childbearing potential who are pregnant, nursing, or not practicing effective contraception (oral, injectable, or implantable contraceptives, intrauterine device, or barrier method with spermicide).
C: Inclusion Criteria:

* The sample, 40 women and 40 men, will be hospitalized patients recruited from Stanford Hospital and Clinics who report smoking at least 10 cigarettes per day prior to hospitalization, have confirmed tobacco use by cotinine testing, and an expected hospitalization of at least 3 days duration from the date of study enrollment. Intention to quit smoking will not be required for study participation.

Exclusion Criteria:

- Study exclusion criteria are: dementia or other brain injury precluding ability to participate; Alzheimer's Disease; Parkinson's Disease; Huntington's Disease; meningitis; seizure disorder of a sustained nature; delirium; brain surgery; drug and/or alcohol dependence; suicidal ideation; end-stage renal disease (i.e., on dialysis); hypertensive crisis; stroke; myocardial infarction (MI) with severe cardiac damage; pregnancy or breastfeeding; non-English speaking; complete homelessness; or currently engaged in tobacco treatment. Study staff will consult with clinical staff prior to approach for study enrollment. In cases of severe renal impairment (estimated creatinine clearance \<30 mL/min), medical staff will consult with participants' physician to assess the appropriateness for study enrollment.
D: Inclusion Criteria:

* currently smoking at least 15 cigarettes daily
* in good health
* able to read and speak English fluently
* have a home telephone and plan to reside in Western New York for 6 months
* willing to make quit attempt
* signed informed consent
* who planned quit attempt.

Exclusion Criteria:

* serious medical condition
* depression or mental health condition requiring treatment in the past year
* history of panic disorder, psychosis, bipolar disorder
* alcohol or drug abuse in the past year
* use of tobacco products other than cigarettes
* current use of other cessation pharmacotherapies
* pregnancy/planned pregnancy.

Answer: D