Reduced nicotine content cigarettes in smokers of low socioeconomic status: Study protocol for a randomized control trial

Nicolle M. Krebs, Sophia I. Allen, Susan Veldheer, Diane J. Martinez, Kimberly Horn, Craig Livelsberger, Jennifer Modesto, Robin Kuprewicz, Ashley Wilhelm, Shari Hrabovsky, Abid Kazi, Alyse Fazzi, Jiangang (Jason) Liao, Junjia Zhu, Emily Wasserman, Samantha M. Reilly, Lisa Reinhart, Neil Trushin, Robinn E. Moyer, Rebecca BascomJonathan Foulds, John Richie, Joshua Muscat

Research output: Contribution to journalArticle

7 Citations (Scopus)

Abstract

Background: The Family Smoking Prevention and Tobacco Control Act gave the Food and Drug Administration jurisdiction over the regulation of all tobacco products, including their nicotine content. Under this act, a major strategy to reduce harm from cigarette tobacco is lowering the nicotine content without causing unintended adverse consequences. Initial research on reduced nicotine content (RNC) cigarettes has shown that smokers of these cigarettes gradually decrease their smoking frequency and biomarkers of exposure. The effectiveness of this strategy needs to be demonstrated in different populations whose response to RNC cigarettes might be substantially mediated by personal or environmental factors, such as low socioeconomic status (SES) populations. This study aims to evaluate the response to a reduced nicotine intervention in low SES smokers, as defined here as those with less than 16 years of education, by switching smokers from high nicotine commercial cigarettes to RNC cigarettes. Methods/design: Adults (N = 280) who have smoked five cigarettes or more per day for the past year, have not made a quit attempt in the prior month, are not planning to quit, and have less than 16 years of education are recruited into a two-arm, double-blinded randomized controlled trial. First, participants smoke their usual brand of cigarettes for 1 week and SPECTRUM research cigarettes containing a usual amount of nicotine for 2 weeks. During the experimental phase, participants are randomized to continue smoking SPECTRUM research cigarettes that contain either (1) usual nicotine content (UNC) (11.6 mg/cigarette) or (2) RNC (11.6 to 0.2 mg/cigarette) over 18 weeks. During the final phase of the study, all participants are offered the choice to quit smoking with nicotine replacement therapy, continue smoking the research cigarettes, or return to their usual brand of cigarettes. The primary outcomes of the study include retention rates and compliance with using only research cigarettes and no use of other nicotine-containing products. Secondary outcomes are tobacco smoke biomarkers, nicotine dependence measures, smoking topography, stress levels, and adverse health consequences. Discussion: Results from this study will provide information on whether low SES smokers can maintain a course of progressive nicotine reduction without increases in incidence of adverse effects. Trial registration: ClinicalTrials.gov, NCT01928719. Registered on 21 August 2013.

Original languageEnglish (US)
Article number300
JournalTrials
Volume18
Issue number1
DOIs
StatePublished - Jul 3 2017

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Nicotine
Social Class
Tobacco Products
Smoking
Research
Smoke
Tobacco
Biomarkers
Education
Tobacco Use Disorder
United States Food and Drug Administration
Population
Health Status
Randomized Controlled Trials

All Science Journal Classification (ASJC) codes

  • Medicine (miscellaneous)
  • Pharmacology (medical)

