The investigators' goal is to identify the most appropriate smoking cessation treatments for smokers based on genetic information. Smokers try to quit smoking but relapses are common.
The investigators' goal is to determine whether genetic markers can be used to optimize smoking cessation pharmacotherapy to enhance efficacy, medication adherence, and reduce side effects. Smoking is a leading cause of preventable death and disability, and smoking cessation reverses the risk of mortality. However, cessation failure is common despite available cessation medications, which are associated with different efficacy, side effects, adherence, use constraints, and costs. This challenge can be addressed by improving current treatments via personalized medicine based on individual genetic markers to maximize efficacy and minimize side effects. The investigators propose a prospective, genotype-based stratified randomization trial to compare two smoking cessation medications (combination NRT \[patch and lozenge\], varenicline vs. placebo) for 3 months in 720 smokers with known genotypes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
822
Washington University School of Medicine
St Louis, Missouri, United States
7-day Point Prevalence Quit Rate
The definition of this measure requires: (a) no self-reported smoking (not even a puff of a cigarette) for at least the 7 days prior to the assessment, and (b) biochemical verification of abstinence.
Time frame: Week 12
Continuous Abstinence
The definition of this measure requires: Not taking even 1 cigarette puff from target quit date to end of treatment.
Time frame: 12 weeks (with first 1 week initial grace period)
7-day Point Prevalence Quit Rate
The definition of this measure requires: (a) no self-reported smoking (not even a puff of a cigarette) for at least the 7 days prior to the assessment, and (b) biochemical verification of abstinence.
Time frame: Week 24
Number of Days to Lapse
* The number of days to lapse is defined as the number of days from the target quit date until the participant reports smoking (even a single puff). * Participants who did not lapse by the end of the 52 weeks and participants who had missing information on lapse are not included in the overall number of participants analyzed
Time frame: Assessed from the target quit day through 52 weeks
Number of Days to Relapse
* The number of days to relapse is defined as the number of days from the target quit day until the first of seven consecutive days of smoking. * Participants who did not relapse by the end of the 52 weeks and participants who had missing information on relapse are not included in the overall number of participants analyzed
Time frame: Assessed from the target quit day through 52 weeks
Initial Cessation
Defined as at least 1 day of abstinence during the first 7 days after the target quit day.
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Time frame: Assessed for the first seven days after the target quit date
Longitudinal Models of Abstinence Outcomes Across Multiple Time Points
-The definition of this measure requires; no self-reported smoking (not even a puff of a cigarette) for at least 7 days prior to the assessment.
Time frame: 0-52 Weeks
Longitudinal Models of Smoking Quantity in Cigarettes Per Day Outcomes Across Multiple Time Points.
The definition of this measure requires self-reported cigarettes per day.
Time frame: 0-52 Weeks
Medication Adherence
Adherence is the proportion of expected medication (varenicline, patch, lozenge) taken as advised during pre-quit week to week 12
Time frame: Pre-quit week to Week 12
Side Effects
All reported side effects (occurring\>4%) will be summarized and presented for the study. In addition, the investigators will further identify a pre-specified set of key side effects as being related to drug agonist effects (e.g., nausea, vomiting, racing heart, headache, and sleep disturbance). These will be analyzed as rate of occurrence during the period of medication use.
Time frame: Pre-quit week to Week 12
Withdrawal
* Withdrawal severity is assessed by Wisconsin Smoking Withdrawal Scale (WSWS), there are 28 items. * Participants rate each item on a scale of 0-4 (0=Strongly disagree, 1=Disagree, 2=Feel neutral, 3=Agree, 4=Strongly agree). The subscale to each item is determined on how high they agree on the scale. For some items, the subscale is determined on how low they agreed. Each score is determined by the mean of each item that applies. Higher means indicate greater withdrawal. * The scores were calculated by averaging a mean score of each item for each participant with data from time point pre-quit, quit, week 1, week 2, and week 4. The mean score for each participant was averaged for each item and a mean score was taken for each treatment condition (cNRT, Varenicline, Placebo). These data are reported as mean withdrawal scores and not change in withdrawal scores.
Time frame: Pre-quit, quit, week 1, week 2, and week 4