Concurrent Bupropion / Varenicline for Smoking Cessation

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 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, 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.