Nicole L Nollen1, Lisa Sanderson Cox2, Matthew S Mayo3, Edward F Ellerbeck4, Sheshadri Madhusudhana5, Jasjit S Ahluwalia6. 1. Department of Preventive Medicine and Public Health, University of Kansas School of Medicine, Kansas City, KS, United States. Electronic address: nnollen@kumc.edu. 2. Department of Preventive Medicine and Public Health, University of Kansas School of Medicine, Kansas City, KS, United States. Electronic address: lcox@kumc.edu. 3. Department of Biostatistics, University of Kansas School of Medicine, Kansas City, KS, United States. Electronic address: mmayo@kumc.edu. 4. Department of Preventive Medicine and Public Health, University of Kansas School of Medicine, Kansas City, KS, United States. Electronic address: eellerbe@kumc.edu. 5. Department of Hematology/Oncology, Truman Medical Center, Kansas City, MO, United States. Electronic address: sheshadri.madhusudhana@tmcmed.org. 6. Department of Behavioral and Social Sciences, Brown University, Providence, RI, United States. Electronic address: jasjit_ahluwalia@brown.edu.
Abstract
BACKGROUND: Non-daily smokers (NDS) who smoke on some but not all days are a growing subset of United States (US) tobacco users. Racial/ethnic minorities are more likely to be NDS. African American NDS have strikingly high levels of nicotine and carcinogen exposure, making treatment of this high risk group a priority. METHODS: The current study is one of three ongoing federally-funded clinical trials of NDS and, to our knowledge the only RCT focused on racial/ethnic minority NDS. The design has been guided by input from Patient and Stakeholder Advisory Panels who helped develop the research questions, design the intervention, and select the outcomes. The objective is to compare the effectiveness of smoking cessation counseling alone (C) or smoking cessation counseling plus participant's choice of nicotine replacement therapy (NRT; C + NRT) for African American NDS. Two-hundred seventy-eight African American NDS will be randomized in a 2:1 fashion to C + NRT or C. All participants receive five sessions of smoking cessation counseling; those randomized to C + NRT receive their choice of nicotine gum, patch, and/or lozenge. Treatment in both groups lasts for 12 weeks. We hypothesize that C + NRT will be more effective than C on the primary outcome of biochemically-confirmed abstinence from smoking at week 12. Secondary aims will compare C + NRT and C on patient- and provider-desired outcomes including abstinence from smoking at week 26, change in biochemically-verified nicotine and carcinogen exposure, days abstinent, and treatment process measures (e.g., NRT use and side effects). Predictors of abstinence will also be explored. DISCUSSION: Findings will illuminate effective treatment options for African American NDS and contribute to development of evidence-based guidelines for treating the 8.9 million US adult NDS for whom no guidelines currently exist. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov: NCT02244918.
BACKGROUND: Non-daily smokers (NDS) who smoke on some but not all days are a growing subset of United States (US) tobacco users. Racial/ethnic minorities are more likely to be NDS. African American NDS have strikingly high levels of nicotine and carcinogen exposure, making treatment of this high risk group a priority. METHODS: The current study is one of three ongoing federally-funded clinical trials of NDS and, to our knowledge the only RCT focused on racial/ethnic minority NDS. The design has been guided by input from Patient and Stakeholder Advisory Panels who helped develop the research questions, design the intervention, and select the outcomes. The objective is to compare the effectiveness of smoking cessation counseling alone (C) or smoking cessation counseling plus participant's choice of nicotine replacement therapy (NRT; C + NRT) for African American NDS. Two-hundred seventy-eight African American NDS will be randomized in a 2:1 fashion to C + NRT or C. All participants receive five sessions of smoking cessation counseling; those randomized to C + NRT receive their choice of nicotine gum, patch, and/or lozenge. Treatment in both groups lasts for 12 weeks. We hypothesize that C + NRT will be more effective than C on the primary outcome of biochemically-confirmed abstinence from smoking at week 12. Secondary aims will compare C + NRT and C on patient- and provider-desired outcomes including abstinence from smoking at week 26, change in biochemically-verified nicotine and carcinogen exposure, days abstinent, and treatment process measures (e.g., NRT use and side effects). Predictors of abstinence will also be explored. DISCUSSION: Findings will illuminate effective treatment options for African American NDS and contribute to development of evidence-based guidelines for treating the 8.9 million US adult NDS for whom no guidelines currently exist. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov: NCT02244918.
Authors: Megan E Piper; Thomas M Piasecki; E Belle Federman; Daniel M Bolt; Stevens S Smith; Michael C Fiore; Timothy B Baker Journal: J Consult Clin Psychol Date: 2004-04
Authors: Dennis R Trinidad; Eliseo J Pérez-Stable; Martha M White; Sherry L Emery; Karen Messer Journal: Am J Public Health Date: 2011-02-17 Impact factor: 9.308
Authors: Douglas E Jorenby; J Taylor Hays; Nancy A Rigotti; Salomon Azoulay; Eric J Watsky; Kathryn E Williams; Clare B Billing; Jason Gong; Karen R Reeves Journal: JAMA Date: 2006-07-05 Impact factor: 56.272
Authors: Karin A Kasza; Bridget K Ambrose; Kevin P Conway; Nicolette Borek; Kristie Taylor; Maciej L Goniewicz; K Michael Cummings; Eva Sharma; Jennifer L Pearson; Victoria R Green; Annette R Kaufman; Maansi Bansal-Travers; Mark J Travers; Jonathan Kwan; Cindy Tworek; Yu-Ching Cheng; Ling Yang; Nikolas Pharris-Ciurej; Dana M van Bemmel; Cathy L Backinger; Wilson M Compton; Andrew J Hyland Journal: N Engl J Med Date: 2017-01-26 Impact factor: 91.245
Authors: Danielle Frank; Anna F DeBenedetti; Robert J Volk; Emily C Williams; Daniel R Kivlahan; Katharine A Bradley Journal: J Gen Intern Med Date: 2008-04-18 Impact factor: 5.128
Authors: Maciej Lukasz Goniewicz; Jakub Knysak; Michal Gawron; Leon Kosmider; Andrzej Sobczak; Jolanta Kurek; Adam Prokopowicz; Magdalena Jablonska-Czapla; Czeslawa Rosik-Dulewska; Christopher Havel; Peyton Jacob; Neal Benowitz Journal: Tob Control Date: 2013-03-06 Impact factor: 7.552
Authors: Saul Shiffman; Sarah M Scholl; Jason Mao; Stuart G Ferguson; Donald Hedeker; Brian Primack; Hilary A Tindle Journal: Nicotine Tob Res Date: 2020-03-16 Impact factor: 4.244