Cite this

Krebs, Nicolle M. ; Allen, Sophia I. ; Veldheer, Susan ; Martinez, Diane J. ; Horn, Kimberly ; Livelsberger, Craig ; Modesto, Jennifer ; Kuprewicz, Robin ; Wilhelm, Ashley ; Hrabovsky, Shari ; Kazi, Abid ; Fazzi, Alyse ; Liao, Jiangang (Jason) ; Zhu, Junjia ; Wasserman, Emily ; Reilly, Samantha M. ; Reinhart, Lisa ; Trushin, Neil ; Moyer, Robinn E. ; Bascom, Rebecca ; Foulds, Jonathan ; Richie, John ; Muscat, Joshua. / Reduced nicotine content cigarettes in smokers of low socioeconomic status : Study protocol for a randomized control trial. In: Trials. 2017 ; Vol. 18, No. 1.
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abstract = "Background: The Family Smoking Prevention and Tobacco Control Act gave the Food and Drug Administration jurisdiction over the regulation of all tobacco products, including their nicotine content. Under this act, a major strategy to reduce harm from cigarette tobacco is lowering the nicotine content without causing unintended adverse consequences. Initial research on reduced nicotine content (RNC) cigarettes has shown that smokers of these cigarettes gradually decrease their smoking frequency and biomarkers of exposure. The effectiveness of this strategy needs to be demonstrated in different populations whose response to RNC cigarettes might be substantially mediated by personal or environmental factors, such as low socioeconomic status (SES) populations. This study aims to evaluate the response to a reduced nicotine intervention in low SES smokers, as defined here as those with less than 16 years of education, by switching smokers from high nicotine commercial cigarettes to RNC cigarettes. Methods/design: Adults (N = 280) who have smoked five cigarettes or more per day for the past year, have not made a quit attempt in the prior month, are not planning to quit, and have less than 16 years of education are recruited into a two-arm, double-blinded randomized controlled trial. First, participants smoke their usual brand of cigarettes for 1 week and SPECTRUM research cigarettes containing a usual amount of nicotine for 2 weeks. During the experimental phase, participants are randomized to continue smoking SPECTRUM research cigarettes that contain either (1) usual nicotine content (UNC) (11.6 mg/cigarette) or (2) RNC (11.6 to 0.2 mg/cigarette) over 18 weeks. During the final phase of the study, all participants are offered the choice to quit smoking with nicotine replacement therapy, continue smoking the research cigarettes, or return to their usual brand of cigarettes. The primary outcomes of the study include retention rates and compliance with using only research cigarettes and no use of other nicotine-containing products. Secondary outcomes are tobacco smoke biomarkers, nicotine dependence measures, smoking topography, stress levels, and adverse health consequences. Discussion: Results from this study will provide information on whether low SES smokers can maintain a course of progressive nicotine reduction without increases in incidence of adverse effects. Trial registration: ClinicalTrials.gov, NCT01928719. Registered on 21 August 2013.",
author = "Krebs, {Nicolle M.} and Allen, {Sophia I.} and Susan Veldheer and Martinez, {Diane J.} and Kimberly Horn and Craig Livelsberger and Jennifer Modesto and Robin Kuprewicz and Ashley Wilhelm and Shari Hrabovsky and Abid Kazi and Alyse Fazzi and Liao, {Jiangang (Jason)} and Junjia Zhu and Emily Wasserman and Reilly, {Samantha M.} and Lisa Reinhart and Neil Trushin and Moyer, {Robinn E.} and Rebecca Bascom and Jonathan Foulds and John Richie and Joshua Muscat",
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Krebs, NM, Allen, SI, Veldheer, S, Martinez, DJ, Horn, K, Livelsberger, C, Modesto, J, Kuprewicz, R, Wilhelm, A, Hrabovsky, S, Kazi, A, Fazzi, A, Liao, JJ, Zhu, J, Wasserman, E, Reilly, SM, Reinhart, L, Trushin, N, Moyer, RE, Bascom, R, Foulds, J, Richie, J & Muscat, J 2017, 'Reduced nicotine content cigarettes in smokers of low socioeconomic status: Study protocol for a randomized control trial', Trials, vol. 18, no. 1, 300. https://doi.org/10.1186/s13063-017-2038-9

Reduced nicotine content cigarettes in smokers of low socioeconomic status : Study protocol for a randomized control trial. / Krebs, Nicolle M.; Allen, Sophia I.; Veldheer, Susan; Martinez, Diane J.; Horn, Kimberly; Livelsberger, Craig; Modesto, Jennifer; Kuprewicz, Robin; Wilhelm, Ashley; Hrabovsky, Shari; Kazi, Abid; Fazzi, Alyse; Liao, Jiangang (Jason); Zhu, Junjia; Wasserman, Emily; Reilly, Samantha M.; Reinhart, Lisa; Trushin, Neil; Moyer, Robinn E.; Bascom, Rebecca; Foulds, Jonathan; Richie, John; Muscat, Joshua.

In: Trials, Vol. 18, No. 1, 300, 03.07.2017.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Reduced nicotine content cigarettes in smokers of low socioeconomic status

T2 - Study protocol for a randomized control trial

AU - Krebs, Nicolle M.

AU - Allen, Sophia I.

AU - Veldheer, Susan

AU - Martinez, Diane J.

AU - Horn, Kimberly

AU - Livelsberger, Craig

AU - Modesto, Jennifer

AU - Kuprewicz, Robin

AU - Wilhelm, Ashley

AU - Hrabovsky, Shari

AU - Kazi, Abid

AU - Fazzi, Alyse

AU - Liao, Jiangang (Jason)

AU - Zhu, Junjia

AU - Wasserman, Emily

AU - Reilly, Samantha M.

