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Randomised clinical trial of snus versus medicinal nicotine among smokers interested in product switching
  1. Dorothy K Hatsukami1,2,
  2. Herbert Severson3,
  3. Amanda Anderson2,
  4. Rachael Isaksson Vogel1,
  5. Joni Jensen2,
  6. Berry Broadbent3,
  7. Sharon E Murphy1,
  8. Steven Carmella1,
  9. Stephen S Hecht1
  1. 1Masonic Cancer Center, University of Minnesota, Minneapolis, Minnesota, USA
  2. 2Department of Psychiatry, University of Minnesota, Minneapolis, Minnesota, USA
  3. 3Oregon Research Institute, Eugene, Oregon, USA
  1. Correspondence to Dr Dorothy K Hatsukami, Masonic Cancer Center, University of Minnesota, 717 Delaware St SE, Minneapolis, MN 55414, USA; hatsu001{at}umn.edu

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.

  • Harm Reduction
  • Non-cigarette tobacco products
  • Carcinogens

This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/

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