Randomised clinical trial of snus versus medicinal nicotine among smokers interested in product switching

Dorothy K Hatsukami, Herbert Severson, Amanda Anderson, Rachael Isaksson Vogel, Joni Jensen, Berry Broadbent, Sharon E Murphy, Steven Carmella, Stephen S Hecht, Dorothy K Hatsukami, Herbert Severson, Amanda Anderson, Rachael Isaksson Vogel, Joni Jensen, Berry Broadbent, Sharon E Murphy, Steven Carmella, Stephen S Hecht

Abstract

Background: An essential component of evaluating potential modified risk tobacco products is to determine how consumers use the product and resulting effects on biomarkers of toxicant exposure.

Study design: Cigarette smokers (n=391) recruited in Minnesota and Oregon were randomised to either snus or 4 mg nicotine gum for 12 weeks. Participants were instructed to completely switch from cigarettes to these products. Urine samples were collected to analyse for carcinogenic tobacco-specific nitrosamine metabolites (4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol and N'-nitrosonornicotine and their glucuronides) and nicotine metabolites (total cotinine and nicotine equivalents) levels.

Results: Of the 391 participants randomised, 52.9% were male, the mean±SD age was 43.9±12.5 years, baseline number of cigarettes/day was 18.0±6.5 and Fagerstrom Test for Nicotine Dependence score was 5.1±2.0. The mean±SD number of snus pouches used/week at week 6 prior to tapering was 39.1±24.0 and nicotine gum pieces used was 37.6±26.3. Dual use of cigarettes and these products were observed in 52.9% and 58.2% of those assigned to snus and nicotine gum, respectively, at week 12. The end of treatment biochemically verified (carbon monoxide, CO<6 ppm) 7-day avoidance of cigarettes was 21.9% in the snus group and 24.6% in the nicotine gum group. Toxicant exposure in the nicotine gum group was significantly less when compared to snus.

Conclusions: Snus performed similarly to nicotine gum in cigarette smokers who were interested in completely switching to these products, but was associated with less satisfaction and greater toxicant exposure than nicotine gum.

Trial registration number: NCT: 00710034.

Trial registration: ClinicalTrials.gov NCT00710034.

Keywords: Carcinogens; Harm Reduction; Non-cigarette tobacco products.

Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Figures

Figure 1
Figure 1
Flow of participants in study.
Figure 2
Figure 2
Mean (SD) amount of product use (A) and amount of cigarette use among dual users by product group (B).

