Tailored Smoking Cessation Treatment for LIVE FOR LIFE® Participants
Stopped early · Phase 2/Phase 3
Conditions studied: Cigarette Smoking, Nicotine Dependence
In brief
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.
Key facts
- Study ID
- NCT01560507
- Run by
- Duke University
- People needed
- 19
- Starts
- 2012-05-01
- Expected to finish
- 2013-07-01
- Last updated by the study team
- 2014-12-24
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Duke Center forSmoking Cessation — Durham, North Carolina, United States
- Duke Center for Smoking Cessation — Raleigh, North Carolina, United States
Full record on ClinicalTrials.gov
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