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Randomized Controlled Trial
. 2010 Feb;105(2):343-55.
doi: 10.1111/j.1360-0443.2009.02780.x.

Reduced nicotine content cigarettes: effects on toxicant exposure, dependence and cessation

Dorothy K Hatsukami  1 , Michael Kotlyar, Louise A Hertsgaard, Yan Zhang, Steven G Carmella, Joni A Jensen, Sharon S Allen, Peter G Shields, Sharon E Murphy, Irina Stepanov, Stephen S Hecht
Affiliations
Randomized Controlled Trial

Reduced nicotine content cigarettes: effects on toxicant exposure, dependence and cessation

Dorothy K Hatsukami et al. Addiction. 2010 Feb.

Abstract

Aims: To examine the effects of reduced nicotine cigarettes on smoking behavior, toxicant exposure, dependence and abstinence.

Design: Randomized, parallel arm, semi-blinded study. Setting University of Minnesota Tobacco Use Research Center.

Interventions: Six weeks of: (i) 0.05 mg nicotine yield cigarettes; (ii) 0.3 mg nicotine yield cigarettes; or (iii) 4 mg nicotine lozenge; 6 weeks of follow-up. Measurements Compensatory smoking behavior, biomarkers of exposure, tobacco dependence, tobacco withdrawal and abstinence rate.

Findings: Unlike the 0.3 mg cigarettes, 0.05 mg cigarettes were not associated with compensatory smoking behaviors. Furthermore, the 0.05 mg cigarettes and nicotine lozenge were associated with reduced carcinogen exposure, nicotine dependence and product withdrawal scores. The 0.05 mg cigarette was associated with greater relief of withdrawal from usual brand cigarettes than the nicotine lozenge. The 0.05 mg cigarette led to a significantly higher rate of cessation than the 0.3 mg cigarette and a similar rate as nicotine lozenge.

Conclusion: The 0.05 mg nicotine yield cigarettes may be a tobacco product that can facilitate cessation; however, future research is clearly needed to support these preliminary findings.

Trial registration: ClinicalTrials.gov NCT00777569.

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Figures

Figure 1
Figure 1
Flow of subjects through study
Figure 2
Figure 2
Least squares (LS) mean (±standard error) of number of cigarettes smoked per day and exhaled carbon monoxide (CO). *P < 0.05 at that visit compared to baseline (within-group comparison). Groups with different letters were significantly different (P < 0.05) at the week 6 treatment visit (between-group comparison). For example, cigarettes per day are significantly different between each of the groups, but CO concentrations are significantly different between the nicotine lozenge group and each of the two cigarette groups, but the two cigarette groups are not different from each other
Figure 3
Figure 3
Least squares (LS) mean [±standard error (SE)] of Fagerstrom Test for Nicotine Dependence (FTND) score and perceived risk for addiction score (Panels A and B). *P < 0.05 at that visit compared to baseline (within-group comparison). Groups with different letters were significantly different (P < 0.05) at the week 6 treatment visit (between-group comparison). Least squares (LS) mean (±SE) of craving and withdrawal symptoms craving and withdrawal symptoms (Panels C and D). *P < 0.05 at that visit compared to the previous visit (i.e. week 1 versus week 0 and week 7 versus week 6)
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References

    1. Stratton K, Shetty P, Wallace R, Bondurant S. Clearing the Smoke: Assessing the Science Base for Tobacco Harm Reduction. Institute of Medicine, National Academy Press; Washington, DC: 2001. - PubMed
    1. Royal College of Physicians . A Report by the Tobacco Advisory Group of the Royal College of Physicians. Royal College of Physicians; London: 2007. Harm reduction in nicotine addiction. Helping people who can't quit. p. 176.
    1. Hatsukami D, Hecht SS. Hope or hazard: what research tells us about ‘potentially reduced-exposure’ tobacco products. University of Minnesota Transdisciplinary Tobacco Use Research Center; Minneapolis: 2005. [9 December 2009]. Available from http://www.rwjf.org/files/research/Hope%20or%20Hazard.pdf.
    1. Hatsukami D, Joseph AM, LeSage M, Jensen J, Murphy SE, Pentel PR, et al. Developing the science base for reducing tobacco harm. Nicotine Tob Res. 2007;9:S537–53. - PMC - PubMed
    1. US Department of Health and Human Services (USDHHS) The Health Consequences of Smoking: Nicotine and Addiction. A Report of the Surgeon General. USDHHS; Rockville, MD: 1988.

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