AU - Reinhart, Lisa

AU - Trushin, Neil

AU - Moyer, Robinn E.

AU - Bascom, Rebecca

AU - Foulds, Jonathan

AU - Richie, John

AU - Muscat, Joshua

PY - 2017/7/3

Y1 - 2017/7/3

N2 - Background: The Family Smoking Prevention and Tobacco Control Act gave the Food and Drug Administration jurisdiction over the regulation of all tobacco products, including their nicotine content. Under this act, a major strategy to reduce harm from cigarette tobacco is lowering the nicotine content without causing unintended adverse consequences. Initial research on reduced nicotine content (RNC) cigarettes has shown that smokers of these cigarettes gradually decrease their smoking frequency and biomarkers of exposure. The effectiveness of this strategy needs to be demonstrated in different populations whose response to RNC cigarettes might be substantially mediated by personal or environmental factors, such as low socioeconomic status (SES) populations. This study aims to evaluate the response to a reduced nicotine intervention in low SES smokers, as defined here as those with less than 16 years of education, by switching smokers from high nicotine commercial cigarettes to RNC cigarettes. Methods/design: Adults (N = 280) who have smoked five cigarettes or more per day for the past year, have not made a quit attempt in the prior month, are not planning to quit, and have less than 16 years of education are recruited into a two-arm, double-blinded randomized controlled trial. First, participants smoke their usual brand of cigarettes for 1 week and SPECTRUM research cigarettes containing a usual amount of nicotine for 2 weeks. During the experimental phase, participants are randomized to continue smoking SPECTRUM research cigarettes that contain either (1) usual nicotine content (UNC) (11.6 mg/cigarette) or (2) RNC (11.6 to 0.2 mg/cigarette) over 18 weeks. During the final phase of the study, all participants are offered the choice to quit smoking with nicotine replacement therapy, continue smoking the research cigarettes, or return to their usual brand of cigarettes. The primary outcomes of the study include retention rates and compliance with using only research cigarettes and no use of other nicotine-containing products. Secondary outcomes are tobacco smoke biomarkers, nicotine dependence measures, smoking topography, stress levels, and adverse health consequences. Discussion: Results from this study will provide information on whether low SES smokers can maintain a course of progressive nicotine reduction without increases in incidence of adverse effects. Trial registration: ClinicalTrials.gov, NCT01928719. Registered on 21 August 2013.

AB - Background: The Family Smoking Prevention and Tobacco Control Act gave the Food and Drug Administration jurisdiction over the regulation of all tobacco products, including their nicotine content. Under this act, a major strategy to reduce harm from cigarette tobacco is lowering the nicotine content without causing unintended adverse consequences. Initial research on reduced nicotine content (RNC) cigarettes has shown that smokers of these cigarettes gradually decrease their smoking frequency and biomarkers of exposure. The effectiveness of this strategy needs to be demonstrated in different populations whose response to RNC cigarettes might be substantially mediated by personal or environmental factors, such as low socioeconomic status (SES) populations. This study aims to evaluate the response to a reduced nicotine intervention in low SES smokers, as defined here as those with less than 16 years of education, by switching smokers from high nicotine commercial cigarettes to RNC cigarettes. Methods/design: Adults (N = 280) who have smoked five cigarettes or more per day for the past year, have not made a quit attempt in the prior month, are not planning to quit, and have less than 16 years of education are recruited into a two-arm, double-blinded randomized controlled trial. First, participants smoke their usual brand of cigarettes for 1 week and SPECTRUM research cigarettes containing a usual amount of nicotine for 2 weeks. During the experimental phase, participants are randomized to continue smoking SPECTRUM research cigarettes that contain either (1) usual nicotine content (UNC) (11.6 mg/cigarette) or (2) RNC (11.6 to 0.2 mg/cigarette) over 18 weeks. During the final phase of the study, all participants are offered the choice to quit smoking with nicotine replacement therapy, continue smoking the research cigarettes, or return to their usual brand of cigarettes. The primary outcomes of the study include retention rates and compliance with using only research cigarettes and no use of other nicotine-containing products. Secondary outcomes are tobacco smoke biomarkers, nicotine dependence measures, smoking topography, stress levels, and adverse health consequences. Discussion: Results from this study will provide information on whether low SES smokers can maintain a course of progressive nicotine reduction without increases in incidence of adverse effects. Trial registration: ClinicalTrials.gov, NCT01928719. Registered on 21 August 2013.

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