Tailored Smoking Cessation Treatment for LIVE FOR LIFE® Participants

Previous research has shown that the initial response to nicotine patch treatment can be
used to decide whether the patch alone is likely to help smokers to quit or whether
alternative prescription medications may be needed to achieve smoking abstinence. This
study applies the knowledge gained from this previous research to adapt the smoking
cessation treatment provided to participants, based on their degree of smoking reduction
during the first four weeks of nicotine patch treatment. By demonstrating effectiveness of
this algorithm, this study may lead to further dissemination of the adaptive treatment
strategy to other health care settings. Additionally, by gathering further information
relating genomic markers to outcome, the foundation will be laid for potential practical
application of this index in other settings.

Inclusion Criteria:

- Duke employees who are enrolled in a Duke Health Plan and intend to remain employed
at Duke for the next six months;

- Dependents of Duke employees who meet the above criteria;

- 18-65 years old;

- Currently smoke an average of at least 10 cigarettes per day;

- Willing to take Chantix or Zyban;

- Express a desire to quit smoking within the next 30 days.

Exclusion Criteria:

- Hypertension;

- 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);

- Extensive active skin disorder;

- Liver or kidney disorder (except kidney stones, gallstones);

- Gastrointestinal 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;

- 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;

- Suicidal ideation (within the past 10 years) or lifetime occurrence of attempted
suicide;

- Pregnant or nursing mothers;

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

- Current depression;

- Bulimia or anorexia;

- Alcohol abuse;

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

- Use (within the past 30 days) of:

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

- Medications that are known to affect smoking cessation.