This phase IV trial investigates how to personalize treatments (such as medications and/or counseling) for quitting smoking based on the unique character traits of participants. Nicotine replacement therapy, counseling, and/or drugs such as varenicline and bupropion may help participants quit smoking or change smoking behavior. This trial may also help doctors individualize smoking cessation treatment for participants who do not quit smoking after the first course of treatment.
Smoking 5 or more cigarettes, little cigars and/or cigarillos per day, on average, within the past 30 days preceding the screening visit and expired carbon monoxide (CO) ≥ 6 ppm and/or a urine Nic Check test > 0 (or a reading of positive if an alternate nicotine test used)
Interested in treatment that might change smoking behavior or help them quit smoking
Able to follow verbal and written instructions in English and complete all aspects of the study
Provide informed consent and agree to all assessments and study procedures
Current enrollment or plans to enroll in another smoking cessation program during the study time frame, including plans to use other smoking cessation medications (i.e., over the counter [OTC] or prescription medication for smoking cessation) or smoking cessation treatments
Serious or unstable medical or psychiatric disorder within the past 3 months, as determined by the study physician
Being pregnant, engaging in breast-feeding, or being of childbearing potential and engaging in sexual activity that could lead to pregnancy and is not protected by a medically acceptable, effective method of birth control while enrolled in the study, as determined by self-report. Medically acceptable contraceptives include: (1) approved hormonal contraceptives (such as birth control pills, patches, implants or injections), (2) barrier methods (such as a condom or diaphragm) used with a spermicide, or (3) an intrauterine device (IUD). Contraceptive measures sold for emergency use after unprotected sex are not acceptable methods for routine use
Smoking cessation meds (last 7 days; e.g., bupropion, NRT, varenicline). Episodic use of NRT in the last 7 days may be considered if the participant agrees to only use study medication once randomized
Parallel
Bupropion Hydrochloride Controlled-release
DrugGiven PO
Nicotine Replacement
DrugGiven via nicotine patch, lozenges, or gum
Questionnaire Administration
Other interventionAncillary studies
Tobacco Cessation Counseling
Other interventionReceive behavioral smoking cessation counseling
Varenicline
DrugGiven PO
7
Treatment groupsSee each treatment group below.
End of treatment seven-day point prevalence
Will use Bayesian statistical methods to estimate these effects and their accompanying posterior probabilities.
Expired carbon monoxide value
Will use Bayesian statistical methods to estimate these effects and their accompanying posterior probabilities.
Abstinence
Will evaluate utilizing a logistic regression model.
Days to relapse
Will analyze using Cox proportional hazards regression.
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M.D. Anderson Cancer Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
