Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2017 Jul 3;18(1):300.
doi: 10.1186/s13063-017-2038-9.

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

Nicolle M Krebs  1 , Sophia I Allen  2 , Susan Veldheer  2 , Diane J Martinez  3 , Kimberly Horn  3 , Craig Livelsberger  2 , Jennifer Modesto  2 , Robin Kuprewicz  3 , Ashley Wilhelm  2 , Shari Hrabovsky  2 , Abid Kazi  2 , Alyse Fazzi  4 , Jason Liao  2 , Junjia Zhu  2 , Emily Wasserman  2 , Samantha M Reilly  2 , Lisa Reinhart  2 , Neil Trushin  2 , Robinn E Moyer  2 , Rebecca Bascom  5 , Jonathan Foulds  2 , John P Richie Jr  2 , Joshua E Muscat  2
Affiliations
Randomized Controlled Trial

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

Nicolle M Krebs et al. Trials. .

Erratum in

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.

Keywords: Cigarettes; Cotinine; Education; Randomized controlled trial; Reduced nicotine content cigarettes; Smoking; Socioeconomic status; Tobacco; Tobacco control.

PubMed Disclaimer

Figures

Fig. 1
Fig. 1
Study flow diagram
Fig. 2
Fig. 2
SPIRIT diagram
Fig. 3
Fig. 3
Participants are instructed to keep their daily cigarette log attached to their cigarette pack by folding the top of the log at the line and tucking the flap into the pack
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

See all "Cited by" articles

References

    1. Benowitz NL, Henningfield JE. Establishing a nicotine threshold for addiction. The implications for tobacco regulation. N Engl J Med. 1994;331(2):123–5. doi: 10.1056/NEJM199407143310212. - DOI - PubMed
    1. United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health. The Family Smoking Prevention and Tobacco Control Act: hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Tenth Congress, first session, on H.R. 1108, October 3, 2007. Washington, DC: US GPO: For sale by the Supt. of Docs., US GPO; 2008.
    1. US Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health. The Health Consequences of Smoking—50 Years of Progress. A Report of the Surgeon General. Atlanta: US Department of Health and Human Services; 2014. https://www.surgeongeneral.gov/library/reports/50-years-of-progress/full.... Accessed 1 Dec 2016.
    1. Institute of Medicine (IOM) Ending the tobacco problem: a blueprint for the nation. Washington, DC: The National Academies Press; 2007.
    1. Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health. Publications and Reports of the Surgeon General. In: How Tobacco Smoke Causes Disease: The Biology and Behavioral Basis for Smoking-Attributable Disease: A Report of the Surgeon General. Atlanta: Centers for Disease Control and Prevention (US); 2010. - PubMed

Publication types

MeSH terms

Associated data