Cigarette smoking remains the chief preventable cause of cardiovascular and pulmonary disease. While evidence-based treatments improve a smoker?s chances of quitting successfully, even with such treatments, the majority of smokers still fail to quit long-term in a given quit attempt. There is a clear need for more effective treatments. The proposed research would evaluate two treatment modifications that are designed to enhance the effectiveness of varenicline, an FDA-approved smoking cessation medication: 1) extending the duration of varenicline treatment; and 2) adding the nicotine mini-lozenge to varenicline to form a combined treatment. While existing data suggest that both modifications may substantially enhance varenicline effectiveness, neither has been adequately tested. The proposed research will use a 2X2 factorial design to randomize 1000 smokers to one of two levels of each of two factors: Duration (12- vs. 24-weeks of medication) and Adjuvant (varenicline + placebo lozenge vs. varenicline + nicotine mini-lozenge). Thus, smokers will receive either standard varenicline treatment (12 weeks of varenicline therapy) or 1 of 3 innovative, enhanced treatments: 12 weeks of varenicline + mini-lozenge, 24 weeks of extended treatment with varenicline only, or 24 weeks of extended treatment with varenicline + mini-lozenge. Analyses will reveal whether the Duration and Adjuvant modifications produce additive or interactive effects on smoking abstinence at 52 weeks postquit, the primary outcome. Also, planned comparisons will determine if any of the enhanced conditions is superior to standard varenicline therapy. The hypothesis is that 24-week duration and the mini-lozenge adjuvant will produce significant, additive main effects so that their combination (24-weeks of varenicline + mini-lozenge) produces higher abstinence rates at 52-weeks postquit than does standard 12-week varenicline treatment. Other outcomes include prolonged smoking abstinence, treatment cost-effectiveness, withdrawal suppression, and adverse events. In sum, this research is designed to produce an especially effective smoking cessation treatment that should increase the rate of pharmacologic intervention with smokers in healthcare, reduce smoking prevalence in patient populations, and reduce incidence of cardiovascular and pulmonary disease.
This research seeks to determine whether varenicline?s effectiveness as a smoking cessation treatment can be enhanced by two modifications: longer duration treatment and/or adding a second medication (the nicotine mini-lozenge). This research could identify a more effective smoking cessation treatment and thereby help more smokers quit and avoid smoking related disease and premature death.
|Allen, Alicia M; Carlson, Samantha; Eberly, Lynn E et al. (2018) Use of hormonal contraceptives and smoking cessation: A preliminary report. Addict Behav 76:236-242|
|Srivastava, A Benjamin; Ramsey, Alex T; McIntosh, Leslie D et al. (2018) Tobacco use prevalence and smoking cessation pharmacotherapy prescription patterns among hospitalized patients by medical specialty. Nicotine Tob Res :|
|Burgess-Hull, Albert J; Roberts, Linda J; Piper, Megan E et al. (2018) The social networks of smokers attempting to quit: An empirically derived and validated classification. Psychol Addict Behav 32:64-75|
|Hartz, Sarah M; Horton, Amy C; Hancock, Dana B et al. (2018) Genetic correlation between smoking behaviors and schizophrenia. Schizophr Res 194:86-90|
|Glasheen, Cristie; Johnson, Eric O; Saccone, Nancy L et al. (2018) Is the Fagerström test for nicotine dependence invariant across secular trends in smoking? A question for cross-birth cohort analysis of nicotine dependence. Drug Alcohol Depend 185:127-132|
|Teitelbaum, A M; Murphy, S E; Akk, G et al. (2018) Nicotine dependence is associated with functional variation in FMO3, an enzyme that metabolizes nicotine in the brain. Pharmacogenomics J 18:136-143|
|Hancock, D B; Guo, Y; Reginsson, G W et al. (2018) Genome-wide association study across European and African American ancestries identifies a SNP in DNMT3B contributing to nicotine dependence. Mol Psychiatry 23:1-9|
|Mitchell, Carol; Piper, Megan E; Korcarz, Claudia E et al. (2018) Echogenicity of the carotid arterial wall in active smokers. J Diagn Med Sonogr 34:161-168|
|King, Cecile C; Piper, Megan E; Gepner, Adam D et al. (2017) Longitudinal Impact of Smoking and Smoking Cessation on Inflammatory Markers of Cardiovascular Disease Risk. Arterioscler Thromb Vasc Biol 37:374-379|
|Fiore, Michael C; Jorenby, Douglas E; Baker, Timothy B (2016) Don't Wait for COPD to Treat Tobacco Use. Chest 149:617-8|
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