Combination Bupropion / Varenicline for Smoking Cessation in Male Smokers

Inclusion Criteria:

- Have no known serious medical conditions;

- Male;

- Are 18-65 years old;

- Smoke an average of at least 10 cigarettes per day;

- Have smoked at least one cumulative year;

- Have an expired air carbon monoxide (CO) reading of at least 10ppm;

- Able to read and understand English;

- Express a desire to quit smoking in the next thirty days.

Potential subjects must agree to use acceptable contraception.

Potential subjects must agree to avoid the following:

- participation in any other nicotine-related modification strategy outside of this
protocol;

- use of tobacco products other than cigarettes, including pipe tobacco, cigars,
e-cigarettes, snuff, and chewing tobacco;

- use of experimental (investigational) drugs or devices;

- use of illegal drugs;

- use of opiate medications.

Exclusion Criteria:

- Hypertension;

- Hypotension with symptoms;

- Coronary heart disease;

- Lifetime history of heart attack;

- Cardiac rhythm disorder (irregular heart rhythm);

- Chest pains (unless history, exam, and electrocardiogram (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;

- 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;

- Use of opiate medications for pain or sleep (non-opiate medication for pain or sleep
will be allowed) within the past 14 days;

- Smoking more than one cigar a month.

- Alcohol abuse;

- Significant adverse reaction to nicotine patches, bupropion / Wellbutrin / Zyban or
Chantix / varenicline in the past.

- Current participation or recent participation (in the past 30 days) in another
smoking study at our Center or another research facility.

- Current participation in another research study.

Use (within the past 30 days) of:

- Illegal drugs (or if the urine drug screen is positive for tetrahydrocannabinol
(THC), Cocaine, Amphetamine, Opiates, Methamphetamines, phencyclidine (PCP),
Benzodiazepines, or Barbiturates),

- 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), pipes or e-cigarettes;

- Wellbutrin, bupropion, Zyban, Chantix, varenicline, nicotine replacement therapy or
any other smoking cessation aid.