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 ofhypertension); subjects with no previous diagnosis of hypertension may have ascreening 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, heartmurmur, heart failure);

• History of skin allergy;

• Active skin disorder (e.g., psoriasis) within the last five years, except minor skinconditions (including but not limited to facial acne, minor localized infections, andsuperficial 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 chronicobstructive pulmonary disease (COPD), emphysema, and asthma);

• Brain abnormality (including but not limited to stroke, brain tumor, and seizuredisorder);

• 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 lessthan 180mg/dcl and HbA1c is less than 7%);

• Current cancer or treatment for cancer in the past six months (except basal orsquamous cell skin cancer);

• Other major medical condition;

• Current psychiatric disease (with the exception of anxiety disorders, obsessivecompulsive disorder (OCD) and ADHD);

• Suicidal ideation (within the past 10 years) or lifetime occurrence of attemptedsuicide;

• 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 othermedications 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 othersmoking cessation aid.