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:

* 18-65 years old;
* smoked an average of at least 10 cigarettes per day for three cumulative years;
* have an expired air CO reading assessed at screening of at least 10ppm;
* express a desire to quit smoking within the next 30 days.

Exclusion Criteria:

* Hypertension (systolic \>140 mm Hg, diastolic \>100 mm Hg, coupled with a history of hypertension); subjects with no previous diagnosis of hypertension may have a screening blood pressure up to 160/100.
* Hypotension with symptoms (systolic \<90 mm Hg, diastolic \<60 mm Hg).
* Coronary heart disease;
* Lifetime history of heart attack;
* Cardiac rhythm disorder (irregular heart rhythm);
* Chest pains (unless history, exam, and ECG clearly indicate a non-cardiac source);
* Cardiac (heart) disorder (including but not limited to valvular heart disease, heart murmur, heart failure);
* History of skin allergy;
* Active skin disorder (e.g., psoriasis) within the last five years, except minor skin conditions (including but not limited to facial acne, minor localized infections, and superficial minor wounds);
* Liver or kidney disorder (except kidney stones, gallstones);
* Gastrointestinal problems or disease other than gastroesophageal reflux or heartburn;
* Active ulcers in the past 30 days;
* Currently symptomatic lung disorder/disease (including but not limited to chronic obstructive pulmonary disease (COPD), emphysema, and asthma);
* Brain abnormality (including but not limited to stroke, brain tumor, and seizure disorder);
* Migraine headaches that occur more frequently than once per week;
* Recent, unexplained fainting spells;
* Problems giving blood samples;
* Diabetes treated with insulin; non-insulin treated diabetes (unless glucose is less than 180mg/dcl and HbA1c is less than 7%);
* Current cancer or treatment for cancer in the past six months (except basal or squamous cell skin cancer);
* Other major medical condition;
* Current psychiatric disease (with the exception of anxiety disorders, obsessive compulsive disorder (OCD) and ADHD);
* Suicidal ideation (within the past 10 years) or lifetime occurrence of attempted suicide;
* Current depression;
* Bulimia or anorexia;
* Pregnant or nursing mothers;
* Alcohol abuse;
* Use of Opiate medications for pain or sleep in the past 14 days;
* Significant adverse reaction to nicotine patches, nicotine inhalers, bupropion / Wellbutrin / Zyban or Chantix / Varenicline in the past.
* Use (within the past 30 days) of:
* Illegal drugs (or if the urine drug screen is positive),
* Experimental (investigational) drugs;
* Psychiatric medications including antidepressants, anti-psychotics or any other medications that are known to affect smoking cessation (e.g. clonidine);
* Smokeless tobacco (chewing tobacco, snuff), cigars, pipes or e-cigarettes;
* Wellbutrin, bupropion, Zyban, Chantix, nicotine replacement therapy or any other smoking cessation aid.
B: 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.
C: Inclusion Criteria for smoking intervention and weight management intervention:

* Participants must be Medicaid recipients receiving mental health treatment at one of the participating study sites in New Hampshire.
* 18 years or older

Additional Inclusion Criteria for smoking intervention only:

\*Smoking 5 or more cigarettes a day or a carbon monoxide level of 5 or higher at screening.

Additional Inclusion Criteria for weight management only:

\*Body Mass Index of 30 or higher or 25 or higher and sedentary lifestyle.

Exclusion Criteria for both interventions:

* Diagnosis of dementia or terminal illness (expected to result in death in 1 year or less)
* Nursing home
* Inability to speak or understand English

Additional exclusion Criteria for weight management only:

* Previous participation in the In SHAPE program
* Active eating disorder diagnosis
* Pregnancy

Additional exclusion Criteria for smoking intervention only:

\*Active alcohol or drug dependence with use in the past 30 days
D: Inclusion Criteria:

* Smokes at least 10 cigarettes per day
* Good general health
* Negative pregnancy test prior to study entry

Exclusion Criteria:

* Prior exposure to NicVAX or any other nicotine vaccine
* Known allergic reaction to alum or any of the components of the vaccine
* Use of systemic steroids, immunosuppressive agents or other medication that might interfere with an immune response
* Cancer or cancer treatment in the last 5 years
* HIV infection
* History of drug or alcohol abuse or dependence within 12 months
* Significant cardiovascular, hepatic, renal, psychiatric and/or respiratory disease
* Previous intolerance to varenicline
* Inability to fulfill all visits for approximately 54 weeks

Answer: B