Clinical trial NCT01560507 (phase 2/phase 3, status: terminated)
Conditions: cigarette smoking, nicotine dependence
ICD codes: X08.01XS, X08.11XS, X08.01XA, X08.01XD, X08.11XA, X08.11XD, X08.21XS, F17.200, F17.210, F17.208, F17.209, F17.218, F17.219, F17.228
Drugs: varenicline (chantix), bupropion (zyban), nicotine patches
SMILES: [H][C@]12C[C@]([H])(CNC1)C1=CC3=NC=CN=C3C=C21, CC(NC(C)(C)C)C(=O)C1=CC(Cl)=CC=C1, CN1CCC[C@H]1C1=CN=CC=C1
Reason stopped: 
    low recruitment
  
Eligibility criteria:

        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.