References

    1. Fagerstrom KO, Schildt EB. Should the European Union lift the ban on snus? Evidence from the Swedish experience. Addiction 2003;98:1191–5. 10.1046/j.1360-0443.2003.00442.x
    1. Foulds J, Ramstrom L, Burke M, et al. . Effect of smokeless tobacco (snus) on smoking and public health in Sweden. Tob Control 2003;12:349–59. 10.1136/tc.12.4.349
    1. Levy DT, Mumford EA, Cummings KM, et al. . The relative risks of a low-nitrosamine smokeless tobacco product compared with smoking cigarettes: estimates of a panel of experts. Cancer Epidemiol Biomarkers Prev 2004;13:2035–42.
    1. Rodu B, Cole P. Tobacco-related mortality. Nature 1994;370:184 10.1038/370184a0
    1. Bates C, Fagerstrom K, Jarvis MJ, et al. . European Union policy on smokeless tobacco: a statement in favour of evidence based regulation for public health. Tob Control 2003;12:360–7. 10.1136/tc.12.4.360
    1. Ramstrom L, Wikmans T. Mortality attributable to tobacco among men in Sweden and other European countries: an analysis of data in a WHO report. Tob Induc Dis 2014;12:14 10.1186/1617-9625-12-14
    1. Lee PN. The effect on health of switching from cigarettes to snus—a review. Regul Toxicol Pharmacol 2013;66:1–5. 10.1016/j.yrtph.2013.02.010
    1. Gilljam H, Galanti MR. Role of snus (oral moist snuff) in smoking cessation and smoking reduction in Sweden. Addiction 2003;98:1183–9. 10.1046/j.1360-0443.2003.00379.x
    1. Lund KE, McNeill A, Scheffels J. The use of snus for quitting smoking compared with medicinal products. Nicotine Tob Res 2010;12:817–22. 10.1093/ntr/ntq105
    1. Scheffels J, Lund KE, McNeill A. Contrasting snus and NRT as methods to quit smoking: an observational study. Harm Reduct J 2012;9:10 10.1186/1477-7517-9-10
    1. Furberg H, Bulik CM, Lerman C, et al. . Is Swedish snus associated with smoking initiation or smoking cessation? Tob Control 2005;14:422–4. 10.1136/tc.2005.012476
    1. Tomar SL. Snuff use and smoking in US men—Implications for harm reduction. Am J Prev Med 2002;23:143–9. 10.1016/S0749-3797(02)00491-9
    1. Ramstrom LM, Foulds J. Role of snus in initiation and cessation of tobacco smoking in Sweden. Tob Control 2006;15:210–14. 10.1136/tc.2005.014969
    1. Rodu B, Phillips CV. Switching to smokeless tobacco as a smoking cessation method: evidence from the 2000 National Health Interview Survey. Harm Reduct J 2008;5:18 10.1186/1477-7517-5-18
    1. Kotlyar M, Hertsgaard LA, Lindgren BR, et al. . Effect of oral snus and medicinal nicotine in smokers on toxicant exposure and withdrawal symptoms: a feasibility study. Cancer Epidemiol Biomarkers Prev 2011;20:91–100. 10.1158/1055-9965.EPI-10-0349
    1. Heatherton TF, Koslowski LT, Frecker RC, et al. . The Fagerström Test for nicotine dependence: a revision of the Fagerström Tolerance Questionnaire. Br J Addict 1991;86:1119–27. 10.1111/j.1360-0443.1991.tb01879.x
    1. Hatsukami DK, Jensen J, Anderson A, et al. . Oral tobacco products: preference and effects among smokers. Drug Alcohol Depend 2011;118:230–6. 10.1016/j.drugalcdep.2011.03.026
    1. Hughes JR, Hatsukami D. Signs and symptoms of tobacco withdrawal. Arch Gen Psychiatry 1986;43:289–94. 10.1001/archpsyc.1986.01800030107013
    1. Hughes JR, Hatsukami DK. The nicotine withdrawal syndrome: a brief review and update. Int J Smoking Cessation 1992;1:21–6.
    1. National Cancer Institute. Clearing the air. Quit smoking today: U.S. Department of health & human services. National Institutes of Health, 2011.
    1. Hatsukami DK, Zhang Y, O'Connor RJ, et al. . Subjective responses to oral tobacco products: scale validation. Nicotine Tob Res 2013;15:1259–64. 10.1093/ntr/nts265
    1. Westman E, Levin E, Rose J. Smoking while wearing the nicotine patch: Is smoking satisfying or harmful? Clin Res 1992;40:871A.
    1. Cappelleri JC, Bushmakin AG, Baker CL, et al. . Confirmatory factor analyses and reliability of the modified cigarette evaluation questionnaire. Addictive Beh 2007;32:912–23. 10.1016/j.addbeh.2006.06.028
    1. Murphy SE, Link CA, Jensen J, et al. . A comparison of urinary biomarkers of tobacco and carcinogen exposure in smokers. Cancer Epidemiol Biomarkers Prev 2004;13:1617–23.
    1. Scherer G, Engl J, Urban M, et al. . Relationship between machine-derived smoke yields and biomarkers in cigarette smokers in Germany. Regul Toxicol Pharmacol 2007;47:171–83. 10.1016/j.yrtph.2006.09.001
    1. Carmella SG, Ming X, Olvera N, et al. . High throughput liquid and gas chromatography-tandem mass spectrometry assays for tobacco-specific nitrosamine and polycyclic aromatic hydrocarbon metabolites associated with lung cancer in smokers. Chem Res Toxicol 2013;26:1209–17. 10.1021/tx400121n
    1. Yuan JM, Knezevich AD, Wang R, et al. . Urinary levels of the tobacco-specific carcinogen N’-nitrosonornicotine and its glucuronide are strongly associated with esophageal cancer risk in smokers. Carcinogenesis 2011;32: 1366–71. 10.1093/carcin/bgr125
    1. Sobell LC, Sobell MB. Timeline follow-back. A technique for assessing self-reported alcohol consumption. In: Litten R, Allen J, eds. Measuring alcohol consumption. The Humana Press Inc., 1992:41–69.
    1. O'Connor RJ, Norton KJ, Bansal-Travers M, et al. . US smokers’ reactions to a brief trial of oral nicotine products. Harm Reduct J 2011;8:1 10.1186/1477-7517-8-1
    1. Barrett SP, Campbell ML, Temporale K, et al. . The acute effect of Swedish-style snus on cigarette craving and self-administration in male and female smokers. Hum Psychopharmacol 2011;26:58–62. 10.1002/hup.1170
    1. Shiffman S, Gitchell J, Rohay JM, et al. . Smokers’ preferences for medicinal nicotine vs smokeless tobacco. Am J Health Behav 2007;31:462–72. 10.5993/AJHB.31.5.2
    1. Caldwell B, Burgess C, Crane J. Randomized crossover trial of the acceptability of snus, nicotine gum, and Zonnic therapy for smoking reduction in heavy smokers. Nicotine Tob Res 2010;12:179–83. 10.1093/ntr/ntp189
    1. Biener L, Roman AM, Mc Inerney SA, et al. . Snus use and rejection in the USA. Tob Control Published Online First: 25 Feb 2014. doi:10.1136/tobaccocontrol-2013-051342 10.1136/tobaccocontrol-2013-051342
    1. McMillen R, Maduka J, Winickoff J. Use of emerging tobacco products in the United States. J Environ Public Health 2012;2012:989474 10.1155/2012/989474
    1. King BA, Dube SR, Tynan MA. Current tobacco use among adults in the United States: findings from the National Adult Tobacco Survey. Am J Public Health 2012;102:e93–100. 10.2105/AJPH.2012.301002
    1. Cobb CO, Weaver MF, Eissenberg T. Evaluating the acute effects of oral, non-combustible potential reduced exposure products marketed to smokers. Tob Control 2010;19:367–73. 10.1136/tc.2008.028993
    1. Blank MD, Eissenberg T. Evaluating oral noncombustible potential-reduced exposure products for smokers. Nicotine Tob Res 2010;12:336–43. 10.1093/ntr/ntq003
    1. Carter LP, Stitzer ML, Henningfield JE, et al. . Abuse liability assessment of tobacco products including potential reduced exposure products. Cancer Epidemiol Biomarkers Prev 2009;18:3241–62. 10.1158/1055-9965.EPI-09-0948
    1. Henningfield JE, Hatsukami DK, Zeller M, et al. . Conference on abuse liability and appeal of tobacco products: conclusions and recommendations. Drug Alcohol Depend 2011;116:1–7. 10.1016/j.drugalcdep.2010.12.009
    1. Harris AC, Tally L, Schmidt CE, et al. . Animal models to assess the abuse liability of tobacco products: Effects of smokeless tobacco extracts on intracranial self-stimulation. Drug Alcohol Depend 2015; 147:60–7. 10.1016/j.drugalcdep.2014.12.015

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