Tailored Smoking Cessation Treatment for LIVE FOR LIFE® Participants

• Status: Terminated
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to ascertain: 1) the rate of smoking cessation obtained using an adaptive treatment algorithm developed in previous clinical trials, in order to calculate cost-effectiveness of the treatment; 2) the relationship between genotype and response to cigarette smoking cessation treatment.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duke University
• Collaborator: Philip Morris USA, Inc.
• Treatments: Bupropion; Nicotine; Varenicline